The Drugs Consultative Committee (DCC), constituted under Section 7 of the Drugs and Cosmetics Act, 1940, periodically issues guidelines classifying drug quality defects into categories and prescribing differential prosecution responses. This article argues that these guidelines — in particular those requiring Drug Inspectors to establish ‘criminal intent or gross negligence’ before recommending prosecution for not-of-standard-quality (NSQ) drugs — are ultra vires the Act. The Act’s framework under Sections 16, 18, and 27 creates a strict liability scheme: mens rea need not be proved. DCC guidelines purporting to impose a mental intent threshold not only contradict the statutory scheme but exceed the advisory body’s constitutionally circumscribed role. This article traces the statutory framework, examines the DCC’s limited jurisdiction, analyses the ultra vires argument under constitutional and administrative law principles, and proposes judicial and legislative reform pathways.

INTRODUCTION

India’s pharmaceutical regulatory landscape is marked by a persistent gap between the letter of the law and its enforcement reality. The Drugs and Cosmetics Act, 1940 (‘the Act’) is one of the oldest and most comprehensive pieces of public health legislation in the country. Despite clear statutory mandates prescribing strict liability for the manufacture and sale of substandard drugs, prosecution rates under the Act remain abysmally low.

At the centre of this gap sits a set of internal administrative guidelines issued by the Drugs Consultative Committee (DCC) — a statutory advisory body that periodically recommends how Drug Inspectors should respond to not-of-standard-quality (NSQ) drug samples. These guidelines introduce a categorical scheme — classifying drug defects as A, B, or C — and effectively decriminalise a large class of NSQ drugs by requiring proof of criminal intent before prosecution is initiated.

This article examines the legal basis and validity of these guidelines, arguing that they are ultra vires the Act and constitute an impermissible executive override of Parliamentary intent.

THE STATUTORY FRAMEWORK: STRICT LIABILITY UNDER SECTIONS 16, 18, AND 27

Section 16 of the Act empowers the Central Government to prescribe standards of quality for drugs, operationalised primarily through reference to the Indian Pharmacopoeia (IP). Any drug failing to conform to these standards is, by statutory definition, ‘not of standard quality’ (NSQ). The standard is objective and absolute.

Section 18 prohibits the manufacture, sale, stocking, or distribution of any drug not conforming to prescribed standards. The prohibition is categorical and contains no mental element. A manufacturer who produces a batch of NSQ drugs violates Section 18 regardless of whether the substandard quality was intentional, negligent, or accidental.

Section 27 prescribes punishment. For the manufacture of NSQ drugs, the minimum sentence is one year’s imprisonment, extendable to two years, with fine. After the 2008 Amendment, offences involving spurious or adulterated drugs attract a minimum of ten years, extendable to life imprisonment or death in cases causing grievous harm or death to the patient.

The structure of Sections 16, 18, and 27 read together is that of classic strict liability: once it is established that a drug fails the prescribed standard, the offence is complete. The Drug Inspector need not investigate or prove the mental state of the manufacturer. This is a deliberate legislative choice, consistent with the protective public health purpose of the Act.

THE DCC: ITS ADVISORY CHARACTER AND LEGAL LIMITATIONS

The Drugs Consultative Committee is constituted under Section 7 of the Act. Its membership includes all State Drug Controllers and the Drugs Controller General of India. Section 7 describes the DCC’s function as advising the Central Government and State Governments on matters relating to uniform administration of the Act.

Section 7 uses the word ‘advise.’ The DCC has no rulemaking power. Rulemaking is vested exclusively in the Central Government under Section 33, subject to prior Gazette publication and Parliamentary tabling under Section 38. The DCC is excluded from this rulemaking chain.

Where the legislature creates an advisory body and expressly limits it to advisory functions, that body cannot, through guidelines or recommendations, assume rulemaking powers that Parliament has withheld from it. The distinction between advisory and rulemaking functions is constitutionally and statutorily fundamental.

