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Regulatory Focus™ > News Articles > Indian Report Calls for Reforms to CDSCO, Drug Regulations

Indian Report Calls for Reforms to CDSCO, Drug Regulations

Posted 13 September 2013 | By Ansis Helmanis

The Expert Committee convened by India's Central Drugs Standard Control Organization (CDSCO) has issued a report with 25 regulatory reform recommendations on "Policy and Guidelines for Approval of New Drugs, Clinical Trials and Banning of Drugs." 

Although the report acknowledges the local regulatory authority of India's states, it proposes the establishment of a Central Accreditation Council (CAC) at the national level for the accreditation of clinical trial investigators and ethics committees.  The report also recommends rolling the current 12 drug advisory committees into one "broad based" Technical Review Committee (TRC) as a way to expedite the review of marketing approval applications. 

As to the question of banning hazardous or ineffective drugs, the report recommends establishing a Special Expert Committee, independent of the Drug Technical Advisory Board, to review all marketed drugs and recommend removal from the market of drugs that are "potentially hazardous and/or of doubtful therapeutic efficacy." 

The report also calls for the reorganization, upgrading and strengthening of the CDSCO in order for it to be able to "perform the various functions envisaged" by the Expert Committee.  

The Expert Committee was established in February of this year in response to criticism of the CDSCO's regulation of drugs and clinical trials by India's Parliament and Supreme Court.

Expert Committee Report

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