India to delink marketing authorisation and patent status

Home/Policies & Legislation | Posted 07/01/2011 post-comment0 Post your comment

Marketing approvals for generic drugs may soon be delinked from their patent status in India. This comes as a result of long-standing demand from India’s pharmaceutical industry, which depends heavily on the sale of generic drugs.


The health ministry is planning to remove a question on the patent status of a drug from the form that medicine companies fill in when applying to the Drug Controller General of India (DCGI) for regulatory approval, a ministry official said.

The proposal follows a meeting in Mumbai, India, in November 2010 between Indian drugmakers and Health Minister Ghulam Nabi Azad.

If deleted, the DCGI will issue approvals only on the grounds of drug quality and efficacy.

The issue will be taken up at the next Drug Testing Advisory Board meeting.

Source: Livemint

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