US consumer health group Procter & Gamble ‘s Indian business plans to challenge a government ban on its cough-and-cold medicine Vicks Action 500 Extra, citing potential health risks.
Procter & Gamble Hygiene and Health Care said that while it had stopped selling the product, it was evaluating all options to challenge the ban.
. Vicks Action 500 Extra is a fixed-dose combination of paracetamol, phenylephrine and caffeine, which was banned by the health ministry in a notice issued over the weekend.
The product was one of 344 drug combinations, including several antibiotics and analgesics, that India ordered to be prohibited, saying that a government-appointed panel of experts had found the combinations lacked “therapeutic justification”.
What is the ban all about
India has banned 344 fixed dose combination (FDC) medicines that are mostly used for cold, cough, fever etc, over their high toxicity and fears that they could cause anti-microbial resistance.
One of the largest markets for fixed dose combination drugs, India’s market allows sale of some drugs that do not pass more stringent regulations in other countries.
On Tuesday, it was said that another 400-odd medicines could also be added to the banned list.
Why is this happening?
According to experts, 90% of fixed dose combination (FDC) medicines available in market are irrational (not approved by the national regulator), and may have serious side-effects like high toxicity or even multi-organ failure. FDC medicines have two or more medicines that are independently approved for human use in specific amounts. However, combination medicines in most cases aren’t approved, raising doubts about its safety and efficacy. Over the years, markets have been flooded with these FDC drugs, with the Centre blaming state drug regulators and states blaming the Centre for giving approvals. The central government finally decided to regulate the grey area, and introduced the ban.
Why should we care?
The ban means not getting some of the most commonly-used medicines in Indian households for cold, cough, fever etc over-the-counter, i.e., without a prescription.
What other drugs can be banned?
Nearly 1,500 more pharmaceutical units are under scrutiny, and the number of FDC medicines could be close to 400. It, however, may take up to six months for the fresh list to be prepared as it is being scrutinised by an expert committee.
What does this mean for drugmakers?
It means huge losses, to the tune of thousands of crores, for the pharma companies as they will need to pull out existing stocks of the banned combination drugs from the market with immediate effect, and stop manufacturing, sale and distribution of these medicines for future.