The Central Drugs Standard Control Organisation (CDSCO) occupies an unusual institutional position in India’s regulatory landscape: it is simultaneously the authority that approves new drugs for market entry, the body that monitors ongoing drug quality compliance, and the authority that initiates prosecution for quality violations. This concentration of licensor, monitor, and prosecutor functions within a single body creates a conflict of interest within CDSCO in drug prosecution, reflected in India’s persistently low prosecution rates. This article analyses the structural problem, compares the Indian model with international practice (US FDA/DOJ model; UK MHRA/CPS model), examines the role of the screening committee as an internal conflict management device, and proposes structural reforms — including creation of an independent drug prosecution authority.

INTRODUCTION

India’s drug regulatory framework vests extraordinary — and conflicting — powers in CDSCO. The DCGI approves new drugs for market entry. CDSCO’s drug standards division monitors post-market compliance. CDSCO’s enforcement division initiates prosecution for quality failures. The same institutional family that says ‘this drug is safe and effective’ must also say ‘this drug is substandard and its manufacturer must be prosecuted.’

This is not a design flaw unique to India — regulatory bodies worldwide struggle with the tension between promotional and enforcement mandates. But in India, where the screening committee that recommends prosecution sits within CDSCO, where the Drug Inspector who collects samples reports to the same authority that decides whether to prosecute, and where no independent prosecutorial authority exists to provide checks, the conflict of interest is structurally built into the enforcement process.

THE THREE CONFLICTS

CONFLICT 1 — LICENSOR vs. PROSECUTOR: When CDSCO has approved a drug for manufacture (granted a central manufacturing licence), discovering that the approved manufacturer is producing NSQ drugs creates a reputational problem for CDSCO itself. Prosecution draws attention to the quality failure — which is also evidence that CDSCO’s licensing and monitoring functions failed to prevent the problem. The institutional incentive is toward resolution through administrative action, not public prosecution.

CONFLICT 2 — MONITOR vs. PROSECUTOR: Drug Inspectors who build ongoing relationships with regulated manufacturers — visiting their premises, reviewing their records, advising on compliance — have institutional incentives to resolve quality failures through informal compliance guidance rather than prosecution. The monitoring relationship is incompatible with the adversarial relationship required for prosecution.

CONFLICT 3 — NATIONAL AUTHORITY vs. STATE ENFORCEMENT: For state-licensed drugs, prosecution is initiated by state Drug Inspectors supervised by State Drug Controllers. CDSCO’s prosecution guidelines (which are non-binding) attempt to coordinate this state-level enforcement — but CDSCO has no direct authority over state enforcement officers. The screening committee process at the state level reflects local regulatory cultures, not national standards.

THE SCREENING COMMITTEE: AN INADEQUATE INTERNAL FIX

The DCC’s screening committee requirement — that proposed prosecutions be reviewed by a committee before the Drug Inspector files a complaint — was designed precisely to address the conflict of interest within the Central Drugs Standard Control Organisation (CDSCO). By interposing a committee review between the Inspector’s recommendation and the filing of the complaint, the process was intended to ensure that prosecution decisions were deliberate, consistent, and well-founded.

In practice, the screening committee has operated as a prosecution filter rather than a prosecution quality control mechanism. RTI data reveals that the vast majority of NSQ cases are resolved at the screening committee stage through administrative action — not because the screening committee affirmatively determined that prosecution was unwarranted, but because the institutional culture defaults to non-prosecution.

Further, as established in this research series, the screening committee requirement has no statutory basis. It is an administrative overlay on a statutory framework that requires no such step. A Drug Inspector who bypasses the screening committee and files a complaint directly has not violated any law. The screening committee’s filtering function operates entirely through internal discipline, not through legal authority.

INTERNATIONAL COMPARISON

US MODEL — FDA/DOJ: The US Food and Drug Administration is the regulatory and monitoring body. Criminal prosecution of drug quality violations is referred by the FDA to the US Department of Justice (DOJ), which makes independent prosecutorial decisions. The FDA cannot itself initiate criminal prosecution — it can only refer. This separation ensures that prosecutorial decisions are made by a body with no institutional conflict of interest in the outcome.

UK MODEL — MHRA/CPS: The Medicines and Healthcare products Regulatory Agency (MHRA) regulates and monitors. Criminal prosecution is referred to the Crown Prosecution Service (CPS), which applies the Code for Crown Prosecutors — an independent national standard — to the decision whether to prosecute. MHRA can conduct investigations but cannot prosecute.

BOTH MODELS share the same structural feature: separation of the monitoring/regulatory function from the prosecution function. The regulatory body investigates and refers; an independent prosecution authority decides whether to prosecute and on what standard.

India’s model inverts this: CDSCO/State Drug Controllers both regulate and prosecute — with the only check being an internal screening committee that is itself subject to the institutional conflict.

PROPOSED REFORMS

Three structural reforms could address the CDSCO conflict of interest:

Reform 1 — Independent Drug Prosecution Division: Create a dedicated Drug Prosecution Division, either within the Ministry of Health or as an independent statutory authority, with power to make final prosecutorial decisions on Drug Inspector referrals. The Division would apply published prosecution standards (ideally issued under Section 33P) rather than internal administrative guidelines.

