15 June 2016
By: Sunil Sharma
New Delhi : Medical devices such as stents, catheters, orthopaedic implants, heart valves and syringes are set to face stringent scrutiny as the government plans to make regulatory approval mandatory for all such products sold in the country, sources said. Currently, only 22 medical devices are notified in the country, requiring registration and licence for selling in the market.
The latest proposal would mean companies will have to seek regulatory approval prior to launching a product in the local market. Besides, the proposal, aimed at ensuring safety and affordability of medical devices, also suggests inclusion of all such products under the National List of Essential Medicines to bring them under government price control.The proposal, once implemented, can be a major blow to the medical devices industry, pegged at over Rs 47,000 crore. The government has already finalised a plan to set up a testing laboratory for medical devices in Vadodara (Gujarat). The laboratory-first of its kind in India-will also certify medical devices approved and sold in India.
The government may also outsource part of the quality certification process to standardizing bodies such as BIS or some global solution providers. Some devices are as important as life saving drugs. Many of these products are implanted into human body for critical care and therefore, it is very important to keep a check on their quality. If not regulated, patients may fall victim to poor quality medical devices,” an official said. At present, only few reputed companies voluntarily get quality certification from standardizing bodies like BIS.
For a long time, the health ministry has been trying to regulate the medical device industry. However, it has so far failed to do so given the government’s simultaneous push for ‘Make In India’ drive and need for attracting FDI. The Drugs and Cosmetics (Amendment) Bill, 2015, which is waiting to be tabled in Parliament, also proposes to introduce a separate chapter on medical devices, classifying them based on their risk parameters.