Court Must Not Dilute Concerns After Experts Have Identified Risks: Delhi High Court Restores Ban On Type II Diabetes FDCs

The notifications were issued by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940, to prohibit the manufacture and sale of anti-diabetic formulations combining Glimepiride, Pioglitazone, and Metformin.

​The Division Bench comprising Justice Anil Kshetarpal and Justice Harish Vaidyanathan Shankar observed, “In matters of drug regulation, where expert bodies have identified specific risks associated with particular formulations, it is impermissible for the Court to dilute those concerns on the basis of broad generalisations unsupported by technical material…Viewed thus, the approach adopted by the learned Single Judge in relation to Notification S.O. 4472(E) traverses beyond the permissible contours of judicial review, substitutes expert assessment with judicial inference, and fails to accord due deference to the composite and precautionary evaluation undertaken by the statutory authorities in exercise of powers under Section 26A of the Drugs Act.”

ASG Chetan Sharma, CGSC P.S. Singh appeared for the Union of India, while Senior Advocate Raj Sekhar Rao, Advocates R. Jawahar Lal and Tanya Agarwal appeared for Respondents.

Facts of the case

The present appeals arise from a common judgment, wherein the Single Judge of the High Court set aside notifications S.O. 4471(E) and S.O. 4472(E) dated 07.09.2018. These notifications, issued by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940, had prohibited the manufacture, sale, and distribution of certain FDCs used for treating Type-II Diabetes Mellitus. Specifically, the FDCs involved combinations of Glimepiride, Pioglitazone, and Metformin in various dosages. The government’s prohibition was based on the premise that these FDCs posed a risk to human health and lacked adequate safety justification.

The history of this litigation trace back to March 2016, when the Central Government prohibited 344 FDCs based on the Kokate Committee recommendations. After an initial round of litigation where the High Court set aside these prohibitions due to a lack of consultation with the Drugs Technical Advisory Board (DTAB), the matter reached the Supreme Court. In Union of India v. Pfizer Limited & Ors., the Supreme Court remanded the matter to a DTAB Sub-Committee (the Nilima Kshirsagar Committee) with specific instructions: they were to hear manufacturers, identify specific risks or lack of therapeutic value, and provide reasons why a total prohibition was necessary instead of mere regulation or restriction.

Following this remand, the Sub-Committee recommended prohibiting the FDCs. For the 1000 mg Metformin combination, it cited risks of hypoglycemia and a lack of safety data, despite acknowledging that triple-drug therapy is a recognized standard treatment. For the 850 mg Metformin combination, it was argued that therapeutic alternatives existed and that the specific dosage could lead to medication errors. The Central Government accepted these recommendations and issued the 2018 notifications.

However, the Single Judge subsequently quashed these notifications, ruling that the Sub-Committee's reasoning was cryptic and inconsistent. The Judge had noted that the committee had admitted the therapeutic value and approved dosages of the ingredients, but failed to explain why the FDCs could not be regulated rather than banned.

Contention of the Parties

It was contended on behalf of the Union of India that the Impugned Judgment proceeded on a fundamentally erroneous premise by equating the approval of individual drug components with the approval of those same components when formulated as a Fixed Dose Combination (FDC). It was argued that the Single Judge overlooked the principle that an FDC is a distinct drug entity requiring independent evaluation, rather than a mere sum of its approved parts. It was further asserted that the manufacturers failed to provide dedicated clinical trials or safety data for these specific combinations, which was a decisive factor for the expert body’s recommendation to ban them.

It was also maintained that the Single Judge erred by requiring a higher degree of proof than what is mandated under Section 26A of the Drugs Act; it was clarified that the law only requires a determination of whether a drug is "likely" to involve a risk, not the establishment of actual harm. Additionally, it was defended the DTAB Sub-Committee's reasoning as sufficient, noting that they recorded a clear lack of international regulatory acceptance and clinical data. Finally, counsel for the Appellant argued that the Court should not re-examine the scientific weight of expert evidence during judicial review, as the government’s priority was protecting public health over the economic interests of manufacturers.

The Respondents, represented by their respective counsel, opposed the appeals by primarily arguing that the Central Government and the DTAB Sub-Committee failed to follow the mandatory directions laid down by the Supreme Court in Union of India v. Pfizer Limited & Ors.. Their contentions in simple past were as follows:

The Respondents argued that the DTAB Sub-Committee failed to adhere to the specific legal framework established by the Supreme Court. They maintained that the Sub-Committee was legally obligated to identify which specific limb of Section 26A of the Drugs Act was attracted—whether the drug involved a risk, lacked therapeutic value, or lacked therapeutic justification.

They contended that the Sub-Committee did not satisfy the requirement to explain why a total prohibition was necessary in the public interest, instead of simply regulating or restricting the manufacture and sale of the FDCs. They pointed out that the Supreme Court had specifically required the committee to provide reasons for choosing the "extreme step" of a ban.

