NIS Considerations for India

The following page provides an overview of the regulatory requirements and considerations for those who are planning to conduct non-interventional studies in India (NIS Considerations for India).  The good news is that recently published legislation (New Drugs and Clinical Trials Rules, 2019) has provided much needed clarity and direction on the regulatory requirements for non-interventional studies focused on ‘new drugs’, as well as ‘old drugs’.

NIS Considerations for India – Need to Know and Recent Updates

• New Drugs and Clinical Trials Rules, 2019: In the context of this report, the ‘New Rules’ provide details and clarity with regards to the requirements for clinical trials, post-marketing studies, such as biomedical and human research. Rules applicable to biomedical and health research are applicable from 15 September 2019.
• OLD DRUGS – Observational studies of ‘old drugs’ are classed as biomedical and health research and require approval from a Biomedical and Health Research Ethics Committee (see classification table)
• NEW DRUGS – Post Marketing Surveillance Study, Observational Study or Non-Interventional Study of a “New Drug” require approval from the Central Licensing Authority (CLA), as well as approval from a Biomedical and Health Research Ethics Committee (see classification table)
• 2019 ICMR Proposal for Central Ethics Committee Review: At present in India, all centres are required to obtain approval from their respective ECs (Local Ethics Committee), which would consider the local needs and requirements of the population and safeguard the dignity, rights, safety and well-being of the participants. In 2019, the Indian Council of Medical Research (ICMR) proposed as process whereby a designated ethics committee (DEC) would act as a central ethics committee, taking on board the opinion of participating ethics committees and providing researchers with a single point of contact and a single opinion.

NIS Considerations for India – Step #1: Classify your study

NIS Considerations for India – Step #2: Determine Study Start-Up Requirements for each NIS Class

The approval requirements differ for non-interventional studies conducted with ‘New Drugs’ versus those conducted with ‘Old Drugs’.  Classification is based on risk and is explained in Rule 2(w) of the New Drugs and Clinical Trials Rules, 2019.  The English translation begins on page 147.  The Fifth schedule, which deals with the regulatory requirements for thses studies begins on page 228.

NIS Considerations India - NIS with 'New Drugs'

NIS Considerations India - NIS with 'Old Drugs'