Section 26A of the Drugs and Cosmetics Act, 1940 empowers the Central Government to prohibit the manufacture, sale, or distribution of any drug in the public interest by notification in the Official Gazette, without requiring any amendment to the Act or rules. It is the most unilaterally powerful instrument in India’s drug regulation toolkit. This article examines the scope and limits of Section 26A power, the procedural question of whether DTAB/DCC consultation is mandatory or directory (settled by the Supreme Court in the FDC ban litigation), the constitutionality of Section 26A notifications as ‘legislation by notification,’ and the implications for pharmaceutical manufacturers. The article also traces the trajectory of the landmark 344 FDC ban (2016), its quashing by the Delhi High Court, and its restoration by the Supreme Court in Union of India v. Pfizer Ltd.

INTRODUCTION

India’s drug regulatory law contains multiple mechanisms through which the Central Government can control the drugs available in the marketplace. The most comprehensive are the D&C Rules, 1945, which establish standards for manufacturing, labelling, and distribution. But the Rules are cumbersome to amend — they require Gazette publication, prior publication for public comment, and Parliamentary tabling.

Section 26A provides an entirely different pathway: the Central Government can, by notification in the Official Gazette, prohibit the manufacture, sale, or distribution of any drug if it is satisfied that the drug’s use is likely to involve risk to human beings or animals, or that the drug lacks therapeutic value, or that it contains ingredients for which there is no therapeutic justification. No amendment, no Parliamentary procedure — a notification suffices.

This extraordinary power has been deployed with increasing frequency: 344 FDC drugs in 2016, additional FDC batches in 2017 and 2018, and 156 FDCs in 2024. Each exercise has generated intense pharmaceutical industry litigation. Understanding the scope and limits of Section 26A is essential for any regulatory counsel.

THE TEXT OF SECTION 26A: SCOPE AND TRIGGER CONDITIONS

Section 26A reads: ‘Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug or cosmetic.’

Three trigger conditions exist — risk to human beings/animals, absence of therapeutic value, or ingredients without therapeutic justification. The government needs to be satisfied on any one of these three grounds. The ‘public interest’ requirement is not a fourth independent condition but a cumulative test: the government must be satisfied both that a trigger condition exists and that prohibition is in the public interest.

Section 26A covers drugs and cosmetics. It does not require the drug to be already licensed — it can prohibit drugs that were approved pre-1988 (before the current approval regime) as well as post-1988 approvals. The Supreme Court confirmed this in the Pfizer litigation.

THE DTAB/DCC CONSULTATION QUESTION

A central issue in FDC ban litigation has been whether the Central Government must consult the Drugs Technical Advisory Board (DTAB) and the DCC before issuing a Section 26A notification.

The Drugs and Cosmetics Act establishes the DTAB under Section 5 as the primary technical advisory body for matters of drug standards and regulation. Section 26A itself is silent on any consultation requirement.

The Delhi High Court in its 2016 judgment quashing the 344 FDC bans held that DTAB consultation was mandatory. The Government had relied on an Expert Committee (the Kokate Committee) rather than formal DTAB consultation, and the High Court found this procedurally defective.

The Supreme Court reversed this in Union of India v. Pfizer Ltd. & Ors. The Court held that Section 26A does not impose a mandatory consultation requirement with the DTAB or DCC. Such consultation, where done, may be directory — it adds to the quality of decision-making but its absence does not invalidate the notification. The Central Government retains full power to act under Section 26A on the basis of any credible expert material, including Expert Committee reports.

This ruling significantly expanded the Central Government’s Section 26A powers. It also has an important implication for the DCC: even in contexts where DCC consultation is prescribed (by administrative practice), its absence does not automatically vitiate a Section 26A notification.

THE 344 FDC BANS: A CASE STUDY IN SECTION 26A DEPLOYMENT

On March 10, 2016, the Central Government issued a notification under Section 26A prohibiting the manufacture, sale, and distribution of 344 Fixed Dose Combination (FDC) drugs. FDCs — combinations of two or more active pharmaceutical ingredients in a single dose — had proliferated in the Indian market over decades, many without formal approval from the DCGI.

