FDC Drugs: Delhi HC lifts ban on formulation used for treatment of Type-2 Diabetes

In one of several challenges to the ban on the manufacture, sale or distribution of 328 Fixed Dose Combination (FDC) drugs in India, the Delhi High Court has set aside the Centre’s decision to ban FDCs of the formulations used to treat Type-2 Diabetes Mellitus..The combination of Glimepiride, Pioglitazone, and Metformin is used for the treatment of Type-2 Diabetes Mellitus when diet, exercise and the usage of dual therapy do not result in adequate glycemic control. It is manufactured by pharmaceutical companies Lupin, Intas Pharmaceuticals, MicroLabs, and Eris Lifesciences..The judgment was pronounced by a Single Judge Bench of Justice Vibhu Bakhru, who has remanded the formulation for re-consideration to the Drugs Technical Advisory Board (DTAB) sub-committee for failing to provide clear and cogent reasons for the ban..The Centre argued that in view of Article 47 of the Constitution of India, the petitioners had no fundamental right to carry on the manufacture of said drugs as Article 19(1)(g) did not include a fundamental right to carry on trade in alcohol and drugs which are harmful..The Court, however, stated that the argument was not relevant to the controversy at hand. The examination in the present case was limited to whether the ban on the said FDC could be sustained in view of conditions of Section 26A of the Drugs and Cosmetics Act, 1940 and the directions issued by the Supreme Court in Union of India v. Pfizer Limited and Ors..It further clarified that although the power exercised by the Centre under Section 26A of the Act is legislative in nature, it can be exercised only if the Centre is satisfied that it is necessary to exercise the same in larger public interest..Such satisfaction would be required to be based on the relevant considerations, cogent material, and by excluding irrelevant considerations, it further said..Referring to the sub-committee which proscribed the FDC, the Court observed that the the first six paragraphs of the report do not indicate any reasons for doing so..“On the contrary, paragraph 3 of the said reasoning indicates that there is a sufficiently large population of patients that requires a triple drug combination for addressing the chronic disease. It is also noted in paragraph 4 of the said reasons that DCGI has approved the FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg) + Metformin (500 mg ER) uncoated tablet for indication as the third line treatment of Type II diabetes mellitus in cases where diet, exercise and single agents and second line therapy with two drugs, do not result in adequate glycemic control.“.It also noted that the report acknowledged that the FDCs contained “recommended” and “approved” therapeutic dosage of each ingredient. Thus, there is no dispute that the FDC in question has a therapeutic justification and is prescribed for certain patients, it said..Hence, the Court recorded that the only reasons provided by the sub-committee for banning the FDC was that it could lead to risk of hypoglycemia, and that there is no safety data pertaining to this FDC..Rejecting the objections raised by Centre, the Court stated that the sub-committee’s reasons to ban the FDC were “difficult to understand” given the fact that it uses the recommended and approved therapeutic dosages..“Insofar as the observation that the said FDC can lead to risk of hypoglycemia is concerned, the petitioners have produced material on record, which indicates that the risk of hypoglycemia in Metformin is minimum…However, it is difficult to understand the rationale to proscribe the said FDC on this count, considering that it is accepted that the formulations in that dosage included in the FDC is recommended and approved. Admittedly, the said FDC has therapeutic value in certain cases.“.Since the observations made by the Sub-Committee provided little clarity for sustaining an action under Section 26A of the Act, the decision of Centre could not be sustained..“It is also conceded that the Central Government had not examined any other material other than the observations/ recommendations of the Sub-Committee for issuing the impugned notification. In absence of clear and cogent reasons, such a decision would be manifestly arbitrary and not sustainable.”.Further iterating that a drug can be proscribed under Section 26A only if it meets the three conditions enumerated in the provision, the Court clarified that the reason that there are other alternative therapeutic options available is not a ground for prohibiting a drug under the Act..It also rejected that ground that availability of multiple strengths of the FDC could lead to medication error for being cryptic..“There is a compelling argument that an FDC is expedient in cases where a patient is required to take multiple medicines. The risk of over prescription or under prescription is common in all FDCs. The reasons indicated by the Sub-Committee do provide any clarity as to why this reason is relevant for the FDCs in question.”.In view of the above, the Court set aside the ban on the FDC and remanded the issue to DTAB sub-committee. The sub-committee has been directed to examine the FDC in accordance with the directions of the Supreme Court in Pfzier’s case..Accordingly, the DTAB sub-committee shall submit a report to the Central government with an explanation for its recommendations along with the material in support of the same. The Centre would then take an informed decision, the Court has directed..Micro Labs was represented by Advocate Archana Sahadeva. Intas Pharmaceuticals was represented by Advocates Bitika Sharma, Namrita Kochhar and Vrinda Pathak. Erin Lifesciences was represented by Senior Advocate Gopal Jain with Advocates R Jawahar Lal, Siddharth Bawa and Shyamal Anand..Lupin was represented by a team of Khaitan & Co, comprising Partners Ajay Bhargava and Aseem Chaturvedi, and Associate Karan Gupta..The Centre was represented by Additional Solicitor General Maninder Acharya with CGSC Kirtiman Singh and Ripu Daman Bhardwaj. Advocates Waize Ali Noor, Rishikant Singh, Prateek Dhanda, Parth Semwal, Shruti Dutt, Viplav Acharya, Harshul Chowdhary, Sahil Sood, Suparna Srivastava and Sanjna Dua also appeared for the respondents..Read the judgment: