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India Strengthening its Central Regulatory Authority to Keep Pace with Industry Expansion

Aug 13th, 2010

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India is working to strengthen its central drug regulatory authority and related laws and regulations in response to its rapidly expanding domestic industry and the need for more interaction with foreign regulatory counterparts.

The growth of the Indian drug industry and the regulatory response underway was highlighted by Semler Research Center (SRC) Director Gurudatta Gayatri at DIA’s Annual Meeting in June.

The Indian government and its Directorate General of Health Services’ Central Drugs Standard Control Organization (CDSCO), has recognized the need for more stringent regulatory oversight of drug manufacturing in India and has been implementing a plan to improve the related laws and regulations, the SRC official commented.

The current CDSCO plan, which covers the five year period from 2008 – 2012, Gayatri explains, includes initiatives in ten areas:  ● a common technical format following the ICH CTD model ● clinical trials ● medical devices ● pharmacovigilance ● interaction with national and international regulatory bodies ● overseas inspector training ● inspections by CDSCO of foreign firms ● transparency and accountability ● electronic submissions and records, and ● creation of an FDA-like “Central Drugs Authority” (CDA).

Gayatri noted that a more autonomous CDA with a mandate to upgrade the national regulatory system would provide an underpinning for the other initiatives and is the focus of a bill now under consideration in the Indian parliament.

[More on the regulatory efforts by the Indian government and statistics on the growth in US and European filings from Indian manufacturers is provided for subscribers on page 2.]

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