The Hindu Business Line : Novartis' blood cancer drug turns a `bitter' pill

THE country's first exclusive marketing right (EMR), given to Novartis for its blood cancer drug Glivec, was expected to trace uncharted territory. It has been far from smooth sailing for Novartis India Ltd, with the company facing both competition and litigation from chemically-equivalent versions.

And the waters just got more choppy, with the Swadeshi Jagran Manch (SJM) getting onto the anti-EMR bandwagon urging the Indian Government to cancel the EMR provided to the Swiss company.

Novartis got an EMR for its imatinib mesylate, sold under the Glivec brandname late last year.

The drug targets a type of blood cancer called chronic myeloid leukaemia (CML).

However, the issue got a political hue today with the SJM urging the Government to withdraw the EMR and end the company's "monopoly" — since CML was among the "deadliest" of blood-cancers.

Dr Ashwani Mahajan, Member of SJM's national steering committee, told Business Line that they had sent a letter on the issue to the Union Health Minister, Ms Sushma Swaraj, a few days ago.

"Public health will be in jeopardy, because through EMRs and product-patents, companies will retain their monopoly and patients will suffer as drugs will get costlier."

Further, the SJM's communiqué states: "About 25,000 new subjects — many of them children become victims of blood cancer, with about 18,000 of them dying every year in India."

Responding to the timing of the SJM communiqué, in the run-up to the elections, Dr Mahajan said: "The company may have got its EMR a few months ago. But the repercussions are being felt only now. Indian companies were manufacturing the same drug at a fraction of the cost that Novartis sells its drug. But Novartis got a stay on these companies and this would put cancer patients in hardship," he said.

Mr Ranjit Shahani, Vice-Chairman and Managing Director, Novartis India, told the correspondent: "The patient is finally benefiting, since they are accessing our programme that gives the drug free-of-cost to those who are unable to buy it or get their expenses reimbursed.

"The number of patients accessing our free programme has gone up from 580, when generic companies were also in the market, to 1,100 now (when the generic product has been withdrawn).

"Some of the patients, who were buying the generic drug, albeit at one-tenth the cost, are now able to get it free-of-cost.

"So, at no stage, has anyone who needed the drug been deprived of it," he said.

On the number who required the drug, Mr Shahani said that the company's estimates put it around 4,000-odd who were diagnosed with CML.

The EMR issue had split the pharmaceutical industry in the country right through the middle with generic companies and the patent-holders resorting to hair-splitting debates on the existing legal frame-work.

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, pharma industry officials said.

Generic players manufacturing this particular drug include Ranbaxy, Sun, Hetero, Emcure, Intas and Natco.

But with the exception of Natco, who has taken the issue to court, all other companies have withdrawn their generic version of the drug following the stay that Novartis got in late-January, Mr Shahani said.

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