Delhi HC lifts ban on another FDC used for treatment of Type II Diabetes

The Delhi High Court has set aside Central Government Notification banning the manufacture, sale and distribution of drugs having Fixed Dose Combination (FDC) of ‘Pioglitazone 30 mg + Metformin 500 mg’..The judgement was pronounced by a Single Judge Bench of Justice Vibhu Bakhru in a challenge to the Notification by manufacturers and sellers of the FDC. The Petitioners, Lupin Ltd, Eris Lifesciences Ltd and Systopic Laboratories Pvt Ltd sell the FDC under the brand name Gluconorm P 30, Glitaris M 30 and PIO-M 30, respectively..The combination of Pioglitazone 30 mg + Metformin 500 mg is used as a second line treatment for Type – II Diabetes..The Central Government had proscribed the FDC on account of the inclusion of the formulation, Pioglitazone 30 mg. The Sub-committee constituted under the Drug Technical Advisory Board (DTAB) had recommended prohibition of the FDC on the ground that titration of Metformin i.e. increasing the dose of Metformin, presents an inadvertent risk of Pioglitazone overdose..It is also stated that there was no scientific justification for the FDC..The Petitioners assailed the notifications on the ground that the sub-committee’s recommendation was unreasoned and made without application of mind. It stated that the safety concerns regarding Pioglitazone 30 mg were incorrect and contrary to the material on record..The Court reiterated that the powers under Section 26A of the Drugs and Cosmetics Act, 1940 to ban a drug, can be exercised by Central Government only in larger public interest. However, specified conditions for the exercise of such power include risk to human beings or animals, lack of any therapeutic value etc., which should be based on the relevant material, it further said..Considering the fact that the Centre had approved other combinations of Pioglitazone and Metformin, the Court remarked that it was difficult to accept the proscription on the FDC in question..“If the Sub-committee was of the view that Pioglitazone in the strength of 30 mg would provide a significant risk of overdose in an FDC, it would have been apposite for all FDCs including Pioglitazone 30 mg as a component to be proscribed. However, since all FDCs, which include Pioglitazone 30 mg have not be proscribed, the reason as provided by Sub-Committee lacks clarity.”.The risk of an overdose of one of the drugs constituting an FDC would always exist, the Court said..“If the matter is viewed in the context of titration of drugs constituting an FDC; any variation in the dosage of any drug included in an FDC would result in overdose of the other components. Titration of any component drug in an FDC is not feasible. FDCs by their very definition, include formulations in fixed doses.”.Since it was not disputed that FDC was prescribed as a second line therapy in Type – II Diabetes, the finding that the FDC had no therapeutic justification could not be sustained, it further held..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 Union of India v. Pfizer Limited and Ors..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..Lupin was represented by Senior Advocate Gopal Jain and a team of Khaitan & CO. comprising Partners Ajay Bhargava and Aseem Chaturvedi with Associate Karan Gupta. Advocates Vanita Bhargava and Arvind Ray also appeared..Systopic Laboratories was represented by Advocate Deepak Kumar Mahapatra..Eris Lifesciences was represented by Advocates R Jawhar Lal, Siddharth Bawa and Shyamal Anand. .Centre was represented by Additional Solicitor General Maninder Acharya along with CGSC Kirtiman Singh and Advocates Ripu Daman Bhardwaj, Waize Ali Noor, Shruti Dutt and Parth Semwal. .Read the Judgement: