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Indian pharma companies will need to allocate substantial funds to conduct Bioavailability (BA) and Bioequivalence (BE) studies of a new drug or an Investigational New Drug. An application fee of Rs.2 lakh is required for only conducting the BA/BE studies over and above the compensation to be paid to the human subjects in case of an untoward incident.
With the new Drugs & Clinical Trials Rules, 2019 that bring in a set of stringent norms in place to conduct these studies in India, it is still seen to be inexpensive than aboard, said Chandrashekar Ranga Deputy Drugs Controller, CDSCO.
Providing a peek into the submission of BA/BE study data for grant of manufacturing license for oral dosage forms, Chandrashekar who was in Bengaluru explained that a drug substance is considered highly permeable when the extent of absorption in humans is determined to be 90 per cent or more of the administered dose.
Here a BE study is required to ensure that the absorption of drug from the test product is not different from reference product. An innovator product is used as reference product for new drug approval. In case of permission for a new drug already approved, generally first approved brand is used as reference product. BE study is required for approval of oral formulations of new drugs within 4 years of approval. No BA / BE study of any new drug can be conducted without permission from CDSCO. Moreover, BA / BE study of new drug can be conducted only in BA/BE centers registered with CDSCO, he added.
In case of rejection, applicant could request Central Licensing Authority (CLA) to reconsider the application within a period of 60 working days from the date of rejection with fee of Rs.50,000 and resubmit the required information and documents. If aggrieved by decision of CLA, a company could file an appeal before central government within 45 working days from the date of receipt of such decision. Here the Government after enquiry must dispose the appeal within 60 working days, he said.
There are specific conditions for permission like the study at each site is to be initiated after obtaining approval from Ethics Committee (EC) of that site, registered with the CLA. If there is no EC at that site, they can go for approval from institutional EC of another trial site. The EC is responsible for the study at the trial site which should be located in the same city or at 50 km radius. The EC protocol approval is also to be notified to the CLA within 15 days. The study centre will need to maintain data, related to conduct of BA/BE study for 5 years after completion or at least 2 years after expiry date of new drug or investigational new drug, he said.
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