Govt flip-flop on drugs ban prompts demand for stricter rules

The issue of safety of drugs sold in the Indian market has hogged the limelight for long, with regulatory experts often citing instances of drugs banned in other countries continuing to be sold in India. The recent flip-flop in the case of popular painkiller analgin and anti-diabetic drug pioglitazone has exposed the regulatory lacunae once again.

The health ministry, between May and June this year, banned four drugs ? painkillers dextropropoxyphene and analgin; anti-diabetic pioglitazone and antidepressant deanxit ? which together garner sales of R1,200 crore in the domestic

pharma market.

However, within weeks, the statutory drug technical advisory board (DTAB) proposed that since there are ?limited adverse events reported from India from use of pioglitazone and analgin?, the ban on these drugs can be revoked. Pioglitazone has market sales of over R800 crore, whereas analgin is a mere Rs 40 crore.

While the health ministry has subsequently recalled the ban on the anti-diabetic drug, industry and regulatory experts are concerned that in the absence of any transparent system for reporting adverse drug reactions and holding stakeholders? consultation before suspending manufacture and sale of a drug, such ambivalence would continue, potentially impacting lakhs of patients.

In fact, India hasn?t banned many drugs over the past two decades, while strict labelling norms have been imposed on a clutch of drugs to restrict their use. When it comes to prescribing some other drugs, doctors have been advised to do a more diligent cost-benefit analysis. In practice, with many state authorities being lax in enforcing these norms, they are being smugly overlooked.

Even when it comes to approving new drugs ? drugs first introduced in the world less than four years ago ? Indian regulators mostly rely on the innovator?s data. In most cases, adequate care is not taken to ensure that sufficient domestically generated data on the safety and efficacy profiles of these drugs are generated, before they are approved for marketing in the country.

?The industry seeks a clearly defined, predictable process (to ban drugs) based on evidence collected in India,? said DG Shah of Indian Pharmaceutical Alliance. And in the case of older drugs, the adverse drug reaction (ADR) monitoring system is not meticulous enough to avoid unsafe drugs being prescribed and sold.

The decision to ban pioglitazone, in the first place, did not go through DTAB, while the marketing suspension of both analgin and deanxit in India (despite being banned in other countries for decades) is being widely perceived to be a direct result of criticism by the parliamentary standing committee on health.

Industry experts said while India has rules similar to countries like the US and the UK to track side effects of drugs, these mostly remain ?on paper?.

India has banned over 91 drugs between July 1983 and June 2012, including sibutramine (anti-obesity), cisapride (anti-acid reflux), diclofenac (anti-inflammatory) and rosiglitazone (anti-diabetic). However, this is the first time that it has had to retract its decision.

?While the decision to go back on the suspension of pioglitazone is likely to help patients, it is the lack of a standard operating procedure for ban of drugs and for revoking suspensions credibly that causes distress,? said Dr Gopal Dabade, co-convener of All India Drug Action Network (AIDAN), an NGO.

An industry expert said that the move to revoke the ban could also be construed as being in direct contradiction to the recent decision by the drug regulator to automatically ?suspend? in India all drugs banned in countries with a ?robust? regulatory system, till their safety has been established.

Analgin was found to be unsafe and banned in the US in June 1977 and subsequently in most countries. Pioglitazone, which has been under a cloud since 2011 for its link to bladder cancer, is banned in France. Germany has prohibited its prescription to new patients and it is sold with warnings in the US and the EU. India has also decided to put a “box warning” on the pioglitazone packing. It will not be used as the first line of treatment and would not be given to patients with a history of bladder cancer.

However, Dr Chandra M Gulati, editor, medical journal MIMS, questions: ?Not a single drug banned in India is based on adverse reaction data. How come within weeks drugs suspended due to harmful effects (based on global studies) are suddenly found to be safe without any fresh evidence??