Govt banned FDCs without considering clinical data: HC told

Pharma companies on Tuesday told the Delhi high court that the government’s decision to ban 344 fixed drug combinations (FDCs) was taken without considering any clinical data. 

The submission was made in the court of Justice Rajiv Sahai Endlaw, before whom over 150 petitions have been filed by pharma and healthcare majors, including Pfizer, Glenmark, Procter and Gamble (P&G) and Cipla, challenging the government’s March 10 decision. The decision was stayed in each individual case by the court as an interim measure which still continues.

The companies termed as “absurd” the government’s claim that it took the decision to ban the FDCs on the ground that safer alternatives were available. “About 344 FDCs were banned in one go without considering any clinical data. Argument of safer alternative or safer option is absurd. It is a non-starter,” senior advocate Kapil Sibal, appearing for Pfizer, said and adding that what dosage or combination was safe would differ from patient to patient.

He said the industry as a whole would not want to make or sell unsafe drugs and added that many of the affected drugs, like Pfizer’s Corex cough syrup, have been in the market for 20-30 years. Sibal said if state licensing authorities were illegally issuing licences, the government would not have kept quiet till now. He said even if licences were to be taken away, then it has to be done by following a procedure and not the way the government has done it. 

The hearing will take place on Wednesday.