The Supreme Court’s landmark ruling in Union of India v. Ashok Kumar Sharma, (2021) 12 SCC 674 settled a long-contested question: police officers cannot register FIRs or independently investigate Chapter IV offences under the Drugs and Cosmetics Act, 1940. Cognizance of these offences can be taken by a court only upon a complaint by a Drug Inspector, an aggrieved person, a recognised consumer association, or an authorised Gazetted Officer — not on a police report. This article analyses the Ashok Kumar Sharma ruling, traces the legal basis for this exclusion in Section 32, examines the consequences for ongoing prosecutions initiated on police FIRs, contrasts the D&C Act regime with the NDPS Act (where police do have FIR powers), and provides practical guidance for challenge and quashing.

INTRODUCTION

Police officers in India routinely respond to reports of spurious or substandard drugs by registering FIRs under the Drugs and Cosmetics Act. On the surface, this appears logical: drug offences involve criminal liability, and the police are the general criminal law enforcement agency. The reality, however, is that the D&C Act creates a self-contained prosecutorial architecture that deliberately excludes the police from complaint-filing authority.

This exclusion has profound practical consequences. Every prosecution initiated on a police FIR under Chapter IV of the Drugs and Cosmetics Act — rather than on a Drug Inspector’s complaint — is legally defective and liable to be quashed. Courts across India have done precisely this, relying on the Supreme Court’s ruling in Ashok Kumar Sharma.

Yet the error persists. Police continue to file FIRs; Drug Inspectors sometimes refer cases to the police rather than filing complaints themselves; and accused persons are arrested, investigated, and prosecuted through a procedure that the Supreme Court has invalidated. This article aims to eliminate this confusion.

SECTION 32: THE EXCLUSIVE COGNIZANCE PROVISION

Section 32 of the Drugs and Cosmetics Act is the exclusive gateway for judicial cognizance of Chapter IV offences. It provides that no court shall take cognizance of any offence under Chapter IV or Chapter IVA except:
(i) On a complaint made by a person authorised by the Central Government or State Government by general or special order; OR
(ii) On a complaint made by the person aggrieved; OR
(iii) On a complaint made by a recognised consumer association; OR
(iv) In case of cognizable offences, on a complaint made by a Drug Inspector.

A police report is conspicuously absent from this list. The Act’s drafters made a deliberate choice: prosecution of drug quality offences requires specialist investigation, technical understanding of pharmaceutical standards, and custody of legally collected samples — capabilities invested in the Drug Inspector, not in the general police force.

A court that takes cognizance of a Chapter IV offence on a police FIR rather than one of the Section 32-prescribed complaints is acting without jurisdiction. The defect is fundamental, not curable by amendment of the charge sheet or subsequent involvement of the Drug Inspector.

UNION OF INDIA v. ASHOK KUMAR SHARMA: THE DEFINITIVE RULING

The facts of Ashok Kumar Sharma arose from the seizure of a stock of unlicensed drugs from M/s. Sharda Narayan Clinic and Pharmacy in Uttar Pradesh. A Drug Inspector filed an FIR with the local police station for violation of Section 18(a)(i) read with Section 27 of the Act. The accused filed a writ petition in the Allahabad High Court for quashing of the FIR and protection from arrest.

The High Court, referring to Sections 22, 23, 25, 27, and 32 of the Act, observed that the Act lays down a complete code for trial of offences. Section 32 authorises only the Drug Inspector (and specified others) for launching prosecution. The Inspector should not have lodged an FIR and authorised the police to investigate. The FIR was quashed.

The Supreme Court affirmed. In its ruling reported as Union of India v. Ashok Kumar Sharma, (2021) 12 SCC 674, the Court held that prosecution for cognizable offences under the Act initiated solely by a police officer based on the FIR they filed was not legally sustainable. The Act is a complete code; police investigation and FIR filing are not part of that code for Chapter IV offences.

CONSEQUENCES FOR ONGOING POLICE-INITIATED PROSECUTIONS

The practical consequence of Ashok Kumar Sharma is significant for any prosecution that was initiated on a police FIR rather than a Drug Inspector complaint:

First, the accused can file a writ petition under Article 226 of the Constitution before the High Court for quashing of the FIR and all consequential proceedings. The ground: the FIR was lodged contrary to the scheme of Section 32 of the Act.

Second, the accused can seek anticipatory bail, relying on Ashok Kumar Sharma to argue that the investigation itself is without legal authority — weakening the prosecution’s case for custodial interrogation.

Third, even if a charge sheet has been filed and the Magistrate has taken cognizance, the proceedings can be challenged by way of revision or writ, as cognizance taken on an invalid FIR/charge sheet is itself jurisdictionally infirm.

Fourth, any evidence collected by police during the investigation of a Chapter IV offence — which investigation they had no authority to conduct — is of questionable admissibility.

