Strict Liability Offences Under the Drugs and Cosmetics Act, 1940: Are India’s Courts Adequately Enforcing Them?

ABSTRACT

The Drugs and Cosmetics Act, 1940 creates strict liability offences for the manufacture and sale of not-of-standard-quality (NSQ) drugs. Parliament deliberately excluded the requirement of proving mens rea — the offence is complete upon the finding of drug quality failure. Yet the actual enforcement record reveals a systematic departure from this framework: prosecution rates are extremely low, courts are reluctant to convict without evidence of intent, and administrative sanctions routinely substitute for the criminal process that Parliament prescribed. This article traces the legislative history of the strict liability regime, analyses the empirical enforcement gap, examines the judicial tendencies that undermine strict liability in practice, compares the D&C Act regime with analogous legislation (Food Safety and Standards Act, 2006), and argues for legislative and judicial reorientation.

INTRODUCTION

Strict liability in criminal law is not the norm — it is the exception, reserved for categories of offences where Parliament has made a considered judgment that the public interest in deterrence outweighs the traditional requirement of mental culpability. Drug quality offences are among the clearest examples: the harm from substandard drugs falls not on identifiable victims who can alert authorities, but diffusely on patients who may never know they were harmed. Only a manufacturer who cannot safely assume that quality failures will go undetected has a genuine incentive to invest in quality.

Parliament understood this when it drafted the Drugs and Cosmetics Act, 1940. Sections 16, 18, and 27 create a framework where drug quality violations are criminalised without proof of intent. Yet six decades of enforcement practice reveal that neither regulators nor courts have enforced this framework as Parliament intended.

THE LEGISLATIVE HISTORY OF STRICT LIABILITY UNDER THE ACT

The original Drugs Act, 1940 established quality standards and prohibited the sale of substandard drugs. The 1982 Amendment strengthened the penalty regime. The 2008 Amendment was the most significant: it raised the minimum sentence for manufacture of spurious drugs to ten years and made certain drug quality offences cognizable and non-bailable.

The 2008 Amendment was specifically motivated by the finding that low penalties were providing insufficient deterrence — manufacturers were treating criminal prosecution as an acceptable cost of doing business. Parliament’s response was to dramatically increase the stakes, not to introduce a mens rea requirement. The legislative intent was explicitly pro-deterrence and strictly liability-based.

This legislative history is directly relevant when courts are tempted to import a mens rea requirement through the ‘benefit of doubt’ doctrine. A court that acquits a manufacturer of NSQ drugs because the prosecution could not prove intent is, in effect, overriding a deliberate Parliamentary choice.

THE EMPIRICAL ENFORCEMENT GAP

The gap between statutory mandate and enforcement reality in India’s drug regulation is stark and well-documented.

RTI-based research revealed that Drug Inspectors across states consistently resolved NSQ drug findings through administrative action — temporary licence suspensions of as little as one day — rather than criminal prosecution. The screening committee process mandated by DCC guidelines effectively filtered out the vast majority of Category B NSQ cases before they reached the prosecution stage.

The Thakur-Reddy report documented that no state consistently prosecuted for Category B NSQ findings, despite the Act’s strict liability framework requiring no additional evidentiary showing beyond the Analyst’s report.

The consequence: manufacturers of substandard drugs in India face administrative sanctions so light that the regulatory cost of a quality failure is negligible. The market incentive structure is unchanged — perhaps even worse than before the 2008 Amendment’s enhanced penalties, since manufacturers know the penalties will not in practice be imposed.

JUDICIAL TENDENCIES THAT UNDERMINE STRICT LIABILITY

Even in the rare cases that reach prosecution and trial, courts have shown tendencies that undermine the strict liability regime:

First, some courts have imported a mens rea requirement into the ‘benefit of doubt’ analysis — effectively requiring the prosecution to show that the manufacturer ‘must have known’ about the quality failure. This directly contradicts the strict liability structure of Section 27.

Second, courts have sometimes placed undue weight on the manufacturer’s ‘good manufacturing practice’ history, treating compliance in earlier batches as evidence that the failure in the relevant batch was not intentional. Strict liability does not admit of this defence.

Third, courts have occasionally relied on the DCC’s Category B/C distinction to find that a drug which fell into these categories lacked the ‘criminal seriousness’ required for conviction — importing the DCC’s extra-statutory framework into judicial reasoning.

Fourth, the long delays between sampling, analysis, prosecution, and trial — commonly five to ten years in India — result in evidence degradation (sample deterioration, witness unavailability) that disproportionately burdens the prosecution.

COMPARISON WITH THE FOOD SAFETY AND STANDARDS ACT, 2006

The Food Safety and Standards Act, 2006 (FSSA) creates a parallel strict liability regime for food quality offences. Section 51 FSSA prescribes imprisonment and fines for manufacture or sale of adulterated food, without requiring proof of mens rea.