Reform 2 — Mandatory Referral to Public Prosecutor: Amend Section 32 of the Act to require that Drug Inspector complaints for serious NSQ findings (Category A and serious Category B) be routed through the Public Prosecutor’s office, which then decides whether to file the complaint. This leverages the existing public prosecutorial infrastructure without creating a new institution.

Reform 3 — Publication and Accountability: Require CDSCO and State Drug Controllers to publish annually: the number of NSQ findings, the number referred for prosecution, the number where prosecution was declined, and the reasons for declination. Public accountability, even without structural change, creates pressure for enforcement consistency.

CONCLUSION

CDSCO’s dual role as regulator and prosecutor is not merely a theoretical conflict — it has practical enforcement consequences that manifest in India’s low prosecution rates for drug quality violations. The DCC’s screening committee, far from resolving the conflict, institutionalises it within a non-statutory process that lacks legal accountability.

Structural separation of regulatory and prosecutorial functions — on the US FDA/DOJ or UK MHRA/CPS model — is the appropriate long-term solution. In the interim, mandatory referral to the Public Prosecutor, Section 33P prosecution directions, and publication of enforcement statistics would each incrementally address the accountability deficit.

Frequently Asked Questions (FAQs)

1. What is the role of Central Drugs Standard Control Organisation (CDSCO)?
CDSCO is India’s national drug regulatory authority responsible for approving new drugs, monitoring drug quality, and initiating enforcement action against violations.

2. Why is CDSCO’s structure considered a conflict of interest?
Because CDSCO performs three roles simultaneously—licensor, monitor, and prosecutor. This creates institutional tension when the same authority must both approve a drug and later prosecute its manufacturer for quality failures.

3. What is the role of the DCGI in this framework?
The Drug Controller General of India (DCGI), operating under CDSCO, grants approvals for new drugs and oversees regulatory decisions related to drug safety and efficacy.

4. What are NSQ (Not of Standard Quality) drugs?
NSQ drugs are pharmaceutical products that fail to meet prescribed quality standards under the Drugs and Cosmetics Act, 1940, making them potentially unsafe or ineffective.

5. What is the screening committee in drug prosecution cases?
The screening committee is an administrative body that reviews prosecution proposals before a complaint is filed. However, it has no statutory basis and functions as an internal filter rather than a legally mandated step.

6. Is the screening committee legally required under the Drugs and Cosmetics Act, 1940?
No. The Act does not mandate a screening committee. A Drug Inspector can legally initiate prosecution without going through this committee.

7. Why are prosecution rates for drug quality violations low in India?
Low prosecution rates are attributed to institutional conflicts within CDSCO, reliance on administrative resolutions, and the filtering effect of internal screening committees.

8. How does the U.S. model handle drug regulation and prosecution?
In the United States, the Food and Drug Administration (FDA) regulates drugs, but prosecution is handled independently by the Department of Justice (DOJ), ensuring separation of powers.

9. How does the UK model differ from India’s approach?
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates drugs, while prosecution decisions are made by the Crown Prosecution Service (CPS), an independent authority.

10. What is the key difference between India and international models?
International models separate regulatory and prosecutorial functions, while in India, both functions are concentrated within CDSCO and State Drug Controllers.

11. What reforms are suggested to address this conflict of interest within CDSCO?
The article proposes reforms to address the conflict of interest within the Central Drugs Standard Control Organisation (CDSCO) arising from its combined regulatory and prosecutorial roles:

• Creating an independent drug prosecution authority
• Mandatory referral of serious cases to public prosecutors
• Publishing enforcement and prosecution data annually

12. What is Section 32 of the Drugs and Cosmetics Act, 1940?
Section 32 governs who can initiate prosecution under the Act, primarily authorizing Drug Inspectors and certain government authorities.

13. What is Section 33P and how is it relevant?
Section 33P empowers the Central Government to issue directions to ensure uniform enforcement, including potentially setting prosecution standards.

14. Why is transparency in enforcement important?
Publishing data on drug quality violations and prosecution decisions promotes accountability, consistency, and public trust in the regulatory system.

15. What is the main takeaway from this article?
The central issue is structural: combining regulatory and prosecutorial roles within CDSCO undermines enforcement. Long-term reform requires institutional separation and greater accountability mechanisms.

REFERENCES

[1] The Drugs and Cosmetics Act, 1940, Sections 7, 32, 33, 33P.  https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf

[2] 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

[3] 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

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

[5] 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

[6] 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

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

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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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The Drugs and Cosmetics (Compounding of Offences) Rules, 2025, notified on April 24, 2025 under Sections 32B and 33(2)(r) of the Drugs and Cosmetics Act, 1940, represent a fundamental transformation in India’s drug enforcement landscape. For the first time, a statutory framework exists for settling specified drug offences by payment of a compounding amount — without criminal prosecution. This article analyses the 2025 Rules in detail, examines their interface with the existing prosecution procedure under Section 32, compares the framework with CBDT’s well-developed compounding regime, identifies the offences eligible for compounding, and addresses key questions of immunity, withdrawal, and the relationship between compounding and the non-statutory DCC prosecution guidelines that preceded the formal rules.

INTRODUCTION

For decades, India’s pharmaceutical manufacturers who found themselves facing prosecution for drug quality violations had two informal escape routes: first, the DCC’s non-statutory prosecution guidelines, which if followed by the Drug Inspector would result in the case being resolved through administrative action rather than criminal complaint; second, under the original Section 32B, limited compounding provisions that were narrowly applied.