CONTRAST WITH THE NDPS ACT

The Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act) provides an instructive contrast. Under the NDPS Act, police officers are specifically designated as ‘officers’ authorised to make arrests, conduct searches, and file FIRs. Section 42 of the NDPS Act empowers any Gazetted Officer or Sub-Inspector of police to enter, search, seize, and arrest without warrant.

The reason for this difference is conceptual: the NDPS Act targets trafficking and possession — criminal activities detected through intelligence, surveillance, and physical interdiction, tasks suited to the police. The D&C Act targets quality failures in manufactured products — detected through laboratory testing of collected samples, tasks requiring specialist technical authority.

Confusing these two regimes is a common source of error. Police who seize drugs at a medical store and register an FIR under the D&C Act are applying an NDPS-style response to a D&C Act situation — procedurally incorrect and legally vulnerable.

CONCLUSION

Section 32 of the Drugs and Cosmetics Act creates a complaint-based prosecution architecture that excludes the police from FIR filing for Chapter IV of the Drugs and Cosmetics Act, 1940 offences. The Supreme Court’s ruling in Ashok Kumar Sharma makes this exclusion unambiguous and judicially enforceable. Every FIR filed by a police officer for a Chapter IV of Drugs and Cosmetics Act offence — however well-intentioned — is legally defective.

For defence counsel, this ruling provides a powerful tool: any existing prosecution based on a police FIR is vulnerable to quashing at every stage — before charge sheet, after charge sheet, and even after cognizance — as the foundational instrument of prosecution is void. Counsel should routinely check the origin of any D&C Act prosecution to identify this ground.

FAQs: 

1. Can police register an FIR for offences under Chapter IV of the Drugs and Cosmetics Act, 1940?
No. As clarified by the Supreme Court in Union of India v. Ashok Kumar Sharma, police officers cannot register FIRs or independently investigate Chapter IV offences under the Act.

2. Who is authorised to initiate prosecution under the Drugs and Cosmetics Act?
Under Section 32 of the Act, prosecution can only be initiated through a complaint filed by:

• A Drug Inspector
• An authorised government officer
• The aggrieved person
• A recognised consumer association

3. Can a court take cognizance based on a police charge sheet?
No. A court cannot take cognizance of Chapter IV offences on the basis of a police report or charge sheet. Cognizance is valid only when based on a complaint as prescribed under Section 32.

4. What happens if an FIR has already been registered by the police?
Such an FIR is legally defective and can be challenged. The accused may file a writ petition before the High Court seeking quashing of the FIR and all consequential proceedings.

5. Is the defect of a police-initiated FIR curable later?
No. This is a jurisdictional defect. It cannot be cured by later filing of a complaint or by involving a Drug Inspector after the FIR has been registered.

6. Can police assist in drug-related investigations at all?
Police may assist in maintaining law and order or in executing search/seizure operations when required, but they cannot independently initiate prosecution under Chapter IV of the Act.

7. How is the Drugs and Cosmetics Act different from the NDPS Act in this context?
Under the Narcotic Drugs and Psychotropic Substances Act, 1985, police officers are expressly empowered to register FIRs, investigate offences, and make arrests. This is not the case under the Drugs and Cosmetics Act.

8. Can an accused seek anticipatory bail in such cases?
Yes. The accused can rely on the Ashok Kumar Sharma ruling to argue that the investigation itself is without authority, strengthening their case for anticipatory bail.

9. What is the remedy after cognizance has already been taken by a Magistrate?
Even after cognizance, the accused can challenge the proceedings through revision or a writ petition, as the initial FIR itself is void.

10. Why does the law exclude police from initiating such prosecutions?
Because offences under the Act involve technical evaluation of drug quality, which requires specialised expertise and statutory procedures assigned to Drug Inspectors.

REFERENCES

[1] Union of India v. Ashok Kumar Sharma, (2021) 12 SCC 674 — Supreme Court of India.  http://aidcoc.in/pdf/15-Supreme%20Court%20on%20Powers%20of%20Police%20and%20Drugs%20Inspectors%20to%20Arrest.pdf

[2] Section 32 of the Drugs and Cosmetics Act, 1940 — Drishti Judiciary.  https://www.drishtijudiciary.com/current-affairs/section-32-of-the-drugs-and-cosmetics-act-1940

[3] Proceedings under D&C Act can be initiated only on the basis of Drug Inspector’s complaint — Courtrooms.in (March 2024).  https://courtrooms.in/proceedings-under-drugs-and-cosmetics-act-1940-can-be-initiated-only-on-the-basis-of-drug-inspector-and-no

[4] Only Drug Inspectors can probe, file FIRs for certain cognizable offences under D&C Act — Express Pharma (August 2020).  https://www.expresspharma.in/only-drug-inspectors-can-probe-file-firs-for-certain-cognizable-offences-under-dc-act-1940-sc/

[5] The Drugs and Cosmetics Act, 1940 — India Code.  https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.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] Karnataka High Court: Sessions Court Has Exclusive Jurisdiction for Chapter IV Offences (January 2026) — LiveLaw.  https://www.livelaw.in/high-court/karnataka-high-court/karnataka-high-court-ruling-session-court-exclusive-jurisdiction-offences

The post The Drug Inspector as the Sole Prosecution Authority: Why Police Cannot File FIRs Under Chapter IV of the Drugs and Cosmetics Act, 1940 appeared first on Bhatt & Joshi Associates.

