The launch by Ranbaxy last week of Synriam, a new drug to treat malaria, is an important milestone. Having made its name by manufacturing generic (off patent) drugs cheaply, India’s pharmaceutical industry has struggled to achieve original drug discovery since the Uruguay Round of trade negotiations signalled the onset of product patents in India. It began to be realised, in time, that there was more to drug discovery than low-cost science graduates and PhDs. It requires not just vision but persistence (the probability of success is low) as also deep pockets. But Indian drug companies specialise in working on low margins.
While the event deserves to be celebrated, it is important to see it in perspective. The drug has till now been approved only by Indian regulators. Approval from regulators in Africa, where malaria is endemic, is expected soon; clinical trials are almost complete. In general, a drug is not seen as being globally accepted unless it clears better-respected regulatory processes in developed markets. However, malaria is not a serious affliction in such markets — so it does not make immediate sense to seek regulatory approval there. It is, however, becoming more common in Eastern Europe. Global approval will thus come once the World Health Organisation (WHO) pre-qualifies it as an approved medicine. This will enable its inclusion in government-funded anti-malaria programmes (most victims of the disease are poor) which account for the bulk of the market. This should not be too much of a hurdle, as the WHO has been associated with the development of this molecule right from the beginning.
As reported, Synriam appears to have some major pluses. It is a synthetic molecule, not derived from natural substances whose supply can be limited. A tablet has to be taken once a day for three days, at any time of the day, and does not require any dietary restrictions. Ranbaxy has claimed that the drug, which targets one of the most lethal forms of malaria, is the most economical of all available drugs. Medicines for Malaria Venture, a Swiss non-profit initiative, had taken the lead in its development, and the Indian government has part-funded the project. Interestingly, Ranbaxy, which has apparently spent $30 million (about Rs 160 crore) on it, has said it is treating it as a corporate social responsibility initiative and looking only to recover its costs. But in this hour of achievement for both Ranbaxy and India, a powerful irony cannot be ignored. The firm is now owned by the Japanese firm Daiichi Sankyo, with whom the intellectual property ultimately rests — and the new drug discovery programme of Ranbaxy has been transferred to the Japanese parent. Nevertheless, this is an important development: drugs for diseases endemic in low-income countries have been slow to emerge from the big multinational pharma powerhouses. Research and development in India must be pushed into filling this gap, now that it has been shown that success is possible.