The future of Indian Industry catering to the approx USD 3 Billion, Indian Medical Equipments,

Diagnostics and Supplies Market is getting darker day by day as the various unfair unfriendly trade

practices and anti industry regulations hitting the industry hard from all sides.

To wake up the sleeping Govt and initiate a movement against these anti industry regulations and

repressive environment the entire medical devices industry of India has gathered on a one single platform to

form “Association of Indian Medical Device Industry (AIMED)” which will be the single point contact for

Govt of India in this industry. The newly formed association AIMED (Association of Indian Medical

Device), which will represent the interest of over 150 Manufacturers of Medical Devices including

Diagnostics will create a forum to cover issues and address the manufacturer’s problem. The name

“Association of Indian Medical Device Industry (AIMED)” was chosen for the Umbrella Association of

Medical Device Industry.

Commenting on the need of forming such an association Mr. Rajiv Nath the Forum Coordinator said,

“Some of the Indian Medical Devices, equipments are till date controlled by Drugs Act and treated as

similar to medicines, although world over it has been recognized as a separate industry. There are hardly

any similarity in medicines and devices henceforth the industry should be treated as a separate industry

from pharmaceuticals which is regulated by various rules and regulations.”

“The industry needed to create a forum to cover common issues of the stakeholders. So, we all decided to

form an umbrella association of Indian Manufacturers Medical Devices covering all types of Medical

Devices whether consumables, disposables, equipments or diagnostics. AIMED will provide the larger and

more powerful single platform when needed”, concluded Mr. V.Agarwal from M/s Surgiwear.

CII, FICCI the two most powerful industry association in India have limited focus in giving a strong

representation to this relatively small segment 3 billions USD industry which is currently growing at a pace

of 12% pa and likely to touch USD 5 billion by the end of 2010. Healthcare has emerged as one of the

largest service sectors in India. In 2004, national healthcare spending was about 5.2 per cent of GDP and is

estimated to be US$ 34.9 billion. Healthcare spending in India is expected to rise by 12% per annum during

2005-09. Even though much of the demand is met through imports, the Indian Medical Device industry was

at the threshold of a major expansion but is held back due to unfavorable Government policies.

“Once upon a time Indian Medical devices industry was far ahead than its competitors ie China, Malaysia

and Taiwan and now a days the healthcare industry of these countries is over 10-20 times bigger than India

and also these countries have become the most favored FDI destinations for medical device. Not only this

the Govt of India is also loosing approx Rs. 80 to 100 crore foreign exchange earning per month as there is

no regulatory authority who can issue the certificate required to export these products. Majority of

multinational players have also started down sizing their manufacturing operations in India”. said Mr Rajiv

Nath.

Also present at the occasion, Mr Rajiv Chhabra from M/s Orthocare disclosed, “This is a sad state of

affairs from Govt side that there is no administrative ministry willing to promote this industry with great

growth potential instead the un-rational decisions and unfriendly rules and regulation created by The

Ministry of Commerce & the Ministry of Health were not being conducive to in the growth of this industry

. We have met the Jt. DGFT and the DCGI recently. They have assured review of Policy/Procedures to

help AIMED members. The positive attitude by Seniors needs to be reflected in positive action by Junior

Staff . We came to know yesterday that the Jt. DGFT has amended the procedure on 19th Jan which

seemingly address our issues to a great extend. We are seeking clarification”.

“It is very strange that while Indian Medical Device Industry is very well recognized outside India

fulfilling the most stringent European quality parameters and majority of the players are having CE

certification, despite all this, till date Indian authorities have failed to provide proper license to these

manufacturers. Out of 178 Orthopedic units only 2 have been registered, in Ophthalmic industries only 2

out of 20 players have received license despite the fact many of these companies are exporting to Europe

since last 15 years. Let us hope that the DCGI Office also acts fast on their part now” further added Mr.

Chhabra.

Since 2005, after some Medical devices have been notified in the Drugs Act, most of the players could not

able to sell their products out of India (in the absence of Free Sale License) in developing countries in

Africa, Middle East and South America while on the other hand same companies having CE certification

could easily sell the products in most of the European countries.

It is quite surprising and ironical to see that our own country’s regulations restricts and hamper our

business while a European certificate increases our business”. Said Mr Agarwal.

“We had requested DGFT to amend their procedures and also the DCGI. AIMED has succeeded in getting

some quick response from DGFT and we are thankful for that. We do not have any idea how long DCGI

will take. Our application for issuance of Free Sale Certificate - a simple certificate that we are bonafide

manufacturer and are making and exporting these items for over 20 years is not available to us. Without

this our distributors can not get import permission for our product. Monthly loss to Indian economy is over

100 crore Rupees by this indifference”. Said Mr. A. Ramamoorthy of Appasami Associates

“Our application for renewal Free Sale Certificate for Surgical Blades is pending for over 3 months. It

should not take one day for renewal. We have order and cut a sorry figure with our 15 year old customer in

Thailand who is being penalized by his customers for delivery delays. As individual companies our staff’s

pleas were not being heard. As AIMED we are able to have the credibility for requesting for Policy and

Procedure review.” said Mr. Rajiv Nath.

The aim behind forming AIMED is also to allow the Government to access a single point of contact and

provide various services to the manufacturers like Advocacy on policy issues, Information services,

Regulations for medical devices, Education and Training, services, Testing Assistance and guidance for

Quality Certification (ISO, CE, GMP), Lobbying for funding for R&D from the Government, encourage

innovations from member units, Improve clinician and patient access to the modern, innovative and reliable

medical device technologies through organizing Meeting, Seminars, Symposia, Exhibitions and

Demonstrations and also, to promote global harmonization of Indian device industry

AIMED will ensure convergence at a one common platform, when needed, for ensuring over all growth of

Indian Medical Devices Industry and further address the needs of all members of the Medical Device

Industry irrespective of their affiliation or their company size. It will also help in wider dissemination of

information to each player of the industry.

AIMED has initiated the formation of the IMDRRG – Indian Medical Device Regulatory Review Group

for enabling Regulatory Reforms and provided a forum for the regulated/unregulated industry, the regulator

the conformity assessment bodies, the testing institutions and consumer groups for bring around these

overdue reforms. “We wish to collaborate with the Government not confront,” said Rajiv Nath

Category New Issue

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