Banned drugs aplenty in Karnataka

R Baby Manoj - Bangalore

By blatant negligence or willful default, pharmaceutical companies continue selling globally banned and voluntarily withdrawn drugs in the state market.

Further, the suburban and rural physicians in Bangalore districts are absolutely in the dark about recent developments in the drug industry including withdrawal of rofecoxib by Merck. They continue prescribing banned and withdrawn drugs to the unsuspecting patients in the state, a good number of them uneducated or illiterate.

Take for instance analgin; a drug banned world wide because of grievous side-effects, in the form of injections and tablets, and doctors continue prescribing it. Terfenedine originally banned in the US in 1999 was till recently available in the city markets.

Jansen Pharmaceuticals in the US has stopped marketing cisapride and made it available only through an investigational Limited Access Programme. Cisapride is easily available in retail shops in the city.

Even in the rare countries where its use is permitted, there is an accepted norm that the drug should be made available only through the manufacturer and should be sold only if a gastro-enterologist prescribes it.

After remaining complacent for a long period, recently the DCGI has issued instructions to druggists that ciscepride should be sold on prescriptions by gastro-enterologists only. Vigilant professionals in the pharma industry committed to ethical practices can now heave a sigh of relief ; that much action has been taken.

Phenyl Propyl Amine is yet another drug withdrawn from the market by USFDA as early as 2000, because of a number of side effects including cerebral stroke. Children’s combinations of PPA are available in the market in the state.

Lackadaisically, medical practitioners are of the view that in the cough syrup, the quantity of drug would be very small and it would be harmful only at a particular dose. They feel that there is nothing wrong with prescribing it.

Another widely used drug after the ban is Rofecoxib; however it is being slowly getting out of the shelves. Various combinations are also slowly disappearing.

“When the company says it is withdrawing a particular drug from the market, definitely it should not be sold in retail shops,’’ opines P K Lakshmi, deputy director of Drug Information Centre, Karnataka. She says the mechanism of dissemination of information in the country is ill developed. Especially the regulatory authorities are not successful in reaching out to registered medical practitioners with vital information, she adds.

Dr Prakash Rao, an activist who heads Bangalore based ’Drug Action Forum’ says, ‘‘Banned drugs as such are not sold per se. However, the same generic with different brand names are sold. For example, Neurobion is a banned drug. But Neurobion-forte is widely sold. Nimesulide is out of use, however, in the Karnataka market combinations of Nimesulide and Paracetamol are available.’’ There is no effective mechanism to curb such practices and whatever nominal bodies are existing, fail to prevent such practices and protect public health, he feels.

— rbmanoj@rediffmail.com