• Investment World
• eWorld
• Catalyst
• Mentor
• Life
• Canvas
• Praxis
• Urban Pulse
• Brand Quest

P.T. Jyothi Datta

New Delhi , Nov. 14

THE pharmaceutical canvas in the country is set to trace uncharted territory with the Indian Drug Manufacturers' Association (IDMA) protesting against the first exclusive marketing right (EMR) given by the authorities to Novartis' blood cancer drug Glivec.

Only days after Novartis announced that it had received the first-ever EMR granted in the country, IDMA has expressed its "shock" over the Government's decision, besides raising issues regarding the availability and accessibility of the cancer drug.

"Greatest care is required to be taken for any such grant. Some Indian manufacturers have already developed their own processes for this drug and have been marketing it at about one-tenth the international price. The grant of EMR to Novartis can provide a leverage to the EMR holders to interfere with the generic production and distribution of this drug, and worse still, with the treatment of patients," the IDMA said in a communication issued here on Friday.

The international price of the drug is about $27,000 for one-year course requirement of a patient, while the generic price is about $2,700.

Mr Ranjit Shahani, Vice-Chairman and Managing Director, Novartis India Ltd, told Business Line that the granting of the first EMR was a legitimate process that took a step towards integrating India with the global patent regime.

"It is not restricted to just this drug, but the signals that are sent out when patents are honoured — this would bring in investments and innovation. EMR is a legitimate process that gives the patent holder the right to sell and distribute a drug for a period of time under the provisions of the Patent Act. It protects the innovation and research of any drug company, both Indian and multi-national."

Pharma industry representatives pointed out that 2003 had seen EMR applications applied for by Nicholas Piramal India Ltd for its anti-malarial drug Movoquin and Eli Lilly for Cialis — a drug for erectile dysfunction. Other companies that have applied for EMRs in the past, include: Wockhardt for antibiotic Benzoquinolizines, Ranbaxy for a process of antibiotic Cipro, Schering Plough for bio-tech cancer drug Interferon alpha and Bayer for antibiotic Gatefloxacin.

Some EMR applications rejected by the authorities include Roche's HIV/AIDS drug Saquinavir, GlaxoSmithKline's anti-diabetic drug Rosiglitazone and Ranbaxy for a new drug delivery system.

But IDMA pointed out that Novartis had filed its application for Glivec's patent in convention countries in May 1993. Further, it said: "As per the law, EMR would be claimable only in respect of inventions which were subject to matter of applications filed on or after January 1, 1995. During the debate in Parliament on the 1999 Amendment Bill, it was clarified and confirmed that the pre-1995 inventions would not qualify for grant of EMR or patents."

However, with Novartis stating that it met all the requirements to be granted an EMR, the battle is set to explore uncharted territory, said pharma industry analysts.

Article E-Mail :: Comment :: Syndication

Stories in this Section
Festive Oct drives car, 2-wheeler sales

Copyright © 2003, The Hindu Business Line. Republication or redissemination of the contents of this screen are expressly prohibited without the written consent of The Hindu Business Line