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W.P.(C) 10929/2018 and CM APPL. 42570/2018 & 42571/2018
ERIS LIFESCIENCES LIMITED Petitioner
Through: Mr R. Jawahar Lai, Mr Siddhartb Bawa and Mr Shyamal Anand;
Advocates.
Mr Waize Ali Noor, Mr Prateelt Dhanda and Ms Shruti Dutt.i
Ms Tanya Aggarwal, Advocate.
/ W.P.(C) 11087/2018 and CM APPL. 43088/2018 & 43089/2018
MANKIND PHARMA LIMITED Petitioner
Through: Mr R. Jawahar Lai, Mr Siddhartb Bawa and Mr Shyamal Anand,
Through: Mr Kirtiman Singh, CGSC with Mr Ripu Daman Hardwar, CGSC with
Mr Waize Ali Noor, Mr Prateek Dhanda and Ms Shruti Dutt.
Mr Rakesh Kumar, CGSC for UOI.
10.01.2019
ORDER
1. The petitioners have filed the present petitions impugning the notifications dated 07.09.2018 - being S.O. 4474(E) and S.O. 4475(E) issued by respondent no.l (Central Government) under Section 26A of the Drugs and Cosmetics Act, 1940.
2. The petitioner in W.P.(C) 11087/2018 impugns the notification no. S.O. 4474(E), whereby the manufacture, sale and distribution of the Fixed Dose Combinations (FDCs) of the formulation "Metformin 850 mg + Pioglitazone 7.[5] mg + Glimepiride 1 mg" have been proscribed.
3. In W.P.(C) 10929/2018, the petitioner has impugned the notification no. S.d. 4475(E), which proscribes themanufacture, sale and distribution or the FDCs of the formulation "Metformin 500 mg/500 mg + Gliclazide SR 30 mg/60 mg + Pioglitazone 7.[5] mg/7.[5] mg".
4. The said FDCs have been proscribed as they include Pioglitazone 7.S mg, which has not been approved by respondent no.2 (The Drug Controller General of India - DGCI) as a standalone drug. The Sub-Committee constituted to examine the matter of proscribing/restricting the said FDCs had also found that the evidence for efficacy of 7.[5] mg of Pioglitazone is insufficient and, therefore, had recommended prohibition ofthe said FDCs.
5. The learned counsel appearing for the parties state that the issue involved in the present case is covered by the decision of this Court in Unison Pharmaceuticals Pvt. Ltd. v. Union of India and Anr.: W.P.(C) 10403/2018 and other connected matters, decided on 08.01.2019. The said r-r /? decision was in respect ofthe challenge to notifications issued under Section 26A ofthe Act proscribing the FDCs which included Pioglitazone 7.[5] mg as one of its constituents.
6. For the reasons stated in the said decision, the present petitions are dismissed. The pending applications are also disposed of.
JANUARY 10, 2019 RK VIBHUBAKHRU,J