Section 33P of the Drugs and Cosmetics Act, 1940 empowers the Central Government to give binding directions to State Governments for carrying into execution any provision of the Act or rules made thereunder. It is the only provision in the Act capable of converting prosecution norms from non-binding DCC recommendations into legally mandatory instructions for State Drug Controllers and Drug Inspectors. Yet since its insertion into the Act, Section 33P has been exercised only twice — both in 2012, on the comparatively minor issue of generic drug names on licences. It has never been used to prescribe prosecution thresholds, mandatory enforcement standards, or uniform quality enforcement norms. This article argues that systematic underuse of Section 33P is the single most important structural cause of India’s fragmented and ineffective drug enforcement regime, and calls for its immediate activation to fill the enforcement uniformity gap that DCC guidelines have failed — for structural reasons — to fill.

INTRODUCTION

India’s drug enforcement landscape is startlingly fragmented. States with identical legal frameworks — the same Drugs and Cosmetics Act, the same Rules, the same DCC guidelines — produce radically different enforcement outcomes. Some states prosecute aggressively for NSQ drug findings; others resolve the same findings with a one-day licence suspension. The same manufacturer, with the same drug quality failure, faces prison in one state and a nominal fine in another.

This fragmentation is not the product of legitimate jurisdictional diversity — it is the product of a regulatory gap. The DCC’s prosecution guidelines, which represent the only national-level attempt at enforcement uniformity, are advisory recommendations that carry no mandatory force and cannot bind State Drug Controllers as a matter of law.

Section 33P of the Act provides the solution. But it has never been used for this purpose. This article argues that it must be.

THE TEXT AND SCOPE OF SECTION 33P

Section 33P reads: ‘The Central Government may give such directions to any State Government as may appear to the Central Government to be necessary for carrying into execution in the State any of the provisions of this Act or of any rule or order made thereunder.’

Three features of Section 33P deserve attention.

First, the directions are to be given to State Governments — not to individual Drug Inspectors. This means Section 33P directions bind the State Government, which in turn is obligated under the Act to ensure compliance by its Drug Controllers and Inspectors.

Second, the directions must relate to ‘carrying into execution’ a provision of the Act, rule, or order. This means Section 33P cannot be used to impose obligations not contemplated by the Act — it is a tool for uniform execution of existing obligations, not for creating new ones.

Third, the provision uses the word ‘may’ — it is a power, not a duty. The Central Government is not obligated to issue Section 33P directions. But once issued, they are mandatory for State Governments.

THE ONLY TWO DOCUMENTED EXERCISES: 2012

To date, Section 33P appears to have been formally exercised only twice, both in October 2012:

First Direction (October 1, 2012): The Central Government directed all State/UT Governments to instruct drug licensing authorities to grant and renew drug manufacturing licences only in proper and generic names, as required under Rule 96(1)(i) of the D&C Rules, 1945. This addressed a specific, narrow problem: some states were issuing licences using brand names rather than generic names.

Second Direction (October 1, 2012): The Central Government directed all State/UT Governments to ensure that drug licensing authorities abide by the prescribed provisions under the Act regarding manufacturing licences.

Both directions dealt with the comparatively minor issue of licence nomenclature. Neither addressed prosecution standards, NSQ enforcement thresholds, or mandatory quality enforcement procedures. The immense potential of Section 33P to harmonise drug enforcement across India has never been realised.

THE ENFORCEMENT UNIFORMITY PROBLEM

The consequences of not using Section 33P for enforcement uniformity are documented and severe:

RTI-based research revealed that Gujarat imposed a one-day licence suspension on manufacturers of grossly substandard drugs, while Uttarakhand imposed twenty days. Neither state prosecuted. Other states imposed suspensions of between three and ten days. No state consistently prosecuted Category B NSQ findings — the standard that the Act’s strict liability provisions require.

This fragmentation creates a ‘race to the bottom’ dynamic: manufacturers who are aware that enforcement in certain states is perfunctory deliberately locate manufacturing facilities in those states to minimise regulatory risk. The market outcome is systematic underinvestment in quality — rational behaviour given the regulatory environment, but catastrophic for public health.

A Section 33P direction specifying minimum prosecution standards for NSQ drug findings — binding on all State Drug Controllers — would immediately and uniformly raise the enforcement baseline across all 36 states and UTs.

A DRAFT FRAMEWORK FOR SECTION 33P PROSECUTION DIRECTIONS

A model Section 33P direction on prosecution uniformity might include:

1. Mandatory prosecution within 90 days of receipt of a Government Analyst report confirming an NSQ finding, unless a specific exemption is granted by the State Drug Controller in writing with reasons recorded.
2. Prohibition on resolution of NSQ findings through administrative action alone (licence suspension, warning) where the finding relates to potency, sterility, or identity failures — Category A and serious Category B failures.
3. Mandatory reporting to the DCGI of all NSQ findings and the prosecution/non-prosecution decision within 30 days of the Analyst’s report.
4. Uniform application of pharmacopoeial quality standards (not the DCC’s 70% label claim threshold) as the sole benchmark for determining whether an NSQ finding warrants prosecution.

Such a direction would not create new law — it would direct State Governments to execute existing law. It would be entirely within the scope of Section 33P.

COMPARATIVE: SECTION 119 IT ACT AND SECTION 37B CENTRAL EXCISE ACT

The experience of CBDT and the Central Board of Excise and Customs (CBEC/CBIC) with analogous binding direction provisions is instructive.

Section 119 of the IT Act and Section 37B of the Central Excise Act both empower the respective Boards to issue binding instructions to subordinate officers for uniform administration of the Act. These provisions are used extensively — CBDT alone has issued hundreds of circulars and instructions that bind all Income Tax Officers nationally, ensuring enforcement uniformity across all Assessment Units.

The D&C Act’s Section 33P is structurally equivalent to these provisions — but operates at the Central-to-State level rather than within a single national cadre. There is no legal or structural obstacle to its use for prosecution uniformity purposes. The obstacle is purely one of political will.

VII. CONCLUSION: A POLICY RECOMMENDATION

Section 33P of the Drugs and Cosmetics Act is the most powerful unused tool in India’s drug enforcement arsenal. Its activation for prosecution uniformity purposes requires no legislative amendment, no Parliamentary procedure, and no inter-ministerial negotiation beyond the Ministry of Health. A cabinet decision and a Gazette notification suffice.

The Ministry of Health and Family Welfare should, as an urgent priority, exercise the Section 33P power to issue binding directions to all State Governments specifying minimum prosecution standards for NSQ drug findings. This single step would do more for drug enforcement uniformity in India than any amount of DCC advisory recommendations, CDSCO guidance documents, or inter-state best-practice sharing exercises.

REFERENCES

[1] The Drugs and Cosmetics Act, 1940, Section 33P — India Code.  https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf

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

[3] PIB: Generic Names of Drugs on the Packing — Section 33P Direction (October 2012).  https://www.pib.gov.in/newsite/PrintRelease.aspx?relid=94925

[4] PIB: Manufacturing and Marketing of Banned/Unapproved Drugs — Section 33P Direction (October 2012).  https://pib.gov.in/newsite/PrintRelease.aspx?relid=101213

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

[6] 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

[7] Income Tax Act, 1961, Section 119 — Income Tax Department.  https://www.incometaxindia.gov.in

[8] PharmaBAz DCC asks expert committee to relook at guidelines for uniform prosecution — PharmaBiz (March 2025).  https://pharmabiz.com/NewsDetails.aspx?aid=175579&sid=1

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

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