Hindustan Times (Delhi)

SC stays ban on sale of Saridon and two other drugs for now

- HT Correspond­ent letters@hindustant­imes.com

A BENCH OF JUSTICES RF NARIMAN AND INDU MALHOTRA ISSUED NOTICE TO THE GOVERNMENT AND SOUGHT ITS REPLY

NEWDELHI: The Supreme Court on Monday lifted the ban on sale of popular painkiller Saridon and two other drugs — Piriton and Dart — after their makers claimed these medicines were first manufactur­ed before 1988 and thus exempt from last week’s government notificati­on issued to stop the sale of fixed dose combinatio­ns (FDCS).

A bench of Justices RF Nariman and Indu Malhotra issued notice to the government and sought its reply on the plea filed by Piramal Healthcare, Glaxosmith­kline and Juggat Pharma, the three companies in question.

Additional solicitor general Pinky Anand opposed the order, arguing that it would set a bad precedent. She denied the claim made by the manufactur­ers that the drugs were pre-1988.

The Union ministry of health had on September 13 issued a notificati­on FDC drugs, effective from September 7.

FDCS are two or more drugs combined in a fixed ratio into a single dosage form. The government said these drugs did not serve any therapeuti­c purpose.

Piramal Healthcare, Glaxosmith­kline and Juggat Pharma rushed to the top court last Friday. The companies contended that their drugs were exempted as per a January verdict of the apex court referring the banned FDCS to the Drugs Technical Advisory Board (DTAB) for re-examinatio­n.

The firms claimed they have been manufactur­ing and selling the drugs before 1988, when the government came up with a definition of new drugs that included FDCS in one category. They added that the DTAB report, based on which the decision was taken, was not provided to them.

When Anand contested the claim that the drugs were pre1988, Justice Nariman asked her to file a written response. He said the court was only concerned about whether the medicines were manufactur­ed before the cut-off date or not. And such a submission, he said, cannot be countered through an oral submission.

The order lifting the ban would continue until the bench decides the fresh applicatio­n.

The ministry refused to comment on the court order but said it was examining it. “We will go through the order first to know exactly what it contains, after which we will decide the next course of action,” said a senior official, requesting anonymity.

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