The Kokate Committee, appointed by the Government, found that these FDCs lacked therapeutic justification and posed safety risks. The Section 26A notification was immediate and nationwide.

Pharmaceutical manufacturers, including Pfizer, challenged the notification before the Delhi High Court. A Single Judge quashed the notification in December 2016, holding that DTAB consultation was mandatory and had not been conducted.

The Supreme Court, in the subsequent appeal, restored the notification. The Court upheld the Government’s power to issue Section 26A notifications on Expert Committee recommendations without mandatory DTAB consultation, reinforcing the Central Government’s broad, unilateral power under Section 26A. The Delhi High Court’s quashing order was set aside.

In August 2024, the Central Government invoked Section 26A again to ban 156 FDCs, further demonstrating the ongoing centrality of this provision in India’s drug safety enforcement.

SECTION 26A AS LEGISLATION BY NOTIFICATION: CONSTITUTIONAL LIMITS

Section 26A raises a significant constitutional question: is it a conferral of ‘legislative power’ on the executive that violates the doctrine against excessive delegation?

The doctrine against excessive delegation (developed from In re Delhi Laws Act, 1951 AIR SC 332) holds that Parliament cannot abdicate its legislative function by conferring unlimited, unguided power on the executive. For a delegation to be valid, the statute must lay down the policy and the delegatee must merely fill in the details.

Section 26A satisfies this test: it specifies three clear trigger conditions (risk, lack of therapeutic value, unjustified ingredients), requires satisfaction of a ‘public interest’ criterion, and mandates the instrument (Official Gazette notification). The executive cannot act under Section 26A for reasons outside these parameters — a notification issued on pure commercial or political grounds, without the prescribed satisfaction, would be challengeable as ultra vires.

Courts have consistently upheld Section 26A as a valid delegation, noting that drug safety regulation requires rapid, expert-driven responses that parliamentary amendment procedures cannot provide.

SECTION 26A vs. SECTION 26B vs. SECTION 33EED: COMPARATIVE SCOPE

Section 26A: Prohibition — manufacture, sale, and distribution of any drug or cosmetic. Applies nationwide. Effective on Gazette notification.

Section 26B: Regulation or restriction — Central Government can regulate or restrict (short of outright ban) the manufacture, sale, or distribution of essential drugs or drugs in public interest. Provides a graduated response short of prohibition.

Section 33EED: Equivalent to Section 26A for Ayurvedic, Siddha, and Unani (ASU) drugs. Empowers Central Government to prohibit ASU drug manufacture by notification in public interest.

The three provisions together create a comprehensive toolkit: Section 26B for regulatory restriction, Section 26A for outright prohibition of allopathic drugs, and Section 33EED for prohibition of ASU drugs. The absence of a unified framework for all drug categories creates regulatory asymmetry that the pharmaceutical industry exploits through classification arguments.

VII. CONCLUSION

Section 26A is the most operationally powerful provision in the Drugs and Cosmetics Act, 1940. Its broad scope, its freedom from mandatory consultation requirements (as confirmed by the Supreme Court), and its direct operation by Gazette notification make it the instrument of choice for rapid regulatory intervention. The FDC ban litigation settled the major procedural controversies — DTAB consultation is directory, not mandatory; Expert Committee recommendations suffice; and the Supreme Court will not second-guess the government’s satisfaction on questions of drug safety.

For pharmaceutical manufacturers, Section 26A notifications are existential regulatory events. For regulatory counsel, the key defence arguments — absence of procedural safeguards, lack of DTAB consultation, insufficient expert material — have been progressively narrowed by the Supreme Court. The constitutional limits of the provision remain in the trigger conditions and the ‘public interest’ requirement — grounds that require substantive engagement with the scientific record, not just procedural challenges.

FAQ

1. What is Section 26A of the Drugs and Cosmetics Act, 1940?
Section 26A empowers the Central Government to prohibit the manufacture, sale, or distribution of any drug or cosmetic in public interest by issuing a notification in the Official Gazette.

2. Can the Government ban a drug without amending the Drugs and Cosmetics Rules, 1945?
Yes. Under Section 26A, the Government can ban a drug directly through a Gazette notification without amending the Act or the Rules.

