Horizon Bioceuticals Pvt Ltd v. Drugs Controller General of India & Anr

NAVIN CHAWLA, J NOVEMBER 05, 2019/rv

Page 1 * IN THE HIGH COURT OF DELHI AT NEW DELHI Reserved on: 10.10.2019 Date of Decision : 05.11.2019 + W.P.(C) 10111/2018 & CM APPL. 39483/2018 & 39411/2019 ALKEM LABORATORIES LTD. ..... Petitioner Through: Ms.Ishani Chandra & Ms.Shubhie Wahi, Advs. versus UNION OF INDIA AND ANR. ..... Respondents Through: Mr.Kirtiman Singh, CGSC & Mr.Ripu Daman Bhardwaj, CGSC with Mr.Waize Ali Noor, Mr.Rohan Anand, Mr.Prateek Dhanda & Mr.T.P. Singh, Advs. + W.P.(C) 10751/2018 & CM APPL. 41873/2018, 41874/2018 & 41875/2018 M/S LEEFORD HEALTHCARE LTD. ..... Petitioner Through: Mr.Aditya P.Arora and Mr. Udit Chauhan, Adv. versus UNION OF INDIA AND ANR. ..... Respondents Through: Mr.Kirtiman Singh, CGSC & Mr.Ripu Daman Bhardwaj, CGSC with Mr.Waize Ali Noor, Mr.Rohan Anand, Mr.Prateek Dhanda & Mr.T.P. Singh, Advs. + W.P.(C) 11285/2018 & CM APPL. 43810/2018 & 43811/2018 HORIZON BIOCEUTICALS PVT LTD ..... Petitioner Through: Mr.Prabhat Kr. Chaurasia, Adv. versus DRUGS CONTROLLER GENERAL OF INDIA & ANR ..... Respondents Through: Mr.Kirtiman Singh, CGSC & Mr.Ripu Daman Bhardwaj, CGSC Page 2 with Mr.Waize Ali Noor, Mr.Rohan Anand, Mr.Prateek Dhanda & Mr.T.P. Singh, Advs. + W.P.(C) 11399/2018 & CM APPL. 44090/2018 & 44091/2018 ZEE LABORATORIES LTD. ..... Petitioner Through: Mr.Siddhant Bambha, Adv. versus UNION OF INDIA AND ANR. ..... Respondents Through: Mr.Kirtiman Singh, CGSC & Mr.Ripu Daman Bhardwaj, CGSC with Mr.Waize Ali Noor, Mr.Rohan Anand, Mr.Prateek Dhanda & Mr.T.P. Singh, Advs. CORAM: HON'BLE MR. JUSTICE NAVIN CHAWLA 1. These petitions have been filed challenging the Notification bearing SO No. 4380 (E) dated 07.09.2018, issued by the respondent no.1, prohibiting the manufacture, sale and distribution for human use of drug Fixed Dose Combination (FDC) of Nimesulide + Diclofenac with immediate effect. The above Notification has been passed by the respondent no.1 exercising its power under Section 26A of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the "Act"). 2. Section 26A of the Act is reproduced hereinunder:- "26A. Powers of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest.— Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or Page 3 contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by Notification in the Official Gazette, [regulate, restrict or prohibit] the manufacture, sale or distribution of such drug or cosmetic." 3. As the present petition has a history attached to it, it would be useful to first briefly indicate the same. 4. By the Notification No. 706 E dated 10.03.2016, the respondent no.1 had prohibited the manufacture and sale of the above drug in exercise of its power under Section 26A of the Act. The said order was passed based on a report of an Expert Committee known as Kokate Committee Report. The recommendation of the said Committee insofar as the above drug is concerned, is reproduced hereinbelow:- Final Recommendations of the Experts Committee during the meetings held w.e.f 4th to 9th January, 2016 with respect to applications of FDCs received by the O/O DCG (T) for proving safety and efficacy categorized under category "a" S.No of main list Name of FDC Strengt h Dosage Form Categorization of the FDC by the Experts Committee as per Terms of references Final Recommendations by Committee Xxxx Nimesul ide BP + Diclofen ac Soduim IP 100mg +50 mg Soft Gelatin Capsules a, 1. Nimesulide in combination has potential of misuse and have documented safety concern. 2. No addition advantage but hepatotxi potential of nimesulide and adverse effects add up. 3. Pharmacodynami cally irrational FDC as bo