The Supreme Court has allowed the sale of Saridon and two other drugs for now after the government had banned 328 combination drugs last week. The top court's order comes on a petition filed by the drug makers.
While lifting the stay, the court sought the centre's reply on petitions against the order to ban fixed-dose combination or FDCs manufactured before 1988. Painkiller Saridon and skin cream Panderm were among 328 FDC drugs banned by the government to stop their "irrational use".
Major pharma companies while challenging the centre's decision claimed that the only reason given in the government's notification was that the combination had "no therapeutic value".
Saridon and the two other drug manufactures challenged the government's decision and argued in court that they are making the medicines since the 1980s. The government rebutted the pharma companies' argument. The Supreme Court said the stay on the centre's notification, banning these three drugs, remains till it decides on the issue.
FDC drugs 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 the centre's notice said was unfit for consumption.
The government had added restrictions to dosage and use of six more FDCs, not among the 328 banned ones, over their ingredients having no "therapeutic value."
The health ministry's decision was based on the country's top drug advisory body, the Drug Technical Advisory Board or DTAB. The DATB 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.