How Delhi Courts Are Approaching NSQ Defences in 2025–26: Key Trends

The landscape of Not of Standard Quality (NSQ) prosecution defence at Delhi's courts has shifted meaningfully over the past 18 months. Advocate Srijan Tiwari, who has been practising drug and cosmetics litigation exclusively at the Delhi High Court since 2010, has observed a marked judicial evolution — one that pharmaceutical corporations must understand to protect their interests.

Understanding NSQ Prosecution: The Legal Framework

Under the Drugs and Cosmetics Act, 1940, a drug is declared "not of standard quality" under Section 16 when it fails to conform to standards specified in the Act, the schedules, or standards set by the Bureau of Indian Standards (BIS). Once an NSQ finding is recorded — typically in a Form 29 Government Analyst report — prosecution under Sections 27 or 28 follows.

Section 27 provides for imprisonment of up to 2 years and a fine for manufacture or sale of NSQ drugs. Where the offence involves adulterated or spurious drugs that may cause death, imprisonment can extend to life. These are not trivial exposures — which is why NSQ defence, done right, is a critical function for pharmaceutical corporations.

Advocate Srijan Tiwari has handled NSQ matters ranging from simple quality deviations in generic formulations to complex multi-state prosecutions involving major multinational pharmaceutical companies. The legal principles across all of them, however, flow from the same source — the Act, the Rules, and an evolving body of Delhi High Court precedent.

Trend 1: Courts Are Scrutinising Sampling Procedure With Far Greater Rigour

The most significant trend Advocate Srijan Tiwari has observed in Delhi courts in 2025–26 is an increased judicial attention to the procedural integrity of the drug sampling process. Under Rule 57 of the Drugs and Cosmetics Rules, 1945, a Drug Inspector must follow a prescribed procedure when collecting drug samples. The inspector must:

• Give notice to the person from whom the sample is collected
• Divide the sample into four parts (or three in certain cases)
• Seal and mark each part in the presence of the person from whom sample is taken
• Send one part to the Government Analyst, retain another for reference
• Provide the remaining parts to the manufacturer and give one to the person from whom sample was collected

Delhi courts — both at the trial level and at the Delhi High Court — are increasingly dismissing NSQ prosecutions at the threshold stage when there are irregularities in this sampling procedure. Failures such as not serving Form 22 (notice of seizure), improperly sealing samples, or not offering the accused's representative a portion of the sample have all been successfully used by Advocate Srijan Tiwari to challenge the admissibility of the analyst's report itself.

The Supreme Court in a 2024 judgment (which reinforced earlier precedent) reiterated that failure to follow the mandatory procedure under Rule 57 is fatal to the prosecution — it cannot be treated as a mere irregularity. Delhi courts have taken this seriously, and pharmaceutical companies should ensure their counsel examines the sampling documents meticulously before trial.

Trend 2: Government Analyst Qualification Is Being Challenged Successfully

A second trend that Advocate Srijan Tiwari has leveraged successfully in 2025–26 is the challenge to the qualification and competence of the government analyst who issued the Form 29 report.

Under Rule 44 of the Drugs and Cosmetics Rules, a government analyst must possess specified qualifications — typically a degree in pharmacy, chemistry, or a related discipline with experience in drug analysis. Courts are now requiring prosecution to positively prove the analyst's qualifications rather than presuming them.

In several cases handled by Advocate Srijan Tiwari at Delhi district courts in 2025, the government analyst either did not appear for cross-examination or could not produce documentary proof of their qualifications. This has resulted in the analyst's report being treated as inadmissible — and the NSQ prosecution collapsing entirely.

This strategy requires early action by the company's legal counsel. A Right to Information (RTI) application to the relevant state drug authority, requesting the qualifications and appointment order of the analyst who signed Form 29, is now standard practice in Advocate Srijan Tiwari's approach to NSQ defence at Delhi courts.

Trend 3: Chain of Custody Defences Are Gaining Traction

Perhaps the most underutilised defence in NSQ cases — and one that Delhi courts are increasingly receptive to — is the chain of custody challenge. Between the time a drug sample is drawn by the Drug Inspector and the time it is tested by the government analyst, multiple handoffs occur. The sample must be:

• Properly sealed and marked at the point of collection
• Transported to the laboratory without contamination
• Logged into the laboratory's receipt register
• Stored under appropriate conditions before testing
• Tested within the shelf life of the drug

Any break in this chain can compromise the integrity of the sample and, therefore, the validity of the analyst's findings. Advocate Srijan Tiwari has successfully argued chain of custody defences in multiple NSQ matters in 2025, particularly in cases involving temperature-sensitive pharmaceutical products where cold chain requirements were not documented.