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/

The post Compounding of Offences Under the Drugs and Cosmetics Act: The 2025 Rules and Their Interface with Prosecution appeared first on Bhatt & Joshi Associates.

The DCC and CDSCO prosecution guidelines are not legally binding as a matter of positive law — they cannot override the strict liability provisions of the Drugs and Cosmetics Act, 1940 and have no statutory force equivalent to rules framed under Section 33 or directions issued under Section 33P. However, this does not mean they are entirely without legal consequence. Where CDSCO has consistently applied the screening committee process and written permission requirement before initiating prosecutions — and then selectively bypasses that process against a particular manufacturer — the doctrine of legitimate expectation and Article 14 of the Constitution provide grounds for challenge. This article examines the doctrine of legitimate expectation in Indian administrative law, its application to CDSCO’s enforcement practices, and the strategic litigation pathways available to manufacturers who face selective enforcement.

INTRODUCTION

In the earlier research establishing the non-binding character of DCC prosecution guidelines, a paradox emerged: if the guidelines have no force of law, why should any manufacturer care whether CDSCO followed them or not?

The answer lies in a set of constitutional doctrines — legitimate expectation and Article 14 non-arbitrariness — that operate not by validating the guidelines as law, but by requiring the government to treat similarly situated persons consistently. An administrative guideline that is invalid as a source of substantive law may still create a constitutional expectation of consistent application. A government body that departs from its own established practice without reason or notice acts arbitrarily — and arbitrary state action violates Article 14 of the Constitution of India.

This article develops this argument as a litigation strategy for pharmaceutical manufacturers who face prosecution that bypassed CDSCO’s own established process.

THE DOCTRINE OF LEGITIMATE EXPECTATION IN INDIAN LAW

Legitimate expectation is a doctrine of English origin, received into Indian administrative law through the Supreme Court’s jurisprudence beginning in the 1980s. In its simplest formulation: where a public authority has by its conduct, representations, or established practice created a reasonable expectation in a person that a particular procedure will be followed or a particular benefit will be granted, that authority is required — as a matter of procedural fairness — to either fulfil the expectation or give adequate reasons for departing from it.

The doctrine was recognised and applied by the Supreme Court in Council of Civil Service Unions v. Minister for the Civil Service [1985] AC 374 (UK, persuasive), and adopted in India in Attorney General of Hong Kong v. Ng Yuen Shiu [1983] 2 AC 629 (Privy Council, applied in Indian courts). The Supreme Court in Union of India v. Hindustan Development Corporation (1993) 3 SCC 499 fully embraced the doctrine, holding that legitimate expectation arising from established practice or representation could be enforced by courts.

In Managing Director, APSRTC v. P. Srinivasa Rao, the Supreme Court held that government is bound by its own circulars once operative — authorities cannot simply ignore them without challenge or withdrawal. The principle that the government is bound by its own circulars is ‘well settled’ in Indian law.

THE ARTICLE 14 NON-ARBITRARINESS DIMENSION

Article 14 of the Constitution of India guarantees equality before law and equal protection of the laws. The Supreme Court, in E.P. Royappa v. State of Tamil Nadu (1974) 4 SCC 3, dramatically expanded the Article 14 guarantee beyond formal equality to encompass non-arbitrariness: ‘Equality is antithetical to arbitrariness. In fact equality and arbitrariness are sworn enemies; one belongs to the rule of law in a republic while the other, to the whim and caprice of an absolute monarch.’

This means that even where CDSCO has the legal power to prosecute (which it undeniably does under Section 32 of the Act), it must exercise that power consistently and non-arbitrarily. If CDSCO follows the screening committee procedure for 99 manufacturers in the same factual situation and then bypasses it for the 100th — without explanation — the 100th manufacturer has an Article 14 challenge: not against the prosecution per se, but against the selective departure from established enforcement practice.

THE CRITICAL DISTINCTION: USING INVALID GUIDELINES TO ENFORCE EQUAL TREATMENT

The legitimate expectation/Article 14 argument is structurally different from the ultra vires argument:

The ultra vires argument: ‘The DCC guidelines are invalid; therefore, even where CDSCO follows them, they cannot lawfully constrain prosecution.’

The legitimate expectation argument: ‘The DCC guidelines are CDSCO’s own established practice; regardless of their legal validity, CDSCO must apply them consistently or justify its departure.’

