Pioglitazone - Why it is banned in India 2013???

Pioglitazone — an oral anti-diabetic drug which was banned on June 18 2013

Why is it banned?

The Ministry banned piogiltazone based on a letter sent in January to the Drug Control General of India (DCGI) by the Chennai-based diabetologist Dr. V. Mohan, chairman of Dr. Mohan’s Diabetes Specialities Centre. His letter was based on his observation of eight bladder cancer cases in patients taking the drug. 

The ministry and Drugs Controller General of India certainly have the power to ban any drug under Section 26-A of the Drugs & Cosmetic Act if they are satisfied that the use of any drug is likely to involve risk to human beings or that drug does not have the therapeutic value claimed for it or contains ingredients in such a quantity for which there is no therapeutic rationale.

The drug has been banned in Germany and France, but other countries in Europe and the US sell the drug with a risk warning. In India, the drug has been in the market for over a decade and had no reports of adverse drug reactions reported. Diabetologists from the government and corporate hospitals are of the view that pioglitazone is a safe drug for type II diabetes and it also reduces triglycerides and increase HDL levels in patients.

At present, doctors report side-effects to companies, who in turn submit the reports to the drug regulator. But this does not show the entire picture, as there could be under-reporting, or there may not be details of where the incident occurred.

Though 35 lakh patients are estimated to be on pioglitazone, there is little locally generated data to swing the debate for or against its use. A good fall-out though, is that doctors across the country are awakened to the reality of drugs, their side-effects and the need for surveillance, says a local doctor.

Before a drug is banned certain procedures have to be followed by the regulatory authorities of any country. This is because a drug is allowed to be marketed in a country only after completion of a 3 phase clinical trial and after its safety and efficacy profile is approved by a drug advisory board. The whole procedure takes a long time and involves a lot of money for the company which introduces the product in the country. Therefore, before ordering withdrawal of the drug from the market, the regulatory authorities should have adequate and convincing justification for the same.

In the case of pioglitazone, the office of DCGI does not seem to have such compelling data for a decision like this. India currently has a network of about 90 medical colleges, laboratories and hospitals across the country registered under the pharmacovigilance programme, playing a key role in monitoring and signalling timely updates on ADR reports of drugs in the market. Through this ADR centres, IPC currently has a data base of 48,000 ADR reports from different parts of the country.