AS INTRODUCED IN THE RAJYA SABHA 1940

Bill No. LVIII of 2013

 “The Drugs, Cosmetics, Medical Devices & Patient Safety Bill”.

 

 

Further to amend the Drugs and Cosmetics Act, 1940.

BE it enacted by Parliament in the Sixty-fourth Year of the Republic of India as follows: —

1. (1) This Act may be called the Drugs and Cosmetics Medical Device & Patient Safety Act, 2013.

(2) It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint:

Provided that different dates may be appointed for different provisions of this Act, and any reference in any such provision to the commencement of this Act shall be construed as a reference to the coming into force of that provision.

2. In the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the principal Act), for the long title and first paragraph of the preamble, the following shall be substituted, namely:—

“An Act to regulate the import, export, manufacture, distribution and sale of drugs, cosmetics and medical devices to ensure their safety, efficacy, quality and conduct of clinical trials and for matters connected therewith or incidental thereto.

WHEREAS it is expedient to regulate the import, export, manufacture, distribution

And sale of drugs, cosmetics and medical devices to ensure their safety, efficacy, quality

And conduct of clinical trials and for matters connected therewith or incidental thereto.”.

 

1              In section 1 of the principal Act, in sub-section (1), for the words “and Cosmetics”, the words “, Cosmetics and Medical Devices” shall be substituted.

2              Throughout the principal Act, for the word “Inspector”, wherever it occurs, the words “Drugs Control Officer” shall be substituted.

3              In section 2 of the principal Act, for the words and figures “the Dangerous Drugs Act, 1930”, the words and figures “the Narcotic Drugs and Psychotropic Substances Act, 1985” shall be substituted.

 

6. In section 3 of the principal Act,––

(i) After clause (a), the following clauses shall be inserted, namely:––

‘(aA) “bioavailability study” means a study to assess the rate and extent to which the active drug is absorbed from a pharmaceutical formulation and becomes available in the systemic circulation or availability of drug at the site of action;

(aB) “bioequivalence study” means a study to establish the absence of a significant difference in the rate and extent of absorption of an active drug from a pharmaceutical formulation in comparison to the reference formulation having the same active drug when administered in the same molar dose under similar conditions;’;

(ii) In clause (aa), after sub-clause (ii), the following sub-clause shall be inserted, namely:––

“(iii) in relation to Medical Devices, the Medical Device Technical Advisory Board constituted under section 5A;”;

(iii) After clause (aa), the following clauses shall be inserted, namely:–– ‘(ab) “Indian Healthcare Products Regulatory Authority” (IHRA) means the Indian Healthcare Product Regulatory Authority (IHRA) of India constituted under sub-section (1) of section 4A;

 

(ac) “Central Drugs Laboratory” means a drug testing laboratory established by the Central Government, by whatever name, for carrying out the functions assigned to it under this Act and rules made there under; (ad) “Central Licensing Authority” means the Drugs Controller General of India designated as such under sub-section (2) of section 4J; (ae) “Chairperson” means the Chairperson of the Indian Healthcare Product Regulatory Authority (IHRA);

(af) “Clinical trial” means––

(i) in respect of drugs, any systematic study of new drug, 5 investigational new drug or bioavailability or bioequivalence study of any drug in human subjects to generate data for discovering or verifying its clinical, pharmacological (including pharmacodynamic and pharmacokinetic) or adverse effects with the objective of determining safety, efficacy or tolerance of the drug;

(ii) in respect of cosmetics, the systematic study, including dermatological study, of a cosmetic including a new cosmetic on human subjects to generate data for discovering or verifying its adverse effects 10 with the objective of determining safety, efficacy or tolerance of the cosmetic

 

(iv) In clause (aaa), after the words “component of cosmetic”, the words “and includes new cosmetic” shall be inserted;

(v) In clause (b),––

(A) In sub-clause (ii), after the words “destruction of vermin or insects”, the words “or microbes” shall be inserted;

(B) Sub-clause (iv) shall be omitted;

(C) After sub-clause (iv), the following sub-clause shall be inserted, namely:––

 

‘(v) Any new drug for which permission has been granted by the

Central Licensing Authority under the first proviso to clause (c) of

Sub-section (1) of section 18.

Explanation I.––In this sub-clause, “new drug” means––

(i) a drug, including bulk drug substance, which has not been used in the country to any significant extent under the prescribed conditions, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the Central Licensing Authority for the expected claims and its limited use, if any;

(ii) a drug approved by the Central Licensing Authority for certain claims, which is proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration;

 

(iii) a fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in a marketed combination is proposed to be changed, with certain claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration;

(iv) all vaccines, recombinant Deoxyribonucleic Acid derived products, Living Modified Organisms, monoclonal anti-bodies, stem cells, gene therapeutic products and xenografts which are intended to be used as drugs;

Explanation II.––A new drug shall continue to be a new drug for such period as may be prescribed except the type of new drug specified in clause (iv) of Explanation I which shall always remain a new drug;’;

(vi) After clause (b), the following clauses shall be inserted, namely:–– ‘(ba) “Drugs Control Officer” means––

(i) in relation to Ayurvedic, Siddha or Unani drug, a Drugs Control Officer appointed by the Central Government or a State Government under section 33G;

(ii) in relation to any other drug or cosmetic, a Drugs Control Office appointed by the Indian Healthcare Product Regulatory Authority (IHRA) or a State Government under section 21;

(iii) in relation to any medical device, the Medical Device Officer appointed by the Indian Healthcare Product Regulatory Authority (IHRA)  under section 7H;

(bb) “Drugs Controller General of India” means an officer appointed by the Central Government under sub-section (1) of section 4G;

(bc) “Ethics Committee” means the Ethics Committee constituted under section 4T;’;

(vii) in clause (c), in sub-clause (ii), for the words “Central Government”, the words “Indian Healthcare Product Regulatory Authority (IHRA)” shall be substituted;

(viii) After clause (c), the following clauses shall be inserted, namely:––

‘(d) “Indian Pharmacopoeia” means the official book of standards for

Drugs which specifies the standards of identity, purity and strength for the

Drugs mentioned therein;

(da) “Investigational medical device” means a device, which is an object

Of a clinical investigation or research or development involving one or more

Subjects to determine the safety or “Performance” of a device;

 

(db) “Investigational new drug” means chemical entity or substance which

is under investigation in clinical trial regarding its safety and efficacy and which

is required to be approved by the Indian Healthcare Product Regulatory Authority (IHRA);

(dc) “investigator” means a person who is responsible for the conduct of a clinical trial and responsible for the rights, health, safety and well being of the study subjects on the study site;’;

(ix) Clause (e) shall be omitted;

 

(x) For clause (f), the following clause shall be substituted, namely:–– ‘(f) “manufacture” means––

(i) in relation to any drug (except human blood and its components, or any cosmetic) includes any process or part of a process for making, altering, ornamenting, finishing, packing, labeling, breaking up or otherwise treating or adapting any drug or cosmetic with a view to its sale, export, stocking or distribution but does not include the compounding or dispensing of any drug, or the packing of any drug or cosmetic, in the ordinary course of retail business;

(ii) in relation to human blood and its components includes any process or part of a process of collection, processing, storage, packing, labeling and testing for its use, sale, export or distribution for transfusion in human beings;

(iii) in relation to any medical device, For the purpose of regulating activities related to manufacture any Medical Device the scope of regulation shall include any process for making, assembling, packing, labeling & sterilizing (where relevant) of any Medical Device with a view to its sale or stock or export or distribution but does not include assembling or adapting a Device already on the market for an individual patient.

(xi) After clause (f), the following clauses shall be inserted, namely:––

 

‘(fa) “medical device” means––

 

Medical Device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

a)    Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes(s) of:

-       Diagnosis, prevention, monitoring, treatment or alleviation of disease,

-       Diagnosis, monitoring, treatment, alleviation of or compensation for any injury,

-       Investigation, replacement, modification or support of the anatomy or of a physiological process,

-       Supporting or sustaining life,

-       Control of conception,

-       Disinfection of medical devices,

-       Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;

And

Which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

(fb) “Member” means a Member of the Indian Healthcare Product Regulatory Authority (IHRA) and includes the Chairperson and the Member-Secretary;’;

(xii) in clause (h), in sub-clause (ii), for the words “Central Government”, the words “Indian Healthcare Product Regulatory Authority (IHRA)” shall be substituted;

(xiii) After clause (i), the following clauses shall be inserted, namely:—

‘(j) “protocol” means a document that states the background, objectives, rationale, design, methodology (including but not limited to the methods for dealing with adverse events or withdrawals) and statistical considerations of the clinical trial and also states the conditions under which the trial shall be performed and managed;

(k) “Regulations” means the regulations made by the Indian Healthcare Product Regulatory Authority (IHRA) under this Act;

(l) “Sponsor” means and includes an investigator, an individual or a company or an institution responsible for the initiation, financing and management of a clinical trial;

(m) “State Government” includes the administrator of a Union territory appointed by the President under article 239 of the Constitution;

(n) “State Licensing Authority” means an officer designated as such by the State Government under sub-section (3) of section 7F or sub-section (2) of section 18;

 

(o) “Schedule” means a Schedule appended to this Act;’.

 

(p)”IVD Medical Device” means a device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostics, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles.

(q)”Accessories”: An article intended specifically by its manufacturer to be used together with a specific medical device(s), to enable the medical device to be used in accordance with its intended use.

(r)”Abnormal Use”: Act or omission of an act by the operator or user of a medical device as a result of conduct that is beyond any reasonable means of risk control by the manufacturer.

(s)”Clinical Evaluation”: The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.

(t) Tribunal: means the Medical Device Safety Appellate Tribunal established under this Act;

 

7. After Chapter I of the principal Act, the following Chapters shall be inserted, namely:—

‘CHAPTER IA

Indian Healthcare Product Regulatory Authority (IHRA)

4A. (1) The Central Government shall, by notification in the Official Gazette, constitute an Authority to be known as the Indian Healthcare Product Regulatory Authority (IHRA) to exercise the powers conferred on, and perform the functions assigned to it by or under this Act.

(2) The Indian Healthcare Product Regulatory Authority (IHRA) shall be a body corporate by the name aforesaid, having perpetual succession and a common seal, with power to acquire, hold and dispose of property, both movable and immovable, and to contract, and shall, by the said name, sue or be sued.

