Keeping in mind the ‘Make in India’ initiative, India’s Federal government has decided to comprehensively review and revise the existing 76-year old drug laws on two important features: 1) to facilitate the ease of doing business, and 2) to substantially enhance the quality and efficacy of its products. The rewrite of the laws will take into account the regulation of biologics, regenerative medicines and clinical trials.
The Ministry of Health and Family Welfare has framed separate rules under the existing Act for regulating medical devices.The ministry is also working to bring about separate legislations for regulating medical devices and drugs and cosmetics.
A draft of the revised drugs law is expected to be ready in two months, top drug controller G.N. Singh told Reuters last week. “We thought it was better to revise the law than to put more bandages on it,” Singh said. He also mentioned that the government had requested regulators from the U.S. and Europe for input.
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,” added Advamed.