3. What are the grounds for banning a drug under Section 26A?
A drug may be banned if:

• it poses risk to human beings or animals;
• it lacks the therapeutic value claimed; or
• it contains ingredients with no therapeutic justification.

4. Is consultation with DTAB mandatory before issuing a Section 26A notification?
No. The Supreme Court in Union of India v. Pfizer Ltd. held that consultation with the Drugs Technical Advisory Board is directory, not mandatory.

5. What is the 344 FDC drug ban case?
In 2016, the Central Government banned 344 Fixed Dose Combination (FDC) drugs under Section 26A. The ban was initially quashed by the Delhi High Court but later restored by the Supreme Court.

6. What are Fixed Dose Combination (FDC) drugs?
FDC drugs are medicines containing two or more active pharmaceutical ingredients combined in a single dosage form.

7. Can pharmaceutical companies challenge a Section 26A notification?
Yes. Companies can challenge such notifications on grounds like lack of scientific basis, absence of public interest, or arbitrariness.

8. What is the difference between Section 26A and Section 26B?
Section 26A allows complete prohibition of drugs or cosmetics, while Section 26B allows regulation or restriction short of an outright ban.

9. What is Section 33EED of the Drugs and Cosmetics Act?
Section 33EED is similar to Section 26A but applies to Ayurvedic, Siddha, and Unani (ASU) drugs.

10. Is Section 26A constitutionally valid?
Yes. Courts have generally upheld Section 26A as a valid delegation of legislative power because the Act provides sufficient policy guidance and conditions.

REFERENCES

[1] The Drugs and Cosmetics Act, 1940, Sections 26A, 26B, 33EED — India Code.  https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf

[2] Union of India v. Pfizer Ltd. & Ors. — Supreme Court of India (FDC ban restored, DTAB consultation directory).  https://blog.ipleaders.in/union-india-anr-vs-pfizer-limited-ors-flaws-need-recalled/

[3] Delhi High Court quashes 344 FDC drug ban notification (December 2016) — SCC Online.  https://www.scconline.com/blog/post/2016/12/08/central-governments-notification-banning-344-fdc-drugs-quashed/

[4] Central Government bans 156 FDCs under Section 26A (September 2018) — PIB.  https://www.pib.gov.in/Pressreleaseshare.aspx?PRID=1545741

[5] Mondaq, ‘Supreme Court Expands Government’s Powers to Ban Drugs Under Section 26A’ (January 2018).  https://www.mondaq.com/india/food-and-drugs-law/661326/supreme-court-expands-governments-powers-to-ban-drugs-under-section-26a-o

[6] Section 26A — LawGist: The Drugs and Cosmetics Act, 1940.  https://lawgist.in/drugs-and-cosmetics-act/26A

[7] Notifications under Section 26A declared legally untenable (December 2016) — Patents Rewind.  https://patentsrewind.wordpress.com/2016/12/29/notifications-under-section-26a-of-the-drugs-and-cosmetics-act-declared-legally-u/

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

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The Drugs and Cosmetics Act, 1940 establishes a unique prosecution architecture: criminal proceedings for quality offences can be initiated only through a complaint, not through a police FIR. This complaint procedure under the Drugs and Cosmetics Act, 1940 forms the backbone of the statutory enforcement mechanism. The Drug Inspector, as the primary complaint-filing authority, must follow a series of mandatory statutory steps before a court can take cognizance of the offence. Any deviation from these steps is fatal to the prosecution. This article provides a comprehensive statutory walkthrough of the prosecution procedure under the Drugs &Cosmetics Act, identifies the precise provisions whose violation vitiates prosecution, distinguishes mandatory statutory requirements from non-mandatory DCC/CDSCO administrative guidelines, and offers a practical checklist for both prosecutors and defence counsel.

INTRODUCTION

The Drugs and Cosmetics Act, 1940 (‘the Act’) is distinctive among Indian criminal statutes in that it creates a self-contained prosecution architecture. Unlike the general criminal law framework under the Criminal Procedure Code where police cognizance triggers the investigative and prosecutorial process, the Act vests the complaint-filing function in a specialised enforcement officer — the Drug Inspector — and establishes a procedurally specific pathway from detection of a quality violation to the filing of a complaint before a court. In substance, the Act operates through a defined complaint procedure under the Drugs and Cosmetics Act, 1940, which governs how prosecutions are initiated and carried forward.

