Regulatory Focus™ > News Articles > India’s CDSCO Says Bioequivalence Testing Centers Require Approval

India’s CDSCO Says Bioequivalence Testing Centers Require Approval

Posted 09 January 2014 | By Louise Zornoza

India's Central Drugs Standard Control Organization (CDSCO) issued a "clarification" to local authorities that laboratories intending to engage in bioequivalence and bioavailability (BA/BE) testing must first obtain the approval of the CDSCO before engaging in such activities. 

In the clarification, the CDSCO notes that BA/BE study results will only be recognized if they are conducted by approved facilities.  Moreover, the same approval requirement extends to facilities that conduct studies on behalf of laboratories that lack the capacity to conduct either a BA or BE study themselves.

Earlier this year, the Prof. Ranjit Roy Chaudhury expert committee formed by India's Health Ministry to formulate new drug approval policy, recommended that BA and BE studies on patients should be done as part of the clinical trials of all new substances and generics introduced in India. Subsequent generics of the same drug, however, showing good absorption orally and similar in vitro release rate need not undergo BA and BE studies, according to the committee.

CDSCO - Bioequivalence Clarification

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