DCGI to ban few more drugs in india

Its known to major people from this field that there are many drugs baned in other countries like US, Europe, Canada etc for the reason of safety and efficacy issue or harmful side effects but they are still available in our country india. DCGI has started surveying such drugs and already started action to ban all such drugs from indian market. recently the drug Rosiglitazone was banned in india due to safety concerns.
Continuation of that, under the guidance of DCGI, the Drugs Technical Advisory Board (DTAB) has examined few drugs with respect to its safety, efficacy and side effects and concluded that these drugs are to be banned due to its side effects on human beings. These drugs include nimesulide, cisapride, phenylpropanolamine and human placenta extracts. All these drugs will be banned in india very soon after the final decision by DCGI.

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.
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