These two arguments point in opposite directions: the manufacturer charged in a Category B case wants CDSCO to follow the guidelines (screening committee, written sanction) — using the established practice as a procedural shield. The public interest litigant who wants more prosecution wants courts to declare the guidelines ultra vires — so Drug Inspectors can prosecute without them.

Both arguments are simultaneously available and are not contradictory — they operate in different legal registers. The manufacturer argues: ‘Even if these guidelines are not law, you have made them your practice, and you must follow your own practice.’ The public interest litigant argues: ‘These guidelines are ultra vires and should not be followed at all.’

LIMITS OF LEGITIMATE EXPECTATION

The doctrine of legitimate expectation is subject to well-settled limitations that counsel must acknowledge:

First, legitimate expectation cannot enforce an ultra vires practice. Where the established practice is itself illegal — for example, CDSCO’s practice of applying a 70% assay threshold that departs from pharmacopoeial standards — courts will not enforce consistency in an illegal practice. The expectation of equal treatment in illegality is not protected.

Second, legitimate expectation does not override statutory duty. If CDSCO has a statutory obligation to prosecute — which it does, given the mandatory character of Sections 18 and 27 — a manufacturer cannot use legitimate expectation to permanently bar prosecution. At best, the doctrine provides a procedural remedy: require CDSCO to follow its established process before filing the complaint.

Third, the legitimate expectation must be reasonable and established by clear and consistent past practice. Ad hoc or occasional observance of the screening committee process does not create a legitimate expectation.

STRATEGIC IMPLICATIONS FOR LITIGATION

For pharmaceutical manufacturers facing prosecution, the following strategic positions follow from this analysis:

Where the screening committee process was bypassed: File a writ petition challenging the complaint as filed in violation of CDSCO’s own established enforcement procedure, relying on Article 14 and legitimate expectation. Seek stay of prosecution pending correction of procedural irregularity.

Where the screening committee process was followed for similarly situated competitors but not for the petitioner: File a writ petition alleging selective enforcement and discrimination under Article 14. The evidentiary burden is on CDSCO to justify the differential treatment.

Where CDSCO has published and consistently applied internal prosecution thresholds: Rely on those thresholds as creating legitimate expectations of consistent application — even if the thresholds are not statutory.

One important caveat: these arguments provide procedural remedies, not permanent shields. A successful writ petition may delay prosecution, require CDSCO to restart the process with the screening committee, or result in the prosecution being filed through proper channels. It does not result in permanent immunity from prosecution.

VII. CONCLUSION

The non-binding character of DCC and CDSCO prosecution guidelines does not make them legally irrelevant. Through the doctrine of legitimate expectation and Article 14 non-arbitrariness, manufacturers can use CDSCO’s own established practices as procedural weapons against selective or arbitrary enforcement. The key requirement is demonstrating a consistent, established practice that was departed from without justification in the petitioner’s case.

This doctrine sits at the intersection of administrative law and constitutional law — it is available only where the government has, through consistent practice, created a reasonable expectation that specific procedures will be followed. Where that expectation exists, courts will enforce it — not by validating the guidelines as law, but by requiring the government to treat its own practices as binding on its own conduct.

FAQ

1. Are CDSCO prosecution guidelines legally binding?
No. CDSCO prosecution guidelines do not have statutory force under the Drugs and Cosmetics Act, 1940 and cannot override its strict liability provisions. They are administrative in nature and not equivalent to rules framed under Section 33 or directions under Section 33P.

2. If the guidelines are not binding, can they still be used in court?
Yes. Even though they are not legally binding, they can be invoked through constitutional principles like legitimate expectation and Article 14 of the Constitution of India to challenge arbitrary or inconsistent enforcement.

3. What is the doctrine of legitimate expectation in this context?
It means that if the Central Drugs Standard Control Organization (CDSCO) has consistently followed a particular procedure—such as screening committee approval—manufacturers can expect that the same procedure will be followed in their case. A sudden deviation without justification can be challenged.

4. How does Article 14 apply to CDSCO prosecutions?
Article 14 ensures equality and prohibits arbitrary state action. If CDSCO follows a procedure for most manufacturers but selectively bypasses it for one, that manufacturer can challenge the action as arbitrary and discriminatory.

5. Can a manufacturer stop prosecution entirely using these arguments?
No. These arguments provide procedural relief, not complete immunity. Courts may require CDSCO to follow proper procedure or reconsider the case, but they do not permanently bar prosecution.

6. What is the difference between ultra vires and legitimate expectation arguments?

• Ultra vires argument: The guidelines are invalid and should not be followed at all.
• Legitimate expectation argument: Even if not legally binding, CDSCO must follow them consistently if they form an established practice.

7. Can legitimate expectation be claimed in all cases?
No. It applies only where there is clear, consistent, and established practice. Occasional or inconsistent use of a procedure does not create a legitimate expectation.