Enforcement under the FSSA, while imperfect, is more active than under the D&C Act. Food Safety Officers (the FSSA equivalent of Drug Inspectors) more frequently proceed to prosecution, and courts more consistently hold that the strict liability nature of FSSA offences precludes importation of a mens rea requirement.

The contrast with D&C Act enforcement suggests that the enforcement gap under the D&C Act is not inherent to strict liability prosecution — it is the product of the DCC guidelines’ extra-statutory filtering function, which has no equivalent in the FSSA framework.

THE CASE FOR STRICT ENFORCEMENT: A PLEA TO COURTS AND REGULATORS

Strict liability drug quality offences under Drugs and Cosmetics Act are not anomalies in the criminal law — they are essential public health protections. Courts that effectively convert them into intent-based offences are not engaged in principled statutory interpretation; they are substituting their own policy preferences for Parliament’s considered judgment.

The appropriate judicial posture is:
(i) Accept the Government Analyst’s report as prima facie proof of the quality failure (subject to the accused’s right to CDL retesting);
(ii) Hold that proof of quality failure, once established, completes the offence without further showing of intent;
(iii) Treat the DCC’s extra-statutory Category B/C distinctions as legally irrelevant to the criminal liability determination;
(iv) Apply the enhanced sentencing provisions of the 2008 Amendment with fidelity to their deterrent purpose.

CONCLUSION

India’s Drugs and Cosmetics Act, 1940 prescribes one of the clearest strict liability regimes in Indian criminal law. Yet its enforcement is among the most persistently defective. The reasons are systemic: non-statutory DCC guidelines that filter out prosecutions, administrative sanctions that lack deterrent force, judicial tendencies that import mens rea, and institutional reluctance to use criminal law for regulatory violations.

The solution requires action at every level: judicial fidelity to the strict liability structure; CDSCO activation of Section 33P to mandate prosecution of serious NSQ findings; and legislative reaffirmation — if needed — that Parliament’s intent in 1940 and 2008 was a strict liability regime, not a fault-based one.

REFERENCES

[1] The Drugs and Cosmetics Act, 1940, Sections 16, 18, 27 — India Code.  https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf

[2] Drugs and Cosmetics (Amendment) Act, 2008 — CDSCO.  https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/DC_ACT_AMENDMENT_2008_file.pdf

[3] Dinesh Thakur & Prashant Reddy T., ‘A Report on Fixing India’s Broken Drug Regulatory Framework’ (SpicyIP, June 2016).  https://spicyip.com/wp-content/uploads/2016/06/Report_India-Drug-Regulatory-Framework_June-2016.pdf

[4] 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

[5] PMC: ‘Regulating New Drugs in India Needs to Be Improved’ (2023).  https://pmc.ncbi.nlm.nih.gov/articles/PMC10305928/

[6] Section 33P — LawGist: The Drugs and Cosmetics Act.  https://lawgist.in/drugs-and-cosmetics-act/33P

[7] ICLG India — Drug and Medical Device Litigation 2026.  https://iclg.com/practice-areas/drug-and-medical-device-litigation/india

FAQ

1. What is strict liability under the Drugs and Cosmetics Act, 1940?
Strict liability means that for drug quality offences, the prosecution does not need to prove intent or knowledge. If a drug is found to be not of standard quality (NSQ), the offence is complete.

2. Which provisions establish strict liability for drug offences?
Sections 16, 18, and 27 of the Drugs and Cosmetics Act, 1940 create the framework where manufacture or sale of NSQ drugs is punishable without proof of mens rea.

3. Do courts need proof of intent to convict in NSQ drug cases?
No. The law does not require proof of intent. However, in practice, some courts have shown reluctance to convict without evidence suggesting knowledge or negligence.

4. What is the enforcement gap in drug quality regulation?
The enforcement gap refers to the mismatch between strict legal provisions and weak implementation—low prosecution rates, preference for administrative penalties, and delays in trials.

5. Why are prosecutions for NSQ drugs so rare in India?
Many cases are filtered out through administrative processes like DCC guidelines and screening committees, leading to minor penalties instead of criminal prosecution.

6. Can administrative guidelines override the Act?
No. Guidelines issued by bodies like the DCC do not have statutory force and cannot override the provisions of the Drugs and Cosmetics Act.

7. How does the Food Safety and Standards Act compare?
The Food Safety and Standards Act, 2006 also uses strict liability for quality offences but is generally enforced more actively, with more frequent prosecutions.

8. What role does the Government Analyst’s report play?
It serves as primary evidence of drug quality. Once it confirms a drug is NSQ, it is sufficient to establish the offence, subject to the right of retesting.

9. What changes are needed to improve enforcement?
Stronger prosecution practices, reduced reliance on administrative penalties, judicial adherence to strict liability principles, and possible use of Section 33P for central directions.

10. Why is strict enforcement important in drug regulation?
Because substandard drugs can harm patients without detection, strict enforcement ensures deterrence and incentivizes manufacturers to maintain high quality standards.