DCGI Extends Validity Of Registration Of BA/BE Study Centres

Mumbai, 5 May 2020:

The Central Drugs Standard Control Organisation (CDSCO) has clarified that registration of bioavailability-bioequivalence (BA-BE) study centres is valid if application for renewal has been made 90 days prior to expiry in accordance with New Drugs and Clinical Trial (NDCT) Rules 2019.

The clarification comes in the wake of Drugs Controller General of India (DCGI) office having received representations from stakeholders requesting to extend validity of BA/BE study centres registrations whose validities are expiring between now and August 2020 in view of COVID-19 outbreak.

“Matter was examined by CDSCO committee in light of COVID -19 outbreak and it is therefore clarified that in accordance with NDCT Rules, 2019, if application for the renewal of registration of BA/BE study centre in Form CT-08 is received by CDSCO 90 days prior to the date of expiry, the registration shall continue to be in force until order passed by the said authority on the application,” according to a CDSCO circular.

BA/BE centres have been mandated and registered under Rule 44 of NDCT Rules 2019 to conduct the BA/BE study of new drugs in human in the country. Before the implementation of NDCT Rules, 2019 on March 19, 2019, permissions were issued to the study centres to conduct BA/BE studies having validity of 3 years. All such centres permitted by CDSCO before implementation of the NDCT Rules, 2019 also need to be registered under the NDCT Rules.

In view of the above, BA/BE study centres which has already applied or will apply for renewal of the registration 90 days prior to the date of expiry of its existing registration in Form CT-08 along with requisite fees and documents, the registration of such centres will remain valid until any order is issued by CDSCO otherwise, the circular further stated.

CDSCO had earlier urged the manufacturers to submit stability studies data as per NDCT Rules, 2019.

As per NDCT Rules, 2019, clinical trial in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its clinical or pharmacological including pharmacodynamics, pharmacokinetics or adverse effects with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug.

As per the new rules, bio-equivalence study means a study to establish the absence of a statistically significant difference in the rate and extent of absorption of an active ingredient from a pharmaceutical formulation in comparison to the reference formulation having the same active ingredient when administered in the same molar dose under similar conditions. Pharmabiz