FDC medicines combine two or more drugs in a single pill. When multiple drugs from the same therapeutic group, for example antibiotics, are clubbed together, it may lead to resistance, according to experts. In India, many pharma companies obtain licence from a state to make FDCs, and sell them without the consent of the Central government.
The Kokate Committee has reviewed about 6,600 FDCs so far and classified them under four categories — irrational, require further deliberations, rational and require additional data generation.
“Under the irrational category, there were 963 FDCs, out of which 350 have been announced, and the list has been dismantled. We have moved to the ‘require further deliberations’ category, where the final list is expected to come in six months,” an official at the Central Drugs Standard Control Organisation (CDSCO) said.
The DGCI has now submitted the “B” list to the Kokate committee. Out of the 1,200 FDCs mentioned in the list, 8-10%, i.e. around 120 drugs, would fall under the banned category, a senior DGCI official said.
“As per estimate, each FDC has at least 5 to 10 brands in the market, which means around 1,200 more drugs are likely to be banned,” the official at CDSCO added.
According to government estimates, the ban on 350 FDCs , which impacts over 2,700 branded drugs, will lead to a loss of about Rs 7,000 crore for the industry. The domestic pharma industry currently has a market size of Rs 1 lakh crore.
“We are not against any product or brand. We are only siphoning off the irrational combinations,” said CK Kokate, chairman of the committee formed by the government to reviewed FDCs.
Drugs shortage warning
Meanwhile, chemists have warned the government that the recent ban on 350 fixed-dose combinations (FDCs) would lead to shortage of almost 5,000 medicines, including generics, from the market.
All India Organisation of Chemists and Druggists (AIOCD), the association representing about 750,000 medicines sellers across India, has written a letter to the Drug Controller General of India (DGCI) citing the possibility of closing their shops for at least 30 days.
“The unpleasant action many force us to shut down our shops and find out different brands of banned formulations available with us... followed by return of the stock to the concerned distributor and manufacturer,” chemists have written in the letter.
“It will take at least 30 days to complete all formalities and return the stocks. It will create serious impact on availability of the medicines to consumers,” said JS Shinde, AIOCD president, in the letter.
“The notification by the government impacts 5,000 drugs available in the market...It is very difficult for traders to find out brands of these molecules manufactured by other makers. It is very difficult to stop sale of these products with immediate effect,” said the letter.
Chemists have also urged the government to advise all concerned state authorities not to take any action against traders.
Pharm.D @ SRIPMS-CBE-TN