Citation Codes

Equivalent Citations

citation codes

Case Number

Criminal Suo-Moto Public Interest Litigation No. 02 of 2021

Disposition

dismissed

Attorney(S)

Shri D.R. Kale, Chief Public Prosecutor /State.
Shri Ajay G. Talhar, ASGI No. 1;
Shri S.G. Chapalgaonkar, Advocate no. 8;
Shri S.R. Patil, Advocate No. 20;
Shri K.N. Lokhande, Advocate No. 22;
Shri D.M. Shinde, Advocate No. 23;
Shri R.K. Ingole, Advocate no. 25.
Shri Satyajit S. Bora, Advocate appointed as Amicus Curiae;

Judges

SHRI. UJJAL BHUYAN
RAVINDRA V. GHUGE, J.

Acts

Rule 62(8) of the Maharashtra Motor Vehicles Rules,

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Smart Summary

Structured Summary of the Provided Court Opinion

Factual and Procedural Background

The Attorney General's side (learned ASGI) placed before the court an affidavit sworn by Shri G.K. Pillai, Under Secretary, Ministry of Health and Family Welfare (MoHFW), dated 28.05.2021. The affidavit's pagination was incorrect (pages 179 to 331), so it was received and marked as exhibit "X-19" for identification. No supporting affidavit accompanied it. The deponent was stated to be in Aurangabad on the day.

The Chief Public Prosecutor produced a day-to-day report prepared by the Government Medical College and Hospital (GMCH) concerning the use of 113 ventilators from 12.04.2021 onwards. That five-page report, signed by eight ICU doctors documenting ventilator utilization and failures, was taken on record and marked as exhibit "X-20".

The GMCH report (X-20) recorded that the ventilators developed errors from first use; many ventilators installed or distributed were returned by hospital ICUs and private hospitals because they were allegedly not functioning properly and patients complained of breathlessness and related symptoms. The GMCH Committee (eight senior doctors) concluded that the machines were unsafe for patient use and decided not to test them on patients henceforth.

The court also considered an explanation by the Manufacturer (Annexure R-7 in X-19) and engagements between the Manufacturer's service engineers and GMCH. The matter is being dealt with as part of a criminal suo motu public interest litigation (PIL) and was listed for further hearing.

Legal Issues Presented

Whether the ventilators supplied (manufactured by M/s. Jyoti CNC Automation Limited, Rajkot) are malfunctioning and unsafe for patient use as reported by the GMCH (exhibit X-20).
Whether the MoHFW's affidavit (X-19) and the Manufacturer's explanation (Annexure R-7) adequately rebut the medical institution's findings and justify disposal of the PIL.
Who bears responsibility—Manufacturer, procuring agency, State authorities, or the hospitals—for ensuring functionality, infrastructure, training and remedial steps when sophisticated medical equipment supplied to public hospitals malfunctions.
Interim administrative questions: whether remedial steps (repairs, replacements, training) will be undertaken and when the matter should be next listed for further directions.

Arguments of the Parties

Learned ASGI / Ministry of Health and Family Welfare (MoHFW)

Affidavit X-19 (Sworn by Shri G.K. Pillai) asserts that 150 ventilators were never supplied through the PM Cares Fund (denial of earlier announcement that they were so funded).
The ventilators were manufactured by M/s. Jyoti CNC Automation Limited, Rajkot.
All ventilators were tested using world-class testing parameters and are accompanied by instruction/user manuals.
The Central Government provides intensive digital training for installation, operation and maintenance to States for COVID-19 management; MoHFW and the procuring agency (HLL Lifecare Ltd.) will organize online intensive digital training for doctors, paramedics and biomedical engineers.
The machines are modern, sophisticated and highly complex; the affidavit suggested that doctors and paramedics at Aurangabad lack proper training to operate them.
The Manufacturer had provided an explanation (Annexure R-7) and, according to MoHFW, there was no material to conclude ventilators were not working satisfactorily; operating status of the 113 ventilators reportedly showed "OK".
At a later point, the ASGI indicated MoHFW would take remedial steps and ensure proper operation or removal of defects.