8. What are the limitations of using legitimate expectation?

• It cannot enforce an illegal practice
• It cannot override statutory duties
• It requires consistent past conduct by the authority

9. When can a manufacturer file a writ petition against CDSCO?
A writ petition can be filed when:

• Established procedures (like screening committee review) are bypassed
• There is selective enforcement compared to similarly situated entities
• CDSCO departs from its own consistent practice without justification

10. What is the practical benefit of this legal strategy?
It allows manufacturers to:

• Challenge arbitrary prosecution
• Delay or pause proceedings
• Force CDSCO to follow fair and consistent procedures

REFERENCES

[1] E.P. Royappa v. State of Tamil Nadu, (1974) 4 SCC 3 — Supreme Court of India (Article 14 non-arbitrariness).  https://indiankanoon.org/doc/1733604/

[2] Union of India v. Hindustan Development Corporation, (1993) 3 SCC 499 — Supreme Court of India (legitimate expectation).  https://indiankanoon.org/doc/597229/

[3] Managing Director, APSRTC v. P. Srinivasa Rao — Supreme Court of India (government bound by its own circulars).  https://supremetoday.ai/issue/The-Principle-that-the-Government-is-Bound-by-its-own-Circulars-is-Well-Settled

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

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

[6] The Drugs and Cosmetics Act, 1940, Sections 16, 18, 27, 32, 33P.  https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf

[7] 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

[8] 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

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Food and medicine adulteration represents a grave threat to public health in India, compromising the safety and well-being of millions of consumers. Adulteration involves the deliberate degradation of food or pharmaceutical products through the addition, substitution, or removal of substances, rendering them harmful or substandard. The Indian legal system has developed a robust regulatory framework to combat this menace, providing citizens with multiple avenues to seek redress and hold violators accountable. This article examines the legislative architecture governing food and drug safety, enforcement mechanisms, complaint procedures, and judicial interpretations that shape consumer protection in India.

Understanding Food and Medicine Adulteration

Adulteration fundamentally alters the natural composition and quality of consumable products. In the context of food, it includes mixing water in milk to reduce nutritional value, adding non-edible colors to vegetables to simulate freshness, or substituting cheap oils in ghee to compromise both safety and quality. For pharmaceutical products, adulteration can involve contamination with impure substances, storage under insanitary conditions, or the manufacturing of counterfeit medications that imitate genuine products.

The consequences of consuming adulterated products range from minor health complications to life-threatening conditions. Adulterated milk containing detergents can cause severe gastrointestinal disorders, while spurious medications lacking active pharmaceutical ingredients can result in treatment failure and disease progression. The magnitude of this problem is reflected in data from the Food Safety and Standards Authority of India, which indicates that food adulteration rates have increased significantly, underscoring the need for stringent regulatory oversight.

Legislative Framework for Food Safety

The Food Safety and Standards Act, 2006

The Food Safety and Standards Act, 2006 [1] stands as the primary legislation governing food safety in India. This comprehensive statute consolidates various food-related laws and establishes the Food Safety and Standards Authority of India as the apex regulatory body. The Act defines an adulterant as “any material which is or could be employed for making the food unsafe or sub-standard or mis-branded or containing extraneous matter” and prescribes science-based standards for food articles while regulating their manufacture, storage, distribution, sale, and import.

The Act mandates that all food business operators obtain either registration or license from FSSAI depending on their turnover. Food business operators with an annual turnover below Rs. 12 lakhs require registration, while those exceeding this threshold must obtain a license. Operating without valid documentation attracts immediate penalties and potential business closure. The licensing system ensures that food businesses maintain adequate infrastructure, follow proper hygiene practices, and implement food safety management systems.

Penalties Under the Food Safety and Standards Act

The Act prescribes graded penalties based on the severity of violations. For manufacturing, storing, selling, or distributing sub-standard food, violators face penalties up to five lakh rupees. Misbranded food attracts penalties up to three lakh rupees, while misleading advertisements can result in fines up to ten lakh rupees. The possession of adulterants carries penalties of two lakh rupees if the adulterant is not injurious to health, escalating to ten lakh rupees if it poses health risks.

For serious offenses involving unsafe food, the Act prescribes imprisonment alongside monetary penalties. Manufacturing or selling adulterated food not injurious to health results in minimum imprisonment of six months extending up to three years with a minimum fine of one thousand rupees. When the adulterant is injurious to health but does not cause grievous hurt, the punishment increases to minimum imprisonment of one year extending to six years with a minimum fine of two thousand rupees. The most severe punishment applies when adulterated food causes death or grievous bodily harm, prescribing minimum imprisonment of seven years extendable to life imprisonment with a minimum fine of ten lakh rupees [2].

The Act also establishes an adjudication mechanism where designated officers examine evidence of non-compliance and determine appropriate penalties. Food business operators can appeal penalties to the Food Safety Appellate Tribunal within specified timeframes, ensuring procedural fairness in enforcement actions.

