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Delhi High Court - Orders

Manisha Chauhan vs Government Of Nct Of Delhi- & Anr on 17 May, 2021

Author: Vipin Sanghi

Bench: Vipin Sanghi, Jasmeet Singh

                                $~2,5,17,20,21 & 23.
                                *      IN THE HIGH COURT OF DELHI AT NEW DELHI
                                +      W.P.(C) 5256/2021 & CM APPL. 16155/2021, CM APPL.
                                       16156/2021

                                       MANISHA CHAUHAN                              ..... Petitioner
                                                       versus
                                       GOVERNMENT OF NCT OF DELHI- & ANR. ..... Respondent
                                                       Through:
                                +      W.P.(C) 3031/2020 & C.M. No. 15227/2021, C.M. No.
                                       15228/2021,C.M. No. 15229/2021, C.M. No. 15358/2021, C.M. No.
                                       15359/2021,C.M. No. 15360/2021, C.M. No. 15361/2021,C.M. No.
                                       15362/2021,C.M. No. 15363/2021, C.M. NO. 15481/2021, C.M.
                                       15482/2021, C.M NO. 15652/2021, CM NO. 15653/2021, C.M. NO.
                                       15845, CM. NO. 15869/2021, C.M.No. 15962/2021, C.M. Nos.
                                       16081-85/ 2021.

                                       RAKESH MALHOTRA                              ..... Petitioner
                                                     Through:
                                                     versus
                                       GOVERNMENT OF NATIONAL CAPITAL TERRITORY OF
                                       INDIA AND ORS                     ..... Respondent

                                +      W.P.(C) 5050/2021 & CM APPL. 15464/2021, CM APPL.
                                       15465/2021, CM APPL. 15466/2021, CM APPL 15694/2021

                                       BHAVREEN KANDHARI                            ..... Petitioner
                                                             versus

                                       GOVT OF NCT OF DELHI & ORS.                  ..... Respondent

                                +      W.P.(C) 5100/2021 and CM APPL. 15623/2021
                                       MANISHA GUPTA                             ..... Petitioner
                                                             versus



Signature Not Verified
Digitally Signed
By:BHUPINDER SINGH              W.P.(C) No. 3031/ 2020 & connected matters                       Page 1 of 10
ROHELLA
Signing Date:18.05.2021 17:22
                                        GOVT, OF N.C.T OF DELHI & ANR.                ..... Respondent
                                                      Through:

                                +      W.P.(C) 5102/2021 & CM Nos. 15635/2021 & 15636/2021
                                       ASEEMIT SOCIAL PROJECTS FOUNDATION..... Petitioner
                                                             versus

                                       UNION OF INDIA & ANR.                         ..... Respondent

                                +      W.P.(C) 5142/2021 & CM APPL. 15757/2021
                                       MANISHA GUPTA                                 ..... Petitioner
                                                             versus

                                       GOVT, OF N.C.T OF DELHI & ANR.                ..... Respondent

                                MEMO OF APPEARANCE

                                For Petitioners

                                Petitioner in person in W.P.(C) 3031/2020
                                Mr. Sanjeev Sagar and Ms. Nazia Parveen, Advocates in W.P.(C) 5256/2021
                                Mr. Krishnan Venugopal, Senior Advocate with Mr. Manan Verma,
                                Mr.Aditya N Prasad, Mr. Kaushik Mishra & Ms. Anmol Srivastava,
                                Advocates in W.P.C No. 5050/2021.
                                Mr.Sacchin Puri, Senior Advocate with Mr.Praveen K. Sharma and
                                Mr.Dhananjay Grover, Advocates for the petitioner in W.P.(C) Nos.
                                5100/2021
                                Ms. Karuna Nundy, Mr. Sarthak Maggon & Ms. Upasana, Advocates in
                                W.P.(C.) No. 5102/2021.
                                Mr. Abhinav Vashisht, Sr. Adv. with Mr. Sacchin Puri, Sr. Adv., Mr. JS
                                Bakshi, Sr. Adv. with Mr. Praveen K. Sharma, Mr. Dhanjay Grover, Mr.
                                Kamil Khan and Ms. Akshita Sachdeva, Advs. in W.P.(C) No. 5142/ 2021.

