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.
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.