The Swiss pharmaceutical giant Novartis AG, is learnt to have effaced India from the free drug donation programme list for its breakthrough cancer drug Glivec. Instead, the Hyderabad-based Natco Pharmaceuticals, which has recently received regulatory approval for its generic version of Glivec (Veenat), has been asked to do the charity work for the country from May 1, 2003 onwards.
India has been a large beneficiary of the Glivec International Patients Assistance Programme (GIPAP) Novartis runs thorough Max Foundation, USA.
More than 600 chronic myloid leukaemia (CML) patients who could not otherwise afford, got access to this high-cost treatment through GIPAP, so far.
When contacted, Novartis India sources said it had been made clear while launching GIPAP that the company would review its position once a generic substitue was available in the country. ``Now that a generic substitute has been available for some time, effective 1st May 2003, we have chosen to limit GIPAP to the existing pool of patients on the programme,'' a Novartis spokesperson said.
At the same time, the company is aware that there will be some patients in India who may still not be able to afford the generic substitute. Novartis has therefore offered to share the Novartis module for implementing GIPAP with generic manufacturers interested in setting up similar programmes for the Indian patient, she added.
Confirming the development, Natco officials said the company has been asked to take over the programme. ``Max Foundation has informed us that Novartis won't be supplying Glivec to Indian patients enrolled after May 1. And they wanted us to carry forward the programme,'' said Subba Rao, a senior Natco official.
And Natco has agreed to give three months' supplies of Veenat for the 200-odd patients shortlisted by the foundation. ``We have already made the drug availabe to 10-15 patients who were in end stage (blast crisis) of the disease and were in urgent need of treatment,'' he added.
Considered a magic pill, Glivec (imatinib) is the first line treatment against CML with an efficacy rate of more than 80 per cent. However, the prohibive cost of this high-end biotech drug makes it unaffordable to many, especially those in the developing world. It costs work up around Rs 1.2 lakh for a patient per month in India.
Novartis started funding GIPAP in the year 2001 soon after drug got US FDA nod. The idea was no CML patient who need the medicine would go without it.
Nearly 2000 patients worldover, got benefited from the GIPAP, even though it has been criticised widely as a clever marketing gimmick by Novartis to whip up public support in favour of the drug that will facilitate its reach across the continents.
Whatever the motive maybe, the beneficiaries, including physicians, now begin to feel the pinch. ``It [Gipap] made a big difference. About 400-500 of our patients got benefited from the drug. I think the generic entry could have forced the decision,'' said Dr S H Advani, chairman, Asian Institute of Oncology, Mumbai.
Dr Advani said, they still managed to obtain a commitment form Novartis that it would continue to supply the drug to those patients who had enrolled before and are under Glivec treatment.
However, Gipap critics point out that the stoppage of Glivec donations to India, immediately after the generic Veenat's approval is a clear instance that exposes the real motives behind Novartis' charity show. ``The company has desperately tried to stop the generic entry. But they failed. Now this is how they retaliate,'' said a senior official with a generic major based in Mumbai.
Not only in India, Novartis is facing problems in other markets as well. Everywhere the company is trying to encourage patients to campaign for access to Glivec and put pressure on the regulatory authories. Their commercial goal is to block cheaper copycat versions and to build up US 1 billion Glivec sales annually, he added.