Delhi High Court - Orders
Vilco Laboratories Pvt. Ltd. & Ors vs Union Of India & Anr on 29 August, 2024
Author: Tushar Rao Gedela
Bench: Tushar Rao Gedela
$~35 to 39, 41, 45 & 48
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ W.P.(C) 11882/2024 & CM APPL. 49475/2024, CM APPL.
49476/2024, CM APPL. 49477/2024
VILCO LABORATORIES PVT. LTD. & ORS. .....Petitioners
Through: Ms. Archana Sahadeva, Advocate
versus
UNION OF INDIA & ANR. .....Respondents
Through: Mr. Kirtiman Singh, CGSC with Mr.
Waize Ali Noor, GP, Mr. Rudra
Paliwal, GP, Mr. Ranjeev Khatana,
Mr. Maulik Khurana and Mr. Varun
Pratap Singh, Advs. along with Mr.
Babu and Mr. R. Venkateshwar,
CDSCO for UOI
36
+ W.P.(C) 11884/2024 & CM APPL. 49481/2024, CM APPL.
49482/2024
MANKIND PHARMA LIMITED .....Petitioner
Through: Mr. Jawahar Lal, Ms. Meghna Kumar
and Mr. Cecil C. George, Advs.
versus
UNION OF INDIA & ANR. .....Respondents
Through: Mr. Kirtiman Singh, CGSC with Mr.
Waize Ali Noor, GP, Mr. Rudra
Paliwal, GP, Mr. Ranjeev Khatana,
Mr. Maulik Khurana and Mr. Varun
Pratap Singh, Advs. along with Mr.
Babu and Mr. R. Venkateshwar,
CDSCO 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 31/08/2024 at 03:29:42
37
+ W.P.(C) 11887/2024 & CM APPL. 49492/2024, CM APPL.
49493/2024
LEEFORD HEALTHCARE LIMITED THROUGH ITS
AUTHORIZED REPRESENTATIVE MR LOKESH .....Petitioner
Through: Mr. Udit Chauhan, Mr. Aditya
Prakash Arora, Ms. Kashish Khurana
and Mr. Ritvik Chouhan, Advs.
versus
UNION OF INDIA THROUGH THE SECRETARY MINISTRY OF
HEALTH AND FAMILY WELFARE & ANR. .....Respondents
Through: Mr. Kirtiman Singh, CGSC with Mr.
Waize Ali Noor, GP, Mr. Rudra
Paliwal, GP, Mr. Ranjeev Khatana,
Mr. Maulik Khurana and Mr. Varun
Pratap Singh, Advs. along with Mr.
Babu and Mr. R. Venkateshwar,
CDSCO for UOI
38
+ W.P.(C) 11888/2024 & CM APPL. 49494/2024, CM APPL.
49495/2024
MANKIND PHARMA LIMITED .....Petitioner
Through: Mr. Jawahar Lal, Ms. Meghna Kumar
and Mr. Cecil C. George, Advs.
versus
UNION OF INDIA AND ANR & ORS. .....Respondents
Through: Mr. Kirtiman Singh, CGSC with Mr.
Waize Ali Noor, GP, Mr. Rudra
Paliwal, GP, Mr. Ranjeev Khatana,
Mr. Maulik Khurana and Mr. Varun
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 31/08/2024 at 03:29:42
Pratap Singh, Advs. along with Mr.
Babu and Mr. R. Venkateshwar,
CDSCO for UOI
39
+ W.P.(C) 11889/2024 & CM APPL. 49496/2024, CM APPL.
49497/2024
NAVIL LABORATORIES PRIVATE LIMITED .....Petitioner
Through: Mr. Jawahar Lal, Ms. Meghna Kumar
and Mr. Cecil C. George, Advs.
versus
UNION OF INDIA & ANR. .....Respondents
Through: Mr. Kirtiman Singh, CGSC with Mr.
Waize Ali Noor, GP, Mr. Rudra
Paliwal, GP, Mr. Ranjeev Khatana,
Mr. Maulik Khurana and Mr. Varun
Pratap Singh, Advs. along with Mr.
Babu and Mr. R. Venkateshwar,
CDSCO for UOI
41
+ W.P.(C) 11893/2024 & CM APPL. 49510/2024, CM APPL.
49511/2024, CM APPL. 49512/2024
M/S OBSURGE BIOTECH LIMITED .....Petitioner
Through: Mr. Udit Chauhan, Mr. Aditya
Prakash Arora, Ms. Kashish Khurana
and Mr. Ritvik Chouhan, Advs.
versus
UNION OF INDIA & ANR. .....Respondents
Through: Mr. Kirtiman Singh, CGSC with Mr.
Waize Ali Noor, GP, Mr. Rudra
Paliwal, GP, Mr. Vedansh Anand, GP
with Mr. Ranjeev Khatana, Mr.
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 31/08/2024 at 03:29:43
Maulik Khurana and Mr. Varun
Pratap Singh, Advs. along with Mr.
Babu and Mr. R. Venkateshwar,
CDSCO for UOI
45
+ W.P.(C) 11933/2024 & CM APPL. 49629/2024, CM APPL.
