The Health Ministry today has banned the manufacture, sale and distribution of the 328 Fixed Dose Combination (FDC) medicines by claiming the safety grounds related with it. The move will affect the almost 6000 drug brands like Corex, Saridon and Panderm.
The move by the government will surely end the long battle going between Health Ministry and drug manufacturer which was started since 2016. FDC drugs are those drugs made by the combination of two or more active drugs in a single drug form.
Among the popular brands which will get affected by the Health Ministry’s move includes Piramal’s Painkiller Saridon, Alkem Laboratories’ antibacterial Taxim AZ, diabetes drug Gluconorm PG and Macleods Pharma’s Panderm Plus skin cream.
The ban by the Health Ministry is followed by the recommendation of the Drug Technical Advisory Board (DTAB) who said that there is no therapeutic effect of the ingredients involved in the 328 FDC drugs and they even involve risk to the human health.
However, on March 10, 2016, Health Ministry had banned 344 FDCs under the section 26A of the Drugs and Cosmetics Act. Later on, they added five more drugs in the drug list.
The drug manufacturer appealed to multiple High Courts and Supreme Court after that and the apex court has asked the DTAB to examine the matter and they presented the report claiming the risk of those banned drugs.
Along with the 328 FDC drugs, the Health Ministry was also in the mood to ban other 15 major drugs including Phensedyl and Tixylix but Supreme Court restricted to do so as it includes the market price of almost Rs 740 crore and they were manufactured in 1988.
As per the government sources, the 328 FDCs banned currently occupied the market share of Rs 2500 crore and they will soon be vanished from the market.