(3) The head office of the Indian Healthcare Product Regulatory Authority (IHRA) shall be in the National Capital Region.

 

(4)The Indian Healthcare Product Regulatory Authority (IHRA) may, with the prior approval of the Central Government, by notification in the Official Gazette, establish its offices at such other places in India as it considers necessary.

4B. (1) The Indian Healthcare Product Regulatory Authority (IHRA) shall consist of the following, namely:––

(a) Secretary to the Government of India, Ministry of Health and Family Welfare, Department of Health and Family Welfare–– Chairperson, ex officio;

(b) Secretary to the Government of India, Ministry of Health and Family Welfare, Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy–– Member, ex officio;

(c) Secretary to the Government of India, Ministry of Science and Technology, Department of Science & Technology – Member ex officio;

(d) Secretary to the Government of India, Ministry of Commerce and Industry, Department of Commerce–– Member, ex officio;

(e) Secretary to the Government of India, Ministry of Chemicals and Fertilisers, Department of Pharmaceuticals–– Member, ex officio;

(f) Secretary, Department of Health Research and Director General, Indian Council of Medical Research, Ministry of Health and Family Welfare –– Member, ex officio;

(g) Secretary to the Government of India, Ministry of Science and Technology, Department of Bio-technology–– Member, ex officio;

(h) Director General Health Services, Directorate General of Health Services, New Delhi––Member, ex officio;

(i) Additional Secretary or Joint Secretary and Legislative Counsel in the Legislative Department, Ministry of Law and Justice in charge of the Group dealing with the work relating to the Ministry of Health and Family Welfare–– Member, ex officio;

(j)Additional Secretary or Joint Secretary in charge of the Drugs Quality Control Division in the Ministry of Health and Family Welfare–– Member, ex officio;

(k) four experts having such qualifications and experience to be nominated by the Central Government from Engineering ,Scientific ,QMS (quality Management System)Auditing & Medical background representing diverse Technical Fields in such manner as may be prescribed–– Member;

(l) Four State Licensing Authorities to be nominated by the Central Government in such manner as may be prescribed–– Member;

 

(m) Drugs Controller General of India–– Member-Secretary, ex officio.

 

(2) The Members appointed under clause (k) of sub-section (1) shall hold office for a period of three years from the date of their nomination, and shall be eligible for re-nomination;

(3) The Indian Healthcare Product Regulatory Authority (IHRA) shall meet at such time and place and shall observe such rules of procedure in regard to the transaction of business at its meeting and allowances payable to a Member for attending such meetings as may be specified by regulations.

 

4C. (1) on and from the date of constitution of the Indian Healthcare Product Regulatory Authority (IHRA),—

(a) Any reference to the Central Drugs Standards Control Organization in any law other than this Act or in any contract or other instruction shall be deemed as a reference to the Indian Healthcare Product Regulatory Authority (IHRA);

(b) All properties and assets, movable and immovable, of, or belonging to, the Central Drugs Standards Control Organization, shall vest in the Indian Healthcare Product Regulatory Authority (IHRA);

(c) all rights and liabilities of the Central Drugs Standards Control Organization shall be transferred to, and be the rights and liabilities of, the Indian Healthcare Product Regulatory Authority (IHRA);

(d) without prejudice to the provisions of clause (c), all debts, obligations and liabilities incurred, all contracts entered into and all matters and things engaged to be done by, with or for, the Central Drugs Standards Control Organization immediately before the said date, for or in connection with the purpose of the said Central Drugs Standards Control Organization shall be deemed to have incurred, entered into or engaged to be done by, with or for, the Indian Healthcare Product Regulatory Authority (IHRA);

(e) All sums of money due to the Central Drugs Standards Control Organisation immediately before that date shall be deemed to be due to the Indian Healthcare Product Regulatory Authority (IHRA);

(f) all suits and other legal proceedings instituted or which could have been instituted by or against the Central Drugs Standards Control Organization immediately before that date may be continued or may be instituted by or against the Indian Healthcare Product Regulatory Authority (IHRA);

(g) every employee of the Central Drugs Standards Control Organisation holding any office under the Central Drugs Standards Control Organisation immediately before that date shall hold his office in the Indian Healthcare Product Regulatory Authority (IHRA) by the same tenure and upon the same terms and conditions of service as respects remuneration, leave, provident fund, retirement and other terminal benefits as he would have held such office if the Indian Healthcare Product Regulatory Authority (IHRA) had not been constituted and shall continue to do so as an employee of the Indian Healthcare Product Regulatory Authority (IHRA) or until the expiry of the period of six months from that date if such employee opts not to be the employee of the Indian Healthcare Product Regulatory Authority (IHRA) within such period:

 

Provided that the salaries, allowances and other conditions of service of such employees shall not be varied to their disadvantage on exercise of their option to become the employee of the Indian Healthcare Product Regulatory Authority (IHRA).

(2) Notwithstanding anything in the Industrial Dispute Act, 1947 or in any other law for the time being in force, absorption of any employee by the Indian Healthcare Product Regulatory Authority (IHRA) in its regular service under this section shall not entitle such employee to any compensation under that Act or any other law and no such claim shall be entertained by any court, tribunal or other authority.

4D. Any Member having any direct or indirect interest, whether pecuniary or otherwise, in any matter coming up for consideration at a meeting of the Indian Healthcare Product Regulatory Authority (IHRA), shall, as soon as possible after the relevant circumstances have come to his knowledge, disclose the nature of his interest at such meeting and such disclosure shall be recorded in the proceedings of the Authority, and the Member shall not take any part in any deliberation or decision of the Authority with respect to that matter.

4E. No act or proceeding of the Indian Healthcare Product Regulatory Authority (IHRA) shall be invalidated merely by reason of––

(a) Any vacancy in, or any defect in the constitution of, the Indian Healthcare Product Regulatory Authority (IHRA); or

(b) Any defect in the nomination of a person as a Member of the Indian Healthcare Product Regulatory Authority (IHRA); or

(c) any irregularity in the procedure of the Authority not affecting the merits of the case.

 

4F. A Member of the Indian Healthcare Product Regulatory Authority (IHRA) nominated under clause (k) of sub-section (1) of section 4B may, by notice in writing under his hand addressed to the Central Government, resign his office:

Provided that the Member shall, unless he is permitted by the Central Government to relinquish his office sooner, continue to hold office until the expiry of three months from the date of receipt of such notice or until a person duly appointed as his successor enters upon office or until the expiry of his term of office, whichever is the earliest.

4G. (1)The Central Government shall appoint the of Healthcare Controller General of India may be re-designated as Healthcare Controller General of India or other person having such specialised qualifications and experience as may be prescribed to perform the functions and discharge the duties assigned to the Healthcare Controller General of India by or under this Act.

 

(2) The salaries, allowances and pensions payable to the Healthcare Controller General of India, appointed under sub-section (1) shall be such as may be determined by the Central Government.

 

4H. (1) The Central Government may, in consultation with the Indian Healthcare Product Regulatory Authority (IHRA) create, such number of posts as it considers necessary for the efficient discharge of the functions and exercise of the powers by the Indian Healthcare Product Regulatory Authority (IHRA) under this Act.

 

The Indian Healthcare Products Regulatory Authority (IHRA) shall have separate divisions for regulating Drugs, Cosmetics, Medical Devices & Diagnostics.

 

(2) The manner of appointment of officers and employees of the Indian Healthcare Product Regulatory Authority (IHRA), their salaries, allowances and pension and other conditions of service shall be such as may be determined by the Indian Healthcare Product Regulatory Authority (IHRA) by regulations with the approval of the Central Government.

 

4-I. The Indian Healthcare Product Regulatory Authority (IHRA) shall––

(a) Specify, by regulations, the guidelines, norms, structures and requirements for effective functioning of the Central Licensing Authority and the State Licensing Authorities;

(b) Assess periodically the functioning of the Central Licensing Authority and the State Licensing Authorities;

(c) Have power to issue directions to the Central Licensing Authority and the State Licensing Authorities to ensure compliance with the guidelines, norms, structures and requirements specified by it under clause (a);

(d) Review, suspend or cancel any permission, license or certificate issued by the Central Licensing Authority or the State Licensing Authorities;

(e) Specify, by regulations, the fees or charges for issue or renewal of licenses, certificates, approvals and permissions by the Central Licensing Authority and the State Licensing authorities;

(f) Coordinate, mediate and decide upon the disputes arising out of the implementation of the provisions of the Act and rules and regulations made there under between two or more States Licensing Authorities;

(g) Constitute such committees or sub-committees as it considers necessary for the efficient discharge of its functions and exercise of its powers under this Act;

(h) Recommend to the Central Government the measures as regards the standards of drugs, cosmetics and medical devices for effective implementation of the provisions of this Act;

(i) Perform such other functions as may be prescribed by the Central Government.

 

4J. (1) The Healthcare Controller General of India shall exercise the powers conferred upon him under this Act or the rules made there under.

(2) The Healthcare Controller General of India shall act as the Central Licensing Authority and shall have powers to––

(a) Issue, renew, suspend or cancel licenses or certificates or permission, as the case may be, for import, export or manufacture of drugs, cosmetics or medical devices or permission for conducting clinical trials;

(b) Recall or direct to recall any drug, cosmetic or medical device;

(c) Collect the fees or charges for issue or renewal of licenses, certificates, approvals and permissions issued by the Central Licensing Authority under this Act;

(d) Discharge any other functions as may be assigned to him by the Indian Healthcare Product Regulatory Authority (IHRA);

(3) The Healthcare Controller General of India may, with the prior approval of the Indian Healthcare Product Regulatory Authority (IHRA), delegate such of his powers to the officers of the Indian Healthcare Product Regulatory Authority (IHRA) as may be considered necessary.

(4) The Healthcare Controller General of India shall be the legal representative of the Indian Healthcare Product Regulatory Authority (IHRA), and shall be responsible for day-to-day administration of the Indian Healthcare Product Regulatory Authority (IHRA).

(5) The Healthcare Controller General of India shall have administrative control over the officers and employees of the Indian Healthcare Product Regulatory Authority (IHRA).

 

4K. The Central Government may, after due appropriation made by Parliament by law in this behalf, make to the Indian Healthcare Product Regulatory Authority (IHRA) grants of such sums of money as are required by it.

4L. (1) The Indian Healthcare Product Regulatory Authority (IHRA) shall maintain proper accounts and other relevant records and prepare an annual statement of accounts in such form as may be prescribed by the Central Government in consultation with the Comptroller and Auditor-General of India.

