FDC ban order was legislative exercise, government tells Delhi HC
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New Delhi: Justifying its recent ban on 344 combination drugs, the central government told the Delhi high court on Wednesday that it was a “legislative exercise” that was not influenced by earlier approvals granted by the Drug Controller General of India (DCGI), a body which operates under the central act governing medicines in India.
This was in response to a question raised by justice Rajiv Sahai Endlaw, who asked the centre how it could disregard the approvals by the DCGI at earlier stages.
“I wish to understand how something which satisfied the parameters earlier has suddenly been banned? What was the basis for holding that the drugs have ceased to have therapeutic justification?” justice Endlaw asked.
The court was told by additional solicitor general Sanjay Jain that even if the DCGI had given approvals earlier to the drugs in question, there was nothing that prohibited the centre from banning them under wide powers extended to it under Section 26(a) of the Drugs and Cosmetics Act, 1940.
A host of pharmaceutical companies such as Pfizer Ltd, Glenmark Pharmaceuticals Ltd, Cipla Ltd, Workhardt Ltd and Dr. Reddy’s Laboratories Ltd have moved the court challenging the ban and won an interim stay which will continue till the next hearing.
The court will continue to hear the matter on 18 April.