The Jan Vishwas (Amendment of Provisions) Act, 2023 changed this landscape fundamentally. The Act amended over 180 laws to decriminalise minor regulatory offences — converting criminal sanctions to civil penalties and establishing formal compounding frameworks. Under this mandate, the Ministry of Health and Family Welfare notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 on April 24, 2025.

These Rules are the first statutory, transparent, and rule-bound mechanism for settling drug offences without prosecution. They stand in sharp contrast to the ad hoc, non-statutory, and legally dubious DCC prosecution guidelines that previously served this function.

THE STATUTORY FOUNDATION: SECTIONS 32B AND 33(2)(R)

Section 32B of the Drugs and Cosmetics Act provides for compounding of offences. It authorises the Central Government to frame rules prescribing the authority competent to compound offences, the offences that may be compounded, and the amount that may be accepted.

Section 33(2)(r) confers the specific rulemaking power to prescribe procedures for compounding. Together, Sections 32B and 33(2)(r) provide the statutory transmission belt for the 2025 Rules — the Rules are not administrative guidelines or DCC recommendations. They are statutory rules with the full force of law, tabled before Parliament under Section 38.

This statutory character is the defining difference between the 2025 Rules and the DCC compounding guidance that preceded them. The 2025 Rules bind Drug Inspectors, manufacturers, and the Compounding Authority — their terms cannot be departed from except by amendment following the statutory procedure.

OFFENCES ELIGIBLE FOR COMPOUNDING

The 2025 Rules permit compounding of offences under specific sub-sections of the Act, including:
— Section 27(d): Manufacture, sale, stocking, or distribution of drugs in contravention of other provisions of Chapter IV (minor violations, not spurious or adulterated categories);
— Section 27A(ii): Violations relating to cosmetics;
— Section 28: Obstructing an Inspector in the exercise of their duties;
— Section 28A: Disclosure of information to a person from whom a sample was taken.

Critically, the most serious offences — manufacture of spurious, adulterated, or misbranded drugs under Sections 27(a), (b), and (c), which attract minimum ten-year sentences — are NOT eligible for compounding. Compounding is available only for the less serious end of the offence spectrum.

This structure reflects a deliberate policy choice: decriminalise truly minor regulatory violations (labelling errors, administrative non-compliance, minor quality deviations) while preserving criminal prosecution as the mandatory response for public health threats.

THE COMPOUNDING AUTHORITY AND PROCEDURE

The Compounding Authority for centrally licensed drugs is the Drugs Controller General of India (DCGI). For state-licensed drugs, the State Drug Controller or equivalent authority is the Compounding Authority.

The procedure requires: (i) an application by the accused (compounding is not automatic or ex officio); (ii) the accused’s acknowledgement of the offence; (iii) assessment of the compounding amount by the Authority; (iv) payment of the assessed amount; and (v) issue of a compounding certificate.

Compounding is not a right — it is at the discretion of the Compounding Authority. The Authority may refuse compounding where the public interest requires prosecution, where the offence is of a habitual or recidivist nature, or where the application does not meet the conditions of the Rules.

Once compounding is completed and the certificate issued, the accused is immune from prosecution for that specific offence. Importantly, immunity can be withdrawn if conditions were violated or false information was provided during the compounding process.

COMPARISON WITH CBDT COMPOUNDING FRAMEWORK

CBDT’s compounding guidelines, most recently revised in September 2022 and further updated in June 2024, represent a mature, well-developed compounding regime under Section 279(2) of the Income Tax Act, 1961.

Key comparisons:

Statutory basis: Both the CBDT compounding guidelines and the D&C Compounding Rules are underpinned by statutory authority — Section 279(2) IT Act for CBDT, and Sections 32B/33(2)(r) for the D&C Rules.

Threshold approach: CBDT guidelines specify graduated compounding amounts based on the amount of tax evaded. The D&C Rules specify amounts based on the nature of the offence and the scale of the violation.

Discretion: Both frameworks preserve discretion — compounding is not automatic. CBDT can refuse compounding for habitual offenders; the D&C Compounding Authority can similarly refuse.

Immunity scope: CBDT compounding grants immunity from prosecution under the IT Act for the compounded period. D&C Rules similarly grant immunity from prosecution for the compounded offence.

The key difference: CBDT’s regime has decades of operational experience and detailed guidance on compounding amounts. The D&C framework is newly established and the jurisprudence on its application is yet to develop.

INTERFACE WITH NON-STATUTORY DCC GUIDELINES

The existence of the 2025 Compounding Rules has an important implication for the status of the DCC’s non-statutory prosecution guidelines.

Prior to the 2025 Rules, one argument in favour of the DCC guidelines was that they served a quasi-compounding function — they provided an alternative to prosecution for minor violations, filling a gap in the statutory framework. This argument, while not sufficient to save the guidelines from the ultra vires critique, at least provided a policy justification.

Post-2025 Rules, this justification disappears. Parliament has now provided a statutory mechanism for settling minor drug offences without prosecution. The DCC’s non-statutory framework is not only legally invalid — it is now redundant. Drug Inspectors who decline to prosecute Category B or C cases on DCC guideline grounds, when a statutory compounding mechanism is available, are acting without any legitimate justification.

