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Monday, February 21, 2011

New ingredients in drug? Can't retail under old name Read more

NEW DELHI, 16 FEB: The government will no longer allow popular drugs to be sold under the same name in case their vital ingredients have been changed.
Pharmaceutical companies will now have to also change the brand name of the drug if there is a change in their active ingredients.
This was decided by the Drug Controller General of India (DCGI), Dr Surinder Singh, in a specially called meeting of the country's Drugs Consultative Committee (DCC) on Tuesday.

DCGI officials said that there have been several instances where the brand name of a drug has not been changed because of its popularity even though the drug did not have the same ingredient.
"Since it is an established brand, the name is not changed or discontinued. But the new drug with new ingredients is sold under the same brand name to hold on to the market share. We will now send an advisory to all state drug controllers on not granting licence to such drugs," an official added.
Meanwhile, India will decide the fate of three controversial drugs -- Gatifloxacine, Tegaserod and Deanxit -- in a special meeting of the sub-committee of the Drug Technical Advisory Board on Thursday.
These three drugs do business of around Rs 70 crore annually. But lately, concerns have been raised about their safety. A decision on whether these drugs need to be banned in India will be taken on Thursday.
In another development, the government on Tuesday official recommended banning of six drugs including use of nimesulide for children below the age of 12, Phenylpropanolamine (PPA), human placenta extracts, sibutramine and R sibutramine. "Though the ban is effective from February 10, the official notification was issued only today. Manufacturers will now be told to withdraw all their stock from the market and license of manufacture for these drugs will be suspecded from immediete effect," Union health ministry sources told this reporter.
Officials said that the emergency DCC meeting was called on Tuesday following pressure from the parliamentary standing committee on health and family welfare which is meeting on February 18. The last time DCC met was in October 2010.

Times of India

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