13-yr-old bill being redrafted to cover emerging health sectors

NEW DELHI: In a move to strengthen drug regulation in the country, the health ministry has scrapped the Drugs and Cosmetics (Amendment) Bill, and is instead drafting a new law to cover various new therapeutic areas and emerging segments such as stem cells, nutraceuticals, online sale of medicines and medical devices.

"The existing act is very old and the amendment bill is now pending for over 13 years. Meanwhile, there have been many changes in the market. New products and segments have also been introduced. So, the government is of the view that it makes sense to revisit the law as a whole and frame a new act," a senior official said.

At present, the Drugs and Cosmetics Act, 1940 regulates only conventional pharmaceuticals, which account for over Rs 1 lakh crore of annual domestic sales. However, newly emerged segments such as nutraceuticals, supplements with therapeutic usage, stem cell therapies, etc, continue to be outside the purview of the act.

With growing disease burden and emergence of various new treatment methods, the Indian healthcare sector has changed over past few decades and market for many of these new drugs are growing rapidly. For instance, annual nutraceutical or food supplement sales, currently pegged at about $2.2 billion, is estimated to grow at 20 per cent every year to touch over $6 billion by 2020 in India.

While all such products are sold over-the-counter ( OTC) without a doctor's prescription, regulators say many of them have therapeutic effect, and therefore, need certain regulation under the drug law.

The penetration of online retail platforms have also created several challenges for the government and the regulator to monitor manufacturing and sales of medicines .

Despite increased surveillance, the government has failed to keep a tab on such new areas primarily because of lack of provisions in the existing law.

"The idea to revisit the law completely and introduce provisions which can address and take care of such changes as well as is forward looking in nature," the official said.

The proposed act will also include stricter penalties and punishments for those violating the law or selling substandard medicines.

According to the official, deliberations have already started with health ministry regularly holding meetings with drug regulators, inspectors and state authorities to draft the new law.