Further, the existence of statutory compounding actually strengthens the argument that minor violations should be addressed through the Compounding Rules (a transparent, accountable, Gazette-notified process) rather than through opaque administrative screening committees applying non-statutory DCC guidelines.

CONCLUSION

The Drugs and Cosmetics (Compounding of Offences) Rules, 2025 represent the most significant reform of India’s drug enforcement architecture since the 2008 criminal penalty amendments. For the first time, a fully statutory, transparent, and accountable mechanism exists for settling minor drug offences without prosecution. The Rules should be welcomed by industry and regulators alike.

For counsel advising pharmaceutical clients, the 2025 Rules create a new strategic option: rather than relying on the legally tenuous DCC guidelines to avoid prosecution, manufacturers of eligible minor violations can formally apply for compounding — gaining statutory immunity upon successful completion. This is a far more secure legal position than dependence on a non-statutory administrative guideline that any court can declare ultra vires at any time.

REFERENCES

[1] Drugs and Cosmetics (Compounding of Offences) Rules, 2025 — SCC Online (April 24, 2025).  https://www.scconline.com/blog/post/2025/04/29/drugs-and-cosmetics-compounding-of-offences-rules-legal-news/

[2] The Drugs and Cosmetics Act, 1940, Sections 32B, 33(2)(r), 27, 27A, 28, 28A.  https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf

[3] Jan Vishwas (Amendment of Provisions) Act, 2023 — PIB, Government of India.  https://www.pib.gov.in

[4] CBDT Revised Guidelines for Compounding of Offences under the Income-Tax Act, 1961 (September 2022) — PIB.  https://www.pib.gov.in/Pressreleaseshare.aspx?PRID=1860175

[5] Guidelines for Compounding of Offences under the Income-Tax Act, 1961 (2024 Revision) — Income Tax Department.  https://www.incometaxindia.gov.in/w/guidelines-for-compounding-of-offences-under-the-income-tax-act-1961-reg.-2

[6] CDSCO Guidance Document on Compounding of Offences (Drugs Rules 1945) — CDSCO.  https://cdsco.mohfw.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Guidance%20Document%20%5BCompounding%5D.pdf

[7] Compounding of Offences under the Drugs and Cosmetics Act, 1940 — Cliniexperts (January 2026).  https://cliniexperts.com/regulatory-update/guidelines-on-compounding-of-offences-under-the-drugs-and-cosmetics-act-1940-as-per-d

[8] The Drugs and Cosmetics (Compounding of Offences) Rules, 2025 — GKToday.  https://www.gktoday.in/drugs-and-cosmetics-compounding-rules-2025/

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The regulation of narcotic drugs and psychotropic substances in India represents one of the most stringent legislative frameworks in the country’s legal history. The Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act) was enacted to consolidate and amend the laws relating to narcotic drugs and psychotropic substances, making stringent provisions for the control and regulation of operations relating to these substances.[1] The Act replaced several pre-existing legislations including the Opium Act of 1857, the Opium Act of 1878, and the Dangerous Drugs Act of 1930, bringing under one umbrella all aspects of narcotic drugs and psychotropic substances regulation in India. The import and export of narcotic drugs and psychotropic substances form a critical component of this regulatory framework. While these substances have legitimate medical and scientific uses, their potential for abuse necessitates strict control mechanisms. India, as a signatory to international conventions including the Single Convention on Narcotic Drugs of 1961 and the Convention on Psychotropic Substances of 1971, has incorporated these international obligations into its domestic law through the NDPS Act.

The classification of drugs under the NDPS Act follows the international conventions, where narcotic drugs are the subject matter of the 1961 Convention, psychotropic substances are scheduled under the 1971 Convention, and controlled substances or precursors used to manufacture narcotic drugs are addressed under the 1988 Convention. This framework ensures that India’s domestic regulations remain aligned with international drug control standards while addressing the specific needs and challenges faced by the country.

Understanding the Classification of Substances under the NDPS Act

The NDPS Act makes a clear distinction between narcotic drugs, psychotropic substances, and controlled substances. Narcotic drugs are further divided into plant-based drugs such as cannabis, coca, and opium, each of which is defined and regulated separately, and their synthetic variants or derivatives, which are called manufactured drugs. This classification is crucial for understanding the import and export regulations applicable to different categories of substances.

There is a common misconception that the NDPS Act distinguishes between narcotic drugs and pharmaceutical drugs as two separate categories. This categorization is not correct. There is no separate class of pharmaceutical drugs under the NDPS Act. Pharmaceutical drugs are preparations, and depending on their active pharmaceutical ingredient, could be a narcotic drug, a psychotropic substance, or a controlled substance.[2] This distinction is important because it clarifies that most narcotic drugs and psychotropic substances have medicinal properties and legitimate therapeutic uses.

The schedules attached to the NDPS Act and the NDPS Rules, 1985, list various substances according to their potential for abuse, therapeutic value, and the degree of control required. Schedule I of the NDPS Rules contains substances whose import and export are completely prohibited due to their high potential for abuse and limited or no therapeutic value. Other schedules contain substances that can be imported or exported subject to strict regulatory controls and licensing requirements.

Prohibitions on Import and Export

The NDPS Act imposes absolute prohibitions on the import and export of certain narcotic drugs and psychotropic substances. Rule 53 and Rule 64 of the NDPS Rules, 1985, categorically prohibit the import into and export out of India of any narcotic drugs or psychotropic substances specified in Schedule I.[3] This prohibition is absolute and applies regardless of the purpose for which such substances might be required.