Manufacturer (as per Annexure R-7)

The GMCH allegedly was non-cooperative from acceptance/delivery and the local District Collector had to direct unloading and acceptance.
There is assertedly nothing on record demonstrating that the ventilators are malfunctioning.
The operators are not following the user manual and training videos.
GMCH did not use the helpline or e-mail channels on the instrument to lodge complaints.
GMCH allegedly has inadequate infrastructure, impeding proper use.
Manufacturer claims about 300 ventilators are performing satisfactorily in other states/regions; concludes there is no fault on manufacturer's part and it cannot be held responsible for GMCH inadequacies.

Government Medical College and Hospital (GMCH) / Dean / Committee of Doctors

Report X-20, prepared and signed by eight senior ICU doctors, documents ventilator failures from day one and multiple instances where ventilators were returned as not functioning properly; patients complained of breathlessness and other symptoms within hours of use.
The committee recorded that ventilators from other manufacturers were functioning successfully over long periods, whereas the ventilators from Jyoti CNC Rajkot were malfunctioning despite major repairs.
Final conclusion of the committee: these machines are unsafe for patient use and should not be tested on patients henceforth.

Learned Amicus Curiae and Chief Public Prosecutor

The Amicus curiae noted that, as of the hearing, no hospital which received these ventilators had reported any ventilator operating satisfactorily.
The Chief Public Prosecutor indicated the Manufacturer attempted some rectifications but maintained that even at that time not a single ventilator was operational.
Given one-year warranty and likely public payment for the machines, the Chief Public Prosecutor suggested the Manufacturer is duty-bound to ensure proper operation or replacement of the ventilators.

Table of Precedents Cited

No precedents were cited in the provided opinion.

Court's Reasoning and Analysis

The court analysed the matter on two related planes: administrative responsibility and the evidentiary value of the competing accounts (GMCH report versus MoHFW/Manufacturer statements).

First, the court observed that "Public Health and Hospitals" falls under entry 6 of the State List and that the State Government therefore bears legislative, executive and administrative responsibility under Article 162 for the subject. The court inferred that State authorities must, before accepting or acquiring medical equipment for public medical facilities, require manufacturers to undertake full cooperation and assistance in the event of dysfunction, breakdown or sub-optimal performance.

Second, on the evidentiary and factual contest, the court expressed inability to accept the ASGI's contention—based on affidavit X-19—that the ventilators are in perfect operating condition and that hospital personnel lack training. The court found the affidavit to have "a semblance" of defending the Manufacturer and described its tenor as insensitive to patient safety. The court emphasised that the affidavit did not engage with or refute the six specific reasons listed by the Dean/GMCH for malfunctioning ventilators (as recorded in X-18/X-20).

The court specifically criticized the ASGI for adopting a stance that effectively questioned the GMCH report rather than showing sensitivity toward patients and focusing on remedial action. The court found the Manufacturer's claims (Annexure R-7) asserting non-cooperation by GMCH and satisfactory performance elsewhere insufficient, given the medical committee's contemporaneous report of failures and patient complaints.

As a consequence of these findings, the court required MoHFW (through the learned ASGI) to seek proper instructions in light of the GMCH report (X-20) and to apprise the court of remedial steps necessary to address the ventilator failures. The court also requested information on whether the Manufacturer and procuring agency had inquired whether GMCH had the infrastructure to operate the machines and whether any specific training had been imparted to local technicians.

Holding and Implications

Core Ruling: The court did not accept the MoHFW/ASGI's contention that the ventilators were satisfactorily operating and found the GMCH report raising serious concerns that required further inquiry and remedial action. Consequently, the matter was adjourned for further hearing.

Direct Orders and Immediate Consequences:

The court directed that the issue relating to the ventilators be taken up on 2 June, 2021. The learned ASGI was expected to obtain proper instructions in light of report X-20 and to apprise the court of the remedial steps necessary to be undertaken.
On the point of whether Manufacturer/procuring agency had ensured infrastructure and training at GMCH, the court asked MoHFW to provide specific information and to refrain from questioning medical expert reports in a manner that detracts from patient welfare.
On the separate issue of Amphotericin B (mucormycosis treatment), the court recorded information placed before it: a coordinate bench's order noting severe demand, the Central Government's initiative to issue fresh manufacturing licences, and an expectation of 250,000 vials in June 2021. The court listed the supply issue for further consideration on 3 June, 2021 (learned Chief Public Prosecutor to state supply to Marathwada region on that date).
On reported ambulance overcharging, the court observed that aggrieved patients/relatives may complain to the District Collector—who, as Chairperson of the Regional Transport Authority and the Disaster Management Act authority for the district, could deal with such complaints—and that District Collectors should handle such complaints in accordance with established procedure.

