SC Allows Sale Of Saridon, 3 Other Drugs

NEW DELHI — The Supreme Court on Monday allowed sales of pain reliever Saridon and two other drugs in a major but temporary relief to Piramal Healthcare Ltd and GlaxoSmithKline Pharmaceuticals Ltd.

Saridon and two other fixed dose combinations (FDCs), a painkiller called Dart and Piriton Expectorant, used for common cold, cough and other conditions, are part of a long list of FDCs banned by the ministry of health and family welfare last week.

Their manufacturers approached the Supreme Court after the ministry announced prohibiting the manufacture, sale or distribution of 328 FDC drugs for human use with effect from Wednesday. The court after hearing the companies passed an interim order permitting them to continue manufacturing and sale of the products until a final judgement is passed.

Saridon, a commonly used FDC contains a combination of propyphenazone, paracetamol, caffeine and was banned as, according to experts, “propyphenazone appears in the WHO list of drugs which are either banned or severely restricted”. “One reason of the ban is that much safer alternatives are available, so why take a risk?,” said Dr. Chandra M. Gulhati, editor at Monthly Index of Medical Specialities (MIMS).

 “The FDC was banned in Turkey in January 1986 and subsequently in some West Asian nations in 1989. FDC of propyphenazone + paracetamol + caffeine is known to cause some serious side effects, more particularly Kounis syndrome where patients suffer from acute heart attacks with low heart movement. Besides adverse effects of paracetamol are well known including liver failure,” he said.

Chinu Srinivasan of All India Drug Action Network (AIDAN) finds it “morally wrong” on the part of companies to approach the court when the expert committee have declared that these drugs are harmful. “It is morally irresponsible for the manufacturers to continue to insist on the right to market the drugs”.

Piriton Expectorant, a GSK product is used for common cold, cough relief, itchy throat/skin, allergy, kidney stones, acidity, hay fever, rhinitis, allergies. According to GSK spokesperson, “Piriton Expectorant has a less than 1% market share in the ethical cough syrups market”.

The president of the Indian Drug Manufacturers’ Association, Deepnath Roy Chowdhury, had said the ban on 328 combination drugs would have an impact on a market worth an estimated ?1,500 crore a year.

In its report submitted on 20 January 2015, the committee led by Chandrakant Kokate, vice-chancellor of KLE University, Karnataka, had deemed these FDCs irrational, saying they posed health risks, and, hence, suggesting banning them, pushing some of the companies and the pharma groups to challenge in 2015 the government’s notification banning FDCs in the court.

Last December, the apex court referred the matter to India’s top drug advisory board (DTAB) for a fresh review on whether these drugs should continue to be marketed or not. The Supreme court suggested that DTAB should decide whether the manufacture and sale of these drugs should be regulated, restricted or banned outright, and submit its report and recommendations to the government within six months.

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