Regulatory Framework for Medicines

The Drugs and Cosmetics Act, 1940

The Drugs and Cosmetics Act, 1940 [3] provides the regulatory framework for pharmaceuticals and cosmetics in India. This legislation defines adulterated drugs as those consisting wholly or partly of filthy, putrid, or decomposed substances, those prepared or stored under insanitary conditions leading to contamination, or those containing harmful or toxic substances that render them injurious to health. A drug is considered adulterated if any substance has been mixed with it to reduce its quality or strength.

The Act distinguishes between adulterated and spurious drugs. Spurious drugs are counterfeit products manufactured under names belonging to other drugs, imitations or substitutes that resemble genuine drugs in a manner likely to deceive, or products bearing labels claiming fictitious manufacturers. This distinction is crucial because spurious drugs carry more severe penalties given their deliberate deceptive nature.

Penalties for Drug Adulteration

The Drugs and Cosmetics Act prescribes stringent penalties for violations. Importing adulterated or spurious drugs attracts imprisonment up to three years and fines up to five thousand rupees. Manufacturing or selling adulterated drugs that, when used for diagnosis, treatment, mitigation, or prevention of disease, are likely to cause death or grievous hurt results in imprisonment not less than ten years but extendable to life imprisonment, along with fines not less than ten lakh rupees or three times the value of drugs confiscated, whichever is higher [4].

For spurious drugs not falling under the most severe category, the punishment includes imprisonment not less than three years but extendable to five years with fines not less than five thousand rupees. The Act empowers courts to reduce sentences below the minimum for adequate and special reasons, which must be recorded in the judgment. This flexibility allows judicial discretion while maintaining the deterrent effect of stringent baseline penalties.

The compensation provision under the Act mandates that fines imposed on convicted persons must be paid as compensation to victims who used the adulterated or spurious drugs. This ensures that affected consumers receive financial redress for harm suffered due to pharmaceutical violations.

Regulatory Enforcement Mechanisms for Food and Medicine Adulteration

Food Safety Officers and Inspectors

Food Safety Officers appointed under the Food Safety and Standards Act possess extensive powers to ensure compliance. They can enter and inspect any premises where food is manufactured, processed, stored, or distributed. Officers are authorized to search premises with police assistance and search warrants, take samples of food for analysis, seize unsafe food products, and issue written warnings or stop production orders when food is found to be spoiled or unsafe.

The enforcement mechanism involves a structured process beginning with detection and sampling. Food Safety Officers conduct inspections and collect samples for analysis at accredited laboratories. If violations are detected through laboratory testing, notices of non-compliance are issued to the concerned food business operators. The Adjudicating Officer then examines evidence and determines appropriate penalties. Food business operators retain the right to appeal penalties to the Food Safety Appellate Tribunal, ensuring due process in enforcement actions.

Drug Inspectors and Controllers

Under the Drugs and Cosmetics Act, Drug Inspectors serve as the primary enforcement officers. They possess authority to inspect manufacturing facilities, storage premises, and sale outlets to ensure compliance with drug safety standards. Inspectors can take samples of drugs for testing, examine manufacturing processes, and verify licensing requirements. The Drugs Controller India oversees the implementation of the Act at the national level, while State Drug Controllers manage enforcement within their respective jurisdictions.

The enforcement framework includes provisions for emergency prohibition orders when immediate action is necessary to prevent health hazards. The Commissioner of Food Safety can issue such orders under the Food Safety and Standards Act when unsafe products require immediate removal from the market.

Consumer Complaint Procedures

Filing Complaints with FSSAI

Consumers who encounter adulterated food can file complaints through multiple channels established by FSSAI. The Food Safety Connect portal and mobile application enable online complaint submission from anywhere in the country. Complainants must provide detailed information including the product name, batch number, manufacturer details, nature of the complaint, and supporting evidence such as photographs, purchase receipts, or laboratory reports.

Upon receiving a complaint, FSSAI forwards it to the appropriate Food Safety Officer for investigation. The officer conducts an inspection, collects samples if necessary, and initiates action as per the provisions of the Act. Consumers can also contact the FSSAI helpline at 1800-11-2100 to report food safety concerns. For serious violations, consumers can directly approach the Designated Food Safety Court, which has jurisdiction to hear cases involving unsafe food.

Consumer Protection Act Remedies

The Consumer Protection Act, 2019 [5] provides an additional avenue for redress. Consumers can file complaints with District, State, or National Consumer Disputes Redressal Commissions based on the value of goods or services involved. District Commissions handle matters up to one crore rupees, State Commissions address claims between one crore and ten crore rupees, and the National Commission entertains complaints exceeding ten crore rupees.

