Building a Drug Law Risk Management Programme for Pharmaceutical Corporations in India

In 14 years of exclusive drug law practice at the Delhi High Court, Advocate Srijan Tiwari has represented pharmaceutical corporations at every stage of the drug regulatory risk spectrum — from preventive compliance advice to emergency licence suspension stays to full NSQ prosecution defence. The pattern is unmistakable: companies with proactive legal risk frameworks fare significantly better than those that engage counsel reactively. This article provides the blueprint.

The Drug Law Risk Landscape for Indian Pharmaceutical Companies

India's pharmaceutical regulatory environment has become markedly more enforcement-intensive over the past five years. CDSCO's drug quality alert programme, state drug authority inspection drives, and an increasingly aggressive prosecution posture from the DCGI's office mean that pharmaceutical companies — regardless of their size or compliance history — face a persistent risk of regulatory action.

The types of drug law risk that Advocate Srijan Tiwari sees most frequently in his Delhi High Court practice include:

• NSQ (Not of Standard Quality) prosecution: The most common form of drug law risk — triggered when a drug product fails government quality testing and prosecution under Sections 27/28 of the Drugs and Cosmetics Act is initiated.
• CDSCO drug quality alert listing: A company's product appears on CDSCO's market surveillance quality alert — triggering recall action, state prosecution, and reputational damage.
• Manufacturing licence suspension or cancellation: Following a serious quality incident, GMP inspection finding, or regulatory non-compliance, the company's manufacturing licence is suspended or cancelled.
• Drug Inspector prosecution for other D&C Act offences: Including offences related to labelling, misbranding, spurious drugs, or sale without valid licence.
• CDSCO regulatory enforcement: Show cause notices, import alerts, and enforcement actions from CDSCO for violations of import, manufacturing, or marketing approval conditions.

Pillar 1 — Legal Audit of Licences and Regulatory Compliance

The first pillar of any pharmaceutical drug law risk management programme is a systematic legal audit of the company's licensing status and regulatory compliance. Advocate Srijan Tiwari conducts these audits for corporate clients — reviewing:

• Whether all manufacturing licences are current and cover all products and activities actually conducted
• Whether loan licence arrangements and contract manufacturing agreements comply with the D&C Act and Rules
• Whether import licences, marketing approvals, and CDSCO registrations are in place for all products
• Whether the company's quality system documentation is consistent with its regulatory submissions
• Whether there are any outstanding show cause notices or orders that have not been responded to or complied with

Many companies are surprised to discover — during such an audit — that they have licensing gaps they were unaware of. A loan licence product being manufactured beyond the scope of the primary licence, an imported cosmetic without the required CDSCO registration, or an expired drug manufacturing licence for a specific product category — these are the kinds of vulnerabilities that Advocate Srijan Tiwari identifies before they become prosecutions.

Pillar 2 — Drug Inspector Interaction Protocol

The manner in which a pharmaceutical company's personnel interact with Drug Inspectors during factory visits and sampling exercises can significantly affect the company's legal exposure. Advocate Srijan Tiwari advises companies to establish a clear Drug Inspector Interaction Protocol covering:

1. Who speaks to the Drug Inspector. Only designated, trained personnel should interact with Drug Inspectors — not shop floor staff who may inadvertently make admissions. A designated "regulatory point person" should be available at all times.
2. Documentation of every inspection. Every Drug Inspector visit should be logged — the date, the Inspector's name and designation, the purpose of the visit, the products sampled, and the documents requested and provided. This log may be critical evidence later.
3. Exercising rights at the point of sampling. The company's personnel should be trained to ensure all sampling is done in accordance with Rule 57 — that the sample is properly divided and sealed in their presence and that their copy of the sample is received. Acquiescence to irregular sampling is the most preventable cause of NSQ prosecution vulnerability.
4. Immediate notification to legal counsel. The moment a Drug Inspector samples a product or issues a show cause notice, Advocate Srijan Tiwari's office should be notified. Not after the crisis deepens — immediately.

Pillar 3 — CDSCO Drug Quality Alert Monitoring System

CDSCO publishes drug quality alerts on its website — and the companies that discover their product on an alert first are the ones who get the 72-hour advantage that makes the difference between a managed crisis and a disaster. Advocate Srijan Tiwari recommends that pharmaceutical corporations set up a systematic CDSCO Drug Alert Management System monitoring process:

• Assign a compliance team member to monitor CDSCO's drug quality alert page regularly (daily or weekly)
• Set up keyword monitoring for the company's brand names and generic drug names
• Establish an escalation procedure — from compliance team to senior management to legal counsel — when a company product appears on an alert

Pillar 4 — Batch Documentation Readiness

When an NSQ prosecution is initiated, the company's defence depends heavily on its batch documentation — Batch Manufacturing Records, Batch Packing Records, In-Process Quality Control records, stability data, and QC release test reports for the flagged batch. Companies that maintain these documents in a well-organised, easily retrievable format have a significant advantage.

Advocate Srijan Tiwari advises companies to conduct periodic mock exercises — simulate an NSQ notice arriving today, and test how quickly the relevant batch documentation can be located and compiled for legal counsel. This exercise invariably reveals gaps in documentation management that, if left unaddressed, could significantly hamper the defence when an actual notice arrives.

Pillar 5 — Retaining Specialist Drug Law Counsel at the Delhi High Court

The most important element of any pharmaceutical drug law risk management programme is retaining specialist counsel with exclusive drug and cosmetics law expertise — and with access to the Delhi High Court. This is not a recommendation to engage general corporate counsel or a criminal lawyer with peripheral drug law exposure. It is a recommendation for a dedicated, exclusive drug law specialist.

Advocate Srijan Tiwari offers standing retainer arrangements for pharmaceutical corporations. Under such an arrangement, the company has immediate access to drug law expertise at the Delhi High Court — without the delay of finding, briefing, and onboarding a new lawyer every time a regulatory crisis materialises. He is already familiar with the company's products, its manufacturing footprint, its regulatory history, and its specific risk profile.

This institutional familiarity translates directly into faster, more effective legal responses. The first 72 hours of any drug law crisis are the most critical — and a retainer lawyer is there from hour one.

Pillar 6 — Crisis Response Plan

Every pharmaceutical corporation should have a written drug law crisis response plan — a document that specifies exactly what happens, in what sequence, when a drug law crisis materialises. This plan should cover:

• Who is notified first (senior management, legal counsel, quality head)
• What documents are secured immediately
• What external notifications may be required (stock exchanges for listed companies, insurance carriers, group headquarters)
• Whether a voluntary recall is considered and on what grounds
• Who speaks to the media (if at all) and what the communication strategy is

Advocate Srijan Tiwari assists pharmaceutical corporations in drafting and testing these crisis response plans — turning them from theoretical documents into live, practised protocols. A drug law crisis is not the time to improvise. It is the time to execute a plan that was designed when clear-headedness was available.

To discuss building a drug law risk management programme for your pharmaceutical corporation — or to enquire about retainer arrangements — contact Advocate Srijan Tiwari at 9899966225 or srijantiwari@hotmail.com. Delhi High Court.