The Union health ministry's ban on 344 fixed dose combination (FDC) drugs including painkillers, anti-diabetic, respiratory and gastro-intestinal medicines will have an impact of 3.1 per cent or Rs.3,049 crore of the country's pharma retail market currently valued at 98, 042 crores, according to a market based study.
The major market segment which will be impacted is respiratory with 16.9 per cent of the market coming under its effect followed by pain and analgesics market at 8.2 per cent and anti-diabetic at 7.68 per cent.
The ban on FDCs over safety and efficacy concerns will adversely affect MNCs like Abbott, Pfizer and domestic companies including Alkem, Ipca and MacLeods, according to market sources. 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.
As per the notification, a panel appointed by the government has found these medicines likely to involve risk to human beings and where safer alternatives are available. Besides this, these drugs are found to have “no therapeutic justification”, the notification says.
While the industry still studying its options, companies most affected have moved to court. "We have received an interim injunction suspending the operation of the said notification banning the manufacture for sale, and distribution of fixed dose combination of Chlopheniramine Maleate and Codeine Syrup till the next date of hearing. We are awaiting the order from the Delhi High Court," said Pfizer in statement.
Pfizer has discontinued manufacture and sale of popular cough syrup Corex with immediate effect after the ban on fixed dose combination of Chlopheniramine Maleate+Codeine Syrup.
Corex recorded sale of Rs.176 crore for the nine-month period ended December 31, 2015.
Abbott, the maker of popular cough syrup Phensedyl, has approached Delhi high court against the ministry of health and family welfare’s order banning its popular over the counter brand (OTC). The sales of Phensedyl, based on Codeine, an opium derivative, are estimated to be more than 3 per cent of Abbott’s $1 billion India revenue. Abbott’s global annual sales of over $20 billion.
FDCs have faced flak over the years with the drug regulator directing states to stop giving licences and ban some of them.