                                For Respondents.

                                Mr. Tushar Mehta, SGI, Mr. Chetan Sharma, ASG, Ms. Aishwarya Bhati,


Signature Not Verified
Digitally Signed
By:BHUPINDER SINGH              W.P.(C) No. 3031/ 2020 & connected matters                        Page 2 of 10
ROHELLA
Signing Date:18.05.2021 17:22
                                 ASG along with Ms. Monika Arora, Mr. Amit Mahajan, Mr. Anil Soni &
                                Mr. Anurag Ahluwalia, CGSCs, Mr. Kirtiman Singh, CGSC Mr. Syed
                                Husain Adil Taqvi, GP, Mr. Jivesh Kr. Tiwari, Ms. Nidhi Parashar, Mr.
                                Kanu Aggarwal, Mr. Kritagya Kumar Kait, Mr.Shriram Tiwary, Mr. Amit
                                Gupta, Mr. Akshay Gadeock, Mr. Sahaj Garg & Mr. Vinay Yadav, Mr.
                                Vidur Mohan, Mr. Waize Ali Noor and Mr. Taha Yasin, Advocates for
                                UNION OF INDIA in all the matters.
                                Mr. Rahul Mehra, Senior Advocate along with Mr. Satyakam, Mr. Santosh
                                Tripathi, SC Mr. Gautam Narayan, Mr. Anuj Aggarwal & Mr. Anupam
                                Srivastava, ASCs with Mr. Aditya P. Khanna, Ms. Dacchita Sahni, Ms.
                                Ritika Vohra and Mr. Chaitanya Gosain, Ms. Aayushi Bansal, Advocates for
                                GNCTD in all the matters.
                                Mr. Rajshekhar Rao, Senior Advocate (Amicus Curiae), Mr. Anandh
                                Venkataramani, Mr. Vinayak Mehrotra, Ms. Mansi Sood, Mr. Karthik
                                Sundar, Ms. Sonal Sarda, Mr. Areeb Y Amanullah, Advocates in all the
                                matters.
                                Mr. Anil Grover, Senior Additional Advocate General for Haryana along
                                with Ms.Bansuri Swaraj, Additional Advocate General for Haryana and Mr.
                                Siddhesh Kotwal, Ms. Manya Hasija & Ms. Ana Upadhyay, Advocates.
                                Mr. Aseem Chaturvedi & Mr. Ajay Bhargav, Advocates for M/s INOX.
                                Mr. Divya Prakash Pande, Advocate for South Delhi Municipal Corporation.
                                Mr. Abhinav Tyagi, Advocate for M/s Seth Air Products.
                                Ms. Malvika Trivedi, Senior Advocate with Mr. Tanmay Yadav,
                                Ms.Abhisree Saujanya, Ms. Nihaarika Jauhari, Ms. Eysha Marysha,
                                Ms.Vidhi Jain, Advocates along with Ms. Kritika Gupta, applicant in person.
                                Ms. Garima Prashad, Senior Advocate with Mr. Abhinav Agrawal,
                                Advocate.
                                Mr. Ankur Mahindro & Ms Sanjoli Mehrotra, Advocates for intervener.
                                Mr. Om Prakash & Mr. Pradeep Kumar Tripathi, Advocates for the
                                applicant in C.M. No. 15651/2021.
                                Mr. Rohit Priya Ranjan, Advocate for M/s Goyal Gases.
                                Mr. Abhishek Nanda, Advocate for IRDAI.
                                Ms. Urvi Mohan, Adv. for DBOCWW Board.
                                Ms. Himanshi Nailwal with Mr. Ambuj Tiwari, Mr. Ankur Garg, Mr. Akhil
                                Mitta, Advocates in C.M. No. 15922/21
                                Ms. Nitya Ramakrishnan, Sr. Adv. with Mr. Prasanna S, Ms. Vinoothna
                                Vinjam and Mr. Ritesh D, Advocates in C.M. NO. 15962/2021.
                                Ms. Shweta Kabra, Advocate for India Glycols Limited.