(2) The accounts of the Indian Healthcare Product Regulatory Authority (IHRA) shall be audited by the Comptroller and Auditor-General of India at such intervals as may be specified by him and any expenditure incurred in connection with such audit shall be payable by the Indian Healthcare Product Regulatory Authority (IHRA) to the Comptroller and Auditor-General.

(3)The Comptroller and Auditor-General of India and any other person appointed by him in connection with the audit of the accounts of the Indian Healthcare Product Regulatory Authority (IHRA) shall have the same rights and privileges and authority in connection with such audit as the Comptroller and Auditor-General generally has, in connection with the audit of the Government accounts and, in particular, shall have the right to demand the production of books, accounts, connected vouchers and other documents and papers and to inspect any of the offices of the Indian Healthcare Product Regulatory Authority (IHRA).

(4) The accounts of the Indian Healthcare Product Regulatory Authority (IHRA) as certified by the Comptroller and Auditor-General of India or any other person appointed by him in this behalf, together with the audit report thereon, shall be forwarded annually to the Central Government and that Government shall cause the same to be laid, as soon as may be after it is received, before each House of Parliament.

4M. (1)The Indian Healthcare Product Regulatory Authority (IHRA) shall prepare every year an annual report in such form and manner and at such time as may be prescribed by the Central Government, giving summary of its activities during the previous year and copies of the report shall be forwarded to the Central Government.

(2)A copy of the report forwarded under sub-section (1) shall be laid, as soon as may be after it is received, before each House of Parliament.

4N. (1) The Central Government may, after consultation with or on the recommendation of the Indian Healthcare Product Regulatory Authority (IHRA) and subject to previous publication, by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter.

(2) Without prejudice to the generality of the foregoing powers, such rules may provide for all or any of the following matters, namely:—

(a) The form and manner in which the accounts of the Indian Healthcare Product Regulatory Authority (IHRA) shall be maintained under sub-section (1) of section 4L;

(b) The form and manner in which and the time within which annual report is to be prepared under sub-section (1) of section 4M.

 

4-O. (1) The Indian Healthcare Product Regulatory Authority (IHRA) may, with the approval of the Central Government, by notification in the Official Gazette, make regulations consistent with this Act and the rules made there under.

(2) In particular, and without prejudice to the generality of the foregoing powers, such regulations may provide for all or any of the following matters, namely:—

(a) The allowances payable to a Member for attending the meetings of the Indian Healthcare Product Regulatory Authority (IHRA) under sub-section (3) of section 4B;

(b) The manner of appointment of the officers and employees of the Indian Healthcare Product Regulatory Authority (IHRA), their salaries, allowances and pension and other conditions of service under sub-section (2) of section 4H;

(c) The matters specified under clauses (a) and (e) of section 4-I;

(d) The functions of the Central Drugs Laboratory and the functions of the Director of the Central Drugs Laboratory under the proviso to sub-section (1) of section 6.

 

CHAPTER IB

CLINICAL TRIALS

4P. (1) No person shall initiate or conduct any clinical trial in respect of a new drug or investigational new drug or medical device or investigational medical device or cosmetic or bioavailability or bioequivalence study of any drug in human subjects except under, and in accordance with, the permission granted by the Central Licensing Authority in such manner as may be prescribed.

(2) No person shall initiate or conduct any clinical trial unless it is approved by the Ethics Committee constituted under section 4T, in such manner as may be prescribed.

(3) No person shall initiate or conduct any clinical trial before it is registered with the Indian Healthcare Product Regulatory Authority (IHRA) in such manner as may be prescribed.

(4) No permission from the Central Licensing Authority under this Chapter shall be required to initiate or conduct any bioequivalence or bioavailability studies of approved drugs by the Government Institutes, Hospitals, autonomous medical or Pharmacy institutions for academic or research purposes.

 

4Q. In case of injury or death of a person in course of a clinical trial, whether such injury or death has been caused due to the clinical trial, shall be decided by the Drugs Controller General of India or such authority in such manner as may be prescribed.

4R. (1) In case of a person having been injured as a result of his participation in a clinical trial, he shall be provided by the person conducting the clinical trial, such medical treatment in such manner as may be prescribed.

(2) In case injury or death of a person occurs due to the clinical trial, the person conducting such clinical trial shall give him, or as the case may be, his legal heir, such compensation as may be decided by the Drugs Controller General of India or such authority, in such manner as may be prescribed.

4S. notwithstanding anything contained in this Chapter, the Central Licensing Authority may, in public interest, abbreviate, defer or omit the pre-clinical and clinical data requirements for approval of clinical trial of drugs indicated in life threatening or serious diseases or diseases of special relevance to the country.

4T. (1) The Ethics Committee, constituted for the purpose of giving approval to a clinical trial protocol and other related matters, shall be registered with the Central Licensing Authority in such manner as may be prescribed.

(2) The registration of the Ethics Committee shall be valid for a period of five years and may be renewed in such manner as may be prescribed.

4U. (1) The Ethics Committee shall consist of at least seven members including three or more persons from medical field, one legal expert, one social scientist and one person from community having such qualifications and experience as may be prescribed.

(2) The Ethics Committee shall appoint, from amongst its members, a Chairperson (who is from outside the institution), and a member-convener.

4V. (1) The Ethics Committee shall give its approval to the clinical trial protocol and other related documents in such manner as may be prescribed.

(2) The Ethics Committee shall be responsible to safeguard the rights, safety and well being of all trial participants enrolled in the clinical trial.

(3) The Ethics Committee shall make periodic review of the trial, based on the study progress reports furnished by the investigators, or monitoring and internal

Audit reports furnished by the Sponsor, or by visiting the study sites in such manner as may be prescribed.

(4) The Ethics Committee shall have power to revoke its approval to a clinical trial, for reasons to be recorded in writing and shall communicate such decision to the investigator as well as to the Central Licensing Authority.

(5) The Ethics Committee shall perform such other functions and responsibilities as may be prescribed.

4W. (1) In case the Ethics Committee fails to discharge its functions and responsibility under this Act, action shall be taken by the Central Licensing Authority against the Ethics Committee for suspension or cancellation of its registration.

(2) On the suspension or cancellation of the registration of the Ethics Committee under sub-section (1), the Central Licensing Authority shall review the approval granted by the Ethics Committee for continuance or otherwise of the clinical trial in such manner as may be prescribed.

(3) If the registration of the Ethics Committee is cancelled under sub-section (1), the members of such Committee shall be disqualified for becoming a member of any other Ethics Committee for a period of five years under this Act.

 

4X. Any person conducting clinical trial shall allow the Drugs Control Officer or Medical Device Officer of the Indian Healthcare Product Regulatory Authority (IHRA) or any other officer authorized by the Central Licensing Authority to enter with or without prior notice into any premises related to clinical trial to inspect the facilities, any record, data, documents, books, drugs including investigational new drugs, medical devices including investigational medical devices and cosmetics and that officer can seek clarifications, information and records wherever required so as to ensure that the clinical trial is being conducted in accordance with the provisions of this Act and the rules made there under.

4Y. Every person, sponsor, clinical research organization or any other organization or investigator conducting a clinical trial or his agent shall, if so required, disclose to the Drugs Control Officer or the Medical Device Officer or any other officer authorized by the Central Licensing Authority, the name, address and other particulars of the persons involved in conducting the clinical trials, including the trial participants.

4Z. Every person, sponsor, clinical research organization or any other organization or investigator conducting a clinical trial or his agent holding a permission under this Chapter shall keep and maintain such data, records, registers and other documents as may be prescribed and shall furnish such information as may be required by the Indian Healthcare Product Regulatory Authority (IHRA) or any officer authorized by it.

4ZA. Whoever, himself or by any other person on his behalf, conducts clinical trial with any drug or investigational new drug or any medical device or investigational medical device in contravention of section 4P and the rules made there under, shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and with fine which may extend to ten lakh rupees:

Provided that whoever, himself or by any other person on his behalf, conducts clinical trial with any drug or investigational new drug or medical device or investigational medical device in contravention of the provisions of section 4P and the rules made there under, which caused grievous hurt to or death of any trial participant of clinical trial, shall be punishable with imprisonment for a term which shall not be less than five years but which may extend to ten years and shall also be liable to fine which shall not be less than twenty lakh rupees:

Provided further that the fine imposed under this section shall be paid to the trial participant or, as the case may be, his legal heirs:

Provided also that any person convicted of an offence under this section shall not be permitted to conduct any clinical trial.

4ZB. whoever, having been convicted of an offence under section 4ZA, is again convicted under that section, shall be punishable with imprisonment for a term which shall not be less than five years but which may extend to ten years and shall also be liable to fine which shall not be less than thirty lakh rupees.

4ZC. Whoever, himself or by any other person on his behalf, conducts clinical trials with cosmetics in contravention of section 4P and the rules made there under, shall be punishable with imprisonment for a term which shall not be less than two years and shall also be liable to fine which shall not be less than five lakh rupees:

Provided that whoever, himself or by any other person on his behalf, conducts clinical trials with any cosmetics in contravention of the provisions of section 4P and the rules made thereunder, which caused grievous hurt or death of trial participant of the clinical trial shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and shall also be liable to fine which shall not be less than ten lakh rupees:

Provided further that the fine imposed under this section shall be paid to the trial participant or, as the case may be, his legal heirs:

Provided also that any person convicted of an offence under this section shall not be permitted to conduct any clinical trial.

4ZD. Whoever having been convicted of an offence under section 4ZC, is again convicted under that section, shall be punishable with imprisonment for a term which shall not be less than five years and shall also be liable to fine which shall not be less than five lakh rupees.

4ZE. Whoever, himself or by any other person on his behalf, conducts clinical trials with any drug or investigational new drug or medical device or investigational medical device or cosmetic in contravention of conditions of permission issued under section 4P and rules made there under shall be punishable with imprisonment for a term which shall not be less than two years and shall also be liable to fine which shall not be less than five lakh rupees:

Provided that whoever, himself or by any other person on his behalf, conducts clinical trials with any drug or investigational new drug or medical device or investigational medical device or cosmetic in contravention of conditions of permission issued under section 4P and rules made there under, which caused resulted in grievous hurt or death of a subject during the clinical trial shall be punished with imprisonment for a term which shall not be less than three years but which may be extended to seven years and shall also be liable to fine which shall not be less than ten lakh rupees:

Provided further that the fine imposed on and realized from the person convicted under this section shall be paid, by way of compensation to the legal heirs of the person who had suffered the grievous hurt or death during such clinical trial referred to in this clause:

Provided also that whoever, having been convicted of an offence under this section shall be debarred from conducting any further clinical trial.