The Respondents highlighted that the Sub-Committee itself acknowledged the therapeutic value and justification of the FDCs. They argued that because the committee admitted these drugs were effective and the dosages were approved, the recommendation to ban them was logically inconsistent and lacked a scientific basis.

They asserted that the Sub-Committee’s conclusion that the formulations "may involve risk" was founded on mere speculation rather than concrete evidence. They argued that such a "speculative possibility" did not meet the statutory threshold of "likelihood of risk" required under Section 26A and was not sanctioned by the Pfizer judgment.

Finally, the Respondents claimed that the Sub-Committee failed to give any meaningful consideration to the safety and efficacy data they had submitted. They maintained that the learned Single Judge was correct in setting aside the notifications because the underlying expert report remained as cryptic and deficient as the previous ones.

Observations of the Court

The Court analyzed the Supreme Court’s ruling in Pfizer Limited & Ors., noting that it established Section 26A of the Drugs Act as an enabling provision that did not mandate prior consultation with the DTAB. While the Supreme Court had issued specific directions for the DTAB Sub-Committee to identify risks and justify why prohibition was preferred over regulation, the Court found that these instructions did not dilute the Central Government's statutory autonomy. Instead, the Court concluded that the Sub-Committee’s report was intended to serve as an informed, non-binding input, leaving the final authority with the Central Government to independently assess all relevant material and determine the necessity of a ban in the interest of public health.

The Court said, “The statutory threshold under Section 26A is the satisfaction of the Central Government, founded upon relevant considerations, and not a rigid or compartmentalised inquiry divorced from the overall regulatory context. The observation regarding availability of therapeutic alternatives cannot be examined in isolation, particularly when viewed in conjunction with the undisputed position that only general data had been provided by the Respondents and no specific data was made available in respect of the said FDCs as also the fact that the impugned FDCs are not approved or marketed in other jurisdictions, a factor which bears directly upon the regulatory assessment undertaken in public interest.”

The Court noted that the reasoning of the Sub-Committee could not be severed from its other findings, specifically that increments in Metformin dosages were typically prescribed in steps of 500 mg according to treatment guidelines. The Committee had also observed that the availability of multiple strengths within a single Fixed Dose Combination (FDC) could lead to medication errors, such as over-dosing or under-dosing. The Court found that the learned Single Judge erred by approaching these considerations in isolation rather than examining their cumulative impact, which effectively fragmented what was intended to be a holistic expert assessment.

In dealing with the second reason, relating to dosage increments of Metformin, the Single Judge placed emphasis on the fact that Metformin 850 mg is independently marketed as an approved drug and, relying upon material produced by the writ petitioners, concluded that the prescription of such dosage in certain patients rendered the Sub-Committee’s concern untenable.

In this regard, the Court observed, “In our view, this line of reasoning is fundamentally flawed. First, there was no occasion for the learned Single Judge to enter upon an evaluation of scientific or clinical material to arrive at conclusions regarding appropriate dosages, as courts are institutionally ill-equipped to adjudicate upon specialised pharmacological determinations. Secondly, and more importantly, the mere fact that an individual drug component is approved or prescribed at a particular dosage does not ipso facto justify its inclusion in a FDC at that dosage, the combination being a distinct therapeutic entity requiring independent assessment of safety and risk.”

Conclusion

The Court concluded that the Single Judge erred in interfering with the Notifications bearing no. S.O. 4471(E) and S.O. 4472(E), issued by the Central Government in exercise of powers under Section 26A of the Drugs Act, thereby warranting appellate interference by this Court.

Accordingly, the Court allowed the appeals and set aside the Impugned Judgment.

Cause Title: All India Drug Network v. Lupin Ltd. & Ors. [Neutral Citation:2026:DHC:136-DB]

Appearances:

For Union of India/Appellants/Respondents: Senior Advocate Chetan Sharma (ASG), Advocates P.S. Singh (CGSC), Shiva Lakshmi, Amit Gupta, Madhav Bajaj, Vivek Mathur, R.V. Prabhat, Shubham Sharma, Vikram Aditya Singh, Yash Wardhan Sharma, Naman, Dinesh Kumar, Deepak Kumar, Rajneesh K. Sharma, Ashutosh Bharti, Minakshi Singh, and Prituysh Kumar.

For AIDAN/Appellant: Advocates Tanya Agarwal, Krishna Kumar Keshav, and Ankush Khanna.

Lupin Ltd./Respondents: Senior Advocate Raj Sekhar Rao, Advocates Ajay Bhargava, Vanita Bhargava, Aseem Chaturvedi, Milind Jain, Anuj Shrotriya.

For Eris Lifesciences Ltd./Respondents: Advocates R. Jawahar Lal and Sayyam Maheswari.

For Micro Labs Ltd./Respondent: Senior Advocate Akhil Sibal, Advocates Archana Sahadeva, Harshit Bhoi, and Jahnavi Sindhu.

Click here to read/download the Judgment