Implication Regarding Precedent: The opinion does not purport to lay down any new legal precedent. The court's directions are case-specific and administrative in nature: (a) to obtain instructions and remedial proposals from MoHFW/manufacturer/procuring agency, and (b) to have the District Collector address ambulance fare complaints. No broader legal principle was declared as binding precedent in the text of the opinion.

Next listings recorded in the opinion: ventilator issue—2 June, 2021; Amphotericin B supply statement—3 June, 2021.

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Registrar (Judicial), High Court Of Judicature Of Bombay v. Union Of India And Others

1. The learned ASGI has tendered before us an affidavit sworn by Shri G.K. Pillai, Under Secretary, MoHFW, Government of India, dated 28.05.2021. Since the pagination of the said affidavit (179 to 331) is incorrect, we are marking the said document as X-19, for identification. There is no supporting Affidavit. The deponent is stated to be in Aurangabad today.

2. The Chief Public Prosecutor has placed before us a ‘day to day’ report prepared by the GMCH as regards the use of the 113 ventilators, from 12.04.2021 onwards. The said report is signed by eight doctors who deal with ICU and the utilization of ventilators. The said report (5 pages) is taken on record and marked as “X-20” for identification.

3. The report indicates that the ventilators developed errors from day one. The Company Engineers installed 25 ventilators in the Medicine Department and 2 5 ventilators were distributed to the District and private hospitals. All such 25 ventilators were returned by the ICU departments of the concerned hospitals, as they were not functioning properly and patients had started complaining about breathlessness and associated symptoms within hours of the ventilators having been switched on. Private hospitals also returned the ventilators stating that they were not working properly. On 06.05.2021, the Service Engineers of the Manufacturer were informed and a Team of three technicians visited the GMCH on 12.05.2021. On 14.05.2021, a Company Service Engineer joined the Team and calibrated ‘in-put oxygen’ regulators of two ventilators. They worked well overnight and next day by afternoon patients complained about poor oxygen and showed signs of restlessness. Several details are set out in said report X-20, which are quite shocking. Patients even from Super Specialty Block, Trauma ICU complained. The Committee noted that several other ventilators manufactured by different companies were being successfully used for more than six months to one year and it was only those ventilators manufactured by Jyoti CNC Rajkot, which were malfunctioning. Even after major repairs, the results set out below clause 10 of X-20 indicate the failure of the ventilators.

4. In the final conclusions of the Committee, comprising of senior eight doctors, it was opined that these machines are unsafe for patients use and it was decided not to test any of these machines on patients, henceforth.

5. We have perused the said affidavit X-19 and have puts several questions to the learned ASGI. Our interaction with the ASGI led to the following answers:—

(a) These 150 ventilators were never supplied through the P.M. Cares Funds. (As such, there is a complete denial that these ventilators were funded through the P.M. Cares Funds, as was earlier announced).

(b) These ventilators are manufactured by M/s. Jyoti CNC Automation Limited, Rajkot.

(d) Each ventilator is accompanied by an instruction/user manual.

(e) Intensive Digital Training for installation, operation and maintenance of ventilators is provided to the States by the Central Government for Covid-19 management.

(f) These are modern ventilators, which are highly complex and are sophisticated medical equipments.

(g) Doctors and paramedics are not properly trained to operate such ventilators at Aurangabad.

(h) MoHFW and the Procurement Central Public Sector Enterprise/Agency, namely HLL Lifecare Limited will organize online Intensive Digital Training Course for doctors. Paramedics, Biomedical Engineers etc.,

(i) The complaints of the medical institutions/hospitals will have to be assessed objectively.

(j) Optimum utilization of ventilators will be undertaken to identify further training needs and ensure overall improvement.

