The Mandatory Procedure for a Drug Inspector’s Complaint Under the Drugs and Cosmetics Act, 1940

ABSTRACT

The Drugs and Cosmetics Act, 1940 establishes a unique prosecution architecture: criminal proceedings for quality offences can be initiated only through a complaint, not through a police FIR. This complaint procedure under the Drugs and Cosmetics Act, 1940 forms the backbone of the statutory enforcement mechanism. The Drug Inspector, as the primary complaint-filing authority, must follow a series of mandatory statutory steps before a court can take cognizance of the offence. Any deviation from these steps is fatal to the prosecution. This article provides a comprehensive statutory walkthrough of the prosecution procedure under the Drugs &Cosmetics Act, identifies the precise provisions whose violation vitiates prosecution, distinguishes mandatory statutory requirements from non-mandatory DCC/CDSCO administrative guidelines, and offers a practical checklist for both prosecutors and defence counsel.

INTRODUCTION

The Drugs and Cosmetics Act, 1940 (‘the Act’) is distinctive among Indian criminal statutes in that it creates a self-contained prosecution architecture. Unlike the general criminal law framework under the Criminal Procedure Code where police cognizance triggers the investigative and prosecutorial process, the Act vests the complaint-filing function in a specialised enforcement officer — the Drug Inspector — and establishes a procedurally specific pathway from detection of a quality violation to the filing of a complaint before a court. In substance, the Act operates through a defined complaint procedure under the Drugs and Cosmetics Act, 1940, which governs how prosecutions are initiated and carried forward.

Every step in this pathway has legal consequence. Missteps in sampling, failures in service of the Analyst’s report, absence of required prior sanction, and breaches of limitation are each independently fatal to the prosecution. Courts across India have quashed Drug Act prosecutions at every stage of the process for procedural defects.

At the same time, administrative instructions issued by CDSCO and the DCC — requiring screening committee approval and written permission before a complaint is filed — are frequently treated as mandatory requirements even though they have no statutory basis. This article distinguishes the legally mandatory from the merely administrative.

STEP 1: SAMPLING UNDER SECTIONS 22 AND 23

Section 22 empowers a Drug Inspector to enter and inspect any premises, examine any record or register, and take samples of any drug or cosmetic for test or analysis. The sampling power is broad — it covers manufacturers, distributors, retailers, hospitals, and any entity in the drug supply chain.

Section 23 prescribes mandatory procedure for the taking of samples. The Inspector must:
(i) Take the sample in the presence of the person from whom it is drawn, or their representative;
(ii) Divide the sample into four parts;
(iii) Seal each part in the presence of that person;
(iv) Deliver one part to that person (or their representative) against a receipt;
(v) Send one part to the Government Analyst for analysis;
(vi) Retain one part as the office copy;
(vii) Where the test is to be done at the Central Drugs Laboratory (CDL), send a fourth part to the CDL.

Compliance with Section 23 is not optional — it is a mandatory condition precedent. Courts have consistently held that departure from the sampling procedure under Section 23 vitiates the prosecution. A drug that has not been sampled in accordance with Section 23 cannot form the basis of a prosecution regardless of what the analysis reveals.

STEP 2: GOVERNMENT ANALYST’S REPORT — SECTIONS 24 AND 25

After sampling, the Inspector sends the sample to the Government Analyst (for state-licensed drugs) or the CDL (for centrally licensed drugs or where CDL testing is required). The Analyst’s report under Section 24 constitutes the primary evidentiary foundation of the prosecution.

Section 24(2) imposes a mandatory obligation: the Inspector must serve a copy of the Analyst’s report on the person from whom the sample was drawn. This obligation is not discretionary. Failure to serve the report denies the accused the right to challenge the analysis by seeking CDL retesting — a right explicitly preserved by Section 25.

Section 25 provides that the person from whom the sample was drawn may, upon receipt of the Analyst’s report, apply to the court to send the retained sample to the CDL for retesting. The CDL’s report, once issued, is conclusive evidence of the facts stated therein. This procedural right is the accused’s most significant protection against erroneous or compromised laboratory analysis.

STEP 3: INVESTIGATION AND SECTION 18A NOTICES

Once a drug is found to be NSQ or spurious, the Inspector must trace the chain of custody from manufacturer to retailer. Section 18A imposes a statutory obligation on every person in the supply chain to disclose the name and address of the person from whom they received the drug. This enables the Inspector to proceed against the manufacturer — who is the primary target of the strict liability offence under Section 27.

The Inspector’s investigation should include serving notices to obtain: drug manufacturing licences, batch manufacturing records, distribution particulars, and the control or retained sample held by the manufacturer. Where the manufacturer fails to respond, the Inspector is not excused from the investigation — Section 22 provides powers of seizure of records that should be exercised. The thoroughness of this investigation directly affects the strength of the prosecution.