4ZF. Whoever, having been convicted of an offence under section 4ZE, is again convicted of an offence under that section, shall be punished with imprisonment for a term which shall not be less than five years and fine which shall not be less than ten lakh rupees

4ZG.Whoever responsible to provide compensation for clinical trial related injury or death under this chapter fails to do so, he shall be punishable with imprisonment which may extend to two years and with fine which shall not be less than twice the amount of the compensation.

4ZH. Whoever initiates or conducts clinical trial of any drug or investigational new drug or medical device or investigational medical device or cosmetic in contravention to any provisions under this chapter not covered under section 4P, section 4Q, section 4R, section 4S, section 4T, section 4U, section 4W, section 4ZX, section 4Y or section 4Z or any other rules made under this chapter shall be punishable with imprisonment which may extend to two years and with fine which shall not be less than fifty thousand rupees.

4ZI. Where any person has been convicted for contravening any provision of this Chapter or any rule made there under, the stock of the drug or investigational new drug or medical device or investigational medical device or cosmetic in respect of which the contravention has been made as well as any implements or machinery, vehicle, vessel or other conveyances used in or for the purposes of conducting clinical trials shall be liable to confiscation.

4ZJ. (1) No prosecution under this Chapter shall be instituted, except on a complaint made by––

(a) a Drugs Control Officer or a Medical Device Officer appointed by the Indian Healthcare Product Regulatory Authority (IHRA); or

(b) A gazette officer of the Central Government authorized by that Government by an order made in this behalf; or

(c) The person aggrieved; or

(d) Any recognized consumer association.

 

(2) Nothing contained in this Chapter shall be deemed to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence against this Chapter.

4ZK. (1)The Central Government may, after consultation with the Central Drugs Authority, and after previous publication, by notification in the Official Gazette, make rules to provide for––

(a) the guidelines and requirements for conducting clinical trials;

(b) the forms and fees for the purposes of this Chapter;

(c) the conditions for issue of the permission under section 4P;

 

(d) the norms and procedure for approval of any clinical trial by the Ethics Committee under sub-section (2) to section 4P and sub-section (1) of section 4V;

(e) the norms and procedure for registration of any clinical trial under sub-section (3) of section 4P;

(f) the manner in which the Central Lisensing Authority shall review the approval granted by the Ethics Committee for continuance of clinical trial under sub-section (2) of section UW;—

(g) the records, registers or other documents to be kept and maintained under this Chapter;

(h) the manner in which copies of documents relating to clinical trial are to be obtained and certified;

(i) the conditions subject to which small quantities of drugs or cosmetics or medical devices may be imported or manufactured for the purpose of conducting clinical trials;

(j) the powers and duties of Drugs Control Officers or Medical Device Officers;

(k) the norms and procedures for deciding whether injury or death of a trial participant has been caused due to clinical trial, under section 4Q;

(l) the norms and procedures for providing medical treatment to the trial participants under sub-section (1) of section 4R;

(m) the norms and procedures for providing compensation to the trial participants or their legal heirs under sub-section (2) of section 4R;

(n) the norms and procedures for registration and renewal of Ethics Committees under section 4T;

(o) additional functions and responsibilities of the Ethics Committee under sub-section (5) of section 4V;

(p) the norms and procedures for conducting inspections relating to conduct of clinical trials under sections 4X and 4Y.

 

4ZL.(i) Nothing contained in this Chapter shall apply to Ayurvedic, Homeopathy, Siddha or Unani drugs, Low Risk & Moderate Risk Medical Devices

(ii) Clinical Trials of Class D (High Risk Implantable Medical Devices) to be conducted only after :-

 

a)      Approval from Ethics Committee

b)      Online Registration with IHRA

 

 

8. In Chapter II of the principal Act, for the Chapter heading “THE DRUGS TECHNICAL

ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY AND THE DRUGS CONSULTATIVE COMMITTEE”, the Chapter heading “TECHNICAL ADVISORY BOARDS, CENTRAL DRUGS LABORATORIES AND CONSULTATIVE COMMITTEE” shall be substituted.

9. In section 5 of the principal Act,––

(a) In sub-section (1),––

(i) For the words “as soon as may be, constitute”, the words “, by notification in the Official Gazette, constitute” shall be substituted;

(ii) After the words “to advise the Central Government”, the words “, the Indian Healthcare Product Regulatory Authority (IHRA)” shall be inserted;

(b) For sub-section (2), the following sub-section shall be substituted, namely:— “(2) The Board shall consist of the following members, namely:––

(i) The Director General of Health Services, ex officio, who shall be Chairperson;

(ii) The Healthcare Controller General of India, ex officio;

(iii) One Director of the Central Drugs Laboratory to be nominated by the Central Government, ex officio;

(iv) The Director of the Indian Veterinary Research Institute, Izatnagar, ex officio;

(v) Two experts to be nominated by the Central Government from amongst persons who are in charge of drugs control in the States;

(vi) One expert, to be elected by the Executive Committee of the Pharmacy Council of India, from amongst teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian University or a college affiliated thereto;

(vii) one expert, to be elected by the authority established for regulating the medical education, from amongst teachers in medicine or therapeutics on the staff of an Indian University or a college affiliated thereto;

(viii) One person to be nominated by the Central Government from the pharmaceutical industry;

(ix) One pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research;

(x) One person to be elected by the Central Council of the Indian Medical Association;

(xi) Two Government Analysts appointed under this Act, to be nominated by the Central Government;

(xii) The Director of the National Institute of Biological, ex officio;

(xiii) The Secretary-cum-Scientific Director of Indian Pharmacopoeia Commission, ex officio;

(xiv) The Director of a National Institute of Pharmaceutical Education and Research to be nominated by the Department of Pharmaceuticals;

(xv) One expert to be nominated by the Department of Bio-technology;

(xvi) one expert to be nominated by the Central Government from the Medical institutes or institutions controlled by the Central Government or State Governments from amongst persons involved in the conduct of clinical trials;

(xvii) One person representing recognized consumer associations or consumer interests to be nominated by the Ministry of Consumer Affairs.”;

(c) In sub-section (3),––

(i) for the words “but shall be eligible for re-nomination and re-election”, the words “and shall be eligible for re-nomination or, as the case may be, reelection for not more than two consecutive terms” shall be substituted;

(ii) in the proviso, for the words, brackets and figures “clause (ix) or clause (x) or clause (xi) or clause (xvi) of sub-section (2)”, the words, brackets and figures “clause (v) or clause (vi) or clause (vii) or clause (xi) of sub-section (2)” shall be substituted;

 

(d) In sub-section (4), after the words “The Board may”, the words “in consultation with the Indian Healthcare Product Regulatory Authority (IHRA) and” shall be inserted;

(e) For sub-section (7), the following sub-section shall be substituted, namely:—

“(7) The Indian Healthcare Product Regulatory Authority (IHRA) shall appoint a person to be the Secretary of the Board and shall provide the Board with such staff as the Indian Healthcare Product Regulatory Authority (IHRA) considers necessary.”.

10. After section 5 of the principal Act, the following section shall be inserted, namely:—

“5A. (1) The Central Government shall, by notification in the Official Gazette, constitute, a Medical Devices Technical Advisory Board to advise the Central Government, the Indian Healthcare Product Regulatory Authority (IHRA) and State Governments on technical matters pertaining to medical devices, arising out of the administration of this Act and to carry out other functions assigned to it by or under this Act.

(2) The Board shall consist of the following members, namely:––

(a) The Director General, Indian Council of Medical Research, who shall be the Chairperson, ex officio;

(b) The Healthcare Controller General of India, ex officio;

(c) One expert each from the following, having qualifications and experience in the field of medical devices, to be nominated by––

(i) The Department of Science and Technology;

(ii) The Department of Atomic Energy;

(iii) The Department of Electronic and Information Technology;

(iv) The Central Government from the Government testing laboratories connected with the testing of medical devices;

(v) The Indian Council of Medical Research;

(vi) The Bureau of Indian Standard;

(vii) The Defense Research and Development Organization;

(viii) The National Accreditation Board of Certifying Bodies (NABCB)

(d) One expert from the field of biomedical technology from recognized technical educational institutions, to be nominated by the Central Government;

(e) One expert from the field of biomaterial or polymer technology from recognized technical educational institutions, to be nominated by the Central Government;

(f) One person representing recognized consumer associations to be nominated by the Ministry of Consumer Affairs;

(g) One pharmacologist to be nominated by the Central Government from recognized medical or research institute in the field of medical devices;

(h) One expert to be nominated by the Central Government from recognized medical or research institute from amongst persons involved in conduct of clinical trials;

(i) 4 Persons to be nominated from Medical Device Industry – 1 Representative each of the 4 Risk Category of Devices – Low Risk, Moderate Risk, Moderate to High Risk & High Risk Devices..

 

(3) The nominated members of the Board shall hold office for a period of three years, and shall be eligible for re-nomination for not more than two consecutive terms:

Provided that the person nominated under clause (c) of sub-section (2) shall hold office for so long as he holds the appointment of the office by virtue of which he was nominated as a member of the Board.

(4)The Board may, in consultation with the Indian Healthcare Product Regulatory Authority (IHRA), and subject to the previous approval of the Central Government, make bye-laws fixing quorum and regulating its own procedure and the conduct of all business to be transacted by it.

(5) The Board may constitute sub-committees and may appoint to such subcommittees for such periods not exceeding three years, as it may decide, for the consideration of particular matters, persons who are not members of the Board.

(6) The functions of the Board may be exercised notwithstanding any vacancy therein.

(7) The Indian Healthcare Product Regulatory Authority (IHRA) shall appoint a person to be the Secretary of the Board and shall provide the Board with such staff as the Indian Healthcare Product Regulatory Authority (IHRA) considers necessary.”.

