Govt’s decision to ban 344 FDCs was taken without consideration: Pharma cos to Delhi HC

The government will advance arguments after the pharma companies make their submissions

Pharmaceutical companies told 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.

“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 added that what dosage or combination was safe would differ from patient to patient.

He also 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 also said that even if licences were to be taken away, then it has to be done by following proper procedure and not the way the government has done it.

After hearing arguments on behalf of the drug companies for about 90 minutes, the court listed the matter for a later hearing.

The government will advance arguments after the pharma companies make their submissions.

During arguments, the companies also contended that the expert panel, which had observed these 344 FDC had no therapeutic justification, was not a statutory body and cited several judgements to show that only a panel as provided under the Drugs and Cosmetics Act could have been set up.