Every step in this pathway has legal consequence. Missteps in sampling, failures in service of the Analyst’s report, absence of required prior sanction, and breaches of limitation are each independently fatal to the prosecution. Courts across India have quashed Drug Act prosecutions at every stage of the process for procedural defects.

At the same time, administrative instructions issued by CDSCO and the DCC — requiring screening committee approval and written permission before a complaint is filed — are frequently treated as mandatory requirements even though they have no statutory basis. This article distinguishes the legally mandatory from the merely administrative.

STEP 1: SAMPLING UNDER SECTIONS 22 AND 23

Section 22 empowers a Drug Inspector to enter and inspect any premises, examine any record or register, and take samples of any drug or cosmetic for test or analysis. The sampling power is broad — it covers manufacturers, distributors, retailers, hospitals, and any entity in the drug supply chain.

Section 23 prescribes mandatory procedure for the taking of samples. The Inspector must:
(i) Take the sample in the presence of the person from whom it is drawn, or their representative;
(ii) Divide the sample into four parts;
(iii) Seal each part in the presence of that person;
(iv) Deliver one part to that person (or their representative) against a receipt;
(v) Send one part to the Government Analyst for analysis;
(vi) Retain one part as the office copy;
(vii) Where the test is to be done at the Central Drugs Laboratory (CDL), send a fourth part to the CDL.

Compliance with Section 23 is not optional — it is a mandatory condition precedent. Courts have consistently held that departure from the sampling procedure under Section 23 vitiates the prosecution. A drug that has not been sampled in accordance with Section 23 cannot form the basis of a prosecution regardless of what the analysis reveals.

STEP 2: GOVERNMENT ANALYST’S REPORT — SECTIONS 24 AND 25

After sampling, the Inspector sends the sample to the Government Analyst (for state-licensed drugs) or the CDL (for centrally licensed drugs or where CDL testing is required). The Analyst’s report under Section 24 constitutes the primary evidentiary foundation of the prosecution.

Section 24(2) imposes a mandatory obligation: the Inspector must serve a copy of the Analyst’s report on the person from whom the sample was drawn. This obligation is not discretionary. Failure to serve the report denies the accused the right to challenge the analysis by seeking CDL retesting — a right explicitly preserved by Section 25.

Section 25 provides that the person from whom the sample was drawn may, upon receipt of the Analyst’s report, apply to the court to send the retained sample to the CDL for retesting. The CDL’s report, once issued, is conclusive evidence of the facts stated therein. This procedural right is the accused’s most significant protection against erroneous or compromised laboratory analysis.

STEP 3: INVESTIGATION AND SECTION 18A NOTICES

Once a drug is found to be NSQ or spurious, the Inspector must trace the chain of custody from manufacturer to retailer. Section 18A imposes a statutory obligation on every person in the supply chain to disclose the name and address of the person from whom they received the drug. This enables the Inspector to proceed against the manufacturer — who is the primary target of the strict liability offence under Section 27.

The Inspector’s investigation should include serving notices to obtain: drug manufacturing licences, batch manufacturing records, distribution particulars, and the control or retained sample held by the manufacturer. Where the manufacturer fails to respond, the Inspector is not excused from the investigation — Section 22 provides powers of seizure of records that should be exercised. The thoroughness of this investigation directly affects the strength of the prosecution.

STEP 4: PRIOR SANCTION — MANDATORY UNDER SECTION 33M, NON-MANDATORY UNDER SECTION 32

The prior sanction requirement is the most frequently litigated procedural issue in D&C Act prosecutions, and the most misunderstood.

For Chapter IVA offences (clinical trials, import violations, and cognate offences under Sections 17B, 17C, 26A etc.), Section 33M mandates prior sanction of the specified authority before a complaint is filed. The absence of this sanction is not a mere procedural irregularity — it is a jurisdictional defect. Courts have ordered acquittal in cases where prosecution was launched without the Section 33M sanction.