 

11. In section 6 of the principal Act,––

(a) for sub-section (1), the following sub-section shall be substituted, namely:—

“(1) The Indian Healthcare Product Regulatory Authority (IHRA) may, with the prior approval of the Central Government, establish a Central Drugs Laboratory under the control of a Director to be appointed by the Indian Healthcare Product Regulatory Authority (IHRA), to carry out the functions entrusted to it by this Act or any rules made thereunder:

Provided that the Indian Healthcare Product Regulatory Authority (IHRA) may, in consultation with the Central Government, specify by regulations the functions of the Central Drugs Laboratory in respect of any drug or class of drugs or cosmetic or class of cosmetics or medical device or class of medical devices to be performed by any other laboratory and the powers of the Director of the Central Drugs Laboratory shall be exercised by the Director of the laboratory to whom the functions have been assigned.”;

(1A) The Indian Healthcare Product Regulatory Authority (IHRA) may, by notification, designate any Central Drugs Laboratory––

(a) for testing of drugs or class of drugs or cosmetics or class of cosmetics or medical devices or class of medical devices;

(b) as an Appellate Laboratory for testing of drugs or class of drugs or cosmetics or class of cosmetics or medical devices or class of medical devices;

 

(b) in sub-section (2),––

(i) in the opening portion, for the words “after consultation with the Board”, the words “in consultation with the Indian Healthcare Product Regulatory Authority (IHRA)” shall be substituted;

(ii) in clause (d), for the words, figures and letter “under Chapter IV or Chapter IVA of samples of drugs or cosmetics”, the words, figures and letters “under Chapter IIA, Chapter III, Chapter IV or Chapter IVA of samples of drugs or cosmetics or medical devices” shall be substituted.

 

12. For section 7 of the principal Act, the following section shall be substituted, namely:––

“7. (1) The Central Government may constitute advisory committees to be called “the Drugs, Cosmetics Consultative Committee and Medical Devices Consultative Committee” to advise the Central Government, the Indian Healthcare Product Regulatory Authority (IHRA), the State Governments, the Drugs Technical Advisory Board and the Medical Device Technical Advisory Board on any matter tending to secure uniformity throughout India in the administration of this Act.

(2) The Drugs, Cosmetics Consultative Committee and Medical Devices Consultative Committee shall consist of the following members, namely:––

(a) the Healthcare Controller General of India, who shall be the chairperson, ex officio;

(b) two representatives of the Indian Healthcare Product Regulatory Authority (IHRA) nominated by it;

(c) the Secretary-cum-Scientific Director of the Indian Pharmacopoeia Commission;

(d) one representative of the Pharmaceuticals Export Promotion Council nominated by it;

(e) one representative of the Department of Revenue, Ministry of Finance, Government of India dealing with the administration of the Narcotic Drugs and Psychotropic Substances Act, 1985; and

(f) one representative of each State Government who is in-charge of the matters relating to regulation of drugs, cosmetics and medical devices in that State.

(g) The Medical Device Consultative Committee shall also have one representative of the Medical Device Industry” ,one Representative from the National Accreditation Board of Confirmatory Assessment Bodies (NABCB) and one representative from EEPC (Engineering Export Promotion Council).

(h) The National Consultative Committees for Drugs, Cosmetics & Devices needs to be separate from each other as experts of Drugs may not be experts on Medical Devices and vice versa.

(3) The Drugs, Cosmetics Consultative Committee and Medical Devices Consultative Committee shall meet at least twice in a year or when required to do so by the Central Government or, as the case may be, the Indian Healthcare Product Regulatory Authority (IHRA) and shall have power to regulate its own procedure.”.

13. After Chapter II of the principal Act, the following Chapter shall be inserted, namely:—

 ‘CHAPTER IIA

IMPORT, MANUFACTURE, SALE, DISTRIBUTION AND EXPORT OF MEDICAL DEVICES

 

7B.

The IHRA has powers to introduce Regulations needed to bring in a disciplined approach in manufacturing Medical Devices as per a formally Structural Quality Management System so that they are safe. Manufacturers need to demonstrate whether they meet certain Principles of Essential Requirements for ensuring Safety & Performance during manufacturing and designing of Medical Devices.

All medical devices placed on the Indian market must meet the following requirements of the ESSENTIAL PRINCIPLES of SAFETY AND PERFORMANCE, namely: 

a.         Use of medical devices should not compromise health and safety

b.         Design and manufacture of medical devices must conform to safety principles

c.         Medical devices should be suitable for the intended purpose and achieve the    performance intended

d.         Long-term safety must be assured

e.         Medical devices should not be adversely affected by transport or storage

f.          Benefits of medical devices must outweigh the risks associated with the use of the device

IHRA shall issue regulations relating to:

a.         General requirements that manufacturers must meet so that devices achieve the performance intended by them during the lifetime of their use, so as to satisfy the requirements of Essential principles of Safety and Performance as laid in the clauses above.

 

 

b.         Design and Manufacturing requirements bearing in mind the following:

i)          Chemical, physical and biological properties

ii)         Infection and microbial contamination

iii)         Manufacturing and environment properties

iv)        Devices with a diagnostic or measuring function

v)         Protection against radiation, including ionizing, non-ionizing radiation and covering electromagnetic compatibility requirements to ensure overall safety in the environment and also complying with the national laws relating to electromagnetic compatibility and ionizing radiation

vi)        Requirements for medical devices connected to or equipped with an energy source

vii)       Protection against mechanical risks

viii)       Protection against the risks posed to the patient by supplied energy or substances

ix)        Protection against the risks posed to the patient for devices for self testing or administration

x)         Information supplied by the manufacturer

xi)        Performance evaluation including, where appropriate, clinical investigation and evaluation

Note: the manufacturer can select the design and manufacturing requirements that are relevant to the device, documenting the reasons for excluding the others. This shall be verified during the conformity assessment process.

Regulatory controls will be proportionate to the level of risk associated with a Medical Device. The level of Regulatory control exercised by the IHRA for Medical Device can increase with increasing degree of risk, taking account of benefits offered by use of the device. At the same time the imposition of regulatory controls may not place an unnecessary or unrequired burden on Regulators & Manufacturers.

The IHRA may work towards the establishment of a classification system to cover Medical Device in Four Risk categories and have the power to define the Rules of Classification and for making exceptions to that Rule. These 4 Risk categories can be of:

(a)  Low Risk

(b)  Moderate Risk

(c)  Moderate to High Risk

(d)  High Risk

Examples of Medical Device for Low Risk are Tongue Depressors and Thermometer, for Moderate Risk are Hypodermic Needles and I V Catheters, for Moderate to High Risk are Lung Ventilator and Bone Fixation Plate and for High Risk are Heart Valves and Pace Makers.

Given the vast diversity of Technologies and varying risk profile of Medical Devices, Regulatory Controls shall be shared and split, the IHRA for Policy, Licensing & Registration of Manufacturers/Importers/Exporters for enabling a single window and  harmonized controls ; Utilization of specialist  CAB's ( Conformity Assessment Bodies)with domain specific knowledge  for delegating the task of factory audits of Indian and Overseas Manufacturers for enabling them to demonstrate Compliance to Good Manufacturing Practices/ Quality Management Systems as prescribed and the State Regulatory Authority for Licensing and Registration of Traders/Distributors/Dealers/Warehousing Sub Contractors/Retailers etc for regulating Logistics and Sales.

 

Keeping in mind the need for Risk Proportionate Regulatory Controls, the IHRA may prescribe the rules for Registration of Class (a) Devices and the rules for Confirmatory Assessment by CAB’s of Class (b), (c) & (d) Devices and the rules for Licensing by IHRA for Class (c) & (d) Devices.

The IHRA & NABCAB (National Accreditation Board of Confirmatory Assessment Bodies) may create a formal review mechanism of the audit quality of CAB’s and for supervision of these CAB’s to ensure harmonized quality of evaluations.

 

7C. For the purposes of this Chapter, a medical device shall be deemed to be misbranded––

a) If it is made to appear of better or superior functional or performance value than it really is or

 b) If its label or container or anything accompanying the Medical Device bears any statement, design or device which make any false claim.

7(D) for the purpose of the Chapter any Medical Device may be deemed to be mislabeled if it is not labeled in the prescribed manner.

 

7E. for the purposes of this Chapter, a medical device shall be deemed to be spurious—

(a) if it is imported, manufactured, sold, distributed or exported under a name which belongs to another medical device; o

(b) if it is an imitation of, or a substitute for, another medical device or resembles another medical device in a manner likely to deceive or bears upon it or upon its label or container the name of another medical device unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other medical device; or

(c) if the label or the container bears the name of an individual or firm or company purporting to be the manufacturer of the medical device, which individual or firm or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another medical device or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

 

7F. (1) No person shall himself or by any other person on his behalf,––

(a) Import, or manufacture for sale or for export, or export––

(i) “Any Medical Device which is not complying to the Essential Requirement of Safety and Performance.

 (ii) Any Misbranded medical device;

(iii) Any Mislabeled medical device

(iv)  Any spurious medical device;

(v) any medical device which by means of any statement, design or accessory accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect;

(vi) Any medical device which has been imported or manufactured in contravention of any of the provisions of this Chapter or rules made there under;

(b) Import or manufacture for sale or for export, or export any medical device, except under, and in accordance with the conditions of, a license or certificate issued by the Central Licensing Authority for the purpose of this Chapter in such manner and on such conditions as may be prescribed:

Provided that nothing contained in clause (a) shall apply to import or manufacture of any medical device in small numbers for the purpose of examination, test, analysis, demonstration or for personal use subject to such conditions as may be prescribed:

Provided further that the Central Government may, in consultation with the Indian Healthcare Product Regulatory Authority (IHRA), by notification in the Official Gazette, permit, subject to any conditions specified therein, the import or manufacture of any medical device or class of medical devices not approved in the country or not of standard quality for sale or for distribution, stocking or exhibiting or offering for sale or distribution of such medical device under this Act.

(2) No person shall himself or by any other person on his behalf––

(a) sell, or stock or distribute or exhibit or offer for sale any medical device referred to in clause (a) of sub-section (1);

(b) sell, or stock or exhibit or offer for sale or distribute any medical device which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made there under;

(c) sell, or stock or exhibit or offer for sale or distribute any medical device, except under,  and in accordance with the conditions of, a license issued by the State licensing authorities for the purposes of this Chapter in such manner and on such conditions as may be prescribed.

 

(3) The State Government may, for the purposes of this Chapter by notification, designate one or more person, having such qualifications and experience, as the State Licensing Authority, with such powers and functions and on such terms and conditions, as may be prescribed.

