ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

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Sensible Drug Monitoring

WEEKLYECONOMIC AND POLITICAL Sensible Drug Monitoring The government has shown surprising sagacity in the formulation and announcement of the draft rules for the import and manufacture of new drugs for clinical trial or marketing. For the first time there appears to be some semblance of an organised effort towards a comprehensive

The government has shown surprising sagacity in the formulation and announcement of the draft rules for the import and manufacture of new drugs for clinical trial or marketing. For the first time there appears to be some semblance of an organised effort towards a comprehensive – interdepartmental and intersectoral – framework for monitoring a vital and special sector.

The Indian drugs sector is undergoing rapid change not only as a result of mergers and splits of multinationals with interests of various kinds in India, but also because the so-called Indian sector is itself emerging as a big player in the growing market for new drugs. Simultaneously there has been considerable movement on the regulation front. For one, the new draft drug policy is now in the final stages of formulation. And if reports are reliable, it will reduce the price control basket to 24 per cent of the value of the domestic formulations market. This would mean that the number of drugs under price control would come down from 74 to 31. Interestingly though, the policy is expected to set parameters on a whole range of issues that have been hanging fire for a considerable time: guidelines for good manufacture, research and development and foreign direct investment. While there have been numerous reactions from the industry, it is more difficult to capture its impact on the availability and accessibility of drugs to consumers.

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