Pharma firms likely to face MRTPC inquiry

NEW DELHI: Seeking to crack down on pharma companies trying to beat price regulations by making cosmegptic changes to drug formulations while retaining brand names, the investigative arm of the Monopolies and Restrictive Trade Practices Commission (MRTPC) has asked state drug controllers to list firms that indulge in such practices.

According to sources, the Director General of Investigation and Registration (DGIR) has sent letters to various state drug controllers seeking details of companies, whose drugs have escaped the purview of Drug Control Order (DGO) due to tinkering in formulations, sources said.

Following directions from the MRTPC last year, the DGIR has been asked to submit a report after conducting a probe into the matter.

The Commission had received complaints that some pharma companies were making minor changes in formulation to keep their drugs out of the purview of price control order. According to the sources, despite changes in their drug formulation, pharma companies retained their respective brand names of the drugs.

In the letter sent to the state drug controllers, the DGIR also asked them to submit names and other details of pharma companies that had withdrawn their registration for drugs, whose formulations had been altered in the last three years, the sources said.

The same issue was taken up late last year by the Drug Controller General (DCG), who alerted various state drug controllers and all zonal officers of Central Drugs Standard Control Organisation (CDSCO) against such violation of the 'Drugs and Magic Remedies Act'.

The DCG in its letter also said that in the case of the the companies holding the same brand name even after changing compositions, particularly in respect of active ingredients, they must be directed to change the brand name to avoid misleading the public and healthcare professionals.It said that retention of brand name in such cases could also be interpreted as “misbranding” under the Drugs and Cosmetics Act, as they mislead the public and healthcare professionals.

Source: Bussiness Standard
1st May 2007

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