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Health ministry to ban all hazardous and doubtful therapeutic efficacy drugs in market
Ramesh Shankar, Mumbai | Wednesday, November 13, 2013, 08:00 Hrs  [IST]

The Union health ministry will soon ban all the hazardous and irrational drugs in the pharmaceutical market in the country.

In this connection, the ministry will soon constitute a 'special expert committee' which will review all drug formulations in the market and identify drugs which are potentially hazardous and/or of doubtful therapeutic efficacy.   Based on the final report of the committee, the ministry will weed out hazardous and irrational drugs from the pharmaceutical market in the country.

According to senior officials in the ministry, a mechanism would be put in place to remove these drugs from the market by the CDSCO at the earliest.

The ministry will also consider banning of a drug already marketed in the country if two or more countries remove the drug from their market due to issues related to safety and efficacy of the drug. “If two or more countries remove a drug from their market on grounds of efficacy and safety, then the continued marketing of the drug in the country will be considered for examination and appropriate action,” officials said.

For continued evaluation of drugs marketed in the country, the CDSCO will be supported by experts who would recommend, from time to time, removal of drugs from the market due to safety and efficacy issues, the officials further added.

The decision to constitute a 'special expert committee' to review all drug formulations in the market was taken at a meeting held by the ministry recently. The meeting was convened to discuss and examine the report of the Prof Ranjit Roy Chaudhury expert committee, which had submitted its report to the government recently, recommending sweeping changes in approval of new drugs, clinical trials and banning of drugs in the country.

Apart from several other sweeping recommendations, the Prof Ranjit Roy committee had also recommended for the setting up of a committee outside of the Drugs Technical Advisory Board (DTAB) to review all the drug formulations and vaccines now in the market and prepare a list of drugs which should be removed from the pharmaceutical market in the country.

The committee, in its report, noted with concern that in India there are unacceptably large number of formulations in the market at present, somewhere between 60000 and 85000, and many of these medicines should not have been allowed to reach the market in the first place.

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