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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (5646)	9/21/1998 3:38:00 PM
From: BigKNY3	Read Replies (1) \| Respond to of 9523

Govt apathy hits Indian firms' Viagra plans M Ahmed NEW DELHI 09/18/98 Business Standard Page 2 Attempts by Indian companies to cash in on the Viagra craze have fallen flat with the government banning export of bulk drugs based on new, untested molecules. Some 25 tonnes of sildenafil citrate, the raw material for Viagra , worth Rs 150 crore and produced by six Indian companies is lying in quarantine due to the ban. The Drugs Controller-General (DCG) has refused to give a clearance certificate on grounds that there is no provision in the Indian Drugs and Cosmetics Act to accord approval of untested molecules. The certificate is necessary for export of pharmaceutical raw materials. Indian pharmaceuticals companies like Cipla and Orchid Chemicals were in the race to export sildenafil citrate made by a process different from that of Pfizer, the patent holder of Viagra . They were planning to export the drug to markets where it is not protected by patents. Besides, Ranbaxy and Dr Reddys, too, are in the Viagra race. The Indian Drugs Manufacturers Association (IDMA) is up in arms and has shot off letters to minister for chemicals and fertilisers S S Barnala, commerce minister Ramakrishna Hegde and senior officials of the departments of drugs, commerce and health. An emergency meeting of the involved departments was held yesterday under the chairmanship of S K Sood, joint secretary in the ministry of chemicals and fertilisers. Officials said consensus was yet to be arrived at but the industry's problem got a "sympathetic" hearing. IDMA president Dinesh Patel, in a letter to Hegde, said, "By virtue of versatile skills and the most up-to-date technology available with the industry, we have been able to cater to the demand for bulk drugs from various overseas customers, involving new molecules which are not usually manufactured in the country. The authorisation to manufacture such items for export was till recently being given by the DCG but was withdrawn all of a sudden without any explanation since last month". An official said Indian laws do not permit manufacture of new bulk drug molecules. Till the rules are suitably amended, ad hoc permission for manufacture of new-molecule drugs, even for export, would not be proper, he added. If such exports had official approval, they would be seen as meeting all technical requirements in the country while in reality it was just an attempt to cash in on a "hot" commodity, the official pointed out. An industry source said, "It is anybody's guess who inspired the latest government move. For 20 years Indian pharmaceuticals companies have been reverse-engineering drugs introduced by multinationals and tapping the export market. If one fine morning the government decides to stop export permission without any warning, then something is amiss". A Pfizer executive was quoted on the Indian attempts to make Viagra clones that his company was concerned about the violation of patents in countries where this product ( Viagra ) reaches