The Drugs and Cosmetics Act, 1940 regulates the manufacture, sale and distribution of drugs and cosmetics. Most prosecutions begin when a Drugs Inspector draws a sample and the Government Analyst reports that it is not of standard quality, adulterated, spurious or misbranded. Selling or manufacturing without a licence is a separate offence.
These cases affect chemists, distributors, manufacturers, their directors and patients. Many defences turn on whether the Inspector and the court followed the Act's procedure. We act for accused persons, including companies and their directors, and for complainants.
What the Act prohibits and how offences are graded
Section 18 prohibits manufacturing for sale, selling, stocking or distributing a drug or cosmetic that is not of standard quality, misbranded, adulterated or spurious. Section 18(c) prohibits these activities without a licence under Chapter IV. Section 27 grades the punishment for drugs, and the court may go below the minimum in clauses (b), (c) and (d) only for adequate and special reasons recorded in the judgment.
- Section 27(a): an adulterated or spurious drug likely to cause death or grievous hurt. Not less than ten years, up to life, and a fine of at least ten lakh rupees or three times the value of the drugs confiscated, paid as compensation to the user or the user's relatives.
- Section 27(b): other adulterated drugs, or a drug sold or made without the licence required by Section 18(c). Three to five years and a fine of at least one lakh rupees or three times the value.
- Section 27(c): other spurious drugs. Not less than seven years, up to life. For special reasons recorded in the judgment, the court may impose a shorter term, but not less than three years.
- Section 27(d): any other contravention of Chapter IV, which covers most not-of-standard-quality cases. One to two years and a fine of at least twenty thousand rupees.
- Section 27A (cosmetics): up to three years and a fine of at least fifty thousand rupees for spurious or adulterated cosmetics; up to one year or a fine of up to twenty thousand rupees otherwise.
Who can prosecute, and why a police FIR fails
Under Section 32(1), only an Inspector, a gazetted officer authorised by the government, the person aggrieved or a recognised consumer association can institute a prosecution under Chapter IV.
In Union of India v. Ashok Kumar Sharma (2021) 12 SCC 674, the Supreme Court held that the police cannot register an FIR under Section 154 of the CrPC (now Section 173 of the BNSS) for cognizable offences under Chapter IV, or investigate them. FIRs already registered were to be handed to the Drugs Inspector, who may arrest without warrant subject to the D.K. Basu safeguards. The police can still investigate a cognizable offence under another law, as Section 32(3) allows.
Sampling and the Government Analyst's report
Under Section 23, the Inspector tenders a fair price, gives written intimation and divides the sample into four sealed portions (three at manufacturing premises), one of which is returned to the person.
Section 25(3) makes the Analyst's report conclusive unless, within twenty-eight days of receiving a copy, the person notifies the Inspector or the court in writing that they will adduce contrary evidence. After that notice, Section 25(4) lets the court send its portion to the Central Drugs Laboratory, whose report is conclusive.
In State of Haryana v. Brij Lal Mittal (1998) 5 SCC 343, the Supreme Court said the right to a Central Drugs Laboratory test arises only after that written notice. In Medicamen Biotech Ltd. v. Rubina Bose (2008) 7 SCC 196, the manufacturer disputed the report in time, but the court's portion of the sample was not sent to the Central Drugs Laboratory before the drug expired, so no re-test was possible. The court quashed the case because the accused had lost the right under Sections 25(3) and 25(4).
Which court tries the case
Section 32(2) sends Chapter IV offences to a Court of Session unless the Act provides otherwise. Under Section 36AB, the government, in consultation with the Chief Justice of the High Court, designates Courts of Session as Special Courts for adulterated and spurious drug offences, including those under Sections 27(a) and 27(c).
Section 36A provides for summary trial of offences punishable with up to three years, other than those assigned to the Special Court, by a specially designated Judicial Magistrate of the first class or a Metropolitan Magistrate. The sentence in a summary trial cannot exceed one year.
