Drug marketing approval may be delinked with patent status

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Drug marketing approvals may be delinked from patent status Marketing approvals for generic drugs may soon get delinked from their patent status, a long-standing demand of India's pharmaceutical industry that 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 this month between Indian drug makers and health minister Ghulam Nabi Azad. "Removal of the question of patent status was agreed to, in principle, at the meeting. But now, it has to go to the drug technical advisory board (DTAB, the highest advisory board for drugs) for approval," the official said, requesting anonymity. If deleted, the DCGI will issue approvals only on the grounds of drug quality and efficacy. (Source: http://www.livemint.com)
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Sanjay Patel's picture
Author: Sanjay Patel

Comments

Amol Malpani's picture

Dear Sir, Whether this de linking is good for industry prospective?
Sanjay Patel's picture

It will be beneficial for generic industry but not for innovator industry.

Sanjay Patel M.Pharm, LL.B (Continue) Indian Patent Agent patentagent2007@gmail.com

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