Pharmacovigilance: Current Schedule Y perspective

Varun Gupta, Kirandeep Kaur, Ravina Sharma, Ishita Gupta Kaushal, Sandeep Kaushal


Conducting clinical trials for the approval of new drug molecules needs careful safety monitoring procedures in place. Unethical approval of drugs by the pharmaceutical companies just for monetary benefits needs to be restrained. Thus, practice of pharmacovigilance during clinical trials is imperative. The safety of the clinical trial participant is paramount during its conduct. Regular monitoring of the clinical trials, help in keeping a check on the trial activities. If there occurs, an event during the trial, in the form of an injury or death, it needs proper medical management and the trial participant needs to be well compensated financially. A decision regarding continuation or termination of the trial, as the requirement may be, needs to be taken by the Drug Safety Monitoring Board (DSMB). In India, Schedule Y of the Drugs and Cosmetics Act, 1945 pens down the guidelines for the conduct of a clinical trial. Approval from Drug Controller General of India (DCGI) is required prior to the start of the trials in India with strict adherence to Schedule Y. It is regularly updated to include the latest information and new requirements as per the need; in compliance with GCP-ICH guidelines and local conditions. This review discusses the pharmacovigilance practices in India in relation to clinical trials, latest updates and further improvements needed in Schedule Y.


Pharmacovigilance, Clinical trials, Schedule Y, India, Safety.

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