Arrest and bail in spurious and adulterated drug cases
Section 36AC makes offences relating to adulterated or spurious drugs, including those under Sections 27(a) and 27(c), cognizable. Bail requires notice to the Public Prosecutor and, if bail is opposed, the court's satisfaction that there are reasonable grounds for believing the accused is not guilty and will not offend while on bail. The Special Court may release a person under sixteen, a woman or a sick or infirm person. The High Court's powers under Section 439 of the CrPC (now Section 483 of the BNSS) are preserved.
Liability of companies and directors
Under Section 34, when a company commits an offence, every person in charge of and responsible to it for the conduct of its business is deemed guilty with the company, unless they prove lack of knowledge or due diligence. A director or officer whose consent, connivance or neglect led to the offence is also liable.
Brij Lal Mittal held that being a director does not by itself make a person liable, and upheld quashing where the complaint only said the accused were directors. In State of Kerala v. Panacea Biotec Ltd. (2026 INSC 200), the court found quashing on this ground premature for directors in management, because their role is a question of fact for trial. In Inox Air Products Ltd. v. State of Andhra Pradesh ([2025] 1 S.C.R. 1235), it quashed a Drugs Inspector's complaint that disclosed no offence and a summoning order that gave no reasons.
Quashing petitions now lie under Section 528 of the BNSS (formerly Section 482 of the CrPC).
Stages of the case
- 1
Sampling
The Drugs Inspector draws and seals the sample under Section 23.
- 2
Analyst's report
Copies go to the person sampled and to any disclosed manufacturer.
- 3
Notice disputing the report
Written notice within twenty-eight days, or the report becomes conclusive (Section 25(3)).
- 4
Complaint
An authorised person files a complaint under Section 32.
- 5
Re-test
On timely notice, the court may send its portion for testing (Section 25(4)).
- 6
Trial
Before a Special Court, a Court of Session or a Magistrate in a summary trial.
Supreme Court decisions
Union of India v. Ashok Kumar Sharma(2021) 12 SCC 674
Police cannot register an FIR or investigate Chapter IV offences; only the persons named in Section 32 can prosecute.
M/s. Medicamen Biotech Ltd. v. Rubina Bose, Drug Inspector(2008) 7 SCC 196
Where the accused disputed the report in time but the sample was not re-tested before expiry, the case was quashed for loss of the Section 25 right.
State of Haryana v. Brij Lal Mittal(1998) 5 SCC 343
A director is not liable under Section 34 merely for holding the post; the complaint must show responsibility for the business.
Inox Air Products Ltd. v. State of Andhra Pradesh[2025] 1 S.C.R. 1235
A complaint disclosing no offence, and a summoning order without reasons, were quashed.
State of Kerala v. Panacea Biotec Ltd.2026 INSC 200
Whether directors in management were in charge of the business is a question of fact for trial.
Questions
Can the police register an FIR for selling a spurious or substandard drug?
Not for offences under Chapter IV of the Act. Ashok Kumar Sharma holds that only the persons listed in Section 32, such as a Drugs Inspector, can prosecute. The police can still act on a separate offence under another law.
How long do I have to challenge the Government Analyst's report?
Twenty-eight days from receiving the copy. You must notify the Inspector or the court in writing that you intend to adduce contrary evidence, or the report becomes conclusive under Section 25(3).
What if the drug expires before it can be re-tested?
Where notice was given in time and the prosecution's delay prevented a re-test, the Supreme Court has quashed the case, as in Medicamen Biotech. The dates and the cause of the delay decide the point.
Is a company director automatically liable?
No. Section 34 reaches those in charge of and responsible for the business, and they can prove lack of knowledge or due diligence. Bare allegations have led to quashing, though the court may leave the question to trial.
This guide is general information on Indian criminal law as at 21 October 2026. It is not legal advice on any particular case.