The Delhi High Court has reinstated the prohibition on two fixed-dose combination (FDC) drugs used for the treatment of Type II Diabetes Mellitus.
The ban stems from two 2018 notifications issued by the Central government, which barred the manufacture and sale of FDCs containing the formulations “Glimepiride 1 mg/2 mg + Pioglitazone 15 mg/15 mg + Metformin 850 mg/850 mg” and “Glimepiride 1 mg/2 mg/3 mg + Pioglitazone 15 mg/15 mg/15 mg + Metformin 1000 mg/1000 mg”.
A Division Bench comprising Justices Anil Kshetarpal and Harish Vaidyanathan Shankar held that the Centre had acted within its statutory powers, observing that the decision to ban the drugs was taken in the interest of public health.
While upholding the ban, the Delhi High Court overturned a single judge’s order that had earlier struck down the Centre’s 2018 notifications. The Union government had challenged that decision before the Division Bench.
The Court said the single judge was wrong to interfere with the statutory framework under the Drugs and Cosmetics Act, 1940, noting that decisions on drug safety fall within the domain of the government and expert bodies.
Importantly, the Bench clarified that the Central government does not have to prove actual harm to patients before banning a drug under Section 26A of the Act. It held that a ban can be justified even on the basis of a potential or likely risk to public health
“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,” the Court observed.
Additional Solicitor General (ASG) Chetan Sharma, Central Government Standing Counsel (CGSC) PS Singh and Advocates Shiva Lakshmi, Amit Gupta, Madhav Bajaj, Vivek Mathur, RV Prabhat, Shubham Sharma, Vikram Aditya Singh, Yash Wardhan Sharma, Naman, Dinesh Kumar, Deepak Kumar, Rajneesh K Sharma, Ashutosh Bharti, Minakshi Singh and Prituysh Kumar appeared for the Central government.
Advocates Tanya Agarwal, Krishna Kumar Keshav and Ankush Khanna appeared for the Drug Action Network.
Senior Advocate Rajshekhar Rao with Advocates Ajay Bhargava, Vanita Bhargava, Aseem Chaturvedi, Milind Jain and Anuj Shrotriya represented the drug company Lupin and others.
Senior Advocate Akhil Sibal with Advocates Archana Sahadeva, Harshit Bhoi and Jahnavi Sindhu represented Micro Labs Limited.
Advocate R Jawahar Lal and Sayyam Maheswari represented Eris Lifesciences.