In 2005, the Indian National Commission on Macroeconomics and Health labelled 10 out of 25 top-selling brands of medicines in the country as being irrational, non-essential or hazardous. Revital, Combiflam, Digene, Polybion and Liv-52 are some of the drugs named in the list. Shocking as this may be, things haven’t really changed then. The truth is that many drugs that are banned in other countries are sold in India and are easily available to people.
The most recent list published by the Monthly Index of Medical Specialities, India, revealed that 18 such drugs that are globally banned or severely restricted owing to harmful effects are still legally available in our country. The commonly used painkiller Analgin and diabetes drug Pioglitazone are some of them. Analgin is believed to carry the risk of a severe fall in white blood cell count while Pioglitazone is thought to increase the risk of bladder cancer. The strange part about these two drugs is that they were also banned in India, but brought back owing to different reasons, an important one being industry pressure.
Why there’s still no ban?
Not banning harmful drugs that are banned everywhere else in the world is the fallout of a corrupt system. Analgin is banned everywhere, even in Nepal, but here the ban was revoked. In India, after a ban the industry goes up in arms and it is brought back. It took 10 years to ban Nimesulide; yet. It is banned only for kids. Nimesulide is banned in most countries for adults too, as it is believed to cause liver damage.
Diabetologists say the drug Pioglitazone has been in controversy for many reasons. It was banned in France, then in Germany for its suspected relation to bladder cancer. We are short on data in India. Additionally, the dosage advised in India is much lesser than in other countries. It was first suspended and then reintroduced with certain warnings.
In America, everyone can read and write. There, with every drug a medical guide is given. People read the warnings and take the drug only when needed. In India, only a handful of people read these warnings. There is no proper surveillance system in India as far as side-effects are concerned. There is barely any post-marketing surveillance prevalent here. What should marketed and what not depends on the thinking of the Drug Controller General of India. If they don’t think ethically, we the people cannot do anything.
How to go forward from here?
The Pharmacovigilance Programme of India (PvPI), which started in July 2010, should involve corporate hospitals and general practitioners through medical councils as many of the new drugs are expensive and they are not sold in government hospitals. Consultants and medical professionals should also be sensitised.
Till date, PvPI is doing an exceptional job in terms of report collection. But the government is still not keen on taking any action. Physicians believe that the solution lies in getting the right people. The most important part is that regulatory decisions need to be taken by the right people. We don’t need more regulatory bodies, but need the right people who can take regulatory decisions.
A list of trouble making drugs
- Flupenthixol + Melitracen FDC