INDIA BUSINESS WORLD - MAY - JUNE 2007
The Month that was ...

BAN OF NOVARTIS ZELNORM DRUG

Generic versions of Novartis' Zelnorm a widely used drug to treat irritable bowel syndrome and constipation may go off the shelves. The new evidence links it with serious side effects such as heart attacks and strokes.

In the wake of reports of adverse reactions and subsequent ban of Zelnorm in 20 countries since March, the Indian government is considering 'appropriate action'. The US government asked Novartis to suspend the sales in March after it concluded that the benefits of this drug no longer outweighed the risks for most patients.

Companies such as Cipla, Zydus Cadila, Torrent Pharmaceuticals and Hetero Drugs market the generic versions of the drugs in India, an industry source said quoting data from market research agency ORG IMS. Sun Pharma officials said that the company had stopped selling it last year soon after its launch. Novartis, which recorded global sales of $561 million in 2006 for the drug, is not selling it in India.

Cipla joint MD Amar Lulla said the company does not plan to pull out its brand Tegod from the market voluntarily as it considers the drug to be safe. Tegod has been in the market for more than two years now. The market size of the drug in India is around Rs 30 crore.

Sources say the authorities in India are likely to follow the lead of drug regulators in the US and other countries. "We are examining the issue and would take a call soon," said Drugs Controller General of India Dr Venkateswarlu.

However, some experts said that a drug banned abroad need not necessarily be forced out of Indian market too. All drugs have side effects and may harm in some way when taken for a long period. The drugs that are banned abroad but are available here are prescribed with caution only for a short term for symptomatic relief in the absence of alternatives. The research head of a leading pharmaceutical company, however, said that there is no reason why India should ignore the wisdom of global regulators if the decision to approve the drug for the local market had relied on their decisions in the first place.