November 4, 2026

Not of Standard Quality Drug Prosecution: Sampling, the Government Analyst and the Right to Re-Test

A not of standard quality drug prosecution begins with a small thing: an Inspector takes a sample from a batch. Months later a report arrives, and with it a criminal complaint against the company, its directors and sometimes its distributor. Most of what decides these cases is procedural: whether the sample was divided and handled as the Act requires, whether the Government Analyst’s report was challenged within the statutory 28 days, and whether the drug was still within its shelf life when anyone could have re-tested it. This guide sets out how the process works and where the Supreme Court and High Courts have drawn the lines.

In short: A drug is “not of standard quality” (NSQ) when it fails the quality standard prescribed under the Drugs and Cosmetics Act 1940. Proof is ordinarily a Government Analyst’s report on a sample taken by a Drug Inspector. The person sampled has 28 days from receiving the report to give notice that he will challenge it and seek re-testing by the Central Drugs Laboratory.

What an NSQ Drug Notice Means for You

If your product has been sampled in an investigation involving a drug suspected to be of Not of Standard Quality, the date on which you receive the Government Analyst’s report starts a 28-day clock. Within that period, write to the Inspector and to the court if a complaint is pending, saying that you intend to contest the report and want the retained sample sent to the Central Drugs Laboratory. Keep proof of the date you received the report and of the notice. Missing that window can cost you the strongest defence the Act gives.

Key Takeaways

  • Section 25(3) makes the Analyst’s report conclusive unless the person sampled gives written notice within 28 days of receiving a copy that he intends to adduce evidence in controversion.
  • If that notice is given, section 25(4) lets the court send the retained sample to the Central Drugs Laboratory, whose report is conclusive evidence of the facts stated.
  • Delay that lets the shelf life expire can quash a case, but only where the right was invoked in time.
  • Directorship alone does not make a person liable under section 34; specific averments are needed, though courts often leave “in charge” to trial.
  • Limitation, the handling of the sample portions and the competence of the complainant are separate grounds that must be examined case by case.

Not of Standard Quality under the Drugs and Cosmetics Act, 1940

Section 16 of the Drugs and Cosmetics Act 1940 provides for standards of quality, and section 18(a)(i) prohibits the manufacture, sale, stocking or distribution of a drug that does not meet them. The punishment is under section 27(d), which covers contraventions of the Chapter not specifically dealt with in the clauses above it and prescribes imprisonment and fine. Spurious and adulterated drugs are separate, more serious categories and are not the subject of this article.

Prosecution may be launched, under section 32, by an Inspector, by the person aggrieved or by a recognised consumer association, and the offence cannot be tried by a court lower than a Metropolitan Magistrate or a Judicial Magistrate of the first class. A company is answerable, and so are its responsible officers, under section 34, which is discussed below.

Sampling under Section 23

Section 23 prescribes how an Inspector must take a sample. He pays the fair price or gives a receipt, tells the person in writing why the sample is being taken, and, in that person’s presence, divides it into portions that are sealed and marked, with the person entitled to add his own seal. One portion goes to the person sampled, one goes to the Government Analyst, and one is produced in court; where a person who has disclosed the manufacturer under section 18A is involved, a further portion is available for that person. The Drugs Rules 1945 supply the forms: the Inspector’s written notice is in Form 17 (rule 56) and the receipt in Form 17-A (rule 56-A), and the sample goes to the Analyst with a memorandum in Form 18 (rule 57).

These steps matter because the whole scheme assumes that the accused can have a fair portion tested a second time. A complaint that does not show how the portions were dealt with, or an accused who never received his, starts on weak ground.

The Government Analyst’s Report and the 28-Day Window

The Analyst examines the sample and, under rule 46, supplies a signed report in Form 13 in triplicate. Under section 25(2), one copy goes to the person sampled and another to any person disclosed under section 18A; the third is kept for the prosecution. The rules require the report “forthwith”; they do not fix a number of days.

