Hyderabad: The ministry of health and family welfare on Saturday cracked the whip on fixed dose combination (FDC) drugs, by banning around 344 such drugs widely available and prescribed in the Indian market. The move is a blow to many pharmaceutical companies.
The government has decided to prohibit manufacturing, sale and distribution of FDCs as the said drugs have “no therapeutic justification” and are likely to “involve risk to human beings”.
The pharmaceutical companies have begun weighing their options to challenge the order. Pfizer Ltd, the Indian unit of US-based Pfizer Inc., on Monday got a stay from Delhi high court against the government order to ban its popular cough syrup Corex.
Last year, the government reviewed some 6,200 combination drugs, of which some 15-20% were considered “irrational”, a Reuters report said quoting an unnamed government official in December.
According to analysts. the ban could cost Indian pharmaceutical companies about Rs.3,500-3,800 crore.
Here are five things you should know about FDCs.
1. What are FDCs? An FDC is a cocktail of two or more active drug ingredients in a fixed ratio of doses. According to US healthcare provider IMS Health, almost half the drugs sold in India in 2014 were FDC, making it a world leader in combination drugs.
2. Why are they popular in India? FDCs’ popularity in India is due to advantages such as increased efficacy, better compliance, reduced cost and simpler logistics of distribution. FDCs have shown to be particularly useful in the treatment of infectious diseases like HIV, malaria and tuberculosis, where giving multiple antimicrobial agents is the norm. FDCs are also useful for chronic conditions especially, when multiple disorders co-exist.
3. Is there a flipside to FDCs? Given that there is not much data available on drug-drug interaction and side-effects in FDC, India’s system for collecting data for problematic drug reactions is weak. When multiple drugs from the same therapeutic group, like antibiotics, are clubbed together, it may lead to resistance. A lot of FDCs sold in India are unapproved, given the lack of coordination between state and central regulators. A study published in the journal of Public Library of Science (PLOS) in May found that over 70% of non-steroidal anti-inflammatory drug (NSAID) combinations, which are used as painkillers, were being marketed in India without central government approval.
4. How commonly are they used? FDCs are quite common and are administered in almost every therapeutic area. Some of the common products include cough syrups based on codeine combinations, NSAID, analgesics and antibiotics. For instance, in the banned list of 344 FDCs, 27 are anti-diabetic drug metformin combinations, 16 anti-inflammatory nimesulide, 18 diclofenac, and half dozen codeine combination cough syrups.
5. Is the ban a first? To be sure, the latest ban on FDCs isn’t the first one. In 2007, the government ordered states to withdraw 294 combinations that were in the market without the approval of the central government. Drug companies and industry associations used legal means to push back the government’s order.
Analysts, however, say that just banning drugs isn’t enough, and that implementation is going to be the key.