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Health warnings over launch of Indian Viagra

Indian markets are getting ready for the launch of a local version the world famous anti-impotence drug 'Viagra', but health officials have warned against its possible misuse.

This week, the Drug Controller of India gave permission to pharmaceutical majors Ranbaxy Laboratories and Zydus Cadila Pharmaceuticals to manufacture and market their versions of the drug.

Another half a dozen companies are in the queue awaiting similar permission.

The long-awaited green light from the government has been accompanied by stern warnings from medical circles against misusing the drug.

"It is not an aphrodisiac nor a cure for impotence," said Sanjiv Malik, secretary general of the Indian Medical Association.

"The medical community welcomes the introduction of the local variant which will be available at much cheaper prices, but I would like to point out that it merely provides temporary relief from erectile dysfunction," he added.

According to Ranbaxy, the size of the market for the drug is estimated at Rs 400 million to Rs 500 million in the next 12 months and is expected to touch Rs 1 billion, in the next two to three years.

Smuggled original Viagra manufactured by US firm Pfizer costs between Rs 500 and Rs 700 for 50 milligrams, while the Ranbaxy version will go for Rs 20.

"Erectile dysfunction is a common yet serious medical disorder that afflicts millions of Indian males," an official release from Ranbaxy Laboratories said.

"In India ... due to shyness and embarrassment this problem does not receive proper medical attention," the release added.

Although the side effects of the drug are "rare, mild and transient," a company spokesman said that it would be sold through "the ethical prescription route" only.

To promote the drug, Ranbaxy has launched a Web site which has sections with information for consumers and doctors.

The site also has an online doctor-to-doctor chat programme.

According to the DCI, all companies granted manufacturing licences have been asked to keep strict records of the amounts of the drug produced and distributed, which would help monitor patterns of use.

"This is a regulatory requirement ... as this is not a pleasure pill," DCI chief Ashwini Kumar said.

"We have also issued instructions that the drug be sold only against prescriptions by urologists, endocrinologists and psychiatrists."

However Sanjiv Malik of the Indian Medical Association was of the view that the government needed to put stronger legislation in place.

"In a country where one is shy about introducing sex education or even discussing such issues, chances of self medication are great, which can prove dangerous in certain circumstances."

The use of Viagra or its variants are forbidden to those suffering from heart disease or chest pain.

There are also concerns about "spurious" versions of the drug being produced by "unscrupulous" companies, said Malik.

While the authorities concede this is a major cause for concern, Kumar said it was up to the drug regulatory bodies in different states to make sure fake variants of the anti-impotence drug did not enter circulation.

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