Run of risky drugs may continue

Will controversial drugs get banned or will the government continue procrastinating? 

That’s the burning question, with the ministry of health and family welfare, through the drugs controller general, cracking down on drugs such as nimesulide, analgin, furazolidone (see table), and bringing it under the pharmacovigilance (PV) programme’s scanner, to monitor their adverse effects.

These drugs, with their side-effects outweighing benefits, have been banned in several countries, including Nepal, Nigeria, and Vietnam.

In India, drugs such as nimesulide and analgin have an annual sale of approximately Rs150 crore and Rs 20 crore respectively.

According to C M Gulhati, editor, medical reference journal Monthly Index of Medical Specialties (MIMS), the World Health Organisation Pharmaceutical Newsletter states that India could not report even a single adverse effect for nimesulide, while countries with lesser populations such as Italy, Finland, and Belgium reported 225, 109, and 83 cases, respectively.

Reporting of adverse effects is a Herculean task in India due to several factors. “PV is a fairly elaborate exercise and private practioners, who treat over 80% of Indians, are not covered. So the coverage would be restricted,” says Gulhati, adding that merely bringing drugs under PV would only delay decisions regarding their continuation.

Experts say the plan to bring them under PV has more to do with finding an alibi and dither a ban. If adverse effects fail to get sufficiently reported, the debate to ban them would die a natural death.

Furthermore, experts argue that if the health ministry could in the past ban painkiller rofecoxib, diabetes drug phenformin, and anti-allergy drugs astemizole and terfenadine due to adverse effects based on global reports, why can’t the same logic be applied in case of other drugs which have been banned globally?
Drug Controller General of India (DCGI) Surinder Singh was unavailable for comment.

Moreover, unless there is an active, incessant effort to point adverse effects, they are sure to be missed, says S M Sapatnekar, former administrator of Maharashtra Medical Council, and dean, clinical research education and management academy (Crema).

“Patients often fail to notice and report side effects. Those reported to doctors may not get reported to the authorities. However, the aim to bring the drugs under the PV programme is a welcome step,” says Sapatnekar.

Moreover, medical students are not taught to monitor adverse effects, says Gulhati. “Several doctors don’t maintain records of their patients. They don’t even seek information to determine adverse effects such as use of other medications, dosages, etc.

Without all this, adverse effects cannot be determined.”  According to a leading internal medicine consultant with a corporate hospital in Bangalore, when there are safer alternatives available, its best to avoid drugs whose side effects are more than their benefits.

“Especially in a country like India, where people self-medicate and drugs are sold without prescriptions.”