(k) The Manufacturer shall ensure that their Technical Experts are available and they will work in close coordination with the Teams at the respective locations.

(1) The Teams would comprise of one representative from M/s. HLL Lifecare Ltd., Directorate General of the Health Services (DGHS) and Central Drugs Standard Control Organization (CDSCO), each.

(m) After the Dean of the Government Medical College submitted a report, the MoHFW sought an explanation from the Manufacturer and the said explanation is at Annexure R-7 on page 298 of X-19.

(n) Considering the explanation given by the Manufacturer, there is no material before the MoHFW to conclude that the ventilators are not working satisfactorily.

(o) All the 113 ventilators are showing operating status as ‘OK’, and hence, the present Criminal Suo-moto PIL may be disposed off (The learned ASGI now submits that the submission of the affiant, praying for the disposal of the PIL, is being withdrawn).

6. The learned Amicus curiae submits that even today, not a single hospital/institution which was delivered with such ventilators, has submitted a report that even one ventilator is operating satisfactorily. The learned Chief Public Prosecutor submits on the basis of the instructions received by him today, that the manufacturer had made an effort to rectify some of the ventilators. However, even today, not a single ventilator is operational. Since there is one year warranty on these machines and as entire payment may have been made by the MoHFW through the public exchequer, it would be the duty of the Manufacturer to ensure proper operation of the machines or replace them.

7. We find from the explanation given by the Manufacturer, at Annexure R-7 (page 301 of Ex-19), as under:—

(a) The Government Medical College, Aurangabad was non-cooperative right from the acceptance of the delivery and the local District Collector had to direct the GMCH for unloading and accepting the ventilators.

(b) There is nothing on record to demonstrate that the ventilators are malfunctioning.

(d) The GMCH did not submit any complaint, either on the helpline number or the e-mail address pasted on the instruments.

(e) There is inadequate infrastructure at the GMCH and hence, the ventilators are not being used properly.

(f) 300 ventilators are performing satisfactorily in other States of India and other regions of Maharashtra and Aurangabad.

(g) There is no fault on the part of the manufacturer and it cannot be held responsible for inadequacies on the part of the GMCH.

8. We find that the subject “Public Health and Hospitals” is at entry-6 in the State list and the legislative powers as well as executive and administrative powers of the State Government pertaining to the said subject are covered by Article 162. Thus, this would be in the domain of the State Government and it would be answerable on this subject. Before accepting or acquiring such medical equipments/instruments, by any medical facility/hospital, the State Government should be making it mandatory for the Manufacturer to undertake fullest cooperation and assistance in the event of the equipment becoming dysfunctional or in the event of break down or the performance of such instrument not being at the optimum level.

9. We are unable to appreciate the contention of the ASGI on the basis of the affidavit X-19, that the ventilators are in perfect operating conditions and it is the hospitals, who do not have trained personnel to operate the said ventilators properly. The affidavit before us has a semblance of the affiant virtually defending the manufacturer and declaring that the ventilators are in operating condition. We find that such statements demonstrate insensitivity on the part of Ministry of Health and Family Welfare (MoHFW). Instead of expressing whole hearted support to ensure that such costly instruments are put to optimum utilization in the interest of the lives of the patients, it appears that the affiant found it advantageous to contend that there is no merit in the report of the Dean of the Government Medical College, and that this PIL should be disposed off. The tenor of the affidavit in reply is that the ventilators are in working condition and the deficiencies are with the hospitals and the doctors/paramedics/technicians. We would have appreciated had the affiant avoided entering into a blame game and instead shown sensitivity towards the patients, it being the paramount object of the welfare State to take care of the health of it's citizens.

10. The learned ASGI hastens to add that the manuf acturer has manufactured these instruments after following the prescribed procedure and the Dean of the Medical College is doubting the said machine and there is no material to fault the ventilators. With this statement of the learned ASGI, we find that he is questioning the report of the Dean, who has listed out six reasons as regards the defects in the ventilators, cognizance of which is taken by us on the last day and which reflects in our order passed on the said day. The affidavit X-19 does not even remotely refer to the six reasons as regards the malfunctioning of the ventilators cited by the GMCH in X-18. The ASGI has addressed us as if he is holding the brief for the Manufacturer.

