The Drug Controller General of India (DCGI) has introduced a new set of guidelines to streamline the application process for conducting bioequivalence (BE) studies for export purposes in order to simplify the procedures and to bring in uniformity in decision making.
As per the guideline, the drug regulator has mandated that all the BE studies for the purpose should be conducted in BE study centres approved by Central Drugs Standard Control Organisation (CDSCO).
With the guideline, the DCGI has specified that all the applications for BE studies for export purpose should carry documents including application in Form-44 duly signed by the competent authority with name and designation, a copy of the approval granted to the BE study centre by CDSCO, the study protocols, sponsor's authorization letter duly signed by the competent authority on their letterhead and adequate supporting safety data in the case of multiple dose BE study.
The guideline categorises the applications into filings for BE studies for a new molecule not approved in India but approved in the other countries, new drugs approved in India within period of one year, new drugs approved within period of more than one year and less than four years, BE No Objection Certificate (NOC) for all the drug products in modified release form irrespective of their approval status.
According to the DCGI's announcement, "A large number of applications are being filed to the office of DCG (I) at CDSCO (HQ) by pharmaceutical companies, both manufacturers and importers as well as CRO's on behalf of them, requesting for the approval to carry out BE studies with various pharmaceutical dosage formulations on Indian subjects." It is in this context that the drug regulator has come up with a new set of guidelines to apply for BE studies for export purposes.
For conducting BE studies on a new molecule not approved in India but approved in the other countries, the applicants should submit clinical study data and published report of pharmacokinetic and pharmacodynamic study carried out in healthy volunteers or patients data published in reputed journals along with regulatory status of the drug, names of the countries where the drug is currently being marketed and package literature on the international product.
A Complete Certificate of Analysis of same batches (both test and reference formulations), to be used in the BE study, has to be submitted with the applications for the rest of the categories. In the case of injectable preparation, the sub-acute toxicity should be submitted on the product of the sponsor, generated in two species for adequate duration. Proper justification for conducting studies on the subjects should be submitted with the application depending on the nature of the drugs like cytotoxic agents, hormonal preparations etc, as per the guideline.
In order to get approval for conducting BE studies on the first two categories, the applicants should pay Rs 25000 even as for the last two categories the fee is Rs 15000 as per the Drugs and Cosmetics Rules.
Even though the guidelines are set for general conditions, the authority may seek further specific information to be furnished by the applicant, depending on the nature of the drug, disease and studies, adds the announcement.
The DCGI, in March 2005, had notified guidelines for bioavailability (BA) and BE studies specifying the instances where these studies are necessary to ensure safety and efficacy of the products. The guideline also describes requirements for design, conduct and evaluation of the relevant products and has also kept options for the possible usage of in vitro instead of in vivo studies with pharmacokinetic end points.