Supreme Court of India lifts ban on Saridon, two other drugs

The Supreme Court of India lifted the ban of painkiller Saridon for the time being on Monday.  Justices R F Nariman and Indu Malhotra’s bench heard the plea challenging the ban.

The court also allowed the sale of  two more drugs Piriton and Dart. The apex court issued a notice to the government of India on the plea filed by Piramal Healthcare, which makes Saridon, GalxoSmithkline and Juggat Pharma.

The petitioners stated that the drugs had were manufactured before 1988 and thus exempted from last week’s government notification issued to stop the sale of 328 fixed dose combination (FDC) drugs. Additional Solicitor General Pinky Anand opposed the order and said that it would set a bad precedent.

Earlier, the Drug Technical Advisory Board of India said there is no therapeutic justification for the ingredients in these drugs and they must be banned in public interest.

An FDC drug has a combination of two or more active ingredients in a fixed dosage ratio, meaning that not a single drug, but a combination of drugs have been banned due to unnecessary consumption.

The order has stated restrictions to dosage and use of six more FDCs, excluding the 328, over their ingredients having no therapeutic value and posing a risk to consumers.

The DTAB had earlier stated in a report that taking the 328 FDCs would be a health risk. “The Delhi High Court stayed this (FDCs ban) on technical grounds, but it is a good move for public health. Individual drugs are approved by the centre, but some manufacturers make combinations of two drugs and get state licences,” Dr KK Agarwal, former president of Indian Medical Association, told NDTV.

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