The Hindu Business Line : After Rofecoxib ban, other drugs on watch list

FOLLOWING the Government's decision to ban Rofecoxib (an anti-arthritis drug), just weeks after Merck voluntarily withdrew its branded version Vioxx, the Health Ministry plans to review the status of drugs that were previously banned or withdrawn from the international market.

Highly placed sources in the Ministry said there are several drugs that have gone off the market in the US due to serious side effects but are still available in India. "We will monitor the level of usage of these drugs and side-effects they can cause," said sources.

They said that concerns have been voiced about 10 drugs that have either been banned globally or whose use is severely restricted or not approved, but are available in India.

These include cerivastatin (cholesterol-lowering drug), droperidol (to reduce nausea and vomiting), furazolidone (to treat infectious diarrhoea and enteritis caused by bacteria), lynestrenol (hormonal agent), nitrofurazone (anti-bacterial for burns), phenformin (for diabetes), phenylbutazone (anti-inflammatory drug), piperazine (treatment of worm infections) and quiniodochlor (anti-fungal).

"Also, the use of nimesulide, a non-steroidal anti-inflammatory drug, which has been reported as causing liver toxicity is something that is to be examined," said sources. In August 2003, the Government banned the anti-allergy drugs astemizole and terfenadine.

According to available data, more than 13 drugs have been withdrawn from the market. However, single-ingredient formulations of some medicines such as phenformin, lynestrenol, piperazine and analgin have been permitted after consultation with medical experts, subject to a cautionary statement and contraindications being given on the label or package insert.

But for now, the Government has recommended the cautious use of other selective cycloxygenase II (Cox II) inhibitory drugs, though there are no immediate plans to ban these drugs. However, the Health Ministry will watch how this class of drugs behaves.

Meanwhile, the National Pharmacovigilance Advisory Committee (NPAC), comprising experts from the medical fraternity, will meet next month to chalk out strategies for effective monitoring.

"The NPAC will conduct studies on various drugs available in the market and how different drugs in the same class behave. It will try to work in a co-ordinated fashion with clinicians in various universities and medical colleges," said sources.

Industry sources said the drugs that have been withdrawn in the international market are generally not available in the country.

"Indian companies in recent times have been swift to respond to such situations. The number of banned drugs in circulation has come down," said an industry source.

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