Ministry may review sale of 12 ‘risky’ drugs

The Drugs Technical Advisory Board (DTAB) is likely to deliberate on 12 drugs which are banned in several parts of the world but are still allowed in India.

The DTAB, which is the highest body on technical matters regarding the pharmaceuticals segment, under the Union ministry of health, is planning to discuss the matter in its meeting this month, said a person closely associated with the body.

Drugs including those like nimesulide (pain/fever, side-effect — liver damage), droperidol (anti-depressant, side-effect-irregular heart beat), furazolidone (anti-diarrhoeal, side-effect-cancer), nitrofurazone (anti-bacterial, side-effect — cancer) are some which have been banned in several parts of the world, including the US and the UK.

Industry experts say the market potential for these drugs in India’s Rs 34,000 crore domestic drug market ranges between Rs 2 crore and Rs 150 crore annually.

Says a senior research analyst with a securities firm in Mumbai: “Though there are no exact figures, we can say that the annual market for nimesulide is about Rs 150 crore at present. India is one of the very few countries to allow this drug to be marketed.”

However, C M Gulhati, editor of Monthly Index for Medical Specialties (MIMS), a reference journal for medical practitioners, says the likelihood of these drugs actually getting banned appears negligible. “If at all they decide to ban, the casualties are most likely to be droperidol, oxyphenbutazone (painkiller, can cause blood disorders), as they have miniscule sales compared with the rest.”

The media relations officer of the ministry of health said he was unaware of what all the DTAB meet will deliberate on.

The Drugs Controller General of India (DCGI) Surinder Singh, who holds authority over granting approvals or banning drugs, could not reached for comment.

According to a consultant, internal medicine, at a leading corporate hospital based in Bangalore, drugs which are banned globally should also be banned in India. “A drug is banned when its risks outweigh its benefits and it is considered to be dangerous. So, if a drug appears dangerous for populations elsewhere, it would be risky for Indians also.”
Says a senior consultant, internal medicine from a north-based hospitals chain: “There are several options available for any indication like fever or pain. So these risky medicines should be best avoided and safer alternatives should be taken.”

These drugs can do more damage in a country like India where several people self-medicate and where drugs are sold without prescriptions, says a former administrator of the Maharashtra Medical Council.

Also, the system of reporting adverse drug reactions is nearly non-existent in India, said Gulhati.

“Doctors do not maintain proper patient records and also at times fail to seek patient information about use of certain medications, etc. Without proper patient data, it is difficult to report any akdverse drug reaction. So it’s tough to say that a drug should be banned in India only if the adverse reaction is reported here.”