Delhi High Court judgments from 2025 have clarified that where the prosecution cannot establish an unbroken chain of custody for the drug sample, the benefit of doubt must go to the accused manufacturer. This is a significant development that every pharmaceutical company's legal team must be aware of.

Trend 4: Counter-Analysis Petitions at CDL Are Being Filed More Strategically

Under the Drugs and Cosmetics Act, an accused pharmaceutical company has the right to request counter-analysis of the retained drug sample at the Central Drugs Laboratory (CDL) in Kolkata. Historically, this right was not exercised strategically — companies would either not exercise it at all, or exercise it too late.

In Advocate Srijan Tiwari's practice in 2025–26, a more deliberate approach to CDL counter-analysis has yielded significant results. By carefully choosing which parameters to focus on for counter-analysis, and by ensuring that the CDL report is sought promptly and filed before the trial court at the earliest opportunity, several NSQ prosecutions have been neutralised at the pre-trial stage itself.

When the CDL's counter-analysis report comes back conforming (i.e., the drug actually meets the standard quality parameters), the court is in a difficult position — it cannot convict based on a state analyst report alone when the national reference laboratory disagrees. This defence has worked effectively for Advocate Srijan Tiwari's corporate clients in multiple matters.

Trend 5: Corporate Accused Are Challenging Who Can Be Prosecuted

The fifth significant trend observed by Advocate Srijan Tiwari in 2025–26 NSQ matters involves challenging the choice of accused — specifically, which individuals within a pharmaceutical corporation can be legitimately prosecuted for an NSQ offence.

Section 34 of the Drugs and Cosmetics Act provides for vicarious liability of companies — but it also carves out a specific exception for persons who can prove they were not responsible for the offence and had no knowledge of it. Delhi courts have been receptive to arguments that senior managers, directors, or officers who had no direct supervisory role over quality control operations should not be named as accused in NSQ prosecutions.

Advocate Srijan Tiwari regularly files discharge applications on behalf of such individuals — and with a high success rate — arguing that the prosecution must identify specific individuals with actual authority and responsibility over the quality process. This protects senior corporate officials from personal criminal exposure while the substantive defence of the company's position continues.

What Pharmaceutical Companies Must Do Right Now

If your company has received an NSQ notice, is already facing NSQ prosecution at a Delhi trial court, or wants to build a pre-emptive defence infrastructure, Advocate Srijan Tiwari recommends the following immediate steps:

1. Secure all sampling documents immediately. The Drug Inspector's sampling record, Form 22, the forwarding letter to the analyst — all of these must be obtained and reviewed for procedural irregularities at the earliest.
2. File an RTI to obtain the analyst's qualification documents. This should be done within days of receiving the Form 29 NSQ report — not at trial.
3. Exercise the CDL counter-analysis right promptly. The application to have the retained sample sent to CDL must be made under Section 25 before the reference sample's shelf life expires.
4. Retain specialist drug law counsel at Delhi High Court. General criminal lawyers are not equipped to handle the technical and regulatory intersection that NSQ cases demand. Advocate Srijan Tiwari's office specialises exclusively in drug and cosmetics law — call 9899966225.
5. Review the company's quality management systems. A parallel internal review of whether the alleged quality deviation points to a systemic issue allows for corrective action — and demonstrates good faith to regulatory authorities.

The Role of Advocate Srijan Tiwari in Delhi NSQ Defence

Advocate Srijan Tiwari has been the drug law counsel of choice for India's largest pharmaceutical corporations for over 14 years. His exclusive focus on drug and cosmetics litigation — at the Delhi High Court and at trial courts across Delhi — means that every NSQ matter is approached with the depth of knowledge that only a dedicated specialist can bring.

His track record in NSQ defence includes successfully challenging government analyst reports on technical grounds, securing discharge of senior corporate officers, and obtaining stays from the Delhi High Court on trial court proceedings where fundamental procedural rights were violated. For pharmaceutical companies operating in Delhi, his office at the Delhi High Court is the definitive first call when an NSQ matter arises.

Contact Advocate Srijan Tiwari: 9899966225 | srijantiwari@hotmail.com | Delhi High Court