A total of 328 combinations of drugs were banned last week by the Supreme Court last week, including a popular over-the-counter drug Saridon. After requests from the manufacturer, the apex court lifted the ban and allowed selling of Saridon as well as three other FDC drugs.
Saridon will be available in medical stores across the country, as Supreme Court has permitted the sale of Saridon as well as three other fixed dose combinations that were banned earlier this week. The ban was lifted as most of the pharma industries and drug makers plead the court to lift the ban on certain medications like Saridon; upon which, the justices of Supreme Court issued a notice to the Centre seeking their reply on the same. After reassessment, few drugs like Piramal Healthcare’s Saridon, GlaxoSmithKline’s Piriton, Juggat Pharma’s Dart and several other drugs were relieved from the FDC ban and will be allowed to be sold.
Another FDC that has been allowed by the Delhi High Court is Wockhardt’s Ace Proxyvon tablets, a mixture of three chemicals i.e. aceclofenac, paracetamol and rabeprazol. This medication is prescribed for patients with painful rheumatic conditions, such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. This combination, according to the pharma company was being manufactured and sold since 11 or more years and they weren’t even provided with the DTAB report till then.
It was on the basis of Drugs Technical Advisory Board (DTAB) report, that the decision was taken, and the sole reason for banning the FDC in that report was stated that it had no therapeutic value. In March 2016, the health ministry had banned the use of 349 FDCs, which was opposed by the pharma companies and the case was filed at Delhi high court. The high court lifted the ban on drugs which was again opposed and challenged by the Centre in the top court. Supreme court defied the order of high court and ordered DTAB to re-examine all the banned FDCs. The DTAB report stated that out of 349 drugs, 328 had no therapeutic specifications, which indicates a potential risk to human health and hence the supreme court suggested to prohibit the making and selling of these 328 drugs out of which some are excluded from the ban.