Section 25(3) then provides that the report is evidence of the facts stated and is conclusive unless the person sampled, within 28 days of receiving a copy, notifies the Inspector or the court in writing that he intends to adduce evidence in controversion. If he does, section 25(4) allows the court, on its own motion or on an application by the complainant or the accused, to send the sample portion produced in court to the Central Drugs Laboratory (CDL). The CDL’s report is “conclusive evidence of the facts stated therein”, and it supersedes the Analyst’s report.

NSQ Drug Prosecution: Delay, Shelf Life and the Right to Re-Test

The Supreme Court’s decisions on Not of Standard Quality Drug prosecutions establish an important distinction between cases where the right to re-testing was exercised in time and those where it was not. In State of Haryana v. Brij Lal Mittal, (1998) 5 SCC 343, the manufacturers had never given the section 25(3) notice. The Court held that the section 25(4) right therefore never arose, the report became conclusive, and a High Court could not quash the proceedings merely because the complaint was filed so late that the drug had passed its shelf life.

In Medicamen Biotech Ltd. v. Rubina Bose, Drug Inspector, (2008) 7 SCC 196, the accused had disputed the report within the 28 days. The complaint was filed about a month before the batch’s expiry date, without explanation, making re-testing practically impossible. The Court quashed the proceedings because the accused had been deprived of a valuable right under sections 25(3) and 25(4).

The Court drew the same line in GlaxoSmithKline Pharmaceuticals Ltd. v. State of Madhya Pradesh, Criminal Appeal No. 1489 of 2011 (28 July 2011), distinguishing Medicamen because the company had never signalled within 28 days that it wanted contrary evidence. And in Laborate Pharmaceuticals India Ltd. v. State of Tamil Nadu, Criminal Appeal No. 364 of 2017, where the portion meant for the manufacturer was never sent and cognizance came about two and a half years after the complaint, the Court quashed the case because the valuable right of CDL analysis had been lost without fault of the manufacturer.

The practical lesson is the order of events. A complaint can be quashed for lost re-testing only where the accused protected the right first; an accused who stayed silent for the 28 days cannot later rely on the delay.

The Other Side

Two points weigh against the accused. The first is the public-health purpose of the Act. A High Court in August 2026 dismissed a petition by out-of-State directors and said that the safeguards should not be pressed in a “hyper-technical” way (Ankur Kirtikumar Mehta v. Bharti Bachloo, Drugs Inspector, CRM(M) 237/2019, Jammu and Kashmir and Ladakh High Court, 11 August 2026). The second is that a manufacturer who responds to the report by seeking leniency, rather than contesting it, may find the court reluctant to treat it as having reserved the right to re-test.

Limitation Period for NSQ Drug Prosecution

An offence under section 27(d) carries a maximum of two years’ imprisonment, and the general bar in section 468 of the Code of Criminal Procedure therefore fell at three years for complaints under the 1973 Code. The Delhi High Court quashed a complaint filed three years after sampling where no application to condone delay under section 473 had been made (Sanofi India Ltd. v. Union of India, W.P.(Crl) 2605/2021, 7 May 2025). The Supreme Court has since held, in 2026, that in a complaint of this kind the period runs from when the identity of the accused became known, not from the date of sampling (State of Kerala v. Panacea Biotec Ltd., 2026 INSC 200), which narrows the force of the limitation argument where the manufacturer was identified only later.

Directors and Officers: Section 34

Section 34 deems the company, and every person in charge of and responsible to it for the conduct of its business, to be guilty, subject to a defence of lack of knowledge or due diligence; it also reaches a director, manager, secretary or other officer through whose consent, connivance or neglect the offence was committed. Brij Lal Mittal held that mere directorship does not make a person “in charge”. The Court has since quashed complaints that lacked specific averments against non-executive directors (Lalankumar Singh v. State of Maharashtra, 2022 INSC 1061; Shailyamanyu Singh v. State of Maharashtra, 2025 INSC 995). The Gujarat High Court did the same on bald averments of being “in charge”, while holding the complaint maintainable against the company (Medipol Pharmaceutical India Pvt. Ltd. v. State of Gujarat, R/SCr.A 748 of 2018, 11 April 2018). But where a complaint pleads more, courts often hold that who was “in charge” is a question for trial, which is the approach reported in Panacea Biotec and followed in Ankur Mehta.

