The Hindu Business Line : No data exclusivity yet for pharma companies

DSIR has recommended data exclusivity be granted to pharma companies for three years, along with "sufficient" safe guards to ensure drug prices are not affected.

Mumbai , June 14

A divided house at a recent inter-ministerial meeting has delayed a decision on granting data exclusivity to drug companies. But, there seems to be a consensus among representatives at the same meeting on granting agro-chemical companies data exclusivity for three years.

Data exclusivity ensures protection of information submitted by companies when they seek a marketing approval in the country. The information is submitted to the regulatory authority, the Drug Controller-General of India in the case of pharma companies. And though the period of protection is limited, say three or five years, the contentious issue is whether the regulator is allowed to rely on the submitted data during this period of time.

The issue has split the pharma industry along predictable lines of domestic and multinational companies. But a consensus eluded the recent inter-ministerial as well.

Time sought

The Department of Scientific and Industrial Research (DSIR) is pushing for data exclusivity. The DSIR has recommended that data exclusivity be granted for three years, along with "sufficient" safe guards so that medicine prices are not affected, a ministry official told Business Line.

But the Ministries of Health and Commerce, respectively, have sought time to "re-examine their stand." They have been given two weeks to study the model of data-protection, where the Government will not rely on the submitted information for the fixed period of time.

Meanwhile, the Ministries of Agriculture and Chemicals and Fertilizers (C&F) will push ahead with their reports for data exclusivity in the agro-chemical sector, which will require changes in the Insecticides Act, 1968.

New definition

On the pharma front, however, the different ministries will have to first come up with a definition of a New Chemical Entity (NCE), from a marketing point of view.

This differs from the NCE definition that is the yardstick for granting patents and has to do with innovation, the Ministry official explained.

If data exclusivity is cleared for the pharma sector, it would be effected through an amendment in the Drugs and Cosmetics Act, 1940.

The apex C&F Ministry, however, is playing it safe on the pharma sector and has asked for a "caliberated" approach.

It is agreeable to data exclusivity for a fixed time, with safeguards. In case data protection is not given, the C&F Ministry has called for strengthening the regulatory system to keep the disclosed information classified.

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