Delhi High Court Restores Ban on Diabetes FDCs: Likelihood of Risk Suffices Under Section 26A

Introduction

In a significant ruling for drug regulation in India, the Delhi High Court has reinstated the Central government's ban on two fixed-dose combination (FDC) drugs used for treating Type II Diabetes Mellitus. A Division Bench comprising Justice Anil Kshetarpal and Justice Harish Vaidyanathan Shankar set aside a single judge's 2019 order that had quashed the bans, emphasizing the precautionary nature of Section 26A of the Drugs and Cosmetics Act, 1940. The court clarified that the government does not need to demonstrate actual or proven harm to prohibit a drug; a reasonable likelihood of risk to human health is sufficient. The appeals—LPA 671/2019 filed by the All India Drug Action Network (AIDAN), and LPA 105/2020 and 106/2020 by the Union of India (UOI)—were preferred against notifications S.O. 4471(E) and S.O. 4472(E) issued in September 2018, targeting FDCs of Glimepiride, Pioglitazone, and Metformin in specific strengths. Respondents include pharmaceutical companies such as Lupin Ltd., Eris Lifesciences Limited, and Micro Labs Limited. This decision underscores the balance between public health imperatives and pharmaceutical interests, potentially streamlining regulatory actions against unverified drug combinations amid India's rising diabetes burden.

Case Background

The controversy traces back to 2016, when the Central government, acting on recommendations from an Expert Committee chaired by Prof. C.K. Kokate, prohibited 344 FDCs, including those involving Glimepiride, Pioglitazone, and Metformin, via notifications like S.O. 806(E) and S.O. 807(E). These were challenged before the Delhi High Court, which in a common judgment dated December 1, 2016, set them aside, holding that consultation with the Drugs Technical Advisory Board (DTAB) was mandatory under Section 26A.

The UOI appealed to the Supreme Court, which in Union of India v. Pfizer Limited (2018) overruled the mandatory consultation requirement but remanded the matter to DTAB or a sub-committee for re-examination. The apex court directed the expert body to assess whether the FDCs posed risks to humans, lacked therapeutic value, or had unjustified ingredients, and to explain why prohibition was preferable to regulation or restriction. It also mandated hearings for manufacturers and stakeholders like AIDAN.

Pursuant to these directions, DTAB constituted a sub-committee under Dr. Nilima Kshirsagar via an Office Memorandum dated February 19, 2018. The sub-committee issued notices on March 12, 2018, seeking data from manufacturers. After deliberations, it recommended prohibition of the impugned FDCs: one (S.O. 4471(E)) for Glimepiride (1/2/3 mg) + Pioglitazone (15 mg) + Metformin (1000 mg), citing risks like hypoglycaemia and lack of safety data; the other (S.O. 4472(E)) for Glimepiride (1/2 mg) + Pioglitazone (15 mg) + Metformin (850 mg), due to dosage increment issues, availability of alternatives, and potential medication errors.

Accepting these recommendations, the government issued the 2018 notifications. The manufacturers—Micro Labs, Eris Lifesciences, and others—filed writ petitions (W.P.(C) 9978/2018, 10936/2018, 11278/2018), arguing the sub-committee's reasons were cryptic and non-compliant with Supreme Court directives. On February 13, 2019, the single judge quashed the notifications, remanding the matter for fresh consideration, finding the sub-committee's rationale inconsistent (e.g., acknowledging therapeutic value yet recommending bans) and failing to justify why lesser measures sufficed. This led to the present Letters Patent Appeals, heard analogously due to overlapping facts and law.

The case highlights ongoing tensions in India's pharmaceutical sector, where over 300 million people live with diabetes, and FDCs—intended for convenience in polypharmacy—have proliferated without rigorous combination-specific trials. Other sources, such as reports on similar bans, note that these FDCs were not approved in other jurisdictions, amplifying regulatory scrutiny.

Arguments Presented

The appellants, represented by Additional Solicitor General Chetan Sharma for UOI and counsel for AIDAN, argued that the single judge exceeded judicial review bounds by re-evaluating expert assessments. They contended Section 26A's "satisfaction" is subjective, based on relevant material like the sub-committee's report, which drew from 395 scientific publications and expert deliberations. The FDCs qualified as "new drugs" under Rule 122E(c) of the Drugs and Cosmetics Rules, 1945, requiring combination-specific safety data, which manufacturers failed to provide. Prohibiting them was precautionary, focusing on likely risks (e.g., hypoglycaemia) rather than proven harm, aligning with public health amid diabetes prevalence. They cited precedents like Systopic Laboratories v. Dr. Prem Gupta (1994), urging deference to experts, and distinguished individual drug approvals from FDC evaluations, as combinations may interact unpredictably. Economic hardship to manufacturers was irrelevant, per 63 Moons Technologies Ltd. v. Union of India (2019).

