New Delhi: The Indian Drugs Manufacturers Association has presented its case to the top drug regulator, urging a re-evaluation of the ban on 14 fixed dose combination drugs (FDC), besides granting a grace period for liquidating existing inventory.
FDC drugs, which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio, were recently baned by Drug Controller General of India (DCGI).
In its representation to the Union health ministry and the DCGI, IDMA said the 14 FDCs have been in use and consumed safely for at least 25 years without any reported adverse consequences.
Seeking to avoid wastage, the drug makers association is advocating for a year’s extension from the government to deplete the current drug stocks available in the market.
“We have requested the government to allow drug makers to use the existing stock available. The 14 FDCs have no side-effects and immediate banning of the drugs have caused a huge financial loss to companies,” Daara Patel, secretary general, IDMA, said in an interview.
Queries to the health ministry remained unanswered till press time.
In June, the Union ministry of health had notified the ban on 14 FDC drugs, such as Paracetamol, Nimesulide, codeine syrup and Chlorpheniramine Maleate, citing “no therapeutic justification“ for the medicines and possible “risks” to patients under section 26 A of the Drugs and Cosmetics Act, 1940.
The estimated market size of these 14 FDCs drugs in India is pegged at around ₹824 crore. About 95% of these are respiratory drugs, while 5% are used in neurological drug therapy and pain relief.
“The expert committee may have opted for regulating these FCD options, depending upon their widespread prescribing, rather than a blanket ban with immediate effect. It could even have the option to ‘restrict’ the availability strictly on prescription for the FDCs, but the same was not exercised,” said IDMA in a letter, adding that the drug regulator should reconsider its decision either by regulating or restricting sales of these drugs.
In 2016, the central government had banned manufacturing, sale and distribution of 344 drug combination after a panel of experts suggested that these drugs were being used in treatment without scientific data.
However, the government order was challenged by the manufacturers in court. The 14 banned cocktail drugs are part of the 344 combination drugs under scrutiny.
