GoI orders ban on 328 FDC drugs, including Saridon and Panderm

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The government of India has ordered the ban of upto 328 fixed-dose combinations (FDC), including painkiller Saridon and skin cream Panderm to stop their ‘irrational use’, NDTV reported. The health ministry says the ingredients in these medicines do not markedly add to the benefits that people can get from taking them.

The order calls for an immediate ban over the manufacture, marketing and sale of several common cough syrups, painkillers, and cold and flu drugs.

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.

Agarwal said that mixing two drugs creates a medicine. If it’s a new medicine, pharma companies should approach the Drugs Controller General of India and apply for a fresh licence, conduct trials, prove safety and only then go to the market, he stated.

Dilip Shah of Indian Pharmaceutical Alliance told NDTV that most firms have already discontinued their FDCs or have little stock left with them.

It will take upto two days for the FDCs to disappear. A few health experts alleged that, ‘quacks often prescribe FDCs as they are unable to pinpoint the exact cause of an illness and carpet-bomb patients with combination doses, in the hope that one of the drugs would work’.

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