Sunday, Oct 02, 2022

DCGI bars state drug regulators from granting combination drug license

Almost,over 60% of new launches in the domestic drug market are combination drugs.

The Drug Controller General of India on Friday barred the state drug regulators from granting manufacturing licenses to pharma companies under brand names of the drugs,directing them to strictly issue licenses under generic name of the molecule.

Additionally the central drug regulator asked the state licensing authorities not to grant licenses to combination drugs,which are technically ‘new drugs’. Under the drugs & Cosmetics Act,only the central drug regulator has the remit to grant license to new drugs and combination drugs,for most of which clinical trials have not been conducted fall under the new drugs category.

Till now,the tradenames or brands were also submitted by the companies to state drug regulators while applying for manufacturing licenses. “It has been observed that at the time of grant of license for manufacture of drug formulation,the trade name as submitted by the manufacturer is also endorsed by the licensing authority along with proper name of the product,thereby giving legitimacy to market the drug under the brand or the tradename,” the regulator said in the notification on Friday. “The grant of drug manufacturing license under a trade name is not in accordance with the spirit of legislation. Therefore,manufacturing license for drug formulation should be granted in proper name or generic name only,” the notification added. While this has been prescribed for single ingredient drug,for drug formulations containing multiple ingredients,the license would be issued to the composition.

“Instances were brought to the notice of central government that the licensing authorities of many states and UTs have been granting licenses for manufacture of new drugs including fixed dose combination falling under the category of new drugs…without prior approval of the licensing authority (DCGI). The Parliamentary standing committee on health had taken strong objection to this practice. For the drug companies it means that for a large part of their new introductions,they would have to apply for the central drug regulator. Almost,over 60% of new launches in the domestic drug market are combination drugs.

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First published on: 13-10-2012 at 09:48:49 pm
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