With a view to stop irrational use of medicines, Health Ministry has banned 328 fixed-dose combination or FDC drugs. It includes popular painkillers, skin cream, antibiotics and cough medications such as Saridon, D-Cold Total and Corex etc. From today, the ministry has put a stop on their manufacture, sale and distribution. These drugs are banned in public interest as there is no therapeutic justification for the ingredients.
After this ban, around 6,000 brands are likely to be affected by the ban. With this ban, the legal battle between health ministry and drug manufactures came to end which started in 2016. In March 2016, the government had banned up to 344 FDCs. After that legal battle began even in Supreme Court.
Then SC asked the Drugs Technical Advisory Board to examine the matter in December 2017. In the report, DTAB concluded that there was no therapeutic justification for the ingredients in FDCs and these are risky for people.
For six other FDCs, the board recommended restrictions on sale and manufacture subject to certain conditions based on their therapeutic justification. Further, SC added not to consider DTAB report to ban 15 drugs in the list as these have been manufactured since 1988.
All India Drug Action Network said that in our estimate, the market for unsafe, problematic FDCs in India is at least one-fourth of the total pharma market which is valued at Rs 1.3 trillion.