For Chapter IV offences (NSQ drugs, spurious drugs, licensing violations under Sections 18, 18A, and 27), Section 32 of the Act does not require any prior sanction from a superior authority. The Drug Inspector, the aggrieved person, a recognised consumer association, or an authorised Gazetted Officer may directly file a complaint before the Court of Sessions without prior administrative approval.

The DCC and CDSCO guidelines, however, require Drug Inspectors to obtain written permission from the controlling authority — through a screening committee process — before filing even Chapter IV complaints. This requirement has no statutory basis. Courts have expressly held that executive instructions from CDSCO do not supersede statutory provisions. An Inspector who bypasses the DCC’s screening committee and files a Chapter IV complaint is not committing any procedural violation — the complaint is legally compliant.

STEP 5: FILING THE COMPLAINT — SECTION 32 AND JURISDICTIONAL REQUIREMENTS

Section 32 is the gatekeeper provision for prosecutorial cognizance under the Act. Cognizance of a Chapter IV offence by a court can be taken only on a complaint by:
(i) A Drug Inspector;
(ii) An aggrieved person;
(iii) A recognised consumer association; or
(iv) A Gazetted Officer authorised by the Central or State Government.

The Supreme Court in Union of India v. Ashok Kumar Sharma, (2021) 12 SCC 674 held unambiguously that a police officer cannot register an FIR or independently investigate Chapter IV offences. Any prosecution initiated on a police complaint is legally invalid and liable to be quashed. The police’s role under the Act is ancillary — they may assist the Inspector, but cannot substitute for the Inspector as the complaint-filing authority.

Jurisdiction: Chapter IV offences that attract imprisonment for three years or more must be tried by the Court of Sessions. The Karnataka High Court in January 2026 confirmed that Sessions Courts have exclusive jurisdiction to try Chapter IV offences for the most serious categories. Complaints filed before Magistrates for cognizable Chapter IV offences may be challenged on jurisdictional grounds.

STEP 6: LIMITATION PERIOD

Section 468 of the Code of Criminal Procedure, 1973 (now Section 531 of the Bharatiya Nagarik Suraksha Sanhita, 2023) prescribes limitation periods for taking cognizance of offences: three years for offences punishable with imprisonment between one and three years.

For D&C Act prosecutions, the limitation period runs from the date the Drug Inspector receives information about the commission of the offence — not from the date sampling was done, not from the date of the Analyst’s report, and not from the date sanction (if any) is obtained. Courts have quashed complaints filed beyond the three-year limitation period as time-barred.

This is a hard deadline that cannot be extended by internal administrative processes. If a screening committee causes delay sufficient to push the complaint beyond the limitation period, the prosecution is extinguished — and the screening committee’s delay itself becomes a ground for challenging the lawfulness of the guidelines that mandated that delay.

PRACTICAL CHECKLIST FOR COUNSEL

For Defence Counsel:

• Was the sample divided, sealed, and delivered in strict compliance with Section 23? Any departure may vitiate.
• Was the Analyst’s report served on the accused/manufacturer per Section 24(2)?
• Was the Section 25 right to CDL retesting preserved and available?
• For Chapter IVA offences: was prior sanction obtained under Section 33M?
• Was the complaint filed within the three-year limitation period from the date of information?
• Was the complaint filed by a competent authority under Section 32?
• Was the complaint filed before the Court of Sessions for offences attracting 3+ year imprisonment?

For Prosecution Counsel:

• Ensure all Section 23 formalities are documented in the sampling records (seizure mahazar).
• Serve the Analyst’s report personally or by registered post with acknowledgement.
• For Chapter IVA: obtain and exhibit the prior sanction.
• Calculate limitation from the date of first information — ensure complaint is within three years.
• DCC screening committee approval, while desirable as good practice, is not a mandatory statutory step — absence does not vitiate the complaint.

