Natco Pharma, the country's leading manufacturer of anti-cancer drug, imatinib mesylate, is all set to contest the grant of EMR to Novartis. The company is considering all options in this regard and looking forward to the gazette notification of the EMR.

However, for the company to challenge the EMR decision, it looks forward to either an official acknowledgement of the EMR or a move from Novartis. "We would, actually, prefer appealing to the government in respect of a life saving drug like imatinib. Here the government should go beyond the legal and commercial considerations and international obligations," the sources said.

The Natco spokesperson added, " even legally there is a sound case in favour of us and the EMR grant to Novartis should be reviewed. Similarly, when we look at the affordability of Indian patients, the multinational price is exorbitant. In that context, the granting of EMRs for such a drug seems to be against the interests of patients in a developing economy like India".

The Novartis' Glivec therapy costs $ 27,000 annually, which comes to about Rs. 1.20 lakh to 1.30 lakh per patient per month in India. However, this treatment from Indian manufacturers comes to only Rs 10, 800 per month.

The company cautioned that in the very short term, and perhaps in the medium time frame as well, it does not see any tangible benefits for Indian companies due to the EMRs. This is because there are hardly any Indian inventions and that too, for which patents have been granted after January 1995. One can, therefore, say that it is only multi-nationals that benefit by the EMRs, the company sources added.

According to the Natco chairman and managing director, Dr VC Nannapaneni, the company does not consider granting of EMRs as a threat to Indian industry. Rather, he feels, such a measure would create a level playing field for Indian companies vis-à-vis their counterparts in the west. "However, our view is with the rider that the ultimate beneficiary should be the patient. It is in this context that we have been emphasizing the need to bridge the gap between the original and generic versions of certain drugs, as far as the pricing is concerned. For example, in the oncology segment, we have seen that it is possible to make and market these drugs at a fraction of the cost that the original inventor is currently charging, and yet, make decent profits. Thus, in the case of non-life style, critical and life saving drugs, the generic versions should be allowed to be marketed irrespective of the national obligations towards world trade norms," he says.