7G. (1) The law for the time being in force relating to customs and to goods, the import of which is prohibited by the Customs Act,  1962 or rules made or notifications issued there under or any other law for the time being in force shall, subject to the provisions of section 7J, section 7K and section 7L of this Act, apply in respect of medical device, the import of which is prohibited under this Chapter, and officers of Customs and officers empowered under that Act or law to perform the duties  imposed thereby on a Customs Collector and other officers of Customs, shall have the same powers in respect of such medical device as they have for the time being in respect of such goods as aforesaid.

(2) Without  prejudice to the provisions of sub-section (1), the Commissioner of Customs or any officer of the Government authorized by the Central Government in this behalf, may detain any imported package which he suspects to contain any medical device, the import of which is prohibited under this Chapter or any other law for the time being in force and shall forthwith report such detention to the Drugs Controller General of India and, if necessary, forward the package  or sample of any suspected medical device found therein to the Laboratory prescribed for the purpose:

 

Provided that in the event of that package or sample of that medical device found in contravention of any of the provisions of this Chapter or any rule made there under, the same shall not be allowed to be imported from that or any other port of entry in the country.

7H. (1) The Indian Healthcare Product Regulatory Authority (IHRA) may, by notification in the Official Gazette, appoint such persons, as it thinks fit, having such qualification and experience as may be prescribed, to be The Medical Device Officers who will be trained and certified auditors for such areas as may be assigned to them by the Indian Healthcare Product Regulatory Authority (IHRA).

 (2) The power for prescribing or recommending corrective actions by a Medical Officer and the duties which may be performed by him after evaluating the associated risk and the profile of class of Medical Devices in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed by IHRA”.

 

(3) No person who has any financial interest in the import, export, manufacture or sale of medical devices shall be appointed to be a Medical Device Officer under this section.

(4) Every Medical Device Officer shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code and shall be officially subordinate to such authority having the prescribed qualifications, as the Indian Healthcare Product Regulatory Authority (IHRA) may specify in this behalf.

 

7-I. Without prejudice to any  other provisions contained in this Chapter,  if the Central Government is satisfied that the use of any medical device is likely to involve any risk to human beings or animals or that any medical device does not have the functional value claimed or purported to be claimed for it or which is not safe or effective for use or for which there is no functional justification and that in the public interest it is necessary or expedient so to do, then, it may,  by notification in the Official Gazette, regulate, restrict or prohibit the import or manufacture, sale or distribution of such medical device.

(R/Sir, As per our earlier comments Section 7J, 7K & 7L has to be deleted but later we have proposed some changes. So please advise that 7J, 7K & 7L has to be deleted or retained with proposed changes that is mentioned below).

 

7J. Whoever, himself or by any other person on his behalf, imports or manufactures without any license for sale or for export or for distribution or sells or exports or stocks or exhibits or offer for sale

(a) any medical device deemed to be misbranded or spurious under section 7D or 7E and which when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such bodily harm which amount to grievous hurt within the meaning of section 320 of the Indian Penal Code, solely on account of such medical device being spurious or not of safe quality, as the case may  be liable to fine which shall not be less than ten lakh rupees or three times value of the medical device confiscated, whichever is more:

Provided that the fine imposed under this clause shall be paid to the person who had used the misbranded or spurious medical device:

Provided further that where the use of misbranded or spurious medical device referred to in this clause has caused the death of a person who used such medical device, the fine imposed shall be paid to his legal heir;

(b) Any medical device––

(i) Deemed to be misbranded under section 7C, but not being a medical device referred to in clause (a); or

(ii) Without a valid license as required under clause (b) of sub-section

(1) For clause (c) of sub-section (2) of section 7F,

 

Shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and/or shall also be liable to fine which shall not be less than one lakh rupees or three times the value of the medical device confiscated, whichever is more:

Provided that the court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of less than three years and of fine of less than one lakh rupees;

(c) any medical device deemed to be spurious under section 7E, but not being a medical device referred to in clause (a) shall be punishable with imprisonment for a term which shall not be less than seven years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than five lakh rupees or three times the value of the medical device confiscated, whichever is more:

Provided that the court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of less than seven years but not less than three years and of fine of less than one lakh rupees;

(d) any medical device, other than a medical device referred to in clause (a) or clause (b) or clause (c), in contravention of any other provisions of this Chapter or any rule made there under, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years and shall also be liable to fine which shall not be less than one lakh rupees.

 

7K. Whoever himself or by any other person on his behalf imports or manufactures or sells or exports or distributes any medical device in contravention of the provisions of any notification issued under section 7-I, shall  be liable to fine which shall not be less than one lakh rupees.

7L. (1) whoever having been convicted of an offence,––

(a) under clause (b) of section 7J, is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than 1 year  but which may extend to ten years and shall also be liable to fine which shall not be less than two lakh rupees:

Provided that the court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of less than 1 year and of fine of less than one lakh rupees;

(b) under clause (c) of section 7J, is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than 1 year but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees;

(c) under clause (d) of section 7J, is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to five years and shall also be liable to fine which shall not be less than two lakh rupees.

 

(2) Whoever having been convicted of an offence under section 7K is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and shall also be liable to fine which shall not be less than two lakh rupees.

 

 

7M. (1) Where any person has been convicted under this Chapter for contravening any provision of this Chapter or any rule made there under, the stock of the medical device in respect of which the contravention has been made shall be liable to confiscation and if such contravention is in respect of—

(a) import or manufacture of any medical device deemed to be misbranded under section 7C or mislabeled under section 7D or spurious under section 7E; or

(b) import or manufacture for sale or for export or for distribution, sale, export or stocking or exhibiting or offering for sale or for export, or distribution of any medical device without a valid license as required under clause (b) of sub-section (1) or clause (c) of sub-section (3) of section 7F,

 

 

any implements or machinery used in such import or manufacture, sale, export or distribution and any receptacles, packages or coverings in which such medical device is contained and the animals, vehicles, vessels or other conveyances used in carrying such medical device shall also be liable to confiscation.

(2) Without prejudice to the provisions contained in sub-section (1) where the court is satisfied, on the application of a Medical Device Officer or otherwise and after such inquiry as may be necessary that the medical device is not of standard quality or is a misbranded, mislabeled or

 

spurious medical device, such medical device shall be liable to confiscation.

7N. The Central Government may after consultation with or on the recommendation of the Indian Healthcare Product Regulatory Authority (IHRA) and subject to previous publication, by notification in the Official Gazette; make rules for the purpose of giving effect to the provisions of this Chapter which may––

(a) Provide for classification of medical devices into different classes based on the degree of risk associated with their use or application;

(b) Prescribe standards for different classes of medical devices and the organizations or bodies for developing such standards;

(c) Prescribe procedures for assessment of conformity to the standards and quality assurance;

(d) Provide for use of standards as prescribed from time to time for manufacturing or developing new medical device;

(e) Prescribe conditions for import or manufacture of custom made devices and devices for clinical investigations;

(f) Prescribe procedures for reporting adverse events, post marketing surveillance and recall of medical devices;

(g) Prescribe requirements for approval of laboratories, institutions or bodies for carrying out conformity assessment of medical devices;

(h) Prescribe procedures for overseas inspections;

(i) prescribe the qualifications of Medical Device Officer and Government Analysts for medical devices;

(j) Prescribe the methods of test or analysis to be employed in determining whether a medical device is meeting a prescribed standard;

(k) prescribe the forms of licenses or the certificates, as the case may be, for import, manufacture for sale, for distribution or for export or for sale, of medical devices, the form of application for such licenses or certificates, as the case may be, the conditions subject to which such licenses or certificates, as the case may be, may be issued, the authority empowered to issue the same, the qualification of such authority and the fees payable therefore and provide for the suspension or cancellation of such licenses in any case where any provision of this Chapter or the rules made there under is contravened or any of the conditions subject to which they are issued is not complied with;

(l) Prescribe the records, registers or other documents to be kept and maintained;

(m) Prescribe the fees for the inspection including overseas inspection (for the purposes of grant or renewal of license) of premises, wherein any medical device is being or is proposed to be manufactured;

(n) Prescribe the manner in which copies are to be certified;

(o) Specify the diseases or ailments or conditions which a medical device may not purport or claim to prevent, cure or mitigate and such other effects which a medical device may not purport or claim to have;

(p) Prescribe the conditions subject to which small quantities of medical device may be imported or manufactured for the purpose of examination, test, analysis, demonstration or for personal use;

(q) require the month and year of manufacture and the month and year of validity or expiry to be clearly or truly stated on the label or container of any specified medical device or class of medical device, and prohibit the sale, import, export, stocking or exhibition for sale or for export, or distribution of the said medical device or class of medical device after the expiry of a specified period from the date of manufacture or after the expiry of the date of validity or expiry as applicable;

(r) prescribe the conditions to be observed in the packing in packages, and other containers of medical device, including the use of packing material which comes into direct contact with the medical device and prohibit the sale, import, stocking or exhibition for sale or for export, or distribution of medical device packed in contravention of such conditions;

(s) Regulate the mode of labeling of packed medical device, and prescribe the matter which shall or shall not be included in such labels;

 

(t) Prescribe the powers and duties of Medical Device Officers and the qualifications of the authority to which such Medical Device Officers shall be subordinate and specify the medical device or classes of medical device in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed;

(u) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made there under, of any specified medical device or class of medical device;

(v) Specify the places at which medical device may be imported, and prohibit their import at any other place;

(w) Regulate the submission by importers, and the securing of samples of such medical device, as may be specified, for examination, test or analysis by the prescribed laboratory, and specify the fees, if any, payable for such examination, test or analysis;

(x) specify the evidence to be supplied, whether by accompanying documents or otherwise, of the quality of medical device sought to be imported, the procedure for officers of Customs in dealing with such evidence, and the manner of storage at places of import of medical device detained pending admission;

(y) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter and the rules made there under of medical device imported for the purpose only of transport through, and export from, India;

(za) require that the accepted scientific name of any specified software or part or instrument shall be displayed in the prescribed manner on the label or wrapper of any imported, medical device containing such part or ingredient or instrument;

(zb) specify the offences against this Chapter or any rule made there under in relation to which an order of confiscation may be made under section 7M;

(zc)The transition time for the compliance with Chapter IIA and thereafter the prescribed rules will be 5 years to enable manufacturers of Medical Devices already in market to smoothly switch over to Compliance with the provisions and requirements of this Act. Such arrangement shall include permitting manufacturer with devices already on the market to continue marketing those devices while giving them, reasonable time to complete their Conformity Assessment as per their device classification requirement and formally register with the IHRA.

