Drug ban explained: Most irrational combination drugs sold in India do not exist in UK or US

FMCG firm Procter & Gamble (P&G) has discontinued manufacture and sale of its popular brand 'Vicks Action 500 Extra' with immediate effect after the government banned 344 fixed dose combination drugs. The company has also said that it will challenge the ban.

 Drug ban explained: Most irrational combination drugs sold in India do not exist in UK or US


Here's is an all you need to know about the development:

What is the ban all about?

The government on Monday banned 344 fixed dose combination (FDC) drugs, including several antibiotics and analgesics, saying that a government-appointed panel of experts had found the combinations lacked "therapeutic justification". An FDC is a drug that is a combination of two or more drugs in fixed proportion. Vicks Action 500 extra is a combination of Paracetamol, Phenylephrine and Caffeine.

According to the notification, the government, as per the recommendation of an expert committee, found that "it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use" of the drugs.

For a full list of the drugs banned, click here.

What does the move mean for the consumer?

Like Vicks Action 500 Extra, many popular brands are likely to go off the shelves. There will be a scarcity of such OTC drugs, but on the whole the move is indeed good from a health point of view. A report in The Times of India says, the side effects of these drugs mostly go unreported since patients do not generally return to the doctors to consult. Also the mechanism that monitors the healthcare system is weak. According to the report, the health ministry feels such medicines "are causing anti-microbial resistance. The usage could even result in organ-failure, the report says. "Our objective is to ensure only safe products are available in the market. We have reviewed products for several times and there is evidence from research papers and studies to show these medicines are irrational combinations," a healthcare official has been quoted as saying in the ToI report.

What is the industry saying?

The ban has taken the pharma industry by surprise. The Indian Drug Manufacturers' Association has said it is weighing all options. Meanwhile, individual companies are also taking legal route. Abbott, Macleods Pharma and Pfizer have already got relief as court has lifted or stayed the ban. P&G has said it will challenge the ban in the court.

The worry of the industry is understandable. According to estimates, these companies are likely to suffer immediate loss of Rs 1,000 crore. However, the annual loss is pegged at Rs 4,000 crore. This could even go to Rs 10,000 crore, if more drugs are banned. The size of the pharma market in India is estimated to be Rs 1 lakh crore.

What next?

More bans and protracted legal battles. According to media reports, there are more bans on the way. This is because, as the ToI report says, there are 1,000 such cases under scanner. Once the government issues ban order, expect more legal battles.

The problem of FDCs has been there for quite some time in the country. The companies themselves are some of those banned drugs are being sold in the country for the last 30 years. A report in The Hindu in May 2015 citing a paper published in PLOS Medicine notes that India is flooded with such risky FDCs. The paper is based on a study done in just four therapeutic areas including analgesia, anxiety/ depression and psychosis. "Most of the FDC formulations available in India [in the four therapeutic areas studied] were unavailable in either UK or the U.S," the report says quoting from the paper.

All in all, 344 is just the tip of the iceberg.

Updated Date: Mar 16, 2016 14:32:43 IST