Cabinet withdraws drugs and cosmetics amendment bill

New Delhi: The cabinet on Wednesday withdrew the Drugs and Cosmetics (Amendment) Bill, 2013, which was to amend the Drugs and Cosmetics Act, 1940.

The cabinet took the decision as new areas in medical field such as stem cells, regenerative medicines, medical devices and clinical trials cannot be effectively regulated under the law. The health ministry will now frame separate rules for regulating medical devices under the existing Act.

The medical devices industry welcomed the cabinet decision, stating that it provides an opportunity to start fresh discussions around regulation of medical devices in the country.

The Bill was introduced in the Rajya Sabha on 29 August, 2013. It was examined by a standing committee of Parliament which made a number of recommendations for changing the provisions of the Bill.

India is one of the largest manufacturers of pharmaceutical products in the world, which includes medical devices, apart from medicines.

According to the Union health ministry, the annual production of these products is in excess of ₹ 2 trillion. Out of this, over 55% is exported.

The Drugs and Cosmetics Act, 1940 provides a regulatory framework for ensuring quality, safety and efficacy of medical products including medicines and medical devices.

The amendments were proposed to bring the old Act in sync with requirements of advanced scientific discoveries like stem cells and regenerative medicines, among others.

“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,” said a statement by the government.

The statement said that India can leverage the comparative cost advantage in medical products. The country has the potential to become an international hub for manufacturing these products and attracting investment, apart from meeting domestic demand.

The ministry of health and family welfare has already undertaken an exercise to frame separate rules under the existing Act for regulating medical devices. The ministry is also working to bring out separate legislations for regulating medical devices and drugs and cosmetics.

Meanwhile, the medical devices industry has welcomed the Cabinet decision.

“AdvaMed appreciates the government of India’s efforts over the years to press forward with legislation that would create separate and appropriate regulations for medical devices,” said a statement issued by AdvaMed India, a forum of medical devices manufacturers.

“We view the withdrawal of the Drugs and Cosmetics (Amendment) Bill, 2013 as an opportunity to start fresh and consult with relevant stakeholders to draft new and globally harmonized legislation that would once and for all carve out distinct regulations for medical devices. This step is critical to the growth of the industry and — equally as important — to ensure that patients have access to innovative and lifesaving technologies.”