Regulatory Focus™ > News Articles > India Proposes to Waive Phase III Trials for Drugs Approved in a 'Well-Regulated Country'

India Proposes to Waive Phase III Trials for Drugs Approved in a 'Well-Regulated Country'

Posted 27 February 2015 | By Louise Zornoza 

India Proposes to Waive Phase III Trials for Drugs Approved in a 'Well-Regulated Country'

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India’s Drugs Technical Advisory Board (DTAB) has recommended granting Phase III clinical trial waiver to some drugs approved in "well-regulated" countries like the US or EU.

The waiver would also require drug sponsors to agree to implement a four-year post-marketing surveillance plan, which would need to be approved by India's Central Drugs Standard Control Organization (CDSCO). 

Prior to granting a waiver, the CDSCO would have to obtain input from experts in the therapeutic area for which the drug is indicated.  The DTAB recommendation is similar to what the Chaudhry Expert Committee, tasked with overhauling the drug regulatory system in India, had proposed to the Ministry of Health last year. The ministry countered that such a waiver should be limited to national health emergencies and for drugs indicated for rare diseases.

 

DTAB Recommendation


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