THE DCC PROSECUTION GUIDELINES: CONTENT AND THE MENS REA PROBLEM

The DCC’s prosecution guidelines, most significantly those decided at the 40th DCC Meeting and published by CDSCO (2008), classify drug quality defects into three categories:

Category A: Genuinely spurious or adulterated drugs. Prosecution is to be initiated on top priority.
Category B: Grossly substandard drugs (e.g., drugs testing below 70% of label claim for potency). Prosecution recommended only where ‘criminal intent or gross negligence’ is established, and administrative action is first attempted.
Category C: Minor defects (broken tablets, labelling errors, marginal potency deviations). Administrative measures preferred; prosecution only in exceptional circumstances.

The Category B criterion is the critical legal problem. It requires Drug Inspectors to assess and establish criminal intent or gross negligence — a mental element — before recommending prosecution for what Section 27 makes a strict liability offence. The DCC guidelines require proof of something the Act expressly excludes.

Further, the DCC’s 70% label claim threshold for Category B creates a quality standard more lenient than that prescribed under Section 16 and the Indian Pharmacopoeia. Drug Inspectors following this threshold are being directed to ignore statutory violations.

ULTRA VIRES ANALYSIS

An administrative instruction is ultra vires where it: (i) exceeds the powers of the issuing authority; (ii) contradicts a statutory provision; or (iii) modifies rights or obligations created by Parliament without Parliamentary sanction.

The DCC Prosecution Guidelines Under the Drugs and Cosmetics Act fail on all three counts.

First, the DCC has no power to issue binding guidelines. As a Section 7 advisory body, it can only recommend. Any attempt to convert its recommendations into prescriptive guidelines binding on Drug Inspectors amounts to an assumption of rulemaking power Parliament never conferred.

Second, the guidelines contradict Section 27’s strict liability scheme by importing a mens rea requirement. A guideline that says ‘do not prosecute unless you can show criminal intent’ directly contradicts a statute that says ‘prosecute regardless of intent.’

Third, the guidelines modify the effective legal standard for NSQ drugs by using a 70% label claim threshold that departs from pharmacopoeial standards. Only Parliament — through an amendment to Section 16 or a Gazette-notified rule under Section 33 — can alter these quality standards.

The Constitution Bench of the Supreme Court in Commissioner of Central Excise, Bolpur v. Ratan Melting and Wire Industries (2008) 13 SCC 1 settled the principle: a circular contrary to statute has ‘no existence in law.’ Drug Inspectors who follow the DCC guidelines and decline to prosecute Category B NSQ cases are acting without lawful basis.

PUBLIC HEALTH CONSEQUENCES

The consequences of treating these guidelines as operationally binding are severe. RTI-based research documented that many state drug regulators, following DCC guidelines, imposed administrative penalties as light as a single day’s licence suspension on manufacturers of grossly substandard drugs. In several states, the suspension period ranged from one to twenty days — a sanction providing no meaningful deterrence.

NSQ drugs cause real patient harm. A drug testing at 60% of label claim does not merely ‘underperform’ — in the treatment of tuberculosis, cardiovascular conditions, or infectious disease, subtherapeutic dosing leads to treatment failure, disease progression, and in antibiotic contexts, antimicrobial resistance. The DCC guidelines, in functionally insulating manufacturers from prosecution for strict liability crimes, shift the cost of manufacturer negligence onto India’s most vulnerable patients.

REFORM PATHWAYS

Three reform pathways are available.

First, judicial review: Any aggrieved person can seek a writ of mandamus compelling prosecution, arguing that the DCC guidelines are ultra vires and that the statutory duty under Sections 18/27 has been unlawfully evaded.

Second, Section 33P directions: The Central Government could issue a direction under Section 33P prescribing mandatory prosecution thresholds, binding all State Drug Controllers — transforming currently non-binding recommendations into statutory directions.

Third, statutory amendment: The cleanest solution is to insert into the Act a provision equivalent to Section 119 of the Income Tax Act, 1961, expressly authorising CDSCO to issue binding prosecution guidelines subject to Parliamentary oversight. Absent such amendment, DCC guidelines remain an unconstitutional overlay on a statute Parliament intended to be strictly enforced.

