CDSCO issues guidance document to streamline approval process for conducting BA/BE studies for export

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The Central Drugs Standard Control Organisation (CDSCO) has come out with a comprehensive draft guidance document to streamline the approval process for conducting bioequivalence (BE) and bioavailability (BA) studies with human participants in India for export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 conducted to establish that two medicines, usually the original patented drug and a generic version, have the same biological equivalence, which means they work the same way and are interchangeable. The study is crucial for ensuring the safety and tolerability of generics against corresponding innovator drugs.

BA refers to the relative amount of drug from an administered dosage 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 amended the Drugs and Cosmetics Rules, 2017, to make BE studies compulsory for certain classes of generic drugs manufactured 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 recognised globally as an effective method to ensure therapeutic equivalence between a pharmaceutical equivalent test product and a reference drug.

According to industry sources, since the amendment to regulations, the number of pharmaceutical companies approaching the regulators to get approval for BE and BA studies has increased manifold.

The government has decided to come out with a draft guidance document to make the application process smooth-running. According to an official source, many applications get unnecessarily delayed in the absence of a detailed checklist. The new draft is expected to harmonise the submission process, shorten clearance time and help examiners reach quick and uniform decisions.

As per the guidance document, any firm that wants to conduct a BA and BE study should submit detailed study protocol, details of Ethics Committee registration, BA/BE Centre approval copy and other relevant documents mentioned in the checklist.

To obtain the CDSCO nod for the study of a new chemical entity not approved in India but cleared in other countries, an undertaking letter from the sponsor stating that he/she will provide complete medical care as well as compensation for the injury or death should be provided. Published reports of Pharmacokinetic and Pharmacodynamics studies carried out in healthy subjects demonstrating safety and tolerability of the molecule are also 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 a proper risk evaluation and mitigation strategy should be submitted. The guidance document also states that the firm should submit separate applications for different protocols along with requisite fee.

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