In yet another measure to facilitate ease of business in the area of clinical trial in the country, the Drug Controller General of India (DCGI) has extended the validity period of approval of bioavailability, bioequivalence (BA/BE) study centres and bioanalytical laboratories from one year to three years subject to certain conditions.
The conditions mentioned in the DCGI order in this regard include periodic surveillance audit shall be carried out; any major/critical changes with respect to site and systems during the validity shall be submitted to CDSCO immediately; audit report of international regulatory authority/WHO shall be submitted to the CDSCO after receiving the observations/reports; and BA/BE study centre shall submit renewal application at least 4 months before the expiry of the present approval.
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 subject to the following conditions”, the DCGI order said.
BA/BE studies are conducted in healthy human volunteers in study centres. Study centres require Clinical Pharmacology Unit (CPU) and bioanalytical laboratory, which is being approved by the DCGI office (CDSCO) as per Schedule Y, Ll of Drugs and Cosmetics Rules, Indian GCP and bioavailability/bioequivalence study guidelines issued by the DCGI office.