Dr Reddys can now sell Zafirlukast
By Praveen Chandran | 15 Dec 2001
Hyderabad: The city-based Dr Reddy’s Laboratories has obtained the marketing approval from the Drug Controller General of India to launch the blockbuster drug Zafirlukast. The approval was obtained after submitting data on multi-centric clinical trials conducted in India on a total of 125 patients.
Zafirlukast is one of the latest anti-asthmatic drugs to hit the global market and now it will be available in the domestic market.
Industry sources said two other pharma companies - the Mumbai-based Unichem Laboratories and the Delhi-based Morepen Labs - are also awaiting the DCGI nod for Zafirlukast. While Unichem is planning to launch its formulation immediately after getting the DCGI nod, Morepen is in the process of completing the toxicity studies of the bulk drug at the Central Drug Laboratory in Kolkata.
The patent for Zafirlukast is held by the multinational AstraZeneca in the US and various European markets. The patent will be valid until September 2010.
Zafirlukast had recorded global sales of $152.9 million in 2000. DRL and Unichem are understood to be keen on exploring export markets for the drug in non-patent countries like Russia and the Gulf, besides supplying to the domestic market anti-asthmatic drugs that are growing at a healthy rate of 11 per cent. The anti-asthmatics market in India is estimated at Rs 482 crore at present, whereof Rs 341 crore is for orals and Rs 141 crore is the market for inhalers. Morepen Labs can also supply the bulk drug to non-patent export markets.
In the meantime, the ongoing rift between DRL and Nicholas Piramal India over the packing inserts claims of the former’s cancer drug Grastim continues unresolved.
Sources said both DRL and NPIL have recently submitted the pharmacological and clinical data to support their respective claims to the high-level committee examining the case. The three-member committee headed by Dr N K Ganguli (director-general, Indian Council of Medical Research) had earlier asked the two companies to submit the entire relevant data.