1. Introduction and Objective

The Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, constitute the primary legal framework for ensuring the quality, safety, and efficacy of drugs and cosmetics in India. Given the technical nature of pharmaceutical evidence and the direct impact on public health, investigations must be meticulous, scientifically grounded, and procedurally airtight.

The objective of this SOP is to provide a standardized roadmap for Investigating Officers (I.Os.) and Drugs Inspectors to conduct search, seizure, and prosecution activities that withstand judicial scrutiny.

2. Preliminary Steps: Jurisdictional and Legal Basis

Before initiating any field action, the investigating team must establish the legal foundation:

• Identification of Authority: Under Section 21 of the Act, only a gazetted “Inspector” appointed by the Central or State Government has the power to inspect, sample, and seize.
• Information Gathering: Action usually stems from a specific complaint, a report from a Government Analyst, or reliable intelligence regarding the manufacture/sale of Spurious (Section 17B), Adulterated (Section 17A), or Misbranded (Section 17) drugs.
• Formation of Team: A composite team of Drugs Inspectors and local police (to maintain law and order and provide witnesses) should be briefed.

3. Entry, Search, and Inspection

Under Section 22 of the Act, an Inspector may enter and search any premises where they believe an offense is being committed.

• Arrival and Identification: Upon arrival, the Inspector must show their identity card to the owner/occupier.
• Presence of Witnesses: As a matter of evidentiary fairness and procedural robustness, two independent local witnesses should ordinarily be associated with searches, consistent with general criminal search safeguards embodied in BNSS.
• Detailed Inspection: The Inspector must examine:
  • Manufacturing logs and Batch Records.
  • Raw material purchase invoices and analytical reports.
  • Storage conditions (temperature control, hygiene).
  • The finished inventory for labelling discrepancies.

4. Procedure for Sampling (Section 23)

Sampling is the most critical technical step. Any deviation here can lead to the “Benefit of Doubt” for the accused.

• Selection of Samples: Pick samples from the original, unopened containers. If the drug is in a large container, ensure the contents are well-mixed before drawing.
• Division of Samples: The Inspector must divide the sample into four equal portions:
  1. One portion is given to the person from whom it was taken.
  2. One portion is sent to the Government Analyst for testing.
  3. One portion is produced in Court.
  4. One portion is kept as a reserve for future testing (at the Central Drugs Laboratory, if challenged).
• Sealing and Labelling: Each portion must be sealed with the Inspector’s official seal. The person from whom the sample is taken must be allowed to add their own seal if they wish. Form 17 must be filled out to record the sampling details.
• Under Section 23(2), when an Inspector takes a sample, they must pay the “fair price” of the sample to the person from whom it is taken and obtain a receipt. If the person refuses the money, the Inspector must still document the offer. The tender of payment is a mandatory procedural step to avoid “theft” allegations by the defense.

5. Seizure and Documentation

If the Inspector has reason to believe an offense has been committed (e.g., finding unlicensed manufacturing or spurious drugs), a seizure is conducted under Section 22(1)(c).

• Preparation of Seizure Memo: A detailed inventory of all seized items (drugs, machinery, records, labels) must be prepared on-site along with the Panchnama. The Panchnama should be written in the local language (or translated) to prevent “language barrier” defenses later.
• Form 16: The Inspector must issue a receipt for the seized property in Form 16.
• Digital Evidence: If computers or digital manufacturing logs are involved, use write-blockers to preserve data integrity and ensure the “Chain of Custody” is documented via cryptographic hashing where applicable.
• Handling “Nil” Seizures: Sometimes an inspection reveals no contravention. It is often helpful to include a step for a “Visit Memo” or “Inspection Report” even when no seizure is made, to document that a legal inspection occurred and everything was found in order.

6. Custody and Judicial Reporting

• Reporting to Magistrate: Under Section 23(6), if an Inspector seizes any stock, they must inform a Judicial Magistrate “as soon as may be” and take the Magistrate’s orders for the custody thereof.
• Safe Storage: Seized drugs, especially those requiring refrigeration (like vaccines or insulin), must be stored in a facility that maintains the cold chain to prevent degradation of evidence.

7. Analytical Testing and “Not of Standard Quality” (NSQ) Reports

The Government Analyst will test the sample and issue a report in Form 13.

