NEW DELHI: 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".
Here are the top 10 facts on Supreme Court's stay on centre's ban on FDC drugs
1. 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.
2. 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.
3. 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."
4. 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.
5. The Delhi High Court had stayed the ban last week on technical grounds after a pharma giant approached the court.
6. 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, had told NDTV.
7. 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, said Dr Agarwal.
8. In March 2010, the government restricted sales of 344 FDCs, a move that was challenged by pharma firms in court. The Supreme Court last December told the DTAB to ascertain whether FDCs should be banned from the market.
9. A government panel was constituted after the Supreme Court's December 15, 2017 order to review the safety and therapeutic use of these FDC drugs
10. In 2016, several top pharmaceutical firms including Pfizer Ltd and Glenmark Pharmaceuticals Ltd had gone to the Delhi High Court to challenge the centre's move to ban a separate list of 344 FDCs, including brands like Corex cough syrup, Vicks Action 500 and D'Cold. The court later stayed the government's ban.