The Act enables electronic filing of complaints through the eDaakhil portal, facilitating access to justice from any location. Consumer commissions can order replacement of goods, refund of prices paid, removal of defects, discontinuation of unfair trade practices, and payment of compensation for losses suffered. The Act prescribes penalties for non-compliance with commission orders, including imprisonment up to three years or fines up to twenty-five thousand rupees.

The Central Consumer Protection Authority established under the 2019 Act possesses suo motu powers to initiate action against unfair trade practices, misleading advertisements, and violations of consumer rights. It can recall products, order reimbursement, cancel licenses, impose penalties, and file class action suits on behalf of affected consumers.

Judicial Interpretation and Landmark Cases

Ram Nath v. State of Uttar Pradesh

The Supreme Court in Ram Nath v. State of Uttar Pradesh [6] addressed the critical issue of overlapping jurisdiction between the Indian Penal Code and the Food Safety and Standards Act. The appellant faced prosecution under Sections 272 and 273 of the Indian Penal Code for adulteration of mustard oil, edible oil, and rice bran oil. The Supreme Court held that Section 89 of the Food Safety and Standards Act gives overriding effect to its provisions over any other law concerning food-related matters. The Court stated that “the main Section clearly gives overriding effect to the provisions of the FSSA over any other law in so far as the law applies to the aspects of food in the field covered by the FSSA.”

The judgment emphasized that Section 59 of the Food Safety and Standards Act is more stringent than Sections 272 and 273 of the Indian Penal Code because it does not require proof of intention, which the IPC provisions contemplate. Consequently, the Court quashed the criminal proceedings under the IPC while clarifying that authorities remain free to act against violators under the Food Safety and Standards Act. This ruling established the primacy of specialized food safety legislation over general criminal law in adulteration cases.

Swami Achyutanand Tirth v. Union of India

In Swami Achyutanand Tirth v. Union of India [7], the Supreme Court addressed widespread concerns about adulterated and synthetic milk. The public interest litigation sought directions for the Union and State Governments to implement the Food Safety and Standards Act more effectively. The Court issued comprehensive directions requiring State Food Safety Authorities to identify high-risk areas and times for milk adulteration, collect samples from those locations, and ensure that all laboratories obtain National Accreditation Board for Testing and Calibration Laboratories accreditation.

The judgment mandated that dairy owners and retailers be informed that stringent action would be taken upon discovery of chemical adulterants in milk. The Court emphasized the State’s duty under Article 21 of the Constitution to protect citizens against hazardous and injurious food articles, affirming that food safety is a fundamental aspect of the right to life.

Centre for Public Interest Litigation v. Union of India

The Supreme Court in Centre for Public Interest Litigation v. Union of India [8] examined allegations of soft drink adulteration. The Court observed that people are protected under Article 21 against hazardous and injurious food articles and that the State bears a constitutional duty to ensure such rights. This judgment reinforced the principle that food safety is not merely a statutory obligation but a constitutional imperative flowing from the fundamental right to life and personal liberty.

Procedural Requirements for Taking Action Against Food and Medicine Adulteration

Evidence Preservation and Documentation

Successful action against adulteration requires proper evidence collection and preservation. Consumers should retain portions of adulterated food or medicine products whenever possible, keeping original packaging intact as it contains essential details like batch numbers, manufacturing dates, expiry dates, and manufacturer information. Photographic or video documentation of the adulterated product, its packaging, and any visible contaminants strengthens the complaint.

Purchase receipts, bills, and transaction records serve as proof of purchase and establish the consumer-seller relationship necessary for legal proceedings. Medical records documenting health complications resulting from adulterated products provide crucial evidence of harm suffered, supporting claims for compensation. Laboratory analysis reports confirming adulteration constitute definitive proof of violations and are essential for successful prosecution.

Notice Requirements and Limitation Periods

Before initiating formal legal proceedings, consumers should consider issuing a legal notice to the manufacturer, seller, or service provider detailing the complaint, relief sought, and timeframe for compliance. While not mandatory, such notices often facilitate amicable settlements and demonstrate good faith efforts at resolution.

Complaints under the Food Safety and Standards Act must be filed promptly after discovering adulteration. Under the Consumer Protection Act, complaints must be filed within two years from the date when the cause of action arises. However, consumer commissions possess discretion to condone delays beyond the limitation period if complainants demonstrate sufficient cause for not filing within the prescribed timeframe.

Integration of Multiple Remedies

Consumers possess the right to pursue remedies under multiple statutes simultaneously. While the Ram Nath judgment clarified that the Food Safety and Standards Act overrides the Indian Penal Code for food-related offenses, it does not preclude consumers from seeking compensation through consumer protection mechanisms. The Supreme Court has held that if an act constitutes an offense under two enactments prescribing punishment for the same, the offender may be prosecuted and punished under either or both enactments but shall not be liable to be punished twice for the same offense.

This principle enables consumers to file criminal complaints under the Food Safety and Standards Act or Drugs and Cosmetics Act for punitive action against violators while simultaneously pursuing civil remedies through consumer forums for compensation. The integration of criminal prosecution and civil compensation ensures both deterrence and restitution.

