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Tuesday, June 30, 1998

Viagra exports all set for a big bonanza 

Anju Ghangurde  
MUMBAI, June 29: The Drugs Controller-General of India (DCI) has cleared export licences amounting to 39,262 kg and 5,000 tablets of sildenafil citrate, the active ingredient that goes into Pfizer's anti-impotence wonder drug, Viagra.

Once the export deals are consummated, the country's forex earnings on this count could amount to a staggering $785 million, assuming an average export price of $20,000 per kg. Alternatively, if the price is taken at the lower end of $3,000 per kg, forex earnings will be $1,178 lakh. Much will, however, depend on whether subsequent entrants start undercutting the early birds, but there is no doubt that fiscal 1998-99 will see a Viagra bonanza for Indian companies. The Indian companies involved in the export effort include Ranbaxy Laboratories, Cipla, Orchid Chemicals and Hetero Drugs.

The DCI's decision, which was preceded by much doubt about whether granting export licences would amount to patent infringements, came after the commerce ministry gave the green signal earlierthis month. The Financial Express tracked the Indian Viagra saga right from the time the DCI wrote to the commerce ministry to the final clearance on the patents angle.

Here's how it happened:
On May 19, the drugs controller-general wrote to the joint secretary, ministry of commerce, seeking a "clear cut direction on the subject of export of new drugs, which would give uniformity in taking action and also ensure that such export orders do not infringe on intellectual property rights". The letter makes direct references to sildenfil citrate.

Among other things, the letter notes that "preliminary enquiries from Pfizer have indicated that the company is at the moment not interested in the registration of the product in India". Pfizer, apparently, was not quite sure about whether their technology was pilfered. According to them, the registration of their patent and the process approval of the drug would by themselves have facilitated the registration of the same drug under different brand names bycompetitors.

Sources in the ministry of commerce also indicated that the Drugs Controller apparently asked the American multinational to furnish details about the countries in which it had filed a patent for Viagra to avoid infringement problems. Pfizer's official response to this could not be obtained, though this data was apparently unavailable.

The Drugs Controller also asked the ministry of commerce to arrange for an "inter-sectoral meeting" of representatives from the DCI's office, the department of chemicals and the ministry of health so that clear-cut directions on this subject were received.

This meeting took place on June 1, where full-fledged discussions were held on the "possible infringement of WTO rules" in case export permission was granted for sildenafil citrate.

The full details of this meeting are still not available, but the very next day the ministry of commerce gave the green signal to the Drugs Controller-General for the grant of export licences. Udyog Bhavan confirmed thatthere would be no violation of WTO rules in granting a "no-objection certificate" for the export of drugs patented abroad and that such grant would be governed by the Exim Policy.

Three days later, on June 5, the DCI cleared Cipla's proposal to export 12 kg of sildenfil citrate bulk to Uruguay and Argentina while 5,000 tablets are headed for Malaysia. Ranbaxy has been allowed to export 150 kg of the product to Switzerland while Orchid obtained clearance to export 39 tonnes of the bulk drug to Switzerland, Spain and Hongkong. Hetero Drugs has got the nod for 100 kg of sildenafil citrate to Switzerland and Uruguay.

Viagra, just over a month old in May, had, according to reports in the foreign media, generated 1,13,134 prescriptions in the second week after launch (up 200 per cent over the previous week). And pharmacists have since been apparently filing 15,000 to 20,000 new prescriptions per day despite some worries about its side-effects, these reports add.

Copyright © 1998 Indian Express Newspapers (Bombay) Ltd.


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