Blindness scare spooks impotence drug firms

USFDA to alert drug controllers & to restrict their use by issuing warnings.

The Rs 480-crore anti-erectile dysfunction drug market may lose its vigour with the Drug Controller-General of India planning to put these drugs under a safety watch.

The move comes two days after the US Food and Drug Administration (FDA) issued an alert saying that the use of popular impotency drugs like Viagra (sildenafil citrate) and Cialis (tadalafil) may cause sudden blindness due to blockage of blood to optic nerves.

Anti-impotency drugs are made in India by Ranbaxy, Cipla, Zydus Cadila, Sun Pharma, Torrent, Cadila Pharma, Unichem and a few others. An official in the Central Drugs Standards Control Organisation told Business Standard that since the drug alert had been notified by the regulator at the location of invention (US FDA), immediate action would be taken to alert all state drug controllers to caution patients across the country and also to restrict their use by issuing safety warnings.

PR Joshi, president (corporate affairs), Zydus Cadila, the largest player in the segment, said the company was yet to hear from the regulator about the alert. "We will follow the regulator's directive once it reaches the company," he said.

The US agency said men over 50 and those who smoke were in the high-risk categories and it had received 46 ADR (adverse drug reaction reports) in such cases.

Indian authorities, however, said they were in no position to immediately pinpoint the side effects caused by such drugs as the Central Drugs Standards Control Organisation did not have an effective adverse drug-reaction monitoring systems.

In India, the generic versions of sildenafil citrate (Viagra of Pfizer) were launched in 2001. Initially, the market for the impotence-management drug was pegged at Rs 70 crore with an estimated annual growth of more than 20 per cent.

Though the drug was approved by DCGI as a restricted prescription category, it is a known fact that product is available without prescription in all medical stores.

The major brands of sildenafil citrate in India are Penegra (Zydus), Caverta ( Ranbaxy), Silegra (Cipla), Androz (Torrent), Edigra (Sun Pharma), and Juan (Cadila Pharma), Erix (Unichem). The other drug -- tadalafil -- was launched last year by Ranbaxy.

It is estimated that about 50 million Indians suffer from impotency and about 9 out of every 10 men do not seek treatment. Studies indicate that men with diabetes have three-fold higher incidence of erectile dysfunction and 50 per cent of them develop the condition within 10 years of being diagnosed with diabetes.