The Delhi High Court on Wednesday asked the Union government if its recent decision to ban over 300 fixed dose combination (FDC) drugs was based on the failure of manufacturers to get approval for them, or was it the lack of their therapeutic efficacy. The court’s query sought to get the line of arguments on a batch of writ petitions clarified.
Justice Rajiv Sahai Endlaw of the High Court asked Additional Solicitor General Sanjay Jain whether the issue of legitimacy of approvals needed to be considered. Mr. Jain said that though the March 10 notification had banned FDC drugs on the ground of lack of therapeutic justification, most manufacturing firms did not hold a valid licence.
Senior advocate Kapil Sibal, appearing for drug companies including Pfizer, said that while the ban could be challenged, the manner in which the provisions in the Drugs and Cosmetics Act were applied was objectionable. “If they are banning a drug on the pretext of it being a new medicine, they have to show that it is a new drug. Otherwise, they have to show there is no therapeutic justification,” said Mr. Sibal.
Pharmaceutical companies opposing the Centre’s decision have contended that the prohibition was imposed without considering any clinical data.