Challenges in Implementation

Despite robust Food and Medicine Adulteration Laws in India, implementation challenges persist. Inadequate testing infrastructure, especially in rural areas, hampers the detection of adulterated products. The shortage of Food Safety Officers and Drug Inspectors relative to the number of food businesses and pharmaceutical establishments limits enforcement capacity. Additionally, low consumer awareness about complaint mechanisms and available remedies reduces reporting of adulteration incidents.

Delays in laboratory testing and adjudication proceedings can undermine enforcement effectiveness. The Supreme Court has noted that delays in filing complaints after sample collection can prejudice defendants by preventing them from exercising their legal right to have samples analyzed by the Director of the Central Food Laboratory. Such procedural lapses can result in acquittals despite genuine adulteration.

Resource constraints affecting regulatory bodies limit the frequency and scope of inspections. Many food businesses, particularly small-scale operators, lack adequate knowledge of food safety standards and compliance requirements. Addressing these challenges requires sustained investment in testing infrastructure, capacity building for enforcement personnel, consumer education initiatives, and streamlined adjudication processes.

Preventive Measures and Consumer Vigilance

While legal remedies provide recourse after adulteration occurs, preventive measures can minimize exposure to unsafe products. Consumers should verify FSSAI license numbers on food products and check their validity on the FSSAI website. Examining expiry dates, manufacturing dates, and batch numbers before purchase helps identify potentially unsafe products. Purchasing food from licensed establishments with visible hygiene ratings reduces adulteration risks.

For pharmaceuticals, consumers should purchase medicines only from licensed pharmacies and verify the authenticity of products through the Drugs Authentication and Verification Application developed by the Central Drugs Standard Control Organization. Checking for proper sealing, manufacturer details, and batch numbers helps identify spurious drugs. Reporting suspicious products to regulatory authorities prevents their circulation and protects other consumers.

Consumer organizations play a vital role in raising awareness about food and drug safety, educating the public about complaint mechanisms, and filing class action suits on behalf of affected groups. Active consumer participation in food safety initiatives strengthens the overall regulatory ecosystem.

Conclusion

India’s legal framework for combating food and medicine adulteration encompasses comprehensive legislation, robust enforcement mechanisms, and accessible complaint procedures. The Food Safety and Standards Act, 2006, and the Drugs and Cosmetics Act, 1940, prescribe stringent penalties ranging from substantial fines to life imprisonment for serious violations. Regulatory authorities including FSSAI and Drug Controllers possess extensive powers to inspect premises, collect samples, and initiate prosecution against violators.

Consumers can seek redress through multiple avenues including direct complaints to regulatory authorities, criminal prosecution under specialized statutes, and civil remedies through consumer protection forums. Judicial pronouncements have clarified the primacy of specialized food safety legislation while affirming constitutional protections against hazardous consumables. Despite implementation challenges, the legal architecture provides a solid foundation for protecting public health.

Effective action against adulteration requires collaboration among regulatory authorities, enforcement officers, consumer organizations, and vigilant citizens. As the Supreme Court has emphasized, food and drug safety constitutes a fundamental aspect of the constitutional right to life. Strengthening enforcement capacity, enhancing consumer awareness, and ensuring timely adjudication will progressively realize this constitutional guarantee, ensuring that every citizen has access to safe and wholesome food and effective medicines.

References

[1] Food Safety and Standards Act, 2006. Available at: https://www.indiacode.nic.in/handle/123456789/2027 

[2] IndiaFilings. (2025). FSSAI Penalty and Offenses. Available at: https://www.indiafilings.com/learn/fssai-penalty-and-offenses/ 

[3] The Drugs and Cosmetics Act, 1940. Available at: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf 

[4] Indian Kanoon. The Drugs And Cosmetics Act, 1940. Available at: https://indiankanoon.org/doc/1891720/ 

[5] Consumer Protection Act, 2019. Available at: https://byjus.com/free-ias-prep/consumer-protection-act-2019/ 

[6] LiveLaw. (2024). Food Safety and Standards Act Overrides IPC on Food Adulteration | Supreme Court. Available at: https://www.livelaw.in/supreme-court/food-safety-and-standards-act-overrides-indian-penal-code-simultaneous-prosecution-under-both-acts-not-possible-supreme-court-250555 

[7] iPleaders. (2021). Role of judiciary in the implementation of food adulteration laws in India. Available at: https://blog.ipleaders.in/role-of-judiciary-in-the-implementation-of-food-adulteration-laws-in-india/ 

[8] iPleaders. (2021). Role of judiciary in the implementation of food adulteration laws in India. Available at: https://blog.ipleaders.in/role-of-judiciary-in-the-implementation-of-food-adulteration-laws-in-india/ 

Authorized and Published by Dhrutika Barad

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