Signature Not Verified
Digitally Signed
By:BHUPINDER SINGH              W.P.(C) No. 3031/ 2020 & connected matters                         Page 3 of 10
ROHELLA
Signing Date:18.05.2021 17:22
                                 Mr. Tushar Sannu, Standing Counsel, IHBAS with Mr. Ankit Bhadouriya
                                and Mr.Subham Jain, Advocates for IHBAS.

                                       CORAM:
                                       HON'BLE MR. JUSTICE VIPIN SANGHI
                                       HON'BLE MR. JUSTICE JASMEET SINGH

                                                                        ORDER

% 17.05.2021

1. It has been pointed out by Mr. Rao, the learned Amicus that in paragraph 12 of our order dated 10.05.2021, in the third line from the bottom, the word "sanitize" has been typed, in place of "sensitize". The said typographical error is corrected. The relevant line would read "The State should sensitize the Petrol Pumps through their local police and, wherever necessary, assistance may be provided. Status report in this regard be filed by 20.05.2021."

2. It has also been brought to our notice that in our order dated 13.05.2021, the date of the order has been incorrectly typed as 11.05.2021 on the last page. The said typographical error has been corrected by us in the order dated 13.05.2021 under the initials of one of us (Vipin Sanghi, J).

3. Mr. Sagar, who appears for the petitioner in W.P.(C) No. 5256/ 2021

- wherein the petitioner has raised issues relating to hoarding and black marketing of medicines and medical equipment, and other related issues, raises a grievance that by not issuing a notification under the Essential Commodities Act in respect of Oxygen Concentrators, and other equipment, the Central Government is failing in ensuring that such undesirable activities do not continue.

4. The learned Amicus, Mr. Rao, however, points out that the term Signature Not Verified Digitally Signed By:BHUPINDER SINGH W.P.(C) No. 3031/ 2020 & connected matters Page 4 of 10 ROHELLA Signing Date:18.05.2021 17:22 "Essential Commodity" has been defined under Section 2(A) of the Essential Commodities Act, 1955 ("ECA"). Section 2(A)(1) states that "essential commodity" means a commodity specified in the schedule of the ECA. The schedule to the ECA includes "Drugs" as the first entry. The explanation to the said entry further explains that "Drugs" has the meaning assigned to it in clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940 (DCA).

5. Mr. Rao submits that Section 3(b)(iv) of the DCA defines "Drug" to include, inter alia, "such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;"

6. Mr. Rao further submits that "medical devices" are defined under Rule 3(zb) of the Medical Devices Rules, 2017 (MDR), which are framed under Sections 12(1) and 33(1) of the DCA, and include such devices as are notified from time to time under Section 3(b)(iv) of the DCA. Thus, any device which is duly notified for inclusion would be a "medical device", and would fall within the definition of a "drug". He has also brought to our notice Notification No. S.O. 648(E), dated 11.02.2020, issued by the Ministry of Health and Family Welfare, in pursuance of sub Clause (iv) of Section 3 of the DCA, by which a vide range of devices were notified for inclusion as "medical devices" in the following terms:

"all devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination ... for one or more of the specific purposes of - ...
Signature Not Verified Digitally Signed By:BHUPINDER SINGH W.P.(C) No. 3031/ 2020 & connected matters Page 5 of 10 ROHELLA Signing Date:18.05.2021 17:22
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
...
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life"

7. Vide notification No. S.O. 1232(E) dated 31.03.2020, issued by the National Pharmaceutical Pricing Authority (NPPA) under the Ministry of Chemicals and Fertilizers, it was also clarified that all such Medical Devices would be governed by the provisions of the Drug (Price Control) Order, 2013 (DPCO), issued under Section 3 of the ECA Act. Accordingly, any device that is covered by the aforesaid notification dated 11.02.2020 will be independently governed by the provisions of both statutes i.e. the DCA read with the MDR, as well as the ECA read with DPCO.

