Commenting on the need of forming such an association Rajiv Nath, the Forum Coordinator, said, “Some of the Indian medical devices, equipments are till date controlled by the drugs act and treated as similar to medicines, although world over it has been recognised 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 V Agarwal from M/s Surgiwear.

Health care has emerged as one of the largest service sectors in India. In 2004, national health care spending was about 5.2 per cent of GDP and is estimated to be US$ 34.9 billion. Health care spending in India is expected to rise by 12 per cent 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 unfavourable 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 health care industry of these countries is over 10-20 times bigger than India and also these countries have become the most favoured FDI destinations for medical device. Not only this, the Government 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 Nath.

Also present at the occasion, Rajiv Chhabra from M/s Orthocare disclosed, “This is a sad state of affairs from government 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 and the Ministry of Health were not being conducive to in the growth of this industry. We have met the Joint DGFT and the DCGI recently. They have assured review of the 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 Joint DGFT has amended the procedure on January 19, 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 recognised 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 two have been registered; in ophthalmic industries, only two 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,” Chhabra added.

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 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 A Ramamoorthy of Appasami Associates

“Our application for renewal Free Sale Certificate for surgical blades is pending for over three 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 penalised 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 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 research and development from the government, encourage innovations from member units, improve clinician and patient access to the modern, innovative and reliable medical device technologies through organising meeting, seminars, symposia, exhibitions and demonstrations and also, to promote global harmonisation 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 Nath

Over 60 members from 40 industries - orthopedic, diagnostic, ophthalmic, syringes, I.V.cannula, wound dressing, shunts, drapes, electrodes, gloves, anesthesia equipments, cardiovascular etc and four multinational companies were present at the initial meeting, additionally the ones from conformity assessment bodies like BSI, DNV, TUV and Intertek for contributing to the IMDRRG. AIMED would be horizontally divided into common groupings like – legal issues, tax issues, export related issues, medical device regulatory issues common to all vertical groups of different families of product lines with zonal representations.