A Checklist, in Date Order

  1. Date of sampling, and whether Form 17 and the receipt were issued.
  2. Date you received the Analyst’s report; date of your section 25(3) notice.
  3. Expiry date of the batch.
  4. Date the complaint was filed and the date of cognizance.
  5. Whether the court portion was sent to the CDL and, if not, why.
  6. What the complaint says about each director’s role.

FAQ

What is a not-of-standard-quality (NSQ) drug?

A drug that fails the standard of quality prescribed under the Act and the Rules, usually shown by a Government Analyst’s report on an Inspector’s sample. Manufacture or sale is prohibited by section 18(a)(i) and punishable under section 27(d).

How long do I have to challenge the Government Analyst’s report?

Twenty-eight days from receiving a copy, under section 25(3), by written notice to the Inspector or the court. Without it the Supreme Court has held that the right to CDL re-testing does not arise.

Does delay in filing the complaint quash the case?

Not by itself. It has succeeded where the re-test right was invoked in time and delay let the shelf life expire; where no timely notice was given, it has not. Limitation under the Code of Criminal Procedure is a separate ground.

Can a director be prosecuted just because he is a director?

No. Section 34 requires that the person was in charge of and responsible for the business, or that the offence occurred through his consent, connivance or neglect. Courts quash bare allegations but often leave pleaded ones to trial.

Who can launch a prosecution for an NSQ drug?

An Inspector, the person aggrieved or a recognised consumer association, under section 32. The trial court must be a Metropolitan Magistrate or a Judicial Magistrate of the first class, or higher.

Glossary

NSQ
Not of standard quality: a drug that fails the prescribed quality standard.
Government Analyst
The officer who tests the sample and issues the statutory report.
CDL
The Central Drugs Laboratory, whose report on re-testing is conclusive under section 25(4).
Shelf life
The period for which the manufacturer states the drug will meet its specification.

Related Reading

Sources

  • Drugs and Cosmetics Act 1940, sections 16, 18, 19, 23, 25, 27, 32 and 34; Drugs Rules 1945, rules 46, 56, 56-A and 57. CDSCO; India Code.
  • State of Haryana v. Brij Lal Mittal, (1998) 5 SCC 343 (Supreme Court).
  • Medicamen Biotech Ltd. v. Rubina Bose, Drug Inspector, (2008) 7 SCC 196 (Supreme Court).
  • GlaxoSmithKline Pharmaceuticals Ltd. v. State of Madhya Pradesh, Criminal Appeal No. 1489 of 2011, 28 July 2011 (Supreme Court).
  • Laborate Pharmaceuticals India Ltd. v. State of Tamil Nadu, Criminal Appeal No. 364 of 2017 (Supreme Court).
  • Lalankumar Singh v. State of Maharashtra, 2022 INSC 1061; Shailyamanyu Singh v. State of Maharashtra, 2025 INSC 995; State of Kerala v. Panacea Biotec Ltd., 2026 INSC 200 (Supreme Court).
  • Medipol Pharmaceutical India Pvt. Ltd. v. State of Gujarat, R/SCr.A 748 of 2018, 11 April 2018 (Gujarat High Court).
  • Sanofi India Ltd. v. Union of India, W.P.(Crl) 2605/2021, 7 May 2025 (Delhi High Court); Ankur Kirtikumar Mehta v. Bharti Bachloo, Drugs Inspector, CRM(M) 237/2019, 11 August 2026 (Jammu and Kashmir and Ladakh High Court).
By Advocate Aaditya Bhatt

Advocate Aaditya Bhatt

Senior Standing Counsel Income Tax Department, Advocate Gujarat High Court. Aaditya combines his technical and legal expertise to deliver strategic counsel in litigation, constitutional, and regulatory matters. He represents clients before High Courts and Tribunals with a technology-driven approach.

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