CDSCO’s June 2026 Pharmacovigilance Circular: Why India’s PV Compliance Bar Has Changed

What pharmaceutical companies in India need to know about Schedule M, inspection readiness and building an effective pharmacovigilance system

On 3 June 2026, CDSCO issued a circular on the implementation of the Pharmacovigilance (PV) System under Schedule M of the Drugs & Cosmetics Act, 1940 and the Rules made thereunder. The circular specifically refers to Para 6.11 of Schedule M and directs stakeholders to establish and maintain an effective pharmacovigilance system. It also makes clear that compliance may be verified during routine inspections and other regulatory activities.

That distinction matters. The circular does not simply introduce another reporting requirement. It reinforces an expectation that pharmaceutical companies should be able to demonstrate that their PV system exists, functions and is maintained in compliance when regulators inspect.

For Indian Marketing Authorization Holders (MAHs), manufacturers, licensees and other stakeholders, this changes the conversation from:

“Do we have a PV process?”

to:

“Can we demonstrate that our PV system is effective, documented, operational and inspection-ready?”

The shift in Pharmacovigilance Compliance in India

The June 2026 communication can be viewed as an important shift in the operational significance of pharmacovigilance compliance in India.

That creates three immediate questions for companies:

PV Compliance Assessment	Yes	No
1. Is there a clearly established PV system? Can the company demonstrate how safety information is collected, processed, assessed and forwarded to the appropriate licensing authorities?
2. Is the PV system effectively maintained? Is there evidence that the system is operational, maintained, and supported by appropriate SOPs and oversight?
3. Can the organization demonstrate compliance and inspection readiness? Can the organization demonstrate compliance through appropriate documentation, records, oversight and audit/inspection readiness?

Inspections, Audits & Inspection Readiness become central considerations in assessing the robustness and compliance of the PV system.

 

This is where the difference between having a PV function and having a mature PV operating model becomes important.

The Indian Pharma market and the PV Capability Challenge

India's pharmaceutical market is approximately USD 60 billion, with projections of reaching USD 130 billion by 2030. It also identifies more than 3,000 pharmaceutical companies and approximately 10,500 manufacturing units, spanning large manufacturers, mid-sized branded-generics companies, license holders, importers and biotechnology companies.

The hidden challenge: PV maturity

A company can have products in the market without having a sophisticated internal PV organization.

That can create gaps across areas such as:

• PV system design
• Adverse drug reaction intake and processing
• Medical review
• Regulatory reporting
• Literature surveillance
• Aggregate reports (PSUR)
• Signal and risk evaluation
• Pharmacovigilance System Master File (PSMF)
• Audit and inspection readiness
• Vendor oversight
• Ongoing compliance monitoring

What does an effective PV system look like?

There is no single technology or organizational model that automatically makes a company compliant. However, companies assessing their readiness should consider whether their PV framework can support the core activities expected of an operational safety system.

1. Case intake and processing
Can safety information and adverse drug reaction reports be consistently captured, processed, medically reviewed, documented and tracked?

2. Regulatory reporting
Are processes clearly established for forwarding relevant reports to the appropriate licensing authorities?

3. Quality management
Are PV processes supported by appropriate SOPs, controlled documentation, quality checks, training and oversight?

4. Inspection readiness
Can the organization demonstrate how its PV system operates?

5. Scalability
Can the PV system support the company's current portfolio as well as future products, markets, and reporting volumes?

6. Regulatory alignment
For companies operating across markets, can the Indian PV framework work alongside broader global safety and regulatory requirements?

The benefits of pharmacovigilance extend beyond satisfying a regulatory requirement.

A well-structured PV system can provide a consistent framework for identifying, processing, evaluating and communicating safety information.

For pharmaceutical organizations, that can support:

• Better visibility into emerging safety information
• More consistent safety processes
• Stronger quality oversight
• Greater inspection preparedness
• Scalable safety operations
• Alignment between local and global safety activities

The important point is that PV should not be viewed as a standalone regulatory activity.

It sits at the intersection of drug safety and pharmacovigilance, quality, regulatory affairs, clinical development and post-marketing activities.

Why smaller and mid-sized companies should pay attention

The Indian market includes companies with very different levels of PV maturity.

A large pharmaceutical organization may already have dedicated safety teams, established systems, global processes and technology infrastructure.

A smaller or mid-sized MAH may have a very different model. It may rely on a lean internal team, external partners, manual workflows, or processes developed as the product portfolio expanded.

For these organizations, outsourcing can potentially provide access to established capabilities without requiring the immediate creation of a large internal PV infrastructure.

Outsourcing pharmacovigilance: from cost decision to compliance strategy

The right pharmacovigilance services model is not simply about transferring case processing to an external provider.

A mature outsourcing model can encompass the broader PV operating framework, from system design and database support through ADR processing, medical review, regulatory submissions, quality and compliance activities, audits, inspection readiness, and training.

The accompanying Navitas assessment identifies several service layers:

Foundational support

• PV gap assessments
• SOP development
• Basic ADR intake
• Reporting frameworks

Managed PV operations

• Ongoing case processing
• Literature surveillance
• Periodic reporting

Enterprise PV capabilities

• Global pharmacovigilance
• Safety database management
• Signal detection
• Regulatory audits

Pharmacovigilance for clinical development and beyond

PV should also be considered within the broader lifecycle of drug development.

Clinical research and pharmacovigilance are closely connected because safety information can emerge at different stages of a product's lifecycle. Organizations looking for pharmacovigilance services for clinical trials therefore need to consider how their clinical safety activities connect with their broader PV framework.

Similarly, drug safety services should not operate in isolation from the organization's quality, regulatory and clinical processes.

The objective should be a connected safety framework rather than disconnected activities managed by different teams with limited visibility across the product lifecycle.

What pharmaceutical companies should do now

The best response to the CDSCO circular is not to wait for an inspection.

Pharma companies can use the communication as a trigger for a structured PV readiness review.

Step 1: Map the current PV system
Document the existing processes, responsibilities, vendors, systems and reporting pathways.

Step 2: Identify gaps
Compare the current state against the applicable regulatory expectations and identify areas requiring remediation.

Step 3: Strengthen the operating model
Address gaps in SOPs, case processing, medical review, reporting, quality oversight, training and documentation as applicable to the organization's activities.

Step 4: Test inspection readiness
Ask whether the organization can produce evidence that its PV system is established, maintained and operational.

Step 5: Determine the right sourcing model
Companies with limited internal capacity can evaluate managed pharmacovigilance service models rather than building every capability internally.

Step 6: Build for the future
PV infrastructure should be scalable enough to support portfolio growth and evolving regulatory expectations.

 

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