In a move to strengthen drug regulation in the country, the Health Ministry has scrapped the Drugs and Cosmetics (Amendment) Bill which had been pending for last 13 years, 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.
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% 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 sale of medicines and allied products. 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 proposed Act will also include stricter penalties and punishments for those violating the law or selling substandard medicines.