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The Delhi High Court continued hearing arguments on the much-contested drug ban notification today. The notification issued by the Central Government on March 10 pursuant to the Kokate Committee report had banned 344fixed dose combination drugs (FDC's) has been challenged by largest pharmaceutical manufacturers including Pfizer, Abbott, GlaxoSmithKline and Cipla.
The Court had first heard the petitions on March 14 and provided the manufacturers interim relief by allowing them to continue production and sale of the notified FDC's 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 counsel for the government Advocate Rajul Jain continued his arguments in support of the ban and drew the courts attention to the legislative intent behind the Drugs and Cosmetics Act, 1940 under which the notification was issued. He sought to clarify the extent of the central government's delegatory power under the Act beginning with the mechanism in place before the 1988 amendments to the legislation and subsequent changes thereafter.
In line with his earlier arguments, Jain reiterated before the court that the Act had to be given a purposive interpretation. As such, any rules framed by the government as well as the impugned notification issued to promote the objectives of the legislation, must be treated as valid so long as they were reasonable in nature and did not explicitly contravene the parent statute. He further continued to state that in a dynamic industry such as pharmaceuticals, regular assessments of safety and therapeutic efficacy were vital in light of public interest and well-being and the drugs in the notification had not met such requirements leading to the ban.
“By doing this (the evaluation and subsequent notification) the Central Government is maintaining the objective of the Act as highlighted in the preamble" Jain said in court. The counsel for Pfizer vehemently opposed the government’s stance and took the example of Corex, a drug that had been issued previous approval by the government and yet had been banned as per the notification, even though the Kokate Committee had not deliberated about its safety or efficacy. Jain in response highlighted the government’s power to conduct periodic testing under Section 26 of the Act and said the provision by necessary implication, even allowed for withdrawal of previously issued approvals.
In addition, he submitted that the government had requested data from the manufacturing companies for the previously approved drugs now banned by the notification, but were not furnished any of the necessary particulars as requested.
After hearing the arguments advanced, the court continued its previous interim orders in favour of the petitioners and listed the matter again on May 12. "After so much hearing, let's now draw the general principles on which to establish the basis to proceed" the presiding Justice Rajiv Sahai End law finally remarked while concluding the day's hearing.
