The Central Drugs Standard Control Organization (CDSCO) has turned out with a comprehensive draft guidance document to streamline the approval process for conducting bioequivalence (BE) and bioavailability (BA) studies with human participants in India for export purposes.
BE studies are led to set up that two medicines, usually the original patented drug and a generic version, have the same biological equivalence, which implies they work the same way and are interchangeable. The study is critical for ensuring the safety and tolerability of generics against corresponding innovator drugs.
BA refers to the relative amount of drug from an administered dose that enters the systemic circulation and the rate at which the drug appears in the systemic circulation.
The ministry of health and family welfare has recently changed the Drugs and Cosmetics Rules, 2017, to make BE studies compulsory for certain classes of generic drugs made in India.
However, those drug makers exporting to the US and the European Union are required to conduct these studies to gain marketing approval for those jurisdictions as BA and BE studies are perceived globally as an effective method to ensure therapeutic equivalence between a pharmaceutical equivalent test product and a reference drug.
As indicated by industry sources, since the amendment to regulations, the number of pharmaceutical companies moving toward the regulators to get approval for BE and BA studies have increasingly complex. The government has decided to turn out with a draft guidance document to make the application to process smooth-running.
As per an official source, many applications get unnecessarily delayed in the absence of a detailed checklist. The new draft is expected to harmonize the submission process, shorten clearance time and enable analysts to achieve quick and uniform decisions.
According to the guidance document, any firm that needs to lead a BA and BE study should submit detailed study protocol, details of Ethics Committee registration, BA/BE Center approval copy and other important documents mentioned in the checklist.
To acquire the CDSCO nod for the study of a new chemical entity not approved in India but rather cleared in different countries, an undertaking letter from the sponsor expressing that he/she will give complete medical care as well as compensation for the injury or death should be given.
Published reports of Pharmacokinetic and Pharmacodynamics studies carried out in healthy subjects demonstrating safety and tolerability of the molecule are additionally necessary. For cytotoxic drugs, hormonal preparations, narcotic and psychotropic substances etc to be tested in healthy human subjects, a scientific justification with special emphasis on safety of subjects with an appropriate risk evaluation and mitigation methodology should be submitted.
The guidance document also expresses that the firm should submit separate applications for various protocols alongside requisite fee.