DCGI (Drugs Controller General of India) extends validity of approval of Bioavailability and Bioequivalence Centre from one year to three years to facilitate ease of working.
Bioavailability and Bioequivalence studies are conducted in healthy human volunteer in study centre. Study centres requires Clinical Pharmacology Unit (CPU) and Bio analytical laboratory, which is being approved by CDSCO.
Currently approval of the Bioavailability/Bioequivalence study centre along with Bioanalytical laboratory to conduct Bioavailability/ Bioequivalence studies is given by CDSCO after inspection of the centre for one year. Renewal of the approval is being issued again after assessment of performance by an inspection of the site after one year.
In order to facilitate ease of business, it was decided in consultation with the stakeholders and with the concurrence of the Ministry of Health and Family Welfare (MoHFW) that validity period of approval of Bioavailability, Bioequivalence study centre and Bioanalytical laboratory will be extended from one year to three years.
The study centre will undergo Periodic surveillance audit after this extension. The study centres have to notify CDSCO if any major/critical changes occurred with respect to site and systems after they got approval.
DCGI also laid down the conditions that the CDSCO Audit report of international regulatory authority/WHO shall be submitted to the CDSCO after receiving the observations / reports. BA/BE study centre shall submit renewal application at least 4 month before the expiry of the present approval.