STEP 4: PRIOR SANCTION — MANDATORY UNDER SECTION 33M, NON-MANDATORY UNDER SECTION 32

The prior sanction requirement is the most frequently litigated procedural issue in D&C Act prosecutions, and the most misunderstood.

For Chapter IVA offences (clinical trials, import violations, and cognate offences under Sections 17B, 17C, 26A etc.), Section 33M mandates prior sanction of the specified authority before a complaint is filed. The absence of this sanction is not a mere procedural irregularity — it is a jurisdictional defect. Courts have ordered acquittal in cases where prosecution was launched without the Section 33M sanction.

For Chapter IV offences (NSQ drugs, spurious drugs, licensing violations under Sections 18, 18A, and 27), Section 32 of the Act does not require any prior sanction from a superior authority. The Drug Inspector, the aggrieved person, a recognised consumer association, or an authorised Gazetted Officer may directly file a complaint before the Court of Sessions without prior administrative approval.

The DCC and CDSCO guidelines, however, require Drug Inspectors to obtain written permission from the controlling authority — through a screening committee process — before filing even Chapter IV complaints. This requirement has no statutory basis. Courts have expressly held that executive instructions from CDSCO do not supersede statutory provisions. An Inspector who bypasses the DCC’s screening committee and files a Chapter IV complaint is not committing any procedural violation — the complaint is legally compliant.

STEP 5: FILING THE COMPLAINT — SECTION 32 AND JURISDICTIONAL REQUIREMENTS

Section 32 is the gatekeeper provision for prosecutorial cognizance under the Act. Cognizance of a Chapter IV offence by a court can be taken only on a complaint by:
(i) A Drug Inspector;
(ii) An aggrieved person;
(iii) A recognised consumer association; or
(iv) A Gazetted Officer authorised by the Central or State Government.

The Supreme Court in Union of India v. Ashok Kumar Sharma, (2021) 12 SCC 674 held unambiguously that a police officer cannot register an FIR or independently investigate Chapter IV offences. Any prosecution initiated on a police complaint is legally invalid and liable to be quashed. The police’s role under the Act is ancillary — they may assist the Inspector, but cannot substitute for the Inspector as the complaint-filing authority.

Jurisdiction: Chapter IV offences that attract imprisonment for three years or more must be tried by the Court of Sessions. The Karnataka High Court in January 2026 confirmed that Sessions Courts have exclusive jurisdiction to try Chapter IV offences for the most serious categories. Complaints filed before Magistrates for cognizable Chapter IV offences may be challenged on jurisdictional grounds.

STEP 6: LIMITATION PERIOD

Section 468 of the Code of Criminal Procedure, 1973 (now Section 531 of the Bharatiya Nagarik Suraksha Sanhita, 2023) prescribes limitation periods for taking cognizance of offences: three years for offences punishable with imprisonment between one and three years.

For D&C Act prosecutions, the limitation period runs from the date the Drug Inspector receives information about the commission of the offence — not from the date sampling was done, not from the date of the Analyst’s report, and not from the date sanction (if any) is obtained. Courts have quashed complaints filed beyond the three-year limitation period as time-barred.

This is a hard deadline that cannot be extended by internal administrative processes. If a screening committee causes delay sufficient to push the complaint beyond the limitation period, the prosecution is extinguished — and the screening committee’s delay itself becomes a ground for challenging the lawfulness of the guidelines that mandated that delay.

PRACTICAL CHECKLIST FOR COUNSEL

For Defence Counsel:

• Was the sample divided, sealed, and delivered in strict compliance with Section 23? Any departure may vitiate.
• Was the Analyst’s report served on the accused/manufacturer per Section 24(2)?
• Was the Section 25 right to CDL retesting preserved and available?
• For Chapter IVA offences: was prior sanction obtained under Section 33M?
• Was the complaint filed within the three-year limitation period from the date of information?
• Was the complaint filed by a competent authority under Section 32?
• Was the complaint filed before the Court of Sessions for offences attracting 3+ year imprisonment?

For Prosecution Counsel:

• Ensure all Section 23 formalities are documented in the sampling records (seizure mahazar).
• Serve the Analyst’s report personally or by registered post with acknowledgement.
• For Chapter IVA: obtain and exhibit the prior sanction.
• Calculate limitation from the date of first information — ensure complaint is within three years.
• DCC screening committee approval, while desirable as good practice, is not a mandatory statutory step — absence does not vitiate the complaint.