The substances listed in Schedule I include various derivatives and preparations that have high potential for abuse and are deemed to have no legitimate medical or scientific use in India. The complete prohibition on these substances reflects India’s commitment to preventing their diversion into illicit channels and combating drug trafficking. Even possession of these substances, except as provided under the Act, constitutes a criminal offense punishable with rigorous imprisonment.

Section 8 of the NDPS Act provides the foundational prohibition, stating that no person shall produce, manufacture, possess, sell, purchase, transport, warehouse, use, consume, import inter-State, export inter-State, import into India, export from India, or tranship any narcotic drug or psychotropic substance except for medical or scientific purposes and in the manner and to the extent provided by the provisions of the Act or the rules or orders made thereunder.[4] This provision establishes the general rule that all activities related to narcotic drugs and psychotropic substances are prohibited unless specifically authorized under the Act.

Special Restrictions on Opium and Related Substances

In addition to the general prohibitions under Schedule I, the NDPS Act imposes specific restrictions on the import of opium, concentrate of poppy straw, and certain alkaloids derived from them. The import of opium, concentrate of poppy straw, morphine, codeine, thebaine, and their salts is prohibited except when imported by the Government Opium and Alkaloid Factories.[5] This restriction ensures that these critical substances, which have both legitimate medical uses and high potential for abuse, remain under strict government control.

The Government Opium and Alkaloid Factories, operating under the Ministry of Finance, Department of Revenue, are the sole authorized entities for the import of these substances. This monopoly ensures complete accountability and prevents any possibility of diversion. The factories operate under stringent security protocols and maintain detailed records of all transactions involving these substances.

However, the NDPS Act does provide for limited exceptions to this prohibition. Certain manufacturers who require these substances exclusively for export purposes may be permitted to import them after following due procedure, provided they are specifically notified by the Central Government to do so. Additionally, importers may bring in samples of these substances up to one kilogram per year for testing or analysis purposes, subject to obtaining necessary permissions and following prescribed procedures. These exceptions are narrowly tailored and heavily regulated to ensure that the substances do not enter illicit channels.

Country-Specific Export Restrictions

The NDPS framework also recognizes that different countries have varying regulations regarding psychotropic substances. Schedule II of the NDPS Rules, 1985, lists specific psychotropic substances and identifies countries to which the export of each substance is not permitted. These country-specific restrictions are based on international agreements, bilateral understandings, and the regulatory frameworks of destination countries.

These restrictions serve multiple purposes. They ensure compliance with international drug control conventions, respect the sovereignty and regulatory choices of other nations, and prevent situations where substances exported from India might be diverted into illicit channels in countries with weaker regulatory frameworks. The list is periodically updated based on communications from foreign governments, changes in international conventions, and evolving understanding of drug control challenges globally.

Exporters must carefully verify Schedule II before initiating any export transaction involving psychotropic substances. Violation of these country-specific restrictions can result in severe penalties, including cancellation of licenses, prosecution under the NDPS Act, and international legal complications. The Narcotics Commissioner’s office maintains updated information on these restrictions and provides guidance to licensed entities regarding compliance.

Import Certification Requirements

For substances that are not absolutely prohibited, the NDPS Act establishes a system of import certification to ensure that all legitimate imports are properly authorized and monitored. Any person seeking to import narcotic drugs or psychotropic substances must apply for and obtain an import certificate from the Narcotics Commissioner for each consignment.[6] This requirement applies regardless of the quantity being imported or the purpose for which the substances are required.

The application for an import certificate must contain detailed information including the name and address of the importer, the name and quantity of the substance to be imported, the country of origin, the intended use of the substance, and particulars of any manufacturing or trading licenses held by the applicant. The Narcotics Commissioner examines each application to verify that the importer is duly licensed, that the intended use is legitimate, and that adequate safeguards exist to prevent diversion.

The import certificate serves multiple functions in the regulatory framework. It provides advance notice to enforcement authorities about incoming shipments, enables coordination with customs authorities for clearance, creates an audit trail for monitoring legitimate trade, and facilitates compliance with international reporting obligations under drug control conventions. The certificate is consignment-specific, meaning that a separate certificate must be obtained for each import transaction, even if multiple transactions involve the same substance from the same source.

The Narcotics Commissioner may refuse to issue an import certificate if the application is incomplete, if the applicant lacks necessary licenses, if there are concerns about the legitimacy of the transaction, or if the import would violate any provisions of the Act or Rules. Such refusals are subject to appeal through prescribed channels, ensuring that legitimate importers have recourse if their applications are unjustifiably denied.

Export Authorization Requirements

The export of narcotic drugs and psychotropic substances is similarly controlled through a system of export authorizations. Any person seeking to export these substances must apply for and obtain an export authorization from the Narcotics Commissioner for each consignment.[7] The export authorization system mirrors the import certification process but includes additional requirements to ensure compliance with the regulations of the destination country.

The application for export authorization must include information about the exporter, the substance to be exported, the country of destination, the intended use in the destination country, and evidence that the import is authorized by the competent authorities in the destination country. This last requirement is crucial, as it prevents situations where substances might be exported to countries where their import is not permitted or where adequate controls do not exist.