8. Therefore, it appears that devices such as Oxygen Concentrators, flowmeters, and Oxymeters, which are used for the treatment of COVID 19 are squarely covered by the provisions of the ECA, and the grievance of Mr. Sagar to this effect may not be correct.

9. Mr. Sagar has drawn our attention to Clauses 19 and 20 of the DPCO, which has been issued under Section 3 of the ECA. These clauses have been the matter of debate during the hearing today, and they read as follows:

"19. Fixation of ceiling price of a drug under certain circumstances.- Notwithstanding anything contained in this order, the Government may, in case of extra-ordinary circumstances, if it considers necessary so to do in public interest, fix the ceiling price or retail price of any Drug for such period, as it may deem fit and where the ceiling price or retail price of the drug is already fixed and notified, the Government may allow an increase or decrease in the ceiling Signature Not Verified Digitally Signed By:BHUPINDER SINGH W.P.(C) No. 3031/ 2020 & connected matters Page 6 of 10 ROHELLA Signing Date:18.05.2021 17:22 price or the retail price, as the case may be, irrespective of annual wholesale price index for that year.
20. Monitoring the prices of non-scheduled formulations.-
(1) The Government shall monitor the maximum retail prices (MRP) of all the drugs, including the non-scheduled formulations and ensure that no manufacturer increases the maximum retail price of a drug more than ten percent of maximum retail price during preceding twelve months and where the increase is beyond ten percent of maximum retail price, it shall reduce the same to the level of ten percent of maximum retail price for next twelve months. (2) The manufacturer shall be liable to deposit the overcharged amount along with interest thereon from the date of increase in price in addition to the penalty."

10. Clause 19 extracted herein above enables the Government, in case of extraordinary circumstances, if it considers necessary so to do in public interest, to fix a ceiling price or retail price of any Drug for such period as it may deem fit, and where the ceiling price or retail price of the drug is already fixed and notified, the Government may allow an increase or decrease in the ceiling price or the retail price, as the case may be, irrespective of annual wholesale price index for that year.

11. On the other hand, Clause 20 permits the Government to monitor the maximum retail prices (MRP) of all the drugs, including the non-scheduled formulations and ensure that no manufacturer increases the MRP of a drug more than 10% of MRP during preceding twelve months and where the increase is beyond 10% of MRP, it shall reduce the same to the level of 10% of MRP for next twelve months. It further provides that the manufacturer shall be liable to deposit the overcharged amount along with interest thereon from the date of increase in price, in addition to the penalty.

Signature Not Verified Digitally Signed By:BHUPINDER SINGH W.P.(C) No. 3031/ 2020 & connected matters Page 7 of 10 ROHELLA Signing Date:18.05.2021 17:22

