The Drugs Controller General of India (DCGI) had on June 5, 1998, cleared export licences worth 39,262 kg and 5,000 tablets of sildenafil citrate of four drug firms--Orchid Chemicals & Pharmaceuticals, Ranbaxy Laboratories, Cipla, and Hetero Drugs.

As on February 23, 1999, except for Cipla, none of the other firms has exported significant quantities of the bulk drug. Officials at Hetero Drugs were, however, unavailable for comments. The Chennai-based Orchid Chemicals, which topped the list with an export order of 39,000 kg of bulk sildenafil citrate, is yet to ship its first consignment. The company maintains that exports were not made as the overseas formulators were inthe process of getting their product registrations.

The Delhi-based Ranbaxy's official spokesperson said that exports were made in accordance with the stipulated guidelines, though details on the quantities involved could not be ascertained. Ranbaxy had in June 1998 received the Drugs Controller's clearance to export 150 kg of bulk sildenafil citrate. The consignment, as per the June 5 clearance, cited Swiutzerland as the export destination.

The Mumbai-based Cipla, however, has exported approximately 89.5 kg of bulk sildenafil citrate to various international markets. The Rs 541-crore giant has since received permission to export 1,312 kg of bulk sildenafil citrate and 1,05,000 tablets, though details on pricing could not be acsertained. As on June 5, the Drugs Controller had granted Cipla licences for exporting both the bulk and tablet form of sildenafil citrate to markets like Uruguay, Argentina, and Malaysia.

Meanwhile, the prices of sildenafil citrate, which were ruling at $18,000-$25,000 per kg(depending on the volumes involved), have fallen to lows of $3,000-$5,000 per kg.

Analysts said that after the initial euphoria over the product had died down, the curent prices may be more realistic. "While Orchid has disappointed the market since receiving its huge export order for sildenafil citrate, the current prices are probably more realistic," an analyst added.

An opportunity lost

Increased supply of sildenafil citrate in the international market has resulted in the price of the bulk drug declining from $18,000-25,000 per kg to $3,000-5,000 per kg. Domestic companies were, however, unable to capitalise on the high prices. Orchid, which was expected to lead the pack of exporters, has failed to deliver, in spite of being the first company to come out with the bulk drug in India. Procedural and beuraucratic delays by the Government have also led to the companies losing out on the opportunity.