CONCLUSION

The Drugs and Cosmetics Act, 1940 creates a technically demanding prosecution procedure that is both the prosecution’s source of authority and the defence’s primary toolkit. At its core lies a structured complaint procedure under the Drugs and Cosmetics Act, 1940, which imposes strict statutory discipline at every stage. Every statutory step is mandatory; deviation is at prosecutorial peril. At the same time, the administrative requirements grafted onto this procedure by DCC and CDSCO guidelines — particularly the screening committee and written permission requirements — are not part of the statutory framework. Courts will not invalidate a complaint merely because these administrative steps were skipped. Defence counsel conflating administrative requirements with statutory requirements, and prosecution counsel treating administrative steps as jurisdictional prerequisites, both err. The statute is clear; it deserves to be followed precisely.

FAQS: COMPLAINT & PROSECUTION PROCEDURE UNDER THE DRUGS AND COSMETICS ACT, 1940

1. Can prosecution under the Drugs and Cosmetics Act, 1940 be initiated through an FIR?
   No. Prosecution for offences under the Act can be initiated only through a complaint filed by an authorised person under Section 32. Police cannot independently register an FIR or initiate prosecution.
2. Who is authorised to file a complaint as part of the procedure under the Drugs and Cosmetics Act, 1940?
   A complaint may be filed by a Drug Inspector, an aggrieved person, a recognised consumer association, or a Gazetted Officer authorised by the Central or State Government.
3. Is compliance with the sampling procedure under Section 23 mandatory?
   Yes. The procedure for sampling—division, sealing, and delivery of samples—is mandatory. Any deviation can vitiate the prosecution.
4. What is the importance of the Government Analyst’s report?
   The Analyst’s report forms the primary evidentiary basis of prosecution. It must be served on the accused under Section 24(2), failing which the prosecution may be invalid.
5. What right does the accused have under Section 25?
   The accused has the right to seek retesting of the sample by the Central Drugs Laboratory. The CDL report is conclusive evidence.
6. Is prior sanction required before filing a complaint?
   Prior sanction is mandatory only for offences under Chapter IVA (Section 33M). For Chapter IV offences, no prior sanction is required under Section 32.
7. Are DCC or CDSCO guidelines mandatory before filing prosecution?
   No. Guidelines requiring screening committee approval or prior permission are administrative in nature and do not have statutory force.
8. What is the limitation period for filing a complaint?
   Generally, the limitation period is three years from the date of knowledge of the offence, as per the Code of Criminal Procedure (now BNSS, 2023).
9. Which court has jurisdiction to try offences under the Act?
   Serious offences punishable with imprisonment of three years or more are triable by the Court of Sessions.
10. What are common grounds for quashing prosecution under the Act?
    Common grounds include defective sampling, non-service of the Analyst’s report, denial of the right to retesting, lack of mandatory sanction (where applicable), and filing beyond the limitation period.

REFERENCES

[1] The Drugs and Cosmetics Act, 1940, Sections 22, 23, 24, 25, 18A, 32, 33M — India Code.  https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf

[2] Union of India v. Ashok Kumar Sharma, (2021) 12 SCC 674 — Supreme Court of India (Police cannot file FIR under D&C Act Chapter IV).  http://aidcoc.in/pdf/15-Supreme%20Court%20on%20Powers%20of%20Police%20and%20Drugs%20Inspectors%20to%20Arrest.pdf

[3] Dinesh Thakur, ‘Enforcement Measures Under the Drugs & Cosmetics Act, 1940: Part 2 – Investigations’ (March 2016).  https://dineshthakur.com/2016/03/22/enforcement-measures-under-the-drugs-cosmetics-act-1940-part-2-investigations/

[4] Karnataka High Court: Sessions Court Has Exclusive Jurisdiction for Serious Chapter IV Offences (January 2026) — LiveLaw.  https://www.livelaw.in/high-court/karnataka-high-court/karnataka-high-court-ruling-session-court-exclusive-jurisdiction-offences

[5] Drugs and Cosmetics Complaint quashed as time-barred — STPL Law (2024).  https://stpllaw.in/drugs-and-cosmetics-complaint-quashed-as-time-barred/

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

[7] 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

[8] 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

[9] Prior sanction mandatory for Section 33M — acquittal where absent: LawWeb (2015).  https://www.lawweb.in/2015/10/whether-accused-can-be-acquitted-in.html

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