The drug controller general of India (DCGI) will not accept and approve the reports of bioavailability (BA) and bioequivalence (BE) studies which are conducted at clinical or bioanalytical facilities that are not approved by the Central Drugs Standard Control Organisation (CDSCO).
Cautioning the industry about such malpractices, the DCGI has warned that there is a requirement of obtaining approval from the office of DCGI prior to initiation of activity of bioanalytical labaratory for the purpose of analysis of samples obtained from bioavailability (BA) and bioequivalence (BE) studies.
BA study is conducted to assess the rate and extend to which the active drug is absorbed from a pharmaceutical formulation and becomes available in the systemic circulation or availability of drug at the site of action. BE study is conducted to establish the absence of a significant difference in the rate and extend of absorption of an active drug from a pharmaceutical formulation in comparison to the reference formulation having the same active drug when administered in the same molar dose under similar conditions.
Such BA/BE studies are conducted in various study centres across the country. Reports of BA/BE studies are accepted only from those centres which are approved by the CDSCO to conduct such studies. Such study centres are required to have clinical as well as bioanalytical facilities to conduct BA/BE studies. However, there are some centres which may not have both the facilities of their own. In such cases these centers avail the facility of others to conduct BA/BE studies, the DCGI said.
It is brought to the notice of all concerned that no such facility either clinical or bioanalytical should involve in conduct of BA/BE studies unless otherwise approved by CDSCO, the DCGI in his directive to the industry said.