 

The punitive and criminal judicial action may be maintained for an initial period of 5 years only for any Non Licensed or Non Registered manufacturing facility of Medical Devices and which have not even applied for registration / licensing compliance.

Explanation : Any person who is a regulated / licensed manufacturer / exporter / importer / reseller of Medical Device is to be considered as willing to subject himself to conform and abide with prescribed regulations and regulatory process and needs to be disciplined by the IHRA through an administrative process. This willingness to abide and be disciplined can be part of the Licensing procedures as an undertaking. Reliance needs to be of Correction and Improvement of Processes and Controls at the manufactures / logistics / warehousing / retailing / final utilization for ensuring Patient Safety through administrative methods before using the Judiciary which is already overburdened with pending cases.

The IHRA will have Administrative Powers for putting things Right e.g. Suspension of License, Recall of Goods, Field Corrective Action, Levying a Fine, etc.

Reliance on Judiciary and Police force as a criminal action should be restricted only to non Registered Units or for very exceptional cases where risk to patient safety is high and there is evidence of blatant violation and willful and wide spread non compliance to multiple Rules without scant regard to Patient Safety.

IHRA will have the powers to take any Regulatory administrative action against a licensed manufacturer on the basis of proportionate degree of potential risk / safety of non conformity classification which is to followed by all the Confirmatory Assessment Bodies. Generally the classification of non-conformities is as follow: -

a)        Observations = No non-conformance against the defined system but pointed out as scope for improvements.

b)        Minor = infrequent or lesser deficiency which is unlikely to affect functional quality or safety.

c)        Moderate = General or combined deficiency which could or does affect quality with a moderate probability or seen infrequently or is considered controlled elsewhere in the system.

Major = systems deficiency which could or does affect product quality and its safe usage with a high level of probability.

 

 

14.  In section 8 of the principal Act, in sub-section (2), for the word “Board”, the words Indian Healthcare Products Regulatory Authority” (IHRA)” shall be substituted.

15.  After section 9D of the principal Act, the following section shall be inserted, namely:–

 

“9E. For the purposes of this Chapter, a cosmetic shall be deemed to be adulterated,––

(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of coloring only, a color other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.”.

 

16. In section 10 of the principal Act,––

(i) after clause (bb), the following clause shall be inserted, namely:––

“(bba) any adulterated cosmetic;”;

(ii) in the second proviso, for the word “Board”, the words “IHRA” shall be substituted.

17. In section 11 of the principal Act, in sub-section (2), the following proviso shall be inserted, namely:––

“Provided that in the event of that package or sample of that drug or cosmetic found in contravention of any of the provisions of this Chapter or any rule made thereunder, the same shall not be allowed to be imported from that or any other port of entry in the country.”.

1              In section 12 of the principal Act, in sub-section (1), for the word “Board”, wherever it occurs, the words “IHRA” shall be substituted.

2              For section 13 of the principal Act, the following sections shall be substituted, namely:––

 

 

“13. Whoever, himself or by any other person on his behalf, imports,––

(a) any drug deemed to be adulterated under section 9A or spurious under section 9B and which when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such bodily harm which amount to grievous hurt within the meaning of section 320 of the Indian Penal Code, solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be punishable with imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the drugs confiscated, whichever is more:

Provided that the fine imposed under this clause shall be paid to the person who had used the adulterated or spurious drugs:

Provided further that where the use of adulterated or spurious drugs referred to in this clause has caused the death of a person who used such drugs, the fine imposed shall be paid to his legal heir;

(b) any drug—

(i) deemed to be adulterated under section 9A, but not being a drug referred to in clause (a); or

 

(ii) without a valid license as required under clause (c) of section 10,

shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and shall also be liable to fine which shall not be less than one lakh rupees or three times the value of the drugs confiscated, whichever is more:

Provided that the court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of less than three years and of fine of less than one lakh rupees;

(c) any drug deemed to be spurious under section 9B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall not be less than seven years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than three lakh rupees or three times the value of the drugs confiscated, whichever is more:

Provided that the court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of less than seven years but not less than three years and of fine of less than one lakh rupees;

(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provisions of this Chapter or any rule made there under, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years and shall also be liable to fine which shall not be less than one lakh rupees:

Provided that the court may, for any adequate and special reasons, to be recorded in the judgment imposes a sentence of imprisonment for a term of less than one year;

(e) any cosmetic deemed to be adulterated under section 9E or spurious under section 9D and which when used by any person is likely to cause his death or is likely to cause such bodily harm which amount to grievous hurt within the meaning of section 320 of the Indian Penal Code, solely on account of such cosmetics being adulterated or spurious or not of standard quality, as the case may be, shall be punishable with imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the cosmetics confiscated, whichever is more:

 

Provided that the fine imposed under this clause shall be paid to the person who had used the adulterated or spurious cosmetic:

Provided further that where the use of adulterated or spurious cosmetic referred to in this clause has caused the death of a person who used such cosmetic, the fine imposed shall be paid to his legal heir;

(f) any cosmetic,

(i) deemed to be spurious under section 9D or adulterated under section 9E but not being a cosmetic referred to in clause (e);

 

(ii) without a valid license as required under clause (c) of section 10,

shall be punishable with imprisonment for a term which shall not be less than two years and shall also be liable to fine which shall not be less than fifty thousand rupees;

(g) any cosmetic other than a cosmetic referred to in clause (e) or clause (f), the import of which is prohibited under section 10, or any rule made under this Chapter, shall be punishable with imprisonment for a term which shall not be less than one year and shall also be liable to fine which shall not be less than twenty thousand rupees;

(h) any cosmetic in contravention of the provisions of any notification issued under section 10A, shall be punishable with imprisonment for a term which shall not be less than two years and shall also be liable to fine which shall not be less than fifty thousand rupees.

13A. Whoever having been convicted of an offence––

(a) under clause (b) of section 13 is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than seven years but which may extend to ten years and shall also be liable to fine which shall not be less than two lakh rupees:

Provided that the court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of less than seven years and of fine of less than one lakh rupees;

(b) under clause (c) of section 13 is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than three lakh rupees;

(c) under clause (d) of section 13 is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to four years and shall also be liable to fine which shall not be less than fifty thousand rupees.

(d) under clause (f) or clause (g) or clause (h) of section 13 is again convicted under that clause, shall be punishable with imprisonment for a term which shall not be less than three years, and shall also be liable to fine which shall not be less than one lakh rupees.”.

 

1              In section 16 of the principal Act, in sub-section (2), for the word “Board”, the words “IHRA” shall be substituted.

2              For section 18 of the principal Act, the following section shall be substituted, namely:––

 

“18. (1) Save as otherwise provided in sub-section (3), no person shall himself or by any other person on his behalf––

(a) Manufacture for sale or for export or for distribution, or sell, or stock or exhibit or offer for sale or distribute––

(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;

(ii) any cosmetic which is not of a standard quality, or is misbranded, adulterated or spurious;

(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true formula or list of active ingredients contained in it together with the quantities thereof;

(iv) any drug which by means of any statement, design or device accompanying it or by any 

 

other means, purports or claims to prevent, cure or mitigate any such disease or ailment, or to have any such other effect as may be prescribed;

(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;

(vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made there under;

(b) sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made there under;

(c) Manufacture for sale or for export or for distribution, or sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic, except under, and in accordance with the conditions of a license issued for such purposes under this Chapter:

 

Provided that no license for manufacture of any new drug shall be issued except in accordance with the prior permission granted by the Central Licensing Authority, in such manner as may be prescribed:

Provided further that the State Licensing Authority shall, before issuing any licence for manufacture of any new drug, ensure that the permission from the Central Licensing Authority is obtained:

Provided also that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis:

Provided also that the Central Government may, after consultation with the IHRA, by notification in the Official Gazette, permit, subject to any condition specified in the notification, the manufacture for sale, or for distribution, sale, stocking or exhibiting or offering for sale or distribution of any drug or class of drugs not being of standard quality.

(2) The State Government may for the purposes of this Chapter by notification in the Official Gazette, designate one or more person, having such qualifications and experience, as the State Licensing Authority, with such powers and functions and on such terms and conditions, as may be prescribed.

(3) On and from the commencement of the Drugs, Cosmetics, Medical Device & Patient Safety Act , the Central Licensing Authority shall have power to issue a license or a certificate, as the case may be, for the manufacture for sale or for export of drugs specified in the Third Schedule to this Act:

Provided that no license for manufacture of any drug specified under the Third Schedule shall be issued by the State Licensing Authorities.

(4) The Central Government, after consultation with the Central Drugs Authority and after giving by notification in the Official Gazette not less than

 

Three months’ notice of its intention so to do, may by a like notification add to or otherwise amend the Third Schedule for the purposes of this Chapter, and thereupon the Third Schedule shall be deemed to be amended accordingly.

22.  In section 18A of the principal Act,––

(a) For the words “drug or cosmetic”, at both the places where they occur, the words “drug or cosmetic or medical device” shall be substituted;

(b) After the word ‘‘Inspector’’, the words “or Medical Device Officer” shall be inserted.

 

1              In section 18B of the principal Act, for the words, brackets and figures “clause (c) of section 18”, the words, brackets, figures and letters “clause (b) of sub-section (1) or clause (c) of sub-section (2) of section 7F or clause (c) of section (10) or clause (c) of sub-section (1) of section 18” shall be substituted.

2              After section 18C of the principal Act, the following sections shall be inserted, namely:––

 

“18D. No drug or cosmetic or medical device shall be exported except in

accordance with the conditions of a permission or licence or certificate, as the case

may be, issued by the Central Licensing Authority, in such manner, as may be prescribed.

18E. Whoever, himself or by any other person on his behalf, exports any drug, cosmetic or medical device in contravention of the provisions of section 18D shall be liable to fine which shall not be less than two lakh rupees or three times value of the drug, cosmetic or medical device exported or confiscated, whichever is more.

18F. Whoever having been convicted of an offence under section 18E is again convicted of an offence under that section, shall be punishable with imprisonment for a term which shall not be less than two years and with fine which shall not be less than five lakh rupees or three times value of the drug, cosmetic or medical device exported or confiscated, whichever is more.”.

