Making medical devices more affordable

India is one of the largest manufacturers of pharmaceutical products in the world. The annual production of such products is in excess of Rs 2 lakh crore. Out of this, over 55% is exported to over 200 countries/economies of the world including the developed countries. As such, the pharmaceutical sector in India plays a vital role in managing the public health in large number countries at a substantially lower cost.

The regulatory framework for ensuring the quality, safety and efficacy of medical products including the medicines, medical devices, in-vitro medical devices, stem cells, regenerative medicines, clinical trial/investigation, etc. is provided for in the Drugs and Cosmetics Act, 1940. Medical devices, including surgical and consumable items, are defined as ‘drugs’ under the Drugs and Cosmetics Act, 1940. As many as 165 surgical and consumable items are already being sold through Jan Aushadhi Stores.

The government is working to set up Pharma Parks, Bulk Drugs Parks and Medical Devices Parks to make medicines and devices affordable. Currently, Cardiac and Drug Eluting Stents are notified as ‘Drugs’ under the Drugs and Cosmetics Act, 1940. Health is a State subject, and data regarding annual requirements of Stents in the country is not complied with centrally. Bulk of medical devices including stents consumed in the country is imported and the difference between the landed cost and the MRP thereof is very high.

These medical devices fall under non-scheduled category of Drugs Price Control Order (DPCO), 2013 and as such, no ceiling price has been fixed for these devices. However, DPCO, 2013 provides for monitoring the prices of these devices and price cannot be hiked by more than 10 per cent of MRP during preceding twelve months. Cardiac stents have already been included in the National List of Essential Medicines and will soon come under the DPCO. GST is expected to bring down taxation in the sector by almost 12 per cent.

The first Medical Technology Park has already been set up in Vishakhapatnam with an investment of Rs 1,200 crore. Four more States including Telangana have shown interest in setting up such parks. Indian medical technology sector is pegged at about $5.5 billion contributing to about 7 to 8 per cent of the healthcare spent in India.