Joe C Mathew: Battle's over, debate's begun

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The battle is over, but the debate has just begun, says Ranjit Shahani, the Indian head of Swiss drug maker Novartis AG. What he refers to is a legal battle involving his company and the Indian government over the constitutional validity of a clause unique to the Indian Patent Law "" a clause that makes patenting of slightly modified versions of known medicines almost impossible in the country. The verdict, which went against Novartis last week, was one of the keenly watched court battles the world over.

While emotive international public interest groups consider the dismissal of Novartis' petition as a 'landmark victory' that ensures continued supply of low-cost generic medicines for poor patients, Novartis calls this a regressive step that stifles innovation.

The fact remains: Shahani has succeeded in bringing back the patent debate to the limelight. Back from a BBC interview on Indian patents, he says that he will continue to make domestic industry and the public at large aware of the inadequacies of India's patent system. No one other than Shahani, who has headed the Organisation of Pharmaceutical Producers of India "" the voice of global drug makers in the country "" for a long six years, can perhaps share the same optimism.

A Kanpur IITian, Shahani has rich experience in the field of chemicals and pharmaceuticals. Starting his career with ICI in their businesses of fibres and speciality chemicals, he went on to head Roche Products Limited, and moved to Novartis in India 10 years ago.

Patent law was not the only issue before Shahani. Equally important has been his contribution in generating a national debate on data exclusivity "" another key demand of international pharmaceutical players "" that relates to the need for the protection of clinical trial data submitted by a research-based company for regulatory approval from being used by a generic drug manufacturer. Though the government is yet to take a final view on the issue, Shahani feels that it would happen soon. What could come to his aid is perhaps the clout of another organisation he heads "" the Bombay Chamber of Commerce and Industry "" a body whose members control one-third of India's trillion dollar economy.

Shahani also played a critical role in seeing that the government amends the Drugs and Cosmetics Act 1945 to strengthen penal provisions against counterfeit and spurious drug makers. With Parliament expected to amend the Act during the current session, his agitation against counterfeiters is bound to be fulfilled.

Of all the campaigns of Shahani, the one that could have made the most impressive mark on Indian villages is his suggestion for selling over-the-counter medicines (home remedies) through the 150,000 post offices of the country. The idea is close to his heart as it would bring in 750 million Indian citizens closer to primary medicines within no time. The matter, presented before the authorities three years ago, is still awaiting an official clearance. In Shahani's words, by just allowing the industry to distribute simple medicines like ORS or calcium, the government can extend its primary healthcare reach by over 33 per cent. A decision is pending, and Shahani is hopeful.

The country's staunchest campaigner for an internationally recognised patent regime has found him debating patents and public health both in office and at home, by virtue of being the father of a post-graduate in pharmaceutical sciences who does his research in international health policy at the London School of Economics.