25. In section 19 of the principal Act,––

(a) for the words “drug or cosmetic”, wherever they occur, the words “drug or cosmetic or medical device” shall be substituted;

(b) for the words, “this Chapter”, the words, figures and letter “Chapter IIA or Chapter III or Chapter IV” shall be substituted;

(c) in sub-section (2),––

(i) in the opening portion, for the words, figures and “section 18 a drug shall not be deemed to be misbranded or adulterated or spurious or to be below standard quality nor shall a cosmetic be deemed to be misbranded or to be below standard quality”, the words, figure and letter “section 7F, a medical device shall not be deemed to be misbranded or adulterated or spurious or not of standard quality, or for the purposes of section 18 a drug shall not be deemed to be misbranded or adulterated or spurious or to be below standard quality or shall a cosmetic be deemed to be misbranded or adulterated or spurious or to be below standard quality” shall be substituted;

(ii) in clause (a), after the word “consumption”, the words “or use” shall be inserted;

(d) in sub-section (3), in the opening portion, for the word and figures “section 18”, the words, figures and letter “section 7F or section 18” shall be substituted.

 

26.  In section 20 of the principal Act,––

(a) in sub-section (1), for the words “such drugs or classes of drugs or such cosmetics or classes of cosmetics”, the words “such drugs or classes of drugs or such cosmetics or classes of cosmetics or such medical devices or classes of medical devices” shall be substituted;

(b) in sub-section (2),––

(i) for the words “Central Government”, the words “IHRA” shall be substituted;

(ii) for the words “such drugs or classes of drugs or such cosmetics or classes of cosmetics”, the words “such drugs or classes of drugs or such cosmetics or classes of cosmetics or such medical devices or classes of medical devices” shall be substituted;

(c) in sub-section (3), for the words “Central Government”, the words “IHRA” shall be substituted;

(d) in sub-section (4), for the words “import, manufacture or sale of drugs or cosmetics”, the words “import, export, manufacture or sale of drugs or cosmetics or medical devices” shall be substituted.

 

27. In section 21 of the principal Act,––

(a) in sub-section (1), for the words “Central Government or” at both the places where they occur, the words “IHRA or” shall be substituted;

(b) in sub-section (3), for the words “import, manufacture or sale”, the words “import, export, manufacture or sale” shall be substituted;

 

 

1              cosmetic or medical device” shall be substituted;

33. For section 26A of the principal Act, the following section shall be substituted, namely:––

“26A. Without prejudice to any other provisions contained in Chapter IIA and Chapter IV, if the Central Government is satisfied, that the use of any drug or cosmetic or medical device is likely to involve any risk to human beings or animals or that any drug or medical device does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, regulate, restrict or prohibit the manufacture, sale or distribution of such drug or cosmetic or medical device.”.

2              In section 26B of the principal Act, for the word “drug”, wherever it occurs, the words “drug or medical device” shall be substituted.

 

35. In section 27 of the principal Act,––

(i) in the opening portion, for the words “manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes”, the words “manufactures for sale or for export or for distribution, or sells, or exports, or stocks or exhibits or offers for sale or for export or distributes” shall be substituted;

(ii) in clause (a), in the second proviso,––

(a) for the word “relative”, the words “legal heir” shall be substituted;

(b) the “Explanation” shall be omitted.

 

1              In section 27A of the principal Act, for the words “manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale”, the words “manufactures for sale or for export or for distribution, or sells, or exports, or stocks or exhibits or offers for sale or for export” shall be substituted.

2              In section 28 of the principal Act, for the words “may extend to one year or with fine which shall not be less than twenty thousand rupees or with both”, the words “shall not be less than three years and shall also be liable to fine which shall not be less than three lakh rupees” shall be substituted.

3              In section 28A of the principal Act, for the words “may extend to one year or with fine which shall not be less than twenty thousand rupees or with both”, the words “shall not be less than three years and shall also be liable to fine which shall not be less than three lakh rupees” shall be substituted.

4              In section 28B of the principal Act, for the words “may extend to three years and shall also be liable to fine which may extend to five thousand rupees”, the words “shall not be less than three years and shall also be liable to fine which shall not be less than five lakh rupees” shall be substituted.

 

40. In section 29 of the principal Act,––

(a) for the words “drug or cosmetic”, the words “drug or cosmetic or medical device” shall be substituted;

(b) for the words “which may extend to five thousand rupees”, the words “which shall not be less than fifty thousand rupees” shall be substituted.

 

41. In section 30 of the principal Act,––

(a) in sub-section (1A), for the words “may extend to two years or with a fine which may extend to two thousand rupees”, the words “shall not be less than three years and shall also be liable to fine which shall not be less than ten lakh rupees” shall be substituted;

(b) in sub-section (2), for the words “may extend to two years, or with fine which shall not be less than ten thousand rupees or with both”, the words “shall not be less than two years and shall also be liable to fine which shall not be less than one lakh rupees” shall be substituted;

 

(c) after sub-section (2), the following sub-section shall be inserted, namely:––

“(3) Whoever having been convicted of an offence under section 28A or section 28B is again convicted of an offence under that section shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and shall also be liable to fine which shall not be less than five lakh rupees.”.

42. In section 31 of the principal Act, in sub-section (1),––

(a) in clause (ii),—

(A) for the words “manufacture for sale, or for distribution, sale, or stocking or exhibiting or offering for sale, or distribution”, the words “manufacture for sale or for export or for distribution, sale, export, or stocking or exhibiting or offering for sale or for export or for distribution” shall be substituted;

(B) for the words, brackets, letter and figures “clause (c) of section 18”, the word and figures “section 18” shall be substituted.

 

(b) in the opening portion, after clause (ii), for the words “manufacture, sale or distribution” the words “manufacture, sale, export or distribution” shall be substituted.

43. In section 31A of the principal Act,––

(a) for the words and figures “this Chapter except those contained in section 31”, the words, figures and letters “Chapter IB, Chapter IIA and Chapter IV except those contained in section 4ZI, section 7M and section 31” shall be substituted;

(b) for the words “manufacture, sale or distribution”, at both the places where they occur, the words “manufacture, sale, export or distribution” shall be substituted.

 

44. In section 32 of the principal Act,––

(a) for the words “this Chapter”, wherever they occur, the words, figures and letter “Chapter IIA or Chapter IV” shall be substituted;

(b) in sub-section (1), for clause (a), the following clause shall be substituted, namely:––

 

“(a) a Drugs Control Officer or a Medical Device Officer; or”.

45. In section 33 of the principal Act,––

(a) in sub-section (1), for the word “Board”, wherever it occurs, the words “Indian Healthcare Products Regulatory Authority” (IHRA)” shall be substituted;

(b) in sub-section (2),––

(i) in clause (e), for the words “manufacture for sale or for distribution, for the sale and for the distribution”, the words “manufacture for sale or for export or for distribution for the sale, for the export and for the distribution” shall be substituted;

(ii) in clause (h), for the words “sale, stocking or exhibition for sale, or distribution”, the words “sale, export, stocking or exhibition for sale, or export, or distribution” shall be substituted;

 

(iii) in clause (i), for the words “sale, stocking or exhibition for sale, or distribution”, the words “sale, export, stocking or exhibition for sale, or export, or distribution” shall be substituted;

(iv) in clause (k), for the words “manufacture, sale or stocking or exhibition for sale, or distribution”, the words “manufacture, sale, export or stocking or exhibition for sale, or for export or distribution” shall be substituted.

1              In section 33P of the principal Act, for the words “any State Government”, the words “any State Government or the IHRA” shall be substituted.

2              After section 33P of the principal Act, the following sections shall be inserted, namely:––

 

“33Q. The IHRA may suspend or cancel any permission, license or certificate issued by the 

Central Licensing Authority or the State Licensing Authority, in the public interest and for the reasons to be recorded in writing or if the permission, license or certificate, as the case may be, is found not to have been issued in accordance with the provisions of this Act and the rules and regulations made thereunder, in the manner as may be prescribed.

33R. (1) Any person aggrieved by any action or decision of any State Licensing

Authority or the Central Licensing Authority, may prefer an appeal to the IHRA within such period and in such manner as may be prescribed.

(2) Any person aggrieved by any action or decision of the IHRA, may prefer an appeal to the Tribunal within such period and in such manner as may be prescribed.”.

48. In section 34A of the principal Act,––

(a) for the words, figures and letter “Chapter IV or  Chapter IVA”, at both the places where they occur, the words, figures and letters “Chapter IB, Chapter IIA, Chapter III, Chapter IV or  Chapter IVA” shall be substituted;

(b) for the words “manufacture, sale or distribution of drugs”, the words “clinical trial, import, manufacture, sale, export or distribution of drugs, cosmetics or medical devices” shall be substituted.

 

49. In section 34AA of the principal Act,––

(i) in clause (c), for the words “any drug or cosmetic”, the words “any drug or cosmetic or medical device” shall be substituted;

(ii) in clause (d) for the words “one thousand rupees”, the words “one lakh rupees” shall be substituted.

 

50. After section 34AA of the principal Act, the following section shall be inserted, namely:––

“34AAA. Whoever himself or by any other person on his behalf imports, manufactures, stocks, sells, distributes or exports, or intends to do so, any drug or cosmetic or medical device and submits misleading or wrong information or refuses to provide correct information in that regard as required by the licensing authority under this Act shall be punishable with imprisonment for a term which shall not be less than three years and shall also be liable to fine which shall not be less than one lakh rupees.”.

1              After section 35 of the principal Act, the following sections shall be inserted, namely:––

 

“35A. Any person convicted for an offence under this Act shall be liable to bear the cost of storage of any article related to such offence, seized under this Act.

35B. The seized spurious or misbranded or adulterated or not of standard quality drugs, cosmetics and medical devices, having been proved so and after their use as evidence in the case before the court is over, shall be destroyed by the official authority in custody of these products in the manner as may be prescribed and the convicted person shall be liable to bear the cost of destruction of seized articles.”.

52. For section 38 of the principal Act, the following section shall be substituted, namely:––

“38. Every rule and every regulation made under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or regulation or both Houses agree that the rule or regulation should not be made, the rule or regulation shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of 

anything previously done under that rule or regulation.”.

 

53. After the Second Schedule to the principal Act, the following Schedule shall be inserted, namely:––

 

 

Copyrights 2009. Association of Indian Medical Device Industry.