Delhi HC revokes ban on 344 medicines

R Sedhuraman

Legal Correspondent

New Delhi, December 1

The Delhi High Court on Thursday revoked the ban on the manufacture and sale of 344 fixed dose combination (FDC) medicines such as Corex cough syrup, Vicks Action 500 Extra and D’Cold.

Justice Rajiv Sahai Endlaw quashed the official notifications, holding that the government issued these orders from March 10 this year without following the statutory procedures.

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Citing the findings of an expert committee headed by Prof CK Kokate, Vice-Chancellor of KLE University, Belgaum, Karnataka, the Centre had said these FDCs had no therapeutic justification.

The government had said it was necessary and expedient in public interest to regulate by way of prohibition of manufacture and sale of these drugs.

Justice Endlaw ruled that the government, though acting in public interest, had imposed the ban after dealing with the problem in a haphazard manner.

The HC ruling came on 454 petitions filed mostly by pharmaceutical companies and some NGOs.

The government claimed that the licences for the manufacture of the FDCs were issued by state licensing authorities between September 1988 and October 2012 without the approval of the Drugs Controller.

However, instead of taking action for cancellation of the licences, the manufactures were asked to apply for licences to the Drugs Controller, while continuing to manufacture the drugs for which according to the Central government licence was wrongly given.

After receiving the applications from the companies, instead of getting these considered by the Drugs Controller, the government set up 10 committees.

After the committees failed to examine all the applications, the Kokate Committee was constituted. The Kokate Committee, instead of considering the applications for approval, went into the aspects of risk to consumers and therapeutic value and therapeutic justification. On receiving report, the government banned the FDCs, the HC noted.