Govt consults top foreign regulators to rewrite drug laws

The primary objective of the new law would be to push Make in India, allow better regulation of the latest generation of treatments, boost the quality of domestic manufacturing and improve oversight of clinical trials.

Finally junking the 75-year-old Drugs and Cosmetics Act, the health ministry is consulting top drug regulation bodies worldwide in order to write a new laws for drugs.

Until last year, the government was trying to tweak its archaic Drugs and Cosmetics Act of 1940 with an amendment bill being introduced in the Rajya Sabha in 2013. However, the government withdrew the amendment plan in June.

“The primary objective of the new law would be to push Make in India, allow better regulation of the latest generation of treatments, boost the quality of domestic manufacturing and improve oversight of clinical trials,” said GN Singh, drug controller general of India.

“We will consult almost every health regulator who deals with made-in-India medicines, starting with the FDA of the US, the MHRA of the UK and the European Medicines Agency.”

The D&C Act, labelled as a ‘law of bygone era’, can’t cater to the modern-day requirements. We need laws for the online sale of medicines, separate rules for medical devices, latest compliance methodology, and competitive good manufacturing practices.

“We have also drafted a new set of good manufacturing practices which are on a par with GMPs drafted by the World Health Organisation. The idea is to convince global regulators and domestic consumers about the efficacy of our medicines,” Singh said.

About 44 Indian drugmakers were banned from shipping products to the US, prompting the government to revamp its regulatory framework.