• Conclusive Evidence: Under Section 25, the report is considered “conclusive evidence” of the facts stated therein, unless the person from whom the sample was taken notifies the Inspector within 28 days of receiving the report that they intend to adduce evidence in controversion.
• Challenge to Report: If challenged, the court may send the reserve sample to the Central Drugs Laboratory (CDL), whose report shall supersede the initial report.

8. Investigation of the Supply Chain (Section 18A)

When a bad drug is found, the law says the investigation cannot stop at the shop where it was sold; under Section 18A, every seller is legally required to reveal exactly who they bought the product from. This allows investigators to trace the medicine’s batch number backward—moving from the retailer to the wholesaler, the distributor, and finally the factory—to confirm if the manufacturer is real or a fake. If the investigation leads to a different state, the local Inspector must team up with that state’s authorities to inspect the facility, ensuring the entire supply chain is checked and the source of the problem is caught.

9. Identifying the Type of Offense

An investigator must sort a “bad drug” into one of three categories to file a proper case: Adulterated drugs are those that are contaminated, dirty, or unsafe to use; Spurious drugs are total fakes or “imposters” that use a famous brand’s name or swap out the real medicine for something else; and Misbranded drugs are those with misleading labels, false claims, or missing legal information. Categorizing them correctly ensures the court understands whether the crime was about poor hygiene, deliberate fakery, or deceptive packaging.

10. Arrest and Interrogation

While the Act focuses on prosecution via complaint, certain offenses (like manufacturing spurious drugs causing death or grievous hurt) are cognizable and non-bailable under Section 36AC.

• Grounds of Arrest: Clearly communicate the grounds to the accused.
• Statements: Record statements of the accused and witnesses to establish mens rea (guilty mind), particularly in cases of intentional counterfeiting.

11. Initiation of Legal Action

Under the Drugs and Cosmetics Act, 1940, the process of initiating legal action deviates significantly from the standard criminal procedure found in the Bharatiya Nagarik Suraksha Sanhita (BNSS).

The following breakdown explains the nuances of Section 32, which governs how these cases reach the courtroom.

• The Statutory Requirement: “Complaint” vs. “Police Report”

In general, criminal law, most “cognizable” offenses begin with an FIR (First Information Report) and conclude with a Police Report (Charge Sheet). However, the Drugs and Cosmetics Act is a special statute.

• Written Complaint: Prosecution can only be launched through a formal written complaint.
• The Complainant: According to Section 32, the court can only take cognizance of an offense if the complaint is filed by:
  • A Drugs Inspector (appointed under Section 21).
  • A person aggrieved by the drug/cosmetic.
  • A recognized consumer association.
  • A Gazetted Officer authorized by the Central or State Government.
• Jurisdiction: Where to File

The nature of the offense determines the presiding officer:

• Special Courts: For serious offenses (such as those involving adulterated or spurious drugs likely to cause death or grievous hurt), the case is filed before a Special Judge.
• Magistrates: Less severe contraventions are typically filed in the court of a Metropolitan Magistrate or a Judicial Magistrate of the First Class.

• The Role of the Drugs Inspector

The Inspector acts as the primary investigator and prosecutor. Unlike a police officer who “arrests and investigates,” the Drugs Inspector:

• Gathers Evidence: Collects samples, obtains the Government Analyst’s Report, and seizes stock.
• Drafts the Complaint: The document must detail every contravention of the Act, supported by the Analyst’s findings.
• Direct Filing: The Inspector skips the “Police Station” phase and goes directly to the Judiciary.

• Comparison of Prosecution Paths

• Why this system exists

This mechanism ensures that technical experts (Inspectors) handle the complexities of pharmaceutical chemistry and manufacturing standards. It prevents the legal process from being bogged down by non-specialists, ensuring that the evidence presented—often highly technical laboratory data—is curated by those qualified to interpret it.

While the police do have powers to assist or even investigate under certain conditions (especially when combined with BNS offenses like cheating), the statutory prosecution for violations of the Drugs Act itself remains the domain of the Inspector’s complaint.