The Narcotics Commissioner coordinates with international counterparts and relies on import certificates issued by authorities in destination countries to verify that exports are legitimate. This system of mutual verification ensures that international trade in narcotic drugs and psychotropic substances occurs only between properly authorized entities and for legitimate purposes. The export authorization includes conditions regarding packaging, labeling, transportation routes, and reporting requirements that exporters must comply with.

Exporters must also comply with customs regulations and obtain necessary export licenses from the Directorate General of Foreign Trade in addition to the export authorization from the Narcotics Commissioner. This dual system of authorization ensures multiple layers of verification and reduces the risk of illicit export. Any export transaction completed without proper authorization constitutes a serious offense under the NDPS Act and can result in prosecution, asset forfeiture, and permanent debarment from engaging in any activities related to narcotic drugs or psychotropic substances.

Manufacturing Regulations and Their Impact on Import-Export

The manufacturing regulations under the NDPS Act directly impact the import and export framework. Section 8 of the Act establishes a three-tier system for the manufacture of narcotic drugs. First, certain drugs such as crude cocaine, ecgonine, and diacetylmorphine (commonly known as heroin) and their salts are completely prohibited from manufacture. No person or entity, public or private, is permitted to manufacture these substances under any circumstances.

Second, certain drugs including morphine, codeine, dionine, thebaine, dihydrocodeinone, dihydrocodeine, acetyldihydrocodeine, dihydromorphine, dihydromorphinone, and pholcodine and their respective salts can be manufactured only by the Government Opium and Alkaloid Factories or by licensed manufacturers when the Central Government determines it to be in public interest to issue such a license. This restricted manufacturing regime ensures that critical substances with high therapeutic value but also high abuse potential remain under strict control.

Third, all other narcotic drugs can be manufactured after obtaining a license from the Narcotics Commissioner. The licensing process is rigorous and requires applicants to demonstrate that they possess necessary technical expertise, adequate security arrangements, proper storage facilities, and systems for maintaining detailed records. Manufacturers must also obtain a manufacturing license under the Drugs and Cosmetics Act, 1940, from the State Drugs Controller, and additional licenses from the State Government under the State NDPS Rules for possession, use, and sale of narcotic drugs.

These manufacturing regulations impact import-export in several ways. Manufacturers who are licensed to produce certain substances may need to import raw materials or precursors. Such imports are permitted subject to obtaining necessary import certificates and demonstrating that the imported substances will be used exclusively for manufacturing purposes. Similarly, manufacturers may export their finished products subject to obtaining export authorizations and complying with all applicable regulations. The licensing system ensures that only legitimate manufacturers with proven track records and adequate controls can engage in international trade.

The Concept of Controlled Delivery

The NDPS Act incorporates the modern law enforcement technique of controlled delivery to combat drug trafficking. Section 50A of the Act defines controlled delivery as the technique of allowing illicit or suspect consignments of narcotic drugs, psychotropic substances, controlled substances, or substances substituted for them to pass out of, through, or into the territory of India with the knowledge and under the supervision of an officer empowered in this behalf, with a view to identifying the persons involved in the commission of an offense under the Act.[8]

Controlled delivery represents a significant tool in the arsenal of drug law enforcement agencies. Instead of immediately seizing suspect consignments, authorities allow them to proceed under surveillance to identify the entire network involved in trafficking. This technique has proven effective in dismantling organized drug trafficking operations and identifying key players who might otherwise remain hidden.

The provisions relating to controlled delivery in the NDPS Act are complemented by similar provisions in the Customs Act, 1962. Section 109A of the Customs Act empowers the proper officer or any other officer authorized by him to undertake controlled delivery of any consignment to any destination in India or to a foreign country, in consultation with the competent authority of such country to which such consignment is destined. This coordination between the NDPS Act and the Customs Act ensures seamless operation of controlled delivery techniques across jurisdictional boundaries.

Controlled delivery operations require careful planning, coordination between multiple agencies, and strict adherence to legal procedures. Officers involved in such operations must ensure that their actions remain within the bounds of law and that evidence collected during controlled delivery operations is admissible in court. The technique has been upheld by courts as a legitimate law enforcement tool, provided it is employed in accordance with law and with appropriate safeguards to prevent abuse.

Role of the Narcotics Control Bureau

The Narcotics Control Bureau (NCB), established in 1986 pursuant to Section 4 of the NDPS Act, serves as the nodal agency for coordinating drug law enforcement nationally. The Central Government created the NCB with the specific task of coordinating drug law enforcement activities across various agencies and serving as the national liaison point for international cooperation in drug control matters.

The NCB’s functions include coordinating with state governments and other central agencies on matters related to drug law enforcement, implementing India’s obligations under international drug control conventions, collecting and disseminating intelligence related to drug trafficking, coordinating enforcement actions by various agencies to ensure effective implementation of the national drug control strategy, and maintaining liaison with international drug control organizations and foreign drug law enforcement agencies.

In the context of import and export regulations, the NCB plays a crucial role in monitoring international trafficking patterns, sharing intelligence with customs authorities regarding suspect shipments, coordinating controlled delivery operations involving international consignments, and investigating cases involving illegal import or export of narcotic drugs and psychotropic substances. The Bureau maintains sophisticated intelligence databases and employs modern investigative techniques to detect and prevent illicit international trade.

