Section 26A of the Drugs and Cosmetics Act, 1940: India’s Sharpest Drug Regulatory Instrument

ABSTRACT

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