CONCLUSION

The DCC prosecution guidelines represent a case study in how advisory bodies can, through consistent departmental practice, effectively rewrite the law without Parliamentary sanction. The Act’s strict liability framework for NSQ drugs is not accidental — it reflects a considered legislative choice to protect public health by removing the requirement to prove intent. Guidelines that restore that requirement are ultra vires, unconstitutional, and contrary to settled administrative law principles. This gap must be closed — whether through judicial intervention, Section 33P statutory directions, or legislative amendment.

FAQs

1. What are DCC guidelines for NSQ drugs in India?

The Drugs Consultative Committee (DCC) issues advisory guidelines classifying not-of-standard-quality (NSQ) drugs into Categories A, B, and C, and suggests when prosecution or administrative action should be taken.

2. Are DCC guidelines legally binding?

No. The DCC is an advisory body under Section 7 of the Drugs and Cosmetics Act, 1940. Its guidelines do not have the force of law and cannot override statutory provisions.

3. What does “NSQ drugs” mean under the Drugs and Cosmetics Act?

NSQ (Not of Standard Quality) drugs are those that fail to meet prescribed standards under Section 16 of the Act, usually based on Indian Pharmacopoeia benchmarks.

4. Does the Drugs and Cosmetics Act require proof of intent for prosecution?

No. The Act establishes a strict liability framework under Sections 18 and 27, meaning prosecution does not require proof of mens rea (criminal intent).

5. Why are DCC guidelines considered ultra vires?

They are considered ultra vires because they introduce a requirement of “criminal intent or gross negligence,” which contradicts the Act’s strict liability scheme and exceeds the DCC’s advisory powers.

6. What is the issue with the 70% label claim threshold?

The DCC’s 70% threshold deviates from statutory quality standards under Section 16 and the Indian Pharmacopoeia, effectively lowering the legal standard without legislative authority.

7. What action can be taken against non-prosecution based on DCC guidelines?

An aggrieved party may approach a High Court under Article 226 seeking a writ of mandamus to compel prosecution in accordance with the Act.

8. What reforms are suggested to address this issue?

Suggested reforms include judicial review of DCC guidelines, issuance of binding directions under Section 33P, or legislative amendments to clarify prosecution standards.

9. How do NSQ drugs impact public health?

Substandard drugs can lead to treatment failure, disease progression, and antimicrobial resistance, posing serious risks to patient safety.

10. Who enforces drug quality laws in India?

Drug Inspectors appointed under the Drugs and Cosmetics Act are responsible for enforcing quality standards and initiating prosecution for violations.

REFERENCES

[1] The Drugs and Cosmetics Act, 1940 (Act 23 of 1940), Sections 7, 16, 18, 27, 33, 33P — India Code.  https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf

[2] 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

[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] Commissioner of Central Excise, Bolpur v. Ratan Melting and Wire Industries, (2008) 13 SCC 1 — Constitution Bench, Supreme Court of India.  https://www.casemine.com/judgement/in/56b48d51607dba348fff2555

[5] G.J. Fernandez v. State of Mysore & Ors., AIR 1967 SC 1753, [1967] 3 SCR 636 — Supreme Court of India.  https://www.legitquest.com/case/gj-fernandez-v-state-of-mysore-others/4C41

[6] Sant Ram Sharma v. State of Rajasthan & Anr., AIR 1967 SC 1910 — Supreme Court of India (July 7, 1967).  https://lawlens.in/doc/5aa43bbb-095a-4ff0-96ac-f93abfc56ed5

[7] Drugs and Cosmetics (Amendment) Act, 2008 — Ministry of Health and Family Welfare, Government of India.  https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/DC_ACT_AMENDMENT_2008_file.pdf

[8] 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

[9] CDSCO Guidance Document for Zonal/Sub-Zonal/Port Offices (2022 Edition).  https://www.cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/Guidance_doc/CDSCO%20Guidance%20Document.pdf

[10] Drugs and Cosmetics (Compounding of Offences) Rules, 2025 — SCC Online.  https://www.scconline.com/blog/post/2025/04/29/drugs-and-cosmetics-compounding-of-offences-rules-legal-news/

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