The creation of the NCB represented a recognition that drug trafficking is a transnational phenomenon requiring coordinated responses. No single agency can effectively combat drug trafficking operating in isolation. The NCB ensures that various agencies including customs, border security forces, coast guard, and state police forces work together cohesively, sharing intelligence and coordinating enforcement actions. This institutional innovation has significantly enhanced India’s capacity to prevent illegal import and export of narcotic drugs and psychotropic substances.

Enforcement Powers and Procedural Safeguards

The NDPS Act vests significant powers in designated officers to ensure effective enforcement. Officers empowered under the Act have authority to search premises, seize contraband substances and related materials, arrest persons reasonably suspected of committing offenses under the Act, and take such other actions as may be necessary for effective enforcement. These powers are essential for prompt and effective response to intelligence about violations.

However, the Act also incorporates important procedural safeguards to prevent misuse of these powers. Officers conducting searches must follow prescribed procedures including providing advance notice where required, conducting searches in the presence of witnesses, preparing detailed inventories of seized materials, and forwarding samples to designated laboratories for analysis. The Supreme Court has repeatedly emphasized that strict compliance with these procedural safeguards is mandatory and non-compliance can result in acquittal of accused persons.

In several landmark judgments, courts have held that the procedural requirements under the NDPS Act are not mere technicalities but essential safeguards protecting individual rights. The Supreme Court has held that conviction cannot be based solely on confessional statements in the absence of substantive evidence, that proper procedures must be followed in drawing samples and maintaining chain of custody, and that any serious irregularities in procedure can vitiate the entire case against an accused person.

The power to issue search and arrest warrants has been vested in both Magistrates and specially appointed Central and State Government officers. This dual system ensures prompt action in response to intelligence while maintaining judicial oversight. Officers must exercise these powers judiciously and in accordance with law. Any abuse of power can result in departmental action against the officer and may also provide grounds for discharge or acquittal of accused persons.

International Cooperation Framework

Effective control of import and export of narcotic drugs and psychotropic substances requires robust international cooperation. India is party to the three major international drug control conventions: the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol, the Convention on Psychotropic Substances of 1971, and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.

These conventions establish the international legal framework for drug control, requiring signatory states to limit the production, manufacture, export, import, distribution, trade, use, and possession of narcotic drugs and psychotropic substances exclusively to medical and scientific purposes. The conventions also establish systems for estimating medical and scientific requirements, reporting on production and consumption, and preventing diversion into illicit channels.

India’s import and export regulations under the NDPS Act are designed to implement these international obligations. The requirement for import certificates and export authorizations ensures that international trade occurs only between properly authorized entities. The Narcotics Commissioner exchanges information with counterpart agencies in other countries, facilitating verification of the legitimacy of international transactions. India also participates in various international forums and working groups focused on drug control, contributing to global efforts to combat drug trafficking.

The international cooperation framework extends to law enforcement matters as well. India has signed bilateral and multilateral agreements for mutual legal assistance in matters relating to drug trafficking. These agreements facilitate extradition of fugitives, sharing of evidence, joint investigations, and coordinated enforcement actions. The NCB serves as the central authority for international cooperation, ensuring that requests from foreign authorities are processed efficiently and that India’s requests for assistance receive appropriate attention.

Penalties for Violations

The NDPS Act prescribes severe penalties for violations, reflecting the serious view that Parliament takes of offenses related to narcotic drugs and psychotropic substances. Section 23 of the Act specifically addresses illegal import into India, export from India, or transhipment of narcotic drugs and psychotropic substances. The penalties vary based on the quantity involved, with small quantities attracting lesser punishment and commercial quantities attracting the most severe penalties.

For offenses involving commercial quantities, the Act prescribes rigorous imprisonment for a term which may extend to twenty years and shall not be less than ten years, along with a fine which may extend to two lakh rupees but shall not be less than one lakh rupees. For offenses involving quantities less than commercial quantity but greater than small quantity, the imprisonment may extend to ten years but shall not be less than ten years, with a fine which may extend to one lakh rupees. For small quantities, the punishment is rigorous imprisonment for up to one year or fine which may extend to ten thousand rupees or both.

The determination of what constitutes small quantity, commercial quantity, and quantities falling between these two categories is prescribed by the Central Government through notifications. Different substances have different threshold quantities based on their potency, prevalence of abuse, and other relevant factors. Courts have consistently held that the quantity-based punishment scheme under the NDPS Act is constitutional and represents a rational classification.

Beyond the criminal penalties prescribed by the Act, violations can result in forfeiture of properties used in or derived from drug trafficking, cancellation of licenses and authorizations, permanent debarment from engaging in activities related to narcotic drugs or psychotropic substances, and blacklisting preventing the offender from obtaining any government benefits or contracts. The Act also provides for presumptions against accused persons in certain circumstances, shifting the burden to prove innocence once possession of contraband substances is established.

Judicial Interpretation and Evolution

The implementation of the NDPS Act has generated substantial jurisprudence, with courts at various levels interpreting and applying its provisions in diverse factual situations. The Supreme Court and High Courts have addressed numerous questions relating to the scope of prohibitions, procedural requirements, evidentiary standards, and the balance between effective enforcement and protection of individual rights.

A significant body of case law has developed regarding the procedural safeguards required under the Act. Courts have consistently held that the procedures prescribed for search, seizure, sampling, and analysis are mandatory and must be strictly followed. Any departure from prescribed procedures can vitiate the prosecution’s case. This emphasis on procedural compliance ensures that enforcement actions remain within constitutional bounds and that evidence collected is reliable and admissible.

