The government has banned more than three hundred fixed dose drugs including painkiller Saridon and skin cream Panderm to stop their ‘irrational use’ and adverse health impact on people. The health ministry said that the ingredients in these medicines do not add significantly to the benefits that people can get from taking them.
The order immediately bans the manufacture, marketing and sale of 328 fixed-dose combination or FDC drugs including several common cough syrups, painkillers, and cold and flu drugs and restricted another six.
It will affect around 6,000 medicine brands like Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim with a combined market size of Rs 2,000-2,500 crore in the country.
The country’s drug advisory body, the Drug Technical Advisory Board or DTAB, has said there is no therapeutic justification for the ingredients in these drugs and they must be banned in public interest.
What is FDC?
A fixed-dose combination or FDC drug contains two or more active ingredients in a fixed dosage ratio. For example, one of the FDCs in the banned list is “naproxen plus paracetamol”, meaning it’s not the single drug but a combination of the two that has been ascertained as unnecessary for consumption.
The health ministry took the decision after the country’s top drug advisory body, the Drug Technical Advisory Board or DTAB, in a report said taking the 328 FDCs would be a health risk. India has some 2,000 FDCs as against a little over 500 in the US.
The background of FDC ban
On March 10, 2016 the Health Ministry had prohibited the manufacture for sale and distribution for human use of 349 FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940.
But the matter was contested by the affected manufacturers in various high courts and the Supreme Court. Complying with the Supreme Court verdict in December last year, an expert panel formed by the Drugs Technical Advisory Board (DTAB), in its report to the Centre, stated that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings.
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