CDSCO Tightens Compliance: Why Is Pharmacovigilance Important for All Pharma Companies Now?

What is Pharmacovigilance?

As per the definition of WHO, “Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.” So, pharmacovigilance is the process where information related to any side effects or harmful reactions of a drug, vaccine, or medical device is identified and collected. Such information is then analysed to conduct further studies to prevent such side effects or harmful reactions in the future. Pharmacovigilance is important because the data available regarding a particular pharmaceutical product during a clinical trial is very limited. When the product is released in the market, it becomes important to monitor its possible effects so that public health is not compromised.

Understanding the CDSCO Pharmacovigilance Circular

On 03.06.2026, CDSCO issued a circular directing pharmaceutical companies to establish and maintain an effective pharmacovigilance (“PV”) system. This system must comply with Schedule M of the Drugs and Cosmetics Act, 1940 and Rules, 1945, along with the New Drugs and Clinical Trials Rules, 2019. Under Para 6.11 of Schedule M, it is mandatory for drug manufacturers or marketers to have a pharmacovigilance system in place. The objective is to ensure that adverse drug reactions are reported timely to the licensing authorities. The CDSCO circular clarifies that this compliance is mandatory for all drugs, and is not restricted only to new drugs.

Why is Pharmacovigilance Important for Pharmaceutical Companies?

Beyond simply mandating Schedule M compliance, the CDSCO has instructed regulatory officers to verify PV compliance during routine facility inspections. Pharmacovigilance compliance is critical for pharmaceutical companies to ensure that they are inspection ready. For drug manufacturers, marketers or importers (“MA holders” or “MAHs”), this signals a major shift:

• Routine & Surprise Audits: Drug inspectors from central and state authorities will now review safety data logging workflows right alongside physical manufacturing logs.
• Legal Enforcement: Show-cause notices, stop production orders, product permission cancellation, manufacturing license suspension or cancellation, or legal enforcement actions may be passed in cases of non-compliance.
• Stringent Standard Enforcement: The PV system must comply with specific standards set by the CDSCO, or the company risks severe regulatory penalties.

How to Do Pharmacovigilance and Meet CDSCO Pharmacovigilance Requirements?

The CDSCO published a guidance document on pharmacovigilance systems in 2024 to assist MA holders. The guidance document sets a benchmark for the standards that the PV system needs to comply with. It also lays down the procedure for reporting information to the authorities. An inspection-ready PV system would include the following:

1. Pharmacovigilance System Master File

The MAHs are required to maintain a Pharmacovigilance System Master File (“PSMF”). The PSMF provides a description of the PV system maintained by the MAH. The PSMF should contain the following details:

1. PV personnel and their responsibilities: Clear details of the PV officer in-charge (“PVOIC”), who is responsible for staff training, identifying PV activities, framing or revising SOPs for the PV department, establishing quality management systems, etc., must be mentioned.
2. PV organisation structure: Details of the MAH, along with the description of the PV system, research organisation engaged on a contract basis to manage the PV system, etc., should be mentioned.
3. Sources of safety data: The PVOIC is required to collect data, reports and publications related to the safety of pharmaceutical products from sources such as medical information inquiries, product complaints, information from patients, and reporting by healthcare professionals (“HCPs”).
4. PV process: A detailed description of the entire process, including data handling, record management, safety communications to consumers, HCPs, national regulatory authority, etc., and product information updates must be included.
5. PV system performance: The PSMF should elaborate on the effectiveness of the PV system along with a description of monitoring methods.

2. Individual Case Safety Reports

Individual Case Safety Reports (“ICSRs”) provide the general principles for collection, collation, processing and reporting of ICSR with respect to pharmaceutical products. The process to be followed by MA holders includes:

1. Collection of adverse event reports.
2. Conducting weekly literature reviews, including medical journals, research papers, reports, etc., to identify potential adverse events.
3. Follow-up of ICSR to obtain missing information necessary for clinical evaluation of incomplete case reports.
4. Recording, validating and processing all adverse event reports as per the prescribed procedure.
5. Submission of only valid ICSRs containing identifiable patient data, adverse event, suspected product and identifiable reporter to the relevant authorities in the prescribed format.
6. Reporting all serious adverse events within 15 calendar days of receipt of information, and non-serious adverse events within 90 calendar days of receipt.
7. Assessing the relation between the suspected product and adverse event using the WHO-UMC causality assessment scale.
8. Applying special monitoring and reporting requirements for pregnant, breastfeeding, paediatric and elderly populations.

3. Preparation and Submission of Periodic Safety Update Report

Periodic Safety Update Report (“PSUR”) is a document for evaluation of the benefit-risk profile of a pharmaceutical product. The main objective of a PSUR is to present a comprehensive, concise and critical analysis of new or emerging information on the risks and benefits of pharmaceutical products for the approved indications. The recommended format, content and timelines of PSUR submission are as follows:

1. Post-marketing assessment of new drug: The new drug must be continuously monitored after approval through the PV system, phase IV clinical trial studies and PSUR submissions to assess the safety and effectiveness of the drug.
2. Contents of PSUR: The PSUR should include product details, intended use, therapeutic class, dose, route of administration, formulation, approved indication and population, along with actions taken, changes to reference safety information, patient exposure, risk management plan to manage adverse events, etc.
3. Submission timelines: The PSUR must be submitted every six months for the first two years after drug approval. For the subsequent two years, the PSUR must be submitted annually.

4. Quality Management System

The MAHs are required to establish, maintain and assure the quality of their PV system. This requires the MAH to comply with Quality Management System (“QMS”) requirements to ensure quality, planning, adherence, control and improvement of their PV system. This includes training of MAH personnel, appropriate facilities and equipment, record management, documentation, and monitoring of the PV system. The responsibility for compliance with the guidance document rests on the managerial staff.

5. Audit and Inspection

The main objectives of PV audit and inspection include:

1. Verification by examination and evidence of the implementation and operation of the PV system.
2. Assessment of MAH’s qualified personnel, facilities and systems.
3. Identification of, and addressing, non-compliance.
4. Recommendation of regulatory action wherever necessary.

6. Risk Management Plan

Risk Management Plan (“RMP”) is a document that records the risk management system considered necessary to identify, characterise and minimise a pharmaceutical product’s risks. It includes an overview of the pharmaceutical product, safety specifications, epidemiology indications and target populations, along with clinical trial exposure, potential risk, safety concerns, risk minimisation activities, and PV activities to identify safety concerns of the pharmaceutical product. The RMP must be regularly updated by the MAH throughout the life-cycle of the pharmaceutical product.

Conclusion

For pharmaceutical companies, this may be the right time to conduct thorough due diligence on their PV systems and address any compliance gaps to ensure inspection readiness. Pharmacovigilance is not merely an afterthought anymore. For pharmaceutical companies, it is essential to focus on pharmacovigilance and have a dedicated team to demonstrate strict compliance with the dynamic legal framework.

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Tags: Pharmacovigilance, CDSCO, Regulatory Compliance

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