12. The submission of Mr. Sagar, as well as Mr. Sachin Puri, who appears for the petitioner in W.P.(C) No. 5100/ 2021 is that looking to the large scale hoarding and black marketing of Medical Devices - which are "Drugs" under the DCA, as well as the ECA, has taken place, the Central Government should, in these extraordinary times, and in public interest, fix the ceiling price or the MRP of medical devices, such as Oxymeters, Oxygen Concentrators, and others. On the other hand, the stand taken by the Union of India, and articulated before us by both Mr. Amit Mahajan, and Mr. Kirtiman Singh is that the Government is not inclined to fix either the ceiling price or the MRP for Medical Devices such as Oxygen Concentrators which qualify as "Drug" as that would have an adverse impact on the availability of Oxygen Concentrators in the market. Their submission is that most of the Oxygen Concentrators are imported, and there is very little production of such medical devices within the country. Fixation of the ceiling prices or the MRP of such Medical Devices would deter imports thereof into the country, since there is a global shortage, and there is very high demand internationally for the said Medical Devices. It is further argued that the prices of such Medical Devices keep fluctuating, and consequently it may not be possible to cap the prices of such Medical Devices by fixing either the ceiling price or MRP. On the other hand, the submission of Mr. Sagar and Mr. Puri is that the landed cost of such Medical Devices is known to the Government as the importers file the Bill of Entry, and all such goods are cleared through the Customs upon payment of duties and taxes, as are presently applicable. They submit that the Government could therefore arrive at a ceiling price or retail price in respect of every such consignment which arrives through import into India, by prescribing a Signature Not Verified Digitally Signed By:BHUPINDER SINGH W.P.(C) No. 3031/ 2020 & connected matters Page 8 of 10 ROHELLA Signing Date:18.05.2021 17:22 formula which takes into account the landed cost of such Medical Devices; the duties and taxes paid thereon and; a reasonable rate of return for the importer and others in the supply chain. They argue that the failure of the Government to fix a ceiling price or retail price of such like Medical Devices is leading to the MRP being fixed by the retailers at very high prices which cannot be justified looking to the landed cost of such Medical Devices, and the duties and taxes paid thereon. They also point out that the Government has exempted payment of Custom Duty on such devices and that benefit should be passed on to the customers.

13. To the submission of Mr. Mahajan and Mr. Kirtiman Singh that the international prices of such like Medical Devices keep fluctuating and, therefore, it is not feasible to fix the ceiling price or retail price of such Medical Devices, the answer given by Mr. Sagar and Mr. Puri is that even in respect of oil, the international prices fluctuate on a daily basis. Therefore, it should be possible for the Government to come out with a standard formula for fixation of the ceiling price or retail price of such like Medical Devices. They state that the ceiling price or the retail price may not be fixed in absolute terms i.e. Rupees or Paisa, however, if a formula were to be prescribed by adopting the said formula, the ceiling price or retail price could be worked out and save the consumers from being fleeced. The consumers would also be aware of the basis on which the retailers would charge them for such like Medical Devices if the formula is devised and put in public domain. Both Mr. Kirtiman Singh and Mr. Mahajan wish to take further instructions on this aspect. The Central Government should consider these aspects, and report status on 19.05.2021.

14. Mr. Rakesh Malhotra, petitioner in person W.P.(C) No. 3031/ 2020 Signature Not Verified Digitally Signed By:BHUPINDER SINGH W.P.(C) No. 3031/ 2020 & connected matters Page 9 of 10 ROHELLA Signing Date:18.05.2021 17:22 has submitted that there are numerous instances of patients who have recovered from COVID - 19, succumbing due to post-COVID complications. He submits that even earlier, in the year 2020, this Court had directed the group of experts of both the Governments, namely the GNCTD and the Central Government to evolve a protocol/ SOP to deal with post- COVID complications. He submits that since we are now witnessing a more contagious and lethal variant i.e. the Double Mutant Variant, it is essential that fresh protocols and SOP's be evolved to deal with post-COVID complications.

15. We are of the view that the ICMR is the competent body to look into the aspects and, accordingly, we direct the ICMR to examine this aspect, and report compliance on 20.05.2021.

16. List on 19.05.2021.

17. The matters need not be listed on 18.05.2021.

VIPIN SANGHI, J JASMEET SINGH, J MAY 17, 2021 N.Khanna Signature Not Verified Digitally Signed By:BHUPINDER SINGH W.P.(C) No. 3031/ 2020 & connected matters Page 10 of 10 ROHELLA Signing Date:18.05.2021 17:22