The Union health ministry last month decided to ban the manufacturing and sale of widely prescribed anti-diabetic drug pioglitazone in the country. The decision did surprise the medical fraternity and millions of diabetic patients across the country as it was a totally unexpected step. 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. The sudden banning of the drug without any warning thus placed millions diabetics across the country into a serious problem. Any abrupt discontinuation of the drug on many patients may not be medically prudent as it may cause deaths in some cases.
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. Usually pharmacovigilance reports of the drug and strong objection to marketing of the drug by the advisory body should be the basis for such a decision. Rosiglitazone, another widely used diabetic drug, was banned in India in October 2010 after three years of debate amongst medical experts on its safety. 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. It is not very clear that the DCGI decision to ban pioglitazone was based on the ADR reports or on the guidance of the Drug Technical Advisory Board.