Indian Drugs and Cosmetics Act is No Longer Applicable for Medical Devices

The Indian government will soon face rigorous quality and price monitoring for medical devices including stents, catheters, and MRI machines.

A task force consisting of representatives from the ministry of commerce and industry, department of industrial policy and promotion (DIPP) and the ministry of health have recommended a separate law to keep a check on hospital equipments and implants available in the country.

Currently, the Drugs and Cosmetics Act is the main regulatory for medicines as well as medical devices. Public health experts and medical fraternities advocate that medicines are different from medical devices and should be monitored under separate norms.

A set of new recommendations, under the 'Medical Device Regulatory Act' has been laid. "This will provide dedicated, predictable, transparent, globally harmonized and appropriate regulations for medical devices and will ensure that medical devices are only subjected to device relevant laws and not to those relevant to drugs," the recommendations said.

Chemicals and fertilizers minister Ananth Kumar, released the recommendations of the task-force in the form of a report. He said, "Talks are going on with Tamil Nadu government to set up a medical devices park in Chengalpattu."

At present, 70% of medical devices used in India are imported so the panel has also suggested various measures to promote local manufacturing of medical devices. Most multinational firms import sophisticated devices and hospital equipment while domestic firms have been making small disposables and some implants.

Industry executives said that though the recommendations of the task force are a good idea, local manufacturing might be hampered if the government allows foreign investment.

Source: Medindia