Vibhu Bakhru JUDGMENT
Vibhu Bakhru, J.
1. The petitioners have filed the present petitions impugning notification no. S.O. 4479(E)(hereafter 'the impugned notification') issued by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940 (hereafter 'the Act'), whereby the manufacture, sale and distribution of the Fixed Dose Combination (FDC) of "Pioglitazone 30 mg + Metformin 500 mg" has been proscribed by the Central Government.
2. The Central Government has proscribed the manufacture, sale and distribution of the aforesaid FDC on account of inclusion of the formulation "Pioglitazone 30 mg" in the said FDC. The Subcommittee constituted to examine the matter of proscribing/restricting the said FDC observed that the increased dose of Pioglitazone involves risks to the patients, and further that there is no scientific justification for the said FDC. Accordingly, the Sub-committee had recommended prohibition of the said FDC. Since, the principal issue involved is common, the said petitions were heard together.
3. The impugned notification has been challenged by the petitioners, essentially, on the following grounds:
(i) that the Drug Technical Advisory Board (DTAB) was not in existence at the material time, when the Sub-committee was constituted for examining the matter regarding the FDC in question, and therefore, the constitution of the sub-committee was void.
(ii) that the impugned notifications are based on recommendations, which are unreasoned and made without application of mind.
(iii) That the finding of the Sub-committee, that there are safety concerns regarding Pioglitazone 30 mg, is incorrect and contrary to the material on record.
(iv) that the FDC in question has a sound therapeutic justification and poses no risk to human beings.
(v) that the recommendations made by the Sub-committee of DTAB is not in conformity with the direction issued by the Supreme Court in Union of India v. Pfizer Limited and Ors.: MANU/SC/1611/2017 : 2018 (2) SCC 39.
4. The respondents countered the aforesaid submissions. The respondents dispute that the directions issued by the Supreme Court in Pfizer Limited (supra) have not been followed. It is also contended that the impugned notification has been issued in exercise of legislative powers and the principles of natural justice are not required to be followed in such exercise.
Factual Background
5. The petitioner in W.P.(C) 10917/2018 manufactures and markets the FDC comprising of "Pioglitazone 30 mg + Metformin 500 mg" under the brand name of "Gluconorm P 30"; the petitioner in W.P.(C) 11271/2018 in engaged in the manufacturing and sale of the FDC comprising of "Pioglitazone Hcl 30 mg + Metformin Hcl 500 mg (Sustained Release - SR) under the brand name of "Glitaris M 30"; and the petitioner in W.P.(C) 10965/2018 manufactures and sells the FDC comprising of "Pioglitazone Hydrochloride IP Equivalent to Pioglitazone 30 mg +Metformin Hydrochloride IP 500 mg (in sustained release form)" under the brand name of "PIO-M 30".
6. The aforesaid FDC (Pioglitazone 30 mg + Metformin 500 mg) is hereafter referred as "the FDC in question".
7. The Central Drugs Standard Control Organization (CDSCO) had constituted an Expert Committee of comprising of ten experts for examining the efficacy of the FDCs which were manufactured and sold in the market by various manufacturers. The Expert Committee so constituted did not recommend the FDC in question. A similar view was expressed by another Expert Committee ........