Last Updated on June 4, 2026 by The Health Master
Pharmacovigilance
The Central Drugs Standard Control Organization (CDSCO) has issued a regulatory directive aimed at strengthening drug safety monitoring across the Indian pharmaceutical industry.
In a circular issued by the Office of the Drugs Controller General India (DCGI), all pharmaceutical manufacturer licensees are now required to establish and maintain a functional Pharmacovigilance (PV) system.
This directive aligns strictly with the revised Schedule M of the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials (NDCT) Rules, 2019, making adverse event reporting a mandatory operational standard for all drug manufacturers and drug marketers.
What is Pharmacovigilance
As per Para 6.11 of Schedule M of the Drugs and Cosmetics Act, 1940, the pharmaceutical industry cannot treat post-marketing surveillance as an optional practice.
The law dictates that every drug manufacturing licensee must have a robust system to collect, process, and forward reports regarding adverse drug reactions (ADRs) to the concerned licensing authorities.
The primary objective of the said circular is to monitor the safety profile of drugs after they are supplied to the market, ensuring that any possible side effects or risk issues are promptly identified and remedies can be done in time.
Main Regulatory Requirements for Pharma Industry
To comply with the said latest CDSCO directive, the pharmaceutical industry must transition from passive monitoring to an active pharmacovigilance framework.
The regulatory framework highlights the main core responsibilities as follows:
- Data Collection: Setting up a dedicated system to receive ADR from healthcare professionals, patients, and clinical studies.
- Data Processing: Evaluating and validating the collected ADR data using standardized scientific methods.
- Regulatory Reporting: Forwarding verified data and Periodic Safety Update Reports (PSURs) to the concerned licensing authorities within the specified timelines.
- Alignment with NDCT Rules 2019: Ensuring that the safety monitoring protocols are updated in accordance with NDCT Rules 2019 and post-marketing surveillance standards.
Routine Inspection Measures
The CDSCO has made it clear that this mandate will be strictly enforced through routine inspections at the drug manufacturing units.
Compliance verification will now be integrated into standard operating procedures for regulators.
| Regulatory Body | Inspection | Action |
| CDSCO Central Officers | Routine and surprise inspections | Verification of PV department setup, SOPs, and data logs. |
| State Licensing Authorities (SLA) | Joint or independent manufacturing inspections | Reviewing compliance with Schedule M (Para 6.11) before license renewals. |
| UT Administrations | Local facility checks | Ensuring regional marketing distribution units have an active ADR collection mechanism. |
