CDSCO’s June 2026 Circular Is a Wake-Up Call for Indian Pharma — And a Career Signal for PV Professionals

What Para 6.11 of Schedule M now means in practice

On June 3, 2026, the office of the Drugs Controller General of India issued a circular directing all licensed drug manufacturers to establish and maintain a pharmacovigilance system. The circular references Para 6.11 of Schedule M of the Drugs and Cosmetics Act, 1940 and explicitly states that CDSCO and State Licensing Authority officers may verify compliance during routine inspections.

This is not a new law. The requirement existed in Schedule M for years. What changed is the enforcement mechanism.

That distinction matters.

Watch the full discussion on youtube: https://youtu.be/pntkaU3Qvck

Background

Para 6.11 of Schedule M states that a licensee must have a pharmacovigilance system in place for collecting, processing, and forwarding adverse drug reaction reports to licensing authorities. The system must cover drugs the licensee manufactures or markets.

The New Drugs and Clinical Trials Rules 2019 added further teeth by making QPPV appointment mandatory for new drug approvals. But a large portion of India’s licensed manufacturers — generics companies, older licensees, small and mid-sized manufacturers — operated outside the new drug category and had no functional PV infrastructure at all.

No ADR intake process. No designated responsible person. No periodic safety reporting. Drugs going out the door with zero post-market safety surveillance in place.

The June 2026 circular is CDSCO’s response to that gap.

What the circular actually requires

The circular directs all stakeholders to ensure compliance with three regulatory instruments: the Drugs and Cosmetics Act 1940, the Rules made thereunder, and the NDCT Rules 2019.

Then it adds the enforcement clause: officers of CDSCO, SLA, and UT administrations may verify PV compliance during routine inspections and other regulatory activities.

That single sentence converts a documentation requirement into an inspection checkpoint.

A GMP inspector walking into your facility can now ask to see your PV system. Not just your batch records. Not just your quality SOPs. Your pharmacovigilance infrastructure. And if it doesn’t exist, that is a compliance failure with regulatory consequences.

What a compliant PV system looks like

Companies reading this circular and asking “what do we actually need to build” should start with these components.

A designated QPPV or PV responsible person. Someone accountable for pharmacovigilance at your organization, with documented appointment and contact details on file with your licensing authority.

An ADR intake mechanism. A functioning channel through which healthcare professionals, patients, or your own field force can report adverse events to your company. Email, phone, web form — the medium matters less than the fact that it is monitored and documented.

A case processing workflow. When an ADR comes in, someone needs to assess it, code it using MedDRA terminology, determine seriousness and expectedness, and prepare an Individual Case Safety Report if required.

Reporting to licensing authorities. Serious unexpected ADRs require expedited reporting within 15 calendar days. Periodic safety data goes into PSURs submitted to CDSCO and the relevant SLA.

A safety tracking system. Small companies don’t need Oracle Argus or Veeva Vault Safety on day one. A structured Excel tracker with the right fields can serve as a starting point while capacity is built. But there must be a documented system.

A PV SOP. A written standard operating procedure defining roles, timelines, and responsibilities across the entire safety reporting lifecycle. This is the first document an inspector will ask for.

Six components. None of them exotic. All of them absent in a significant number of Indian pharma companies right now.

Why this is happening in 2026

India is the world’s third-largest pharmaceutical producer by volume and a leading exporter of generic medicines. The country’s post-market drug safety infrastructure has not kept pace with that scale.

The pharmacovigilance programme of India, run through the Indian Pharmacopoeia Commission, manages the national ADR database. But passive surveillance through a central programme is not a substitute for manufacturer-level pharmacovigilance. The two are meant to work together.

The WHO’s global ICSRs database, VigiBase, receives millions of case reports from member countries. India’s contribution has grown, but remains low relative to its drug market size. A significant reason is that many manufacturers have no internal mechanism to detect, capture, and report safety signals.

The June 2026 circular is a direct regulatory response to that structural gap. Tying PV compliance to inspection outcomes is the fastest way to compel action from companies that ignored softer regulatory guidance.

What this means for pharmacovigilance professionals

If you work in drug safety in India, this circular matters to your career in three specific ways.

It creates hiring pressure. When regulatory compliance becomes an inspection item, it stops being a future initiative and becomes an immediate business problem. Companies that have delayed building PV teams now have a deadline. That deadline is the next inspection.

It gives you negotiating power inside your organization. If you’ve been trying to justify PV headcount, system investment, or process improvements to leadership, this circular is your business case. A documented CDSCO directive with inspection consequences is a stronger argument than any internal memo.

It raises the floor for interview preparation. Candidates interviewing for PV roles at Indian companies should expect questions on Schedule M, NDCT Rules 2019, QPPV responsibilities, and ICSR timelines. These are no longer niche topics. They are inspection-ready requirements that hiring managers will care about.

What companies should do now

A gap assessment is the logical first step. Map your current state against the six components listed above. Document what exists and what doesn’t. Be specific about the gaps rather than vague about intent.

Appoint a PV responsible person if you don’t have one. Even if it is an existing employee in a dual role, document the appointment formally and communicate it to your licensing authority.

Build or update your PV SOP. It does not need to be lengthy. It needs to be accurate, current, and followed. An inspector is more concerned with whether your process works than whether your document is long.

Establish your ADR intake channel and test it. Run a mock report through your own system. Trace it from intake to documentation. Identify where it breaks.

Review your backlog. ADRs may have come in through customer complaints, medical information queries, or field force contacts and were never processed as safety cases. That backlog is a liability. Starting to address it now, before an inspection, is considerably better than being asked about it during one.

The circular has been distributed to all State and UT Licensing Authorities, all Zonal and Sub-Zonal CDSCO offices, and published on the CDSCO website. Every inspection officer in the country has it.

The bottom line

Schedule M Para 6.11 was always law. The NDCT Rules 2019 extended that obligation. The June 2026 circular is CDSCO saying, in plain terms, that they intend to check.

For pharmacovigilance professionals, this is the regulatory environment you are entering or already operating in. For companies without PV infrastructure, the question is no longer whether to build it. It is how fast.

Vinay Kumar is an Associate Manager in Pharmacovigilance with over 10 years in drug safety. He founded The Drug Safety Coach, a pharmacovigilance education platform on youtube. He is the author of PV360 and PV101.

Follow on LinkedIn and YouTube: @TheDrugSafetyCoach