Courts have also grappled with questions regarding the interpretation of specific provisions, such as the meaning of possession, the circumstances under which conscious possession can be inferred, the evidentiary value of confessional statements, and the applicability of the presumption under Section 54 of the Act. The evolving jurisprudence reflects the courts’ efforts to ensure that the stringent provisions of the Act are applied fairly and that innocent persons are not convicted while guilty offenders receive appropriate punishment.

The judiciary has also addressed constitutional challenges to various provisions of the NDPS Act. While upholding the constitutional validity of the Act’s stringent provisions, courts have read down certain provisions or interpreted them in ways that balance the state’s interest in effective drug control with the constitutional rights of individuals. This judicial interpretation has helped refine the implementation of the Act and address unintended consequences that may arise from literal application of its provisions.

Challenges in Implementation

Despite the stringent legal framework, implementation of import and export controls faces several challenges. The sheer volume of international trade makes it difficult to scrutinize every transaction thoroughly. Traffickers constantly evolve their methods, using increasingly sophisticated techniques to conceal contraband substances. The emergence of new psychoactive substances that may not be explicitly scheduled under the Act creates regulatory gaps that traffickers exploit.

Coordination challenges between various enforcement agencies can sometimes hamper effective implementation. While the NCB serves as the coordinating agency, practical difficulties in information sharing, jurisdictional issues, and resource constraints can affect the seamless operation of the regulatory system. The customs authorities, who form the first line of defense against illegal import and export, require specialized training and equipment to detect sophisticated concealment methods.

International cooperation, while generally effective, faces challenges due to varying legal systems, differences in evidentiary standards, language barriers, and sometimes conflicting national interests. The process of obtaining mutual legal assistance can be time-consuming, allowing suspects to abscond or evidence to be destroyed. Some countries have weaker regulatory frameworks, making it difficult to verify the legitimacy of transactions involving those jurisdictions.

Resource constraints affect various aspects of implementation. The number of officers with specialized training in drug law enforcement is limited relative to the scale of the challenge. Forensic laboratories face backlogs in analysis of seized samples, causing delays in prosecution. The legal system itself is burdened, with many NDPS cases pending in courts for years. These resource constraints, while being gradually addressed, continue to impact the effectiveness of the regulatory system.

Conclusion

The import and export regulations under the NDPS Act represent a carefully calibrated balance between facilitating legitimate trade in narcotic drugs and psychotropic substances for medical and scientific purposes while preventing their diversion into illicit channels. The framework incorporates multiple layers of control, from absolute prohibitions on certain substances to licensing and certification requirements for permitted substances, from country-specific export restrictions to procedural safeguards in enforcement actions.

The evolution of this regulatory framework over the past several decades demonstrates India’s commitment to international drug control obligations while addressing domestic challenges. The creation of specialized agencies like the NCB, the incorporation of modern enforcement techniques like controlled delivery, and the development of robust international cooperation mechanisms have strengthened India’s capacity to regulate import and export effectively.

However, challenges remain, and the framework must continue to evolve in response to emerging threats. The rapid development of new psychoactive substances, the increasing use of technology by traffickers, and the changing patterns of drug abuse require continuous adaptation of legal and regulatory responses. Ongoing dialogue between policymakers, enforcement agencies, the medical and scientific community, and civil society will be essential to ensure that the framework remains effective while respecting fundamental rights and supporting legitimate medical and scientific research.

References

[1] Narcotics Control Bureau. (n.d.). Enforcement. Central Bureau of Narcotics. Retrieved from http://cbn.nic.in/en/prevention/ 

[2] National Institute of Mental Health and Neuro Sciences. (2022). Medical Use, Decriminalization, and Legalization of Narcotic Drugs and Psychotropic Substances. PMC. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC10011858/ 

[3] Department of Revenue. (n.d.). Import and Export of Narcotic Drugs and Psychotropic Substances. Government of India. Retrieved from https://dor.gov.in/import-and-export-narcotic-drugs-and-psychotropic-substances 

[4] Delhi High Court. (n.d.). Directorate of Revenue Intelligence vs. Raj Kumar Arora. Narcotics India. Retrieved from https://narcoticsindia.nic.in/Judgments/Directorate%20of%20Revenue%20Intelligence%20Vs.RAJ%20KUMAR%20ARORA.pdf 

[5] Central Bureau of Narcotics. (n.d.). Overview: Export/Import. Retrieved from http://cbn.nic.in/en/exim/overview/ 

[6] Government of India. (1985). The Narcotic Drugs and Psychotropic Substances Act, 1985. India Code. Retrieved from https://www.indiacode.nic.in/bitstream/123456789/18974/1/narcotic-drugs-and-psychotropic-substances-act-1985.pdf 

[7] Narcotics India. (1985). The Narcotic Drugs and Psychotropic Substances Act, 1985. Retrieved from https://narcoticsindia.nic.in/legislation/ndpsact.pdf 

[8] Indian Kanoon. (1985). The Narcotic Drugs And Psychotropic Substances Act, 1985. Retrieved from https://indiankanoon.org/doc/1727139/ 

Author and Editor: Vishal Davda

The post Import and Export of Narcotic Drugs and Psychotropic Substances under the NDPS Act: A Legal Analysis appeared first on Bhatt & Joshi Associates.