11. In the backdrop of the above, the learned ASGI now submits that the MoHFW would take all remedial steps and ensure that the ventilators would operate normally and all defects, if any, would be removed. We, however, need to be apprised by the MoHFW, as to whether the manufacturer and procuring agency, which delivered the machines to the Government Medical College at Aurangabad, had ever inquired as to whether the GMCH had the infrastructure to operate the said machines and whether any specific training was imparted to the technicians, who were supposed to operate them. We would also appreciate if the MoHFW refrains from questioning the reports of the Medical Experts and instead respects such reports in the larger interest of the society and concentrates on rectifying the said machines.

12. In view of the above, we would be taking up this issue on 2 June, 2021. We expect the learned ASGI to seek proper instructions in the light of the report X-20 and apprise us of the remedial steps that would be necessary to be undertaken.

MUCORMYCOSIS

13. The learned Chief Government Pleader has placed before us an order passed by a Coordinate bench at Mumbai on 27.05.2021 in Public Interest Litigation No. 10276/2021 along with connected matters. The learned Bench has noted the submissions of the learned Advocate General that the treatment of Mucormycosis requires about 4-5 vials per patient per day for about 3-4 weeks and the approximate number of Mucormycosis patients in the State are about 3200, who would require 14000 vials per day. The allocation by the Central Government is approximately 4000-5000 vials per day.

14. The learned ASGI Shri Anil Singh has informed the learned Bench that the Central Government has taken initiatives to issue fresh licences to manufacturers, who intend to manufacture the drug. He expects a supply of 2,50,000 vials in the month of June, 2021.

15. The learned Chief Public Prosecutor informs us that there would be a rise in the supply of the drug for ‘Amphotericin B’ to treat the Mucormycosis patients and he would make the statement on 3 June, 2021 as regards the supply of number of vials of Amphotericin B’ to the Marathwada region. There is no dispute that even today, there is an insufficient supply of ‘Amphotericin B’ for treating patients in the Marathwada region. As such, we would take up this issue on 3 June, 2021.

AMBULANCE OPERATORS OVERCHARGING PATIENTS

16. The learned Amicus Curiae has placed before us news reports published in Divya Marathi/D.D. Star dated 26 May, 2021 and the reports published in Dainik Lokmat Today. The reporter of Divya Marathi has resorted to a sting operation and has published the discussions between the reporter and several Ambulance operators, which indicate that the Ambulance operators are openly demanding multi-fold times of the approved rates of Ambulances. It is also stated in Divya City/Divya Marathi dated 28.05.2021, that the State Government has published the rates of fare to be paid to the Ambulances. These fares are suppressed and patients/relatives are compelled to pay multi-fold times the approved rates. The circular bearing the signatures of the Regional Transport Authority is also published in the said news report. The Deputy Regional Transport Officer has expressed a view that he has not received any complaint from any aggrieved patient/relative of a patient.

17. Shri Chapalgaonkar, the learned Advocate points out the powers of the Regional Transport Authority under Rule 62(8) of the Maharashtra Motor Vehicles Rules, vide which, the said Authority can prescribe the fare to be paid to Taxis and Ambulances. He submits that the District Collector is the Chair person of the Regional Transport Authority and he can deal with complaints as regards overcharging of the fare.

18. We are of the view that since the District Collector of every district is the authority under the Disaster Management Act, all aggrieved patients/relatives of patients would be at liberty to complain to the District Collector, if they have suffered such overcharging of Ambulance fare and the District Collector would deal with such complaints in accordance with the procedure as is laid down.

19. Stand over to 2 June, 2021.

Registrar (Judicial), High Court Of Judicature Of Bombay v. Union Of India And Others

Structured Summary of the Provided Court Opinion

Factual and Procedural Background

Legal Issues Presented

Arguments of the Parties

Learned ASGI / Ministry of Health and Family Welfare (MoHFW)

Manufacturer (as per Annexure R-7)

Government Medical College and Hospital (GMCH) / Dean / Committee of Doctors

Learned Amicus Curiae and Chief Public Prosecutor

Table of Precