After imposing a ban on more than 300 fixed-dose combinations (FDC), the government is now planning another shutdown on 1,600 of these tablets.
The Chandrakant Kokate committee had said these combinations will be looked into for the second round of ban, reports Business Standard. About 600 of the total 1,600 FDC tablets are vitamins.
The report quoted the committee saying while some of the medicines fell short of therapeutic value, others lacked the rationality and more research on the drugs were needed.
On March 10, 2016, the government banned 344 FDCs and later added five more drugs to the list. The ban came after a lengthy legal battle between the drug manufacturers and the government after the latter banned these drugs in 2016, saying they were irrational and unsafe.
But the drug manufactures appealed in high courts and the Supreme Court against the ban. The top court in December 2017 had asked the Drugs Technical Advisory Board (DTAB) to examine drug manufacturers' complaint.
In its report, the DTAB stated that the ingredients used in the 328 FDCs could pose serious health risks to the people consuming these medicines and recommended to impose a ban on them. The DTAB is now looking into all the 1,600 combination drugs in order to decide which one to ban.
The FDCs are estimated to contribute 1.8 percent of the total domestic drug market. This segment is reporting a comparatively lower growth rate of 4.7 percent in June as against the rest of the domestic drug market, which is 8.6 percent.
Around 6,000 brands are covered under the FDCs and these include popular drugs like painkiller Saridon, antibiotic Lupidiclox, skin cream Panderm, diabetes drug Gluconorm PG and antibacterial AZ. While the Supreme Court lifted the ban on the sale of Saridon on September 17, other 327 combination drugs still face ban.
All India Drug Action Network (AIDAN), a civil society group, which keeps a watch on safety and access to medicines, lauded the ban and had requested the government to act swiftly on the excluded FDCs.