Medical devices panel hits amendment roadblock

Attempts to set up a regulator for the burgeoning medical devices sector seem to have hit a roadblock.

An autonomous body — Medical Device Regulatory Authority of India — to regulate the quality of medical devices being marketed in the country may not succeed as the Ministry of Health and Family Welfare, which currently regulates medical devices under the drug laws, is planning a major amendment to the existing drug laws to incorporate comprehensive medical device regulation norms.

While the science and technology ministry is yet to finalise its Medical Devices Regulation Bill, 2006, the health ministry has already introduced the Drugs and Cosmetics (Amendment) Act, 2007, in Parliament. With the science ministry moving ahead with its plans for a separate regulatory authority for medical devices, the health ministry will further fine-tune the scope of drug laws to incorporate regulation of all types of medical devices, a health ministry official told Business Standard.

“We have decided to take medical devices, biotechnology products and vaccines as separate categories. All these categories are currently defined as drugs and are bound by the rules meant for medicines. Since each of them need special treatment, we will draft specific regulatory framework for all categories of products meant for medical use”, the official said.

The drugs Act amendment bill, introduced in Parliament last year, is currently being scrutinised by a committee of Parliamentarians. Once the Parliamentary panel submits its recommendation, the health ministry will incorporate the changes and place the amended version of the bill before Parliament. The panel is expected to submit its report during the forthcoming session of Parliament.

The health ministry is also busy working on good manufacturing practice (GMP) norms for medical device manufacturers. The GMP guidelines as well as standard protocols for clinical trials of medical devices are expected to be ready soon.

The Drugs and Cosmetics (Amendment) Act 2007 calls for the formation of an umbrella organisation called Central Drug Authority that will assume all the powers of the current drug regulatory mechanism and also expand its regulatory responsibilities on categories like medical devices in a big way.