Government withdraws Bill that amends existing Drugs Act
The government withdrew a Bill which was introduced in Parliament in 2013 to amend the existing Drugs and Cosmetics Act. It was done as part of the health ministry’s move to replace the old laws governing India’s pharmaceutical and medical devices industries.
According to a statement released by the government, work is underway on two separate Acts— one to regulate drugs and cosmetics and the other for medical devices.
While a draft set of Rules to regulate medical devices under the existing Act has already been prepared, the ministry has also begun work on the separate Act for medical devices, the statement said.
The government had earlier banked on amendments to the existing 1940 Drugs & Cosmetics Act, introducing amendment bills in the Rajya Sabha between 2013 and 2015.
The Union Cabinet has withdrawn the Bill and is now focusing the new Acts that would be better suited to accommodate innovations and developments in pharma, healthcare and medical devices sector.
The government also aims to improve ease of doing business for the industries without compromising on safety, efficacy and quality of treatment here through this move, according to the government’s statement.
“The Cabinet has, keeping in view the role of the sector in managing public health, decided that it will not be appropriate to carry out further amendments in the present Act especially as newer areas of biological, stem cells and regenerative medicines, medical devices and clinical trial/investigation, etc. cannot be effectively regulated under the existing law,” the statement said.
The statement added that keeping in view the objective of make in India, it has been decided to comprehensively review the existing law with two fold objectives viz. to facilitate the ease of doing business and substantially enhancing the quality and efficacy of our products.
India is one of the largest manufacturers of pharmaceutical products in the world, with an annual production in excess of Rs 2 lakh crore, according to the government. Over 55% of this is exported to over 200 countries, including developed countries, it added.
