India to review drugs laws, extend regulation to new areas

The government is revising its drugs law to take care of new therapeutic areas and emerging segments such as stem cells, nutraceuticals, online sale of medicines and medical devices.

The Narendra Modi government's latest move to withdraw the existing draft Drugs and Cosmetics Amendment Bill pending in the Rajya Sabha and introduce a new one incorporating necessary changes is also intended to make it easier for companies to do business in the country while also ensuring the safety and efficacy of medicines.

India had introduced an amendment bill in the upper house of parliament in 2013 in order to tweak archaic Drugs and Cosmetics Act of 1940,  but that has now been withdrawn, the government said in a statement on Wednesday.

Ministers decided the current law cannot effectively regulate areas such as biological drugs, stem cells and regenerative medicines, medical devices, and clinical trials, the statement said.

Draft guidelines to regulate the medical devices industry have already been prepared after consultations with stakeholders, and these will be "notified shortly."

So far, medical devices in India have been regulated as drugs, but companies have been clamoring for separate rules over the years as the industry has grown to roughly $5 billion.

With Modi championing a "Make in India" campaign, the government statement said the medical products sector is "poised for exponential growth in the near future" and "has the potential to become an international hub."

A draft of the revised drugs laws, which aim to bring regulatory standards of the drugs industry in line with global norms, is expected to be ready in two months.

India's $15-bn drug industry, however, has been facing regulatory warnings and bans in the US, for poor. manufacturing standards. More than 40 of the plants are under US ban, including those owned by India's largest drugmakers.