The ban on “irrational” 350-odd fixed dose combination (FDC) drugs including wide-selling pain-killers, anti-diabetic medicines and respiratory therapies, will impact nearly 4% or Rs 3,800 crore of the organised pharma retail market.
The ban on FDCs over safety and efficacy concerns will adversely affect MNCs like Pfizer and Abbott and domestic companies including Alkem, Ipca and MacLeods, and is likely to be contested by companies, sources say.
Top brands which will face a ban include popular analgesics Zerodol and Sumo, dermatology drug Panderm Plus, anti-diabetic medicine Tripride, and gastro-intestinal drug Zenflox, besides cough syrups Phensedyl and Corex.
Taking the drug industry by surprise, the health ministry in a notification on March 12 has prohibited the manufacture, sale and distribution of nearly 350 FDCs with immediate effect. A fixed dose combination contains two or more drugs combined in a fixed ratio of doses, and available in a single dosage form.
The notification, a copy of which was reviewed by TOI , includes medicines “likely to involve risk to human beings”, where safer alternatives are available, and which are found to have “no therapeutic justification”, a panel appointed by the government found.
While the industry is still studying its options, companies most affected may go to court, sources told TOI.
FDCs have faced flak over the years with the drug regulator directing states to stop giving licences and ban some of them.
Date: 14th March, 2016.