49630/2024, CM APPL. 49631/2024
INDOCO REMEDIES LIMITED & ANR. .....Petitioners
Through: Ms. Archana Sahadeva, Advocate
versus
UNION OF INDIA & ANR. .....Respondents
Through: Mr. Kirtiman Singh, CGSC with Mr.
Waize Ali Noor, GP, Mr. Rudra
Paliwal, GP, Mr. Ranjeev Khatana,
Mr. Maulik Khurana and Mr. Varun
Pratap Singh, Advs. along with Mr.
Babu and Mr. R. Venkateshwar,
CDSCO for UOI
48
+ W.P.(C) 11940/2024 & CM APPL. 49654/2024, CM APPL.
49655/2024
NAVIL LABORATORIES PRIVATE LIMITED .....Petitioner
Through: Mr. Jawahar Lal, Ms. Meghna Kumar
and Mr. Cecil C. George, Advs.
versus
UNION OF INDIA AND ANR .....Respondents
Through: Mr. Kirtiman Singh, CGSC with Mr.
Waize Ali Noor, GP, Mr. Rudra
Paliwal, GP, Mr. Ranjeev Khatana,
Mr. Maulik Khurana and Mr. Varun
Pratap Singh, Advs. along with Mr.
Babu and Mr. R. Venkateshwar,
CDSCO 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 31/08/2024 at 03:29:43
CORAM:
HON'BLE THE ACTING CHIEF JUSTICE
HON'BLE MR. JUSTICE TUSHAR RAO GEDELA
ORDER
% 29.08.2024
1. Present writ petitions have been filed challenging the Notifications bearing S.O. No. 3355 (E), S.O. No. 3294 (E), S.O. No. 3368 (E), S.O. No. 3388 (E), S.O. No. 3340 (E), S.O. No. 3299 (E), S.O. No. 3330 (E), all dated 02nd August 2024, uploaded on 21st August, 2024 whereby the respondents have prohibited the manufacture for sale, distribution for human use of various fixed-dose combinations (FDCs) with immediate.
2. Learned counsel for the petitioners have drawn the attention of this Court to an order dated 28th June, 2023 passed in W.P.(C) No. 8593/2023 titled in Lupin Limited and Anr. v. Union of India and Anr. The said order passed by a Coordinate Bench reads as under:
"CM APPL. 32649/2023 (Exemption)
1. Exemption allowed, subject to all just exceptions.
2. The application stands disposed of.
W.P.(C) 8593/2023 & CM APPL 32648/2023
3. This is a petition seeking writ, order or direction to set aside the impugned notification S.O. 2405 (E) dated 2 June 2023 issued by Respondent 1 which prohibits manufacture for sale and distribution for human use, the Fixed Dose Combination (FDC) of Phenytoin + Phenobarbitone Sodium ("Subject FDC") with immediate effect. The Petitioner No. 1 has been manufacturing the Subject FDC under the brand name, EPILAN.
4. The petitioner manufactures the said tablet since 2022 containing the above mentioned FDCs.
5. The impugned notification based on the recommendations of the Expert Committee and Drugs Technical Advisory Board has prohibited the manufacture for sale or distribution for human use or drug FDC of Phenytoin + Phenobarbitone Sodium ("Subject FDC") with immediate 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 31/08/2024 at 03:29:43 effect. The Petitioner No. 1 has been manufacturing the Subject FDC under the brand name, EPILAN.
6. In the present case, it is stated that the impugned notification only states that the FDC may involve risk in human beings without specifying the reasons / extent and the nature. In addition, the FDC has been in the market marked since 1988.
7. Issue notice. Mr. Rakesh Kumar, learned CGSC accepts notice, seeks and is granted two weeks to file a reply.
8. In somewhat similar circumstances, this Court in WP(C) 8465/2023 vide order dated 14 June 2023 granted interim protection for the drugs already in the distribution network. Hence, it is directed that the drugs which are already in the distribution channel shall not be withdrawn. However, no fresh manufacture of the drug will take place till the next date of hearing. In addition, no coercive steps will be taken against the petitioner for the drugs which are already in the distribution channel.
9. It is clarified that the direction against taking of coercive action would apply with respect to stocks manufactured on or before 2 June 2023 and that the distribution channel would cover all persons including stockists, wholesalers, retailers etc., with whom the stocks or the drug in question may be present after they have left the premises of the petitioner.
10. The parties will complete the pleadings and list the matter before the Roster Bench on 3 July 2023.
11. The petitioner will file the details of their stock as on 2 June 2023 before the next date of hearing and will give the affidavit of stock in circulation."
2. In light of the aforesaid order passed by the Co-ordinate Bench and in order to maintain parity, it is directed that the interim-order, extracted above, shall apply mutatis mutandis in respect of the drugs which are subject matter of the present writ petitions.
3. The petitioners shall file details of the stock of their respective drugs as on today, if not filed earlier, within three days from today. They shall also give an affidavit of stock in circulation, within three days.
4. As prayed for, the respondent/Union of India is granted four weeks' time to file a counter-affidavit. Rejoinder, if any, be filed on or before the next date of hearing.
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 31/08/2024 at 03:29:43
5. List on 10th December, 2024.
ACTING CHIEF JUSTICE TUSHAR RAO GEDELA, J AUGUST 29, 2024 ns 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 31/08/2024 at 03:29:43