The Delhi High Court recently restored the ban on two fixed-dose combination (FDC) medicines to treat Type II Diabetes Mellitus.

The government had issued two notifications in 2018 proscribing the manufacture and sale of FDCs comprising the formulation “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 of Justices Anil Kshetarpal and Harish Vaidyanathan Shankar said that the Central government was within its powers to prohibit the manufacture and sale of these FDC drugs in the interest of public health.

While upholding the ban on these drugs, the Court set aside a single-judge's order which had quashed the government notifications. The Union government then challenged the order.

Now, the Division Bench has held that the single-judge had erred in interfering with the statutory process under the Drugs and Cosmetics Act, 1940.

Moreover, the Court also rendered a finding that for the Central government to ban a drug under Section 26A of the Drugs and Cosmetics Act, 1940, there is no requirement to establish actual or proven harm to human beings. A ban can be imposed if there is a likelihood that the drug poses a risk to human health, the Court said. 

“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.

[Read Judgment]