CONCLUSION

The Drugs and Cosmetics Act, 1940 creates a technically demanding prosecution procedure that is both the prosecution’s source of authority and the defence’s primary toolkit. At its core lies a structured complaint procedure under the Drugs and Cosmetics Act, 1940, which imposes strict statutory discipline at every stage. Every statutory step is mandatory; deviation is at prosecutorial peril. At the same time, the administrative requirements grafted onto this procedure by DCC and CDSCO guidelines — particularly the screening committee and written permission requirements — are not part of the statutory framework. Courts will not invalidate a complaint merely because these administrative steps were skipped. Defence counsel conflating administrative requirements with statutory requirements, and prosecution counsel treating administrative steps as jurisdictional prerequisites, both err. The statute is clear; it deserves to be followed precisely.

FAQS: COMPLAINT & PROSECUTION PROCEDURE UNDER THE DRUGS AND COSMETICS ACT, 1940

1. Can prosecution under the Drugs and Cosmetics Act, 1940 be initiated through an FIR?
   No. Prosecution for offences under the Act can be initiated only through a complaint filed by an authorised person under Section 32. Police cannot independently register an FIR or initiate prosecution.
2. Who is authorised to file a complaint as part of the procedure under the Drugs and Cosmetics Act, 1940?
   A complaint may be filed by a Drug Inspector, an aggrieved person, a recognised consumer association, or a Gazetted Officer authorised by the Central or State Government.
3. Is compliance with the sampling procedure under Section 23 mandatory?
   Yes. The procedure for sampling—division, sealing, and delivery of samples—is mandatory. Any deviation can vitiate the prosecution.
4. What is the importance of the Government Analyst’s report?
   The Analyst’s report forms the primary evidentiary basis of prosecution. It must be served on the accused under Section 24(2), failing which the prosecution may be invalid.
5. What right does the accused have under Section 25?
   The accused has the right to seek retesting of the sample by the Central Drugs Laboratory. The CDL report is conclusive evidence.
6. Is prior sanction required before filing a complaint?
   Prior sanction is mandatory only for offences under Chapter IVA (Section 33M). For Chapter IV offences, no prior sanction is required under Section 32.
7. Are DCC or CDSCO guidelines mandatory before filing prosecution?
   No. Guidelines requiring screening committee approval or prior permission are administrative in nature and do not have statutory force.
8. What is the limitation period for filing a complaint?
   Generally, the limitation period is three years from the date of knowledge of the offence, as per the Code of Criminal Procedure (now BNSS, 2023).
9. Which court has jurisdiction to try offences under the Act?
   Serious offences punishable with imprisonment of three years or more are triable by the Court of Sessions.
10. What are common grounds for quashing prosecution under the Act?
    Common grounds include defective sampling, non-service of the Analyst’s report, denial of the right to retesting, lack of mandatory sanction (where applicable), and filing beyond the limitation period.

REFERENCES

[1] The Drugs and Cosmetics Act, 1940, Sections 22, 23, 24, 25, 18A, 32, 33M — India Code.  https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf

[2] Union of India v. Ashok Kumar Sharma, (2021) 12 SCC 674 — Supreme Court of India (Police cannot file FIR under D&C Act Chapter IV).  http://aidcoc.in/pdf/15-Supreme%20Court%20on%20Powers%20of%20Police%20and%20Drugs%20Inspectors%20to%20Arrest.pdf

[3] Dinesh Thakur, ‘Enforcement Measures Under the Drugs & Cosmetics Act, 1940: Part 2 – Investigations’ (March 2016).  https://dineshthakur.com/2016/03/22/enforcement-measures-under-the-drugs-cosmetics-act-1940-part-2-investigations/

[4] Karnataka High Court: Sessions Court Has Exclusive Jurisdiction for Serious Chapter IV Offences (January 2026) — LiveLaw.  https://www.livelaw.in/high-court/karnataka-high-court/karnataka-high-court-ruling-session-court-exclusive-jurisdiction-offences

[5] Drugs and Cosmetics Complaint quashed as time-barred — STPL Law (2024).  https://stpllaw.in/drugs-and-cosmetics-complaint-quashed-as-time-barred/

[6] Section 32 of the Drugs and Cosmetics Act, 1940 — Drishti Judiciary Analysis.  https://www.drishtijudiciary.com/current-affairs/section-32-of-the-drugs-and-cosmetics-act-1940

[7] Cyril Amarchand Mangaldas, ‘A Guide to Prosecutions under the Drugs and Cosmetics Act, 1940’ (2025).  https://www.cyrilshroff.com/wp-content/uploads/2025/10/A-Guide-to-Prosecutions-under-the-Drugs-and-Cosmetics-Act-3.pdf

[8] DCC Guidelines for Taking Action on Samples of Drugs Declared Spurious or NSQ — CDSCO (2008).  https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Consumer_Section_PDFs/DCC_Guidelines_Spurious_Drugs.pdf

[9] Prior sanction mandatory for Section 33M — acquittal where absent: LawWeb (2015).  https://www.lawweb.in/2015/10/whether-accused-can-be-acquitted-in.html