India to rewrite 75-year old drug laws with an eye on business, biologics and devices

By Gareth Macdonald contact

- Last updated on GMT

India to rewrite 75-year old drug laws with an eye on business, biologics and devices
India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.

Originally, the Indian Government planned to update the Drug and Cosmetics Act of 1940 with an amendment​ put forward in 2013.

However, last night​ Prime Minister Narendra Modi said the Union Cabinet had abandoned this idea in favour of a more extensive revision.

Modi said the new plan is to rewrite the legislation to “facilitate the ease of doing business​” and “enhance the quality and efficac​y” of drugs and medical devices made in India.

Few details of the changes have been provided, although the Government did say it has already developed separate legislation for medical devices.

Under current laws such products are classed as drugs.

Draft law in two months

The CDSCO announced it had “initiated steps, to revisi​t” the laws covering the safety, efficacy and quality of drugs earlier​ this month.

The organisation also called for suggestions from industry, however, the 15-day comment period was due to expire on June 20.

CDSCO head G.N. Singh told Reuters​ a draft of the new legislation will be ready in two months, explaining that "We thought it was better to revise the law than to put more bandages on it​"

He also said India’s Ministry of Health and family Welfare has already asked US and European regulators for input.

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