Delhi HC hears further arguments by pharma firms against FDC drug ban

Centre had notified a ban 344 fixed-dose combination drugs, impacting large pharma firms such as Pfizer, Abbott, GSK and Cipla

The Delhi High Court continued hearing petitioner rebuttals to the central government's stand in the FDC (fixed dose combination) drug ban case today.

The conflict arose after the central government issued a notification on March 10 pursuant to the Kokate Committee report banning 344 FDC's, leading most large pharmaceutical manufacturers including Pfizer, Abbott, GlaxoSmithKline and Cipla to challenge the move in the Delhi High Court.

The court first heard the batch of petitions on March 14 and provided the manufacturers interim relief by allowing them to continue production and sale of the notified FDC's.

In today's hearing, the petitioners continued highlighting their objections against the government's justification of the ban. Senior advocate Ashwini Mata opened the arguments for the pharma companies by reiterating the absence of DTAB (Drug Testing Advisory Board) and DCC (Drug Consultative Committee) consultations prior to issuance of the notification by the government. He vehemently contending that such prior advice was mandatory in nature and as a result rendered the ban 'ipso-facto' void due to the deficiency.

Appearing next, senior advocate Gopal Jain furthered the stand of the petitioners by seeking to clarify the scope of the government's power under the Drugs and Cosmetics Act, 1940. He submitted that the statute contained an in-built doctrine of proportionality, which specifically provided for safeguards from unreasonable government action. "The act is a conclusive code with built in checks and balances, it needs to be followed strictly. In modern day governance, there is a well established need for full statutory compliance and transparency" Jain said.

In support of their contentions, the counsels for the petitioners also drew the attention of the court to Sections 6, 12 and 33 of the Drugs and Cosmetics Act, which allow the government to frame rules only after prior consultations and argued that the same requirement applied to notifications under Section 26A (under which the ban was issued) as well.

After hearing the arguments advanced, the bench presided by Justice Rajiv Sahai Endlaw further extended the interim orders previously advanced and listed the matter again for tomorrow in an attempt to expedite proceedings before the close of the court for the summer vacation.