M/S BIOLOGICAL E LIMITED v. DRUGS CONTROLLER GENERAL OF INDIA AND ANR.
W.P.(C)/10130/2018 · 2025-01-29
Rekha Palli, Saurabh Banerjee
Writ Petition (Civil)body2025
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[ 2025 DAILYLAW 50027 (DEL) · dailylaw.ai ]
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[ 2025 DAILYLAW 50027 (DEL) · dailylaw.ai ]
Judgment text
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$~2, 3, 4, 5 to 10, 12 to 25, 31, 33 to 36, 39 to 42 * IN THE HIGH COURT OF DELHI AT NEW DELHI + W.P.(C) 9836/2018 & CM APPL. 42292/2018 –Impleadment ALKEM LABORATORIES LTD. .....Petitioner versus UNION OF INDIA AND ANR. .....Respondent + W.P.(C) 9837/2018 & CM APPL. 42191/2018 –Impleadment ALKEM LABORATORIES LTD .....Petitioner versus UNION OF INDIA AND ANR. .....Respondents + W.P.(C) 9857/2018 & CM APPL. 42287/2018 –Impleadment MACLEODS PHARMACEUTICALS LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA & ANR .....Respondents + W.P.(C) 9871/2018 ALKEM LABORATORIES LTD. .....Petitioner versus UNION OF INDIA AND ANR. .....Respondents + W.P.(C) 10037/2018 ALKEM LABORATORIES LTD. .....Petitioner versus UNION OF INDIA AND ANR. .....Respondents + W.P.(C) 10038/2018 ALKEM LABORATORIES LTD. .....Petitioner versus UNION OF INDIA AND ANR. .....Respondents + W.P.(C) 10040/2018 ALKEM LABORATORIES LTD. .....Petitioner versus UNION OF INDIA AND ANR. .....Respondents + W.P.(C) 10048/2018 ALKEM LABORATORIES LTD .....Petitioner versus UNION OF INDIA & ANR .....Respondents + W.P.(C) 10049/2018 ALKEM LABORATORIES LTD. .....Petitioner versus This is a digitally signed order. The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 01/07/2025 at 17:40:57
UNION OF INDIA AND ANR. .....Respondents + W.P.(C) 10105/2018 ALKEM LABORATORIES LTD. .....Petitioner versus UNION OF INDIA AND ANR. .....Respondents + W.P.(C) 10125/2018 ALKEM LABORATORIES LTD. .....Petitioner versus UNION OF INDIA AND ANR. .....Respondents + W.P.(C) 10228/2018 CIPLA LIMITED .....Petitioner versus DRUGS CONTROLER GENERAL OF INDIA AND ANR. .....Respondents + W.P.(C) 10310/2018 SYNCHEM LABORATORIES PVT LTD .....Petitioner versus UNION OF INDIA & ANR .....Respondents + W.P.(C) 10356/2018 PHARMA SYNTH FORMULATIONS LTD .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA & ANR. .....Respondents + W.P.(C) 10419/2018 ANTEX PHARMA PRIVATE LIMITED .....Petitioner versus UNION OF INDIA & ANR .....Respondents + W.P.(C) 10443/2018 ANTEX PHARMA PRIVATE LIMITED .....Petitioner versus UNION OF INDIA & ANR .....Respondents + W.P.(C) 10444/2018 ANTEX PHARMA PRIVATE LIMITED .....Petitioner versus UNION OF INDIA & ANR .....Respondents + W.P.(C) 10491/2018 SYNCHEM LABORATORIES PVT LTD .....Petitioner This is a digitally signed order. The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above.
