Introduction

India is an attractive destination for global clinical trials. The reasons are three fold: Sizeable subject pool, well-qualified investigators who are fluent in English and cost-effectiveness. There were some regulatory concerns surrounding clinical trials due an amendment in the law in 2013, but those concerns have been addressed through subsequent amendments and administrative clarifications.

Most Important laws

• The Clinical Trial Rules, 2019 regulate clinical research of drugs and lays down basic quality and safety standards to be followed while undertaking clinical trials involving Indian subjects.
• The Medical Device Rules, 2017 regulate clinical trials of notified medical devices and IVDs and lays down basic quality and safety standards to be followed while undertaking clinical investigations involving Indian subjects.
• The Prevention of Cruelty to Animals Act, 1960 regulates animal experiments involving drugs and medical devices, and prescribes an approval mechanism for use of animals in experiments.
• The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017 lays down ethical guidelines for undertaking any kind of biomedical and health research (not limited to drugs or devices, and covering human genetics research, public health research, biobanking etc.)

Key things to remember

• The Clinical Trial Rules, 2019 apply to all clinical research using drugs, whether interventional or observational, and whether concerning new drug/dosage form/indication or not.
• India has unique formula and methodology to determine compensation in case of clinical trial related death or injury, and the amount so arrived at has to be paid under an order of the regulator.
• The exemption criteria for undertaking clinical trials to import an internationally approved drug has been expanded significantly, especially for drugs approved in countries with developed regulatory systems.
• Animal testing is strictly regulated in India, and is to be undertaken only to the extent necessary. Repeat animal testing is generally not insisted upon.
• If a patient has not specifically consented to be tracked, then should such patient be lost to follow-up, he/she may should not be tracked by any person other than the investigator.
• It is mandatory to undertake audio-visual recording of vulnerable subjects in trials involving NCEs or NMEs.
• It is sometimes considered unethical to ask study subjects to sign a waiver or release even after payment of compensation.
• It is common India for doctors to jump hospitals for opportunities. This sometimes affects the progress of the trial but can be addressed through documentation.

Important sub-segments and related industries

• Clinical Trials
• BA/BE Studies
• Animal Trials
• CROs
• SMOs
• Post Market Surveillance