15000 crore Indian Medical Devices Market unifies the Industry

Jan. 23, 2009 - PRLog -- 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