 "Gavel")
The Delhi High Court continued hearing rebuttals by pharma companies to the central government's stand in the much fought over FDC (fixed dose combination) drug ban case today.
The controversy arose after the central government issued a notification on March 10 pursuant to the Doctor Kokate Committee report banning 344 FDCs, leading most large pharmaceutical manufacturers including Pfizer, Abbott, GlaxoSmithKline and Cipla to immediately challenge the move in the Delhi High Court.
The court first heard the petitions on March 14 and provided the manufacturers interim relief by allowing them to continue production and sale of the notified FDCs on the grounds that the drugs sought to be banned had been in the market for several decades and the notification itself did not make out a case of extreme urgency.
In today's hearing, the court heard intervener applications and petitioner responses to arguments previously advanced by the central government justifying the ban. The interveners sought impleadment in the hotly contested matter on the grounds of public interest and social well-being.
The interveners made impassioned pleas highlighting to the court the present insufficiencyof pharma regulation in the nation and the necessity of the ban by the central government.
"This decision (the ban) has come afterdecades. We are the only country (in the world) with so many unregulated drugs.This is not a global phenomenon as these companies seek compliances themselves elsewhere. I hope my lord will consider the health and safety of citizens asparamount," Bijon Kumar Mishra, an intervening activist said.
The counsels for the petitioners in turn contested the intervener applications while furthering their arguments in opposition to the ban. They rejected the government's previous submission that the notification had been issued as part of a legislative process, which did not require principles of natural justice to be followed, supporting their contentions with relevant case law on the topic.
Parag Tripathi, senior advocate representing Wockhardt Limited questioned the decision making process of the central government in banning the FDC's in question and argued with the help of Supreme Court judgments,the necessity of consultations with the DTAB (Drug Testing Advisory Board) andDCC (Drug Consultative Committee) before the central government could have taken such action.
He further submitted that the constitutional validity of Section 26A of the Drugs and Cosmetics Act, 1940 had been upheld in the past only due to the advisory mechanism in place that specifically prevented arbitrary action being taken by the government.
According toTripathi, this made prior consultations of the government with these statutorybodies mandatory in nature, which could not be substituted by formation of anexpert committee. "One fine day, the government wakes up and suo-moto decidesto ban the drugs it feels. This is a jurisprudential jump which cannot be made," Tripathi said.
The counsels for the pharma manufacturersalso opposed the ban by challenging the power of the central government to issue such a notification under the Drugs and Cosmetics Act after state licensingauthorities had already issued prior approvals. They highlighted relevantsections of the Act favouring their stand, as well as constitutional provisionsthat list public health as a state issue.
Another ground for challenge raisedby the petitioners was the fact that the government had dichotomously targeted FDC's alone while still allowing the same combination of drugs to be prescribed inthe same proportions to patients individually. After hearing the arguments advanced, thecourt presided by Justice Rajiv Sahai Endlaw listed the matter again on 30 Mayfor further hearing.
