India’s new medical device regulations to drop ‘shortly’

Regulators in India are close to releasing new rules governing the medical device industry there, as the world’s 2nd-largest country prepares to create a separate set of regulations for medtech.

India’s Ministry of Health & Family Welfare is looking to make it easier for medical device and pharmaceutical companies to do business there, while ensuring the safety and efficacy of the products. Today the government there said it’s scrapping legislation introduced in 2013 to reform its Drugs & Cosmetics Act as it focuses on crafting separate tracks for the medtech industry.

“The Ministry of Health and Family Welfare has, accordingly, undertaken an exercise at 2 levels; namely (i) to frame separate rules under the existing act for regulating medical devices; and (ii) to bring out separate legislations for regulating medical devices and drugs & cosmetics. While, after extensive discussions with all stakeholders, the draft rules for regulating medical devices have been prepared and will be draft notified shortly, work on drafting the new legislation has also commenced,” prime minister Shri Narendra Modi’s government said today.

India is also taking steps to modernize its approach to intellectual property, announcing in May a new policy meant to speed up online registration of trademarks and patents. As part of the change, India’s Dept. of Industrial Promotion & Policy will regulate the country’s IP rights.

But the move didn’t update didn’t amend India’s patent laws, despite pressure from the U.S. and other Western nations. This means India will still keep its ability to issue compulsory licenses to drug companies under “emergency” conditions. India also won’t initially change any patent laws that weren’t already fully compliant with World Trade Organization rules.

 

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