‘Ensuring data protection is crucial for clinical activity’

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: Incorporated in India in 1994, Roche Scientific Company (India), is a wholly owned subsidiary of the Basel (Switzerland)-based F Hoffmann LA Roche (FHLR). In 1993, FHLR entered into an agreement with Nicholas Piramal India to market and manufacture some of its products, but this was terminated in 2003. Roche is now going on its own, and launching Avastin, its cancer drug, here, just a few months after its global launch.

Dr G Telang, the company’s managing director, spoke to MG Arun on the new patent scenario and Roche’s future plans in India.

There was much euphoria that with the heralding of product patents in India, global pharma companies would step up their activities in the country in a big way, be it in product launches, clinical trials, or research & development. Do you see this happening?

It is a really welcome step that the government has introduced patents in the country. The pharmaceutical fraternity has now been asked by the authorities to give their views on the draft patent law. In general, the industry feels that more clarity is needed in two areas: the definition of ‘patentability’ as per the Draft, and the issue of pre-grant opposition. I feel that the issue of data protection also needs to be addressed, since that is essential for MNCs to do their clinical studies with confidence in the Indian market. Now, even if the regulatory norms are in place, implementing them becomes an issue. It is doubtful whether the office of the Drug Controller General of India (DCGI) has the necessary infrastructure to ensure efficient implementation.

Of course, it’s true that all these issues will not be addressed overnight. Roche has a faith in the Indian regulatory environment, and we were confident the system would change for the better over time. The amendment to the Schedule Y of the Drugs and Cosmetics Act is welcome, whereby international drug companies can now conduct multi-centre phase I and phase II throughout the country. This is a very strong step to show the world that the country is globalising.