Banned, But Not in India

HYDERABAD: In 1996, when the Indian government banned the combination of the drug Analgin with other drugs, countless young women were still merrily popping Baralgan (a combination of Analgin and two other drugs) to get relief from menstrual cramps. Though last year, the Drugs Controller General of India (DCGI) did ban the drug, it again reversed the decision earlier this year. Though other countries like the United States of America, France and Australia continued with their ban. Analgin to this day, continues to be in circulation.

Slow Poison?

For T Shailja, a first year inter student, her migraine outset meant her daily routine would go for a toss. Popping a Disprin tablet would be the only way out for the student. While the headache vanished after a while, Shalja was left to deal with the side effects of nausea which continued for several hours.

Shailja is one among the many who don’t know that Disprin, the brand name of Asprin, is a non-steroidal anti-inflammatory drug that is used to ease pain, was banned by the US Government drug safety body in 2002 for children under 16. The reason being that one of the side-effects of the drug was found to cause a rare condition that causes swelling of the brain and liver. Medically known as Reye’s syndrome, it can lead to severe vomiting and drowsiness.

Though the drug, including several other analgesics used as pain-killers, are banned outside India, they are still abundantly available in retail markets in the city.

Among the long list of banned medicines outside India include commonly used drugs like Novalgin, D’cold, Vicks Action-500, Enteroquinal, Furoxone and Lomofen (anti-diarrheal), Nimulid, Analgin (pain killer), Ciza and Syspride, (acidity and constipation), Nimesulide (painkiller) and Buclizine (appetite stimulant), all of them are still being sold in Indian market.

Docs’ Speak

As much as we like, not everything can be in the realm of right and wrong. Likewise, whether a drug is safe or unsafe is a very grey area.

“We avoid prescribing drugs that have been banned in other countries but these rules change depending on the condition of the patient. If he is suffering from cancer, we don’t mind giving a banned drug whose effects are combining with other medication the patient is taking. This however, is not in the case of vaccines, which are administered to healthy babies, “ explains a surgeon (who did not wished to be named) attached with AIMS, Delhi.

The doctor, however, admitted that a lot of times once they prescribe a banned medication to a patient keeping in mind their condition or to provide temporary relief, the patient themselves go and buy the drug, which are easily available over the counter.

City-based pediatrician Dr Kiran Kumar, points out that doctors practicing in urban areas are more aware than their rural counterparts who are disadvantaged due to lack of information. “As far as I know most doctors in Hyderabad are not prescribing Nimesluide. But the scenario could differ in the suburbs and rural pockets, “ he says who goes on to add that the drug continues to be sold in combination with other drugs.

However, the director of  AP Drugs Control Authority, P Nagabhushanam, begs to differ. Blatantly refuting claims that any of the banned drug are in circulation, he informs, “If a banned drug is in circulation, it must be in combination with other drugs. Besides, if a drug has to be pulled out of market it has to be done by the DCGI.”

Marketing strategy?

While country’s drug regulator has a right to decide which medicines are suitable for its population and which ones aren’t, doctors feels there is more than what meets the eye. “India lacks the mechanism to selectively ban drugs. It approves drugs approved by the FDI but when the same is pulled out of the agency, it gives a reason that the pharmacovigilance data is not India specific, “ says the surgeon from AIMS.

This is precisely what happened with anti-diabetes drug, pioglitazone, which was prescribed to three million patients last year. While France banned it in 2011 for its potential to cause bladder cancer, India’s belated reaction last year met with an uproar among pharma companies. The result being--Pioglitazone was put back on shelves within a couple of months albeit with updated warnings. The logic behind this being such a ban would force patients to move to pricier options or insulin.

Furthermore, the Indian drugs regulatory agency was recently quoted as saying, “If two or more countries remove a drug from their market on grounds of efficacy and safety, then the continued marketing of the drug in the country will be considered for examination and appropriate action.”

This activity, doctors feel favours the pharma companies and also gives the government a reason to “dump these cheap drugs in government hospitals.”

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