From Editor's Desk

Recent initiatives , announcements and actions from Government and Medical Device Industry brings to the limelight the Indian Medical Device Industry and creates hope and indicates trends in the accelerating growth potential for the Industry. Few of the major initiatives include :

Delinking of Medical Device Sector From Pharma : Government has accepted longstanding demand and has agreed to delink Schedule M III from the Drug rules , which deals with medical devices, from Schedule M, which deals with drugs and pharmaceuticals. Industry still demands a separate rule book and separate regulatory authority.

India’s First Industry - Academia Collaboration For Medical Devices R & D launched by “AIMED” : With an objective to catalyze “Make-In-India” program, this collaboration for Industry - Academic/Research Institutes , AIMED launched “UdaiMed”, a new sunrise forum for collaborative interface between User, Developer, Academic and Research Institutes and Industry. To take forward this objective, AIMED & UdaiMed also signed its first MoU with TiMed (Technology Business Incubator), a not-for-profit registered society promoted by Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, for encouraging innovation and entrepreneurship in medical technologies through technology business incubation support.

Mr. D.L. Pandya

Editor

Government Review For Overpricing Of Medical Devices : There is a great concern in the Industry about arbitrary MRP labeling . The Government has asked the companies to review their pricing and submit maximum retail price (MRP) details of their products to drug price regulator NPPA. It is expected that the Government would like to take remedial measures to make the pricing of medical devices reasonable. This is likely to resulting in reducing overall healthcare cost in the country.

Announcements Of Medical Device Parks By Andhra Pradesh , Maharastra and Gujarat States . More States likely to follow : The key is implementation. The Association however feels that these parks can not flourish without a coordinated National Medical Device Policy, which is said to be pending with Government for quite some time.

Beyond the above initiatives, the Government has also taken steps to remove some irritants like eliminating need for NOC from Port Office by DCGI for exports of Medical Devices alongwith Pharmaceuticals. These developments are on and above the previous activities covered in our July - Aug 2015 issue including removal of duty anomalies, Materiovigilance Program to monitor safety of Medical Devices etc.

As per Mr. Rajiv Nath, Forum coordinator, “AIMED”, “the Government needs to focus on 6 key issues to create an appropriate Ecosystem for enabling import substitution of 23,000 crores of imports of Medical Devices for “Make-In-India” to be realized”. It includes, “Business Viability , Consumer Protection, Buy India Policy, Foreign Direct Investment, Regulations For ensuring Patient Safety and Need for a Department of Medical Devices.

D.L. Pandya