The Order is downloaded from the DHC Server on 01/07/2025 at 17:40:57
versus UNION OF INDIA & ANR .....Respondents + W.P.(C) 10760/2018 INTAS PHARMACEUTICALS LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA & ANR .....Respondents + W.P.(C) 10761/2018 INTAS PHARMACEUTICALS LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA & ANR .....Respondents + W.P.(C) 10784/2018 TABLETS (INDIA) LIMITED .....Petitioner versus UNION OF INDIA AND ANR. .....Respondents + W.P.(C) 10801/2018 & CM APPL. 39219/2019 –Delay 124 days In filing counter affidavit. INTAS PHARMACEUTICALS LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA AND ANR. .....Respondents + W.P.(C) 11013/2018 & CM APPL. 42866/2018 –LLOD CIPLA LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA AND ANR. .....Respondents + W.P.(C) 11076/2018 CIPLA LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA AND ANR. .....Respondents + W.P.(C) 11096/2018 PHARMA SYNTH FORMULATIONS LTD. AND ANR. .....Petitioners versus DRUGS CONTROLLER GENERAL OF INDIA AND ANR. .....Respondents This is a digitally signed order. The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 01/07/2025 at 17:40:57
+ W.P.(C) 11098/2018 CIPLA LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA & ANR .....Respondents + W.P.(C) 11099/2018 CIPLA LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA AND ANR. .....Respondents + W.P.(C) 12565/2018 INTAS PHARMACEUTICALS LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA AND ANR. .....Respondents + W.P.(C) 12573/2018 INTAS PHARMACEUTICALS LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA AND ANR. .....Respondents + W.P.(C) 12574/2018 CIPLA LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA AND ANR. .....Respondents + W.P.(C) 12575/2018 INTAS PHARMACEUTICALS LIMITED .....Petitioner versus DRUGS CONTROLLER GENERAL OF INDIA AND ANR. .....Respondents Memo of Appearances: For Petitioners: Mr.Sagar Chandra, Ms.Shubhie Wahi & Ms.Ankita Seth, Advs. in W.P.(C) Nos.9836/2018, 9837/2018, 9871/2018, 10037/2018, This is a digitally signed order. The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 01/07/2025 at 17:40:57
10038/2018, 10040/2018, 10048/2018, 10049/2018, 10105/2018 & 10125/2018. Mr.Praveen Mahajan & Mr.Ronakjeet Singh, Advs. in W.P.(C) Nos.10310/2018 & 10491/2018. Ms.Vaishali Tanwar, Adv. in W.P.(C) 10444/2018. Ms.Sandhya Kukreti, Adv. in W.P.(C) Nos.10760/2018, 10761/2018, 10801/2018, 12565/2018, 12573/2018, 12575/2018 & 13331/2018. Mr.Abhishek Kumar Shrivastava, Adv.
in W.P.(C) 10784 For Respondents: Mr.Rajesh Gogna, CGSC with Ms.Priya Singh, Mr.Nishant Sharma & Mr.Nipun Jain, Advs. in W.P.(C) 10125/2018. Ms.Nidhi Raman, CGSC with Mr.Arnav Mittal, Mr.Zubin Singh & Mr.Akash Mishra, Advs. for UoI in W.P.(C) Nos.10049/2018 & 10228/2018. Mr.Sahaj Garg & Mr.Aakash Pathak, Advs. for UoI in W.P.(C) Nos.10310/2018 & 10491/2018. Ms.Arti Bansal & Ms.Shruti Goel, Advs. in W.P.(C) 10356/2018. Mr.Subhash Tanwar, CGSC with Mr.Sandeep Mishra, Ms.Bhavi Garg & Mr.Naveen, Advs. for UoI in W.P.(C) Nos.11013/2018 & 11076/2018. Mr.Rohan Jaitley, CGSC with Mr.Dev Pratap Shahi, Mr.Yogya Bhatia & Mr.Varun Pratap Singh, Advs. for UoI in W.P.(C) Nos.12565/2018, 12573/2018 & 12575/2018. Mr.Rajesh Kumar, Mr.Yash Narain & Mr.Rahul Kumar Sharma, Advs. for UoI in W.P.(C) 10784/2018. Mr.Dev P Bhardwaj, Adv. in W.P.(C) Nos.10419/2018, 10443/2018 & 10444/2018. Mr.Nishant Gautam, CGSC with Mr.Vipul Verma, Mr.Arindam Sarin, Mr.Vinay Kaushik & Ms.Ananya Sharma, Advs. for UoI. Mr.Ripudaman Bhardwaj, CGSC with Mr.Kushagra Kumar, Mr.Abhinav Bhardwaj & Mr.Amit Kumar Rana, Advs. for UoI. This is a digitally signed order. The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 01/07/2025 at 17:40:57
CORAM:
HON'BLE MS. JUSTICE REKHA PALLI HON'BLE MR. JUSTICE SAURABH BANERJEE O R D E R % 29.01.2025
1. In the present batch of writ petitions, the common challenge of the petitioners is to various notifications issued by the respondents banning the manufacture and sale of different Fixed Dose Combination (FDC) drugs, which were being manufactured and marketed by the petitioners. 2. We may note that vide the interim orders passed in the year 2018, even though the notifications were not stayed, the petitioners were permitted to sell the existing stock of FDCs available with them/ their stockist and/or retailers. 3. In the light of this position, it is evident that none of the petitioners have been manufacturing the subject FDC drugs for the last more than six years. 4.
In these circumstances, we have put to the learned counsel for the petitioners as to whether the petitioners are still keen to pursue their challenge. They pray for and are granted time to obtain instructions. 5. List on 24.02.2025. REKHA PALLI, J SAURABH BANERJEE, J JANUARY 29, 2025 kk This is a digitally signed order. The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 01/07/2025 at 17:40:57