Respondents, led by Senior Advocates Raj Sekhar Rao, Akhil Sibal, and others, defended the single judge's order, asserting the sub-committee flouted Pfizer directives by not clearly linking risks to Section 26A limbs or explaining why prohibition trumped regulation. They highlighted the sub-committee's acknowledgment of therapeutic value (e.g., for third-line Type II diabetes treatment) and approved dosages, arguing speculative risks (e.g., hypoglycaemia) did not meet statutory thresholds. For the 850 mg variant, alternatives' availability and dosage steps were invalid grounds, as Metformin 850 mg was approved standalone. They submitted clinical literature showing FDC safety and convenience, claiming the bans ignored patient needs in chronic care. Judicial intervention was warranted due to arbitrariness, as the government relied solely on a "cryptic" report without independent application of mind.

Legal Analysis

The Division Bench meticulously dissected Section 26A, interpreting it as an enabling provision for the Central government to regulate, restrict, or prohibit drugs if satisfied of risks, lack of therapeutic value, or unjustified ingredients, provided public interest necessitates it. Echoing Pfizer , the court affirmed no mandatory DTAB consultation but stressed satisfaction must stem from relevant material. Crucially, it ruled the provision's precautionary intent obviates proving actual harm: "likelihood" of risk suffices, focusing on foreseeable dangers over demonstrable injury.

The bench critiqued the single judge for elevating the evidentiary bar, substituting judicial logic for expert opinion. It emphasized FDCs' status as distinct entities under Rule 122E, necessitating combination data per Appendix VI, Schedule Y—unmet here, as manufacturers provided only general studies. Deference to experts was paramount, per Systopic Laboratories (1994), where the Supreme Court declined to weigh scientific reports, leaving it to regulators. Similarly, E. Merck (India) Ltd. v. Union of India (2001) upheld bans on therapeutic justification grounds absent proven hazard, relevant here as the sub-committee noted absent global approvals and potential errors.

Distinguishing quashing criteria, the court clarified judicial review tests process (e.g., relevance of material) not merits (e.g., data sufficiency), per 63 Moons . The Pfizer remand was input-oriented, not binding; government's independent satisfaction validated the bans. For S.O. 4472(E), holistic sub-committee reasons (dosage mismatches, errors) weren't isolatable, reinforcing precautionary intervention. Alkem Laboratories Ltd. v. Union of India (2019) bolstered that individual approvals don't extend to combinations. This analysis limits courts from pharmacodynamic inquiries, preserving regulatory autonomy while ensuring rationality.

Other sources integrate seamlessly: reports on the sub-committee's 2018 deliberations align with the court's validation, while critiques of PIL misuse (e.g., Delhi HC rapping an NGO) contrast by showing restrained review in non-expert domains.

Key Observations

The judgment features pivotal excerpts underscoring its rationale:

1. On Section 26A's threshold: “We are of the considered opinion that the statutory standard prescribed under Section 26A of the Drugs Act does not require the establishment of actual or proven harm to human beings. The legislative intent underlying the provision is clearly precautionary in nature and is satisfied once it is shown that the use of a drug is likely to involve risk to human health. The focus of the inquiry, therefore, is not on demonstrable injury but on the potential or foreseeable risk arising from continued use of the drug.” (Para 34)

2. On judicial restraint: “In exercise of judicial review, this Court does not sit in appeal over the sufficiency, adequacy, or scientific weight of the material considered by an expert body, and its scrutiny is confined to examining whether relevant material existed and whether the decision-making process was lawful.” (Para, drawing from ASG submissions, echoed in analysis)

3. On FDC evaluation: “It cannot be presumed... that individual drug components would behave, interact, or manifest identical safety profiles when administered in combination, as opposed to being administered independently. Such a presumption is antithetical to the regulatory framework governing FDCs.” (Para 37)

4. Referencing Systopic : “Having considered the submissions... we must express our inability to make an assessment about the relative merits of the various studies and reports... Such an evaluation is required to be done by the Central Government while exercising its powers under Section 26A.” (Quoted in Para 27)

5. On public interest: “Public health being an integral and inseparable facet of public interest... the prohibition imposed... was justified and in larger public interest.” (Para 17, from ASG; affirmed in decision)

These quotes illuminate the court's deference to expertise and statutory intent.

Court's Decision

The Division Bench allowed the appeals, setting aside the February 13, 2019, single judge order and restoring the 2018 notifications. The bans on the specified FDCs stand, prohibiting their manufacture, sale, and distribution. No costs were imposed, and pending applications were disposed of.

Practically, this reinstates regulatory curbs on these diabetes treatments, compelling manufacturers to reformulate or seek fresh approvals with robust data. For future cases, it lowers the proof bar for bans, empowering swift action against potentially risky FDCs—vital in India, with 77 million diabetics and irrational combinations comprising 15-20% of the market (per sources like IQVIA). It may deter unverified FDCs, enhancing safety but raising costs for patients reliant on affordable options. Pharma firms face compliance burdens, potentially spurring clinical trials, while bolstering DTAB's role without judicial overreach. Broader implications include fortified public health safeguards, aligning with global standards (e.g., FDA scrutiny), and signaling courts' hands-off approach in technical domains. This could influence ongoing probes, like Kerala HC's Sabarimala fund misappropriation order, by emphasizing expert-led accountability.

In sum, the ruling fortifies Section 26A as a prophylactic tool, prioritizing prevention over cure in drug governance.