Any person or institution or organisation which intends to conduct bioavailability or bioequivalence study of a new drug or an investigational new drug in human subjects shall obtain permission for conducting bioavailability or bioequivalence study from the Central Licencing Authority by making an application in Form CT-05.
The Central Licencing Authority may, after scrutiny of the information and documents furnished with the application in Form CT-05 and such further enquiry, if any, as may be considered necessary,—
if satisfied, that the requirements of these rules have been complied with, grant permission to conduct bioavailability or bioequivalence study for a new drug or investigational new drug in Form CT-07; or if not satisfied reject the application, for reasons to be recorded in writing within a period f ninety working days from the date of receipt of the application in FormCT-05;
in case, where the Central Licencing Authority considers that there are some deficiencies in the application and the same may be rectified, the said authority shall inform the applicant of the deficiencies within the stipulated period referred to in clause (i).
These decision generally takes 90 days form the day of application.
The applicant, after being informed as referred to in clause (ii) of subrule (1) by the Central Licencing Authority, may,—
- rectify the deficiencies within a period specified by the Central Licencing Authority; and
- where the applicant rectifies such deficiencies and provides required information and documents, the Central Licencing Authority shall scrutinise the application again and if satisfied, grant permission to conduct bioavailability or bioequivalence study of the new drug or investigational new drug; or if not satisfied, reject the application within a period of ninety working days reckoned from the day when the required information and documents were provided:
Conditions of permission for conduct of bioavailability or bioequivalence study:
- bioavailability or bioequivalence study at each site shall be initiated after approval of bioavailability or bioequivalence study protocol, as the case may be, and other related documents by the Ethics Committee of that site, registered.
- where a bioavailability or bioequivalence study centre does not have its own Ethics Committee, bioavailability or bioequivalence study at that site may be initiated after obtaining approval of the protocol from the Ethics Committee registered
PROVIDED FURTHER that both the approving Ethics Committee and the centre, shall be located within the same city or within a radius of fifty kms of the bioavailability or bioequivalence study centre;
the Central Licencing Authority shall be informed about the approval granted by the registered Ethics Committee within a period of 15 working days of the grant of such approval
bioavailability or bioequivalence study of new drug or investigational new drug shall be conducted only in the bioavailability or bioequivalence study centre registered with the Central Licencing Authority under rule 47
bioavailability or bioequivalence study of investigational new drug shall be registered with the Clinical Trial Registry of India maintained by the Indian Council of Medical Research before enrolling the first subject for the study;
bioavailability or bioequivalence study shall be conducted in accordance with the approved bioavailability or bioequivalence study
protocol and other related documents and as per requirements of Good Clinical Practices Guidelines and provisions of these rules;
in case of termination of any bioavailability or bioequivalence study, the detailed reasons for such termination shall be communicated to the Central Licencing Authority within thirty working days of such termination
Validity period of permission to conduct bioavailability or bioequivalence study
- The permission to conduct bioavailability or bioequivalence study granted under rule 34 in Form CT-07 shall remain valid for a period of one year from the date of its issue, unless suspended or cancelled by the Central Licencing Authority
- In exceptional circumstances, where the Central Licencing Authority is satisfied about the necessity for an extension beyond one year, the said authority may, on the request of the applicant made in writing, extend the period of permission granted for a further period of one year.
