Health ministry in knots over drugs banned elsewhere.

New Delhi: India’s health ministry is tying itself in knots over the ban of drugs that are banned in some countries, and, in some cases, for some population segments.

In an action-taken report submitted on 26 April by the ministry in response to a study by a parliamentary panel that found lapses in drug regulation in the country, it said that “whenever a drug is banned due to adverse drug reactions in countries with well developed and efficient regulatory systems, the manufacture, import and marketing of such drugs would be immediately put under suspension till the safety of the drug is examined and established...”

In effect, the ministry has committed to banning drugs that have been curbed by drug regulators in the UK, the US, European Union, Australia, Japan and Canada. It has simultaneously set up a panel to look into the suspension of sales of these drugs.
Health secretary Keshav Desiraju and Drugs Controller General of Indian G.N. Singh declined to comment on the report.
According to the parliamentary panel, 15 drugs that face curbs elsewhere continue to be sold in India. These include analgin, nimesulide (painkiller) and buclizine (appetite stimulant).

“They set up more review committees instead of taking tough decisions. These are stalling tactics and no amount of flak from the parliamentary panel seems to have an effect on the health ministry,” said Sanjay Jaiswal, member of the parliamentary panel on health.

The delays will benefit drug makers, said an expert. “In a written submission to the parliamentary committee in December, the ministry of health made a categorical commitment that it would ban all drugs prohibited for sale in US, the UK, EU, Australia, Japan and Canada,” said C.M. Gulati, editor of the Monthly Index of Medical Specialities and an expert on the rational use of drugs. “Not a single drug has been banned in the past four months. Such deliberate delay is hurting millions of consumers taking these harmful drugs.

The only beneficiaries are drug companies.”

Nimesulide was never approved for use in countries such as the US and the UK. And in some countries, it is not allowed to be used by children. A spokesperson for Dr. Reddy’s Laboratories Ltd, one of the many generic manufacturers of the drug, maintained that the company “did not sell nimesulide for pediatric use”.

A spokesperson for Sun Pharmaceutical Industries Ltd, which sells thioridazine, an antipsychotic drug, said it was “a very old antipsychotic, dating back to the 1970s. Though Sun Pharma today has (an) entire range of antipsychotic drugs, including the recent ones, there may be older patients who may have been stabilized on the drug. This drug is being made available as an option to the doctors for specific patients.

We sell negligible quantities (0.0003% of domestic sales) in the country which clearly shows the patient pool is very small and it is made available as a service to patients.”

The big global pharmaceutical companies withdrew their thioridazine brands in the early 2000s after it was discovered that the drug could cause neurological disorders, some potentially fatal.

“It is irrelevant if the drugs are old or only sold for adults—they are globally banned and are being sold because they are allowed to be marketed,” said Gulati.

To be sure, many of these drugs continue to be sold in India because the health ministry allows their sale. Take the case of analgin, which is banned in some countries but continues to be sold in India.

A spokesperson for Sanofi Aventis, manufacturer of the painkiller under the brand name Analgin, said it is sold in India because it has “been deemed by regulatory authorities to meet the needs of our patient population and is approved for use in India”.

The marketing of Analgin has been referred to a New Drug Approval Committee for examination by the health ministry.



Source : livemint.com