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.

picture02

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

comment icon Comments (0)
Post your comment
Related content
Strategic plans of ANVISA and COFEPRIS to advance health regulation
11 AA010165
Home/Policies & Legislation Posted 11/03/2024
Panama enacts new bill to guarantees the supply of medicines
53 MD002445
Home/Policies & Legislation Posted 29/02/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010