Cen­tre Can Ban Drugs Ap­proved by DCGI: Delhi HC

The Economic Times - - Companies - Prabha.Ragha­van @times­group.com

New Delhi: The Cen­tre can ban even those drugs ap­proved by the highest drug reg­u­la­tory au­thor­ity, the gov­ern­ment main­tained in the Delhi High Court on Wed­nes­day in de­fence of its ban on sev­eral com­bi­na­tion drugs last month, said a lawyer present at the pro­ceed­ings. The court, mean­while, has ex­tended by nearly two more weeks the stay on the ban of the brands us­ing these com­bi­na­tions, said the lawyer, who is rep­re­sent­ing a large phar­ma­ceu­ti­cal firm in the hear­ings.

Jus­tice RS End­law asked Ad­di­tional So­lic­i­tor General San­jay Jain, the gov­ern­ment's coun­sel, what guided the Cen­tre's de­ci­sion to ban the drugs with ap­proval from the Drug Con­troller General of In­dia (DCGI). "I wish to un­der­stand how some­thing which sat­is­fied the pa­ram­e­ters ear­lier has sud­denly been banned," he said.

The cen­tre re­served the right to ban these drugs in spite of DCGI's ap­proval as it was con­duct­ing a leg­isla­tive ex­er­cise de­tached from the reg­u­la­tor's past de­ci­sions and ap­provals, Jain re­sponded, ac­cord­ing to the lawyer. If al­low­ing the pro­duc­tion and sale of these drugs was against pub­lic in­ter­est, the gov­ern­ment could ex­er­cise the wide pow­ers of Sec­tion 26A of the Drugs & Cos­met­ics Act, Jain said, ac­cord­ing to an­other lawyer rep­re­sent­ing a large drug maker.

Jain also told the court that the pow­ers pro­vided to the gov­ern­ment by 26A were leg­isla­tive in na­ture and the gov­ern­ment, there­fore, was not re­quired to is­sue show-cause no­tices to the com­pa­nies, said the lawyer.

The court ex­tended the stay on the ban to April 18 and asked coun­sels of the pe­ti­tion­ers to nar­row down is­sues yet to be ad­dressed by the gov­ern­ment lawyer in the in­terim, said the first lawyer. More than 60 pharma com­pa­nies ap­proached the Delhi High Court fol­low­ing the health min­istry’s ban of 344 fixed dose com­bi­na­tions (FDCs), no­ti­fied in a March 10 gazette no­ti­fi­ca­tion.

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