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Almost as if it was foreshadowing the COVID-19 pandemic, the New Drugs and Clinical Trial Rules, 2019 (‘NDCTR’/ ‘Rules’) brought about significant developments by consolidating and streamlining the framework for regulating clinical trials and approvals thereof. However, the circumstances in the recent past have raised questions as to whether these new Rules, in their attempt to promote robust clinical research in India, have compromised on the safety and efficacy of trials, making them more sponsor-friendly. This piece explores such issues in the context of striking the right balance between the two.

The article first highlights the concerns with bonus distribution in India which is constrained heavily due to the determination of bonus payments being based on profits generated by the businesses. The article then proceeds to explore the problems with the set-off and set-on rule prescribed in Section 36 of the Code which carries forward the bonus payments to the succeeding year, thereby withholding the employee’s rightful payment for that year.

The COVID-19 pandemic exposed the gaping vulnerabilities in the country’s public healthcare system. States struggled to ramp up their healthcare facilities, hospitals were quick to run out of beds, the costs of medical facilities and drugs rose steeply, and many individuals belonging to socio- economically vulnerable communities were unable to access healthcare facilities. Apart from these structural issues, a few specific issues stood out. These very issues are the focus of the XIV NLSIR-Samvad: Partners Symposium. Through this Symposium, we hope to address some of the pressing concerns relating to India's public healthcare system and hope to reconceptualize the country's healthcare framework in a holistic manner.