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New Body to Streamline Drug Licensing, Imports (India)

This article was originally published in PharmAsia News

Executive Summary

The Indian government plans to introduce legislation to bring about changes to the body that regulates the pharmaceutical industry. The proposed new structure would centralize drug approvals and tighten lax manufacturing practices. A new independent Central Drugs Authority of India (CDAI) would replace the Central Drugs Standard Control Organisation, along the lines suggested by the former CSIR Director Dr. R.A. Mashelkar's expert committee in 2003. The CDA would "be responsible for the development and definition of basic standards," "provide technical vision" and ensure that "for every activity there [is] a clear policy framework and efficient supervision to ensure a uniform legislation." States would continue to grant drugs sales licenses, but responsibility for the manufacturing licenses would move over a five-year period to the CDAI. Both pharmaceutical stakeholders and public health groups are supporting a stronger central authority to streamline licensing and improve quality control monitoring. "The authority on drugs control today is overloaded," said D.G. Shah of the Indian Pharmaceutical Alliance. "If the DCG is away or attending parliamentary questions, the drug approval process comes to a standstill. The changes should bring in more efficiency and allow time for in-depth study of applications." (Click here for more
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