12. The Prosecution Folder must include:

• Original Form 17 (Sampling) and Form 16 (Seizure).
• Government Analyst Report (Form 13).
• Sanction for Prosecution (from the Controlling Authority).
• Certified copies of licenses (or proof of lack thereof).
• Invoices and supply chain documents.
• Photographs/Video of the search and seizure.
• Specimen Seal – A physical impression of the seal used on the samples, affixed to a piece

      of paper and counter-signed by witnesses.

• Acknowledgement of Form 18 – The memorandum to the Government Analyst, ensuring

      there is a “received” stamp from the laboratory to prove the chain of custody.

13. Common Legal Pitfalls to Avoid

• Delayed Testing: Sending samples to the analyst months after seizure can lead to defense claims of “natural degradation.”
• Improper Sealing: Ensure the seal impression on the packet matches the specimen seal sent to the analyst.
• Failure to Join Witnesses: Avoid using “stock witnesses.” Try to include local pharmacists or residents to ensure credibility.
• Chain of Custody Gaps: Every movement of the sample from the shop to the laboratory must be documented in a register.
• Incomplete Documentation: Missing seizure memos, panchnamas, or laboratory forwarding notes can weaken the prosecution case.
• Non‑Compliance with Timelines: Statutory deadlines for filing complaints or charge sheets must be strictly followed to avoid dismissal.
• Improper Sample Division: Failing to divide samples into the required number of parts (e.g., four portions) can lead to challenges in court.
• Ignoring Videography/Photography: Lack of visual evidence during seizure may raise doubts about authenticity.
• Failure to Obtain Sanction: In cases requiring prior sanction from competent authority, omission can nullify proceedings.
• Over‑Reliance on Oral Testimony: Courts prefer documentary and scientific evidence; unsupported oral claims are easily challenged.
• Neglecting Cross‑Verification: Not comparing book balance, e‑POS records, and physical stock can leave loopholes for defense arguments.
• Improper Handling of Expired Drugs: Seizing expired drugs without documenting expiry dates and batch numbers may weaken the case.

14. The Inspector’s 3 Pillars of Success

• The Sample is King: Never deviate from the four-part division and immediate sealing.
• The Paper is the Proof: Every gap in the timeline is a gap in the case; keep the chain of custody unbroken.
• The Witness is the Shield: Independent, local witnesses turn a “police story” into a “public fact.”

15. Landmark Case Laws on Procedural Compliance

Indian courts have consistently reinforced that strict procedural compliance under the Drugs and Cosmetics Act is an indispensable prerequisite for a valid prosecution, as evidenced by the Supreme Court’s ruling in State of Haryana v. Brij Lal Mittal, which emphasized the necessity of specifically identifying responsible persons in pharmaceutical offenses and held that statutory safeguards cannot be casually bypassed.

This judicial rigor was further reaffirmed in Medicamen Biotech Ltd. v. Rubina Bose, Drug Inspector, where the Court upheld the accused’s valuable right under Section 25(4) to seek re-analysis by the Central Drugs Laboratory, ruling that the denial of this statutory opportunity constitutes a serious prejudice to the defense.

Complementing these principles, the Court in Medipol Pharmaceutical India Pvt. Ltd. v. Post Graduate Institute of Medical Education and Research held that administrative delays resulting in the expiry or deterioration of samples effectively defeat the accused’s right to re-analysis and can vitiate the entire prosecution.

Collectively, these landmark decisions establish that the evidentiary sanctity of the Government Analyst’s report, the meticulous execution of sampling procedures, and the preservation of the accused’s right to challenge laboratory findings are not mere technical formalities, but are foundational legal requirements essential for sustaining a conviction and upholding the integrity of drug law enforcement.

16. Conclusion

Investigations under the Drugs and Cosmetics Act combine legal procedure with forensic science. Success depends on the Inspector proving that the seized drug, in its actual condition, violated the provisions of the Act. Careful documentation and adherence to procedure ensure that evidence remains credible and admissible in court.

By following this SOP, investigators strengthen public health protection and uphold consumer safety. A legally sound process not only brings offenders to justice but also builds confidence in regulatory enforcement. In this way, the Act serves as both a safeguard for society and a framework for accountability.

In pharmaceutical crime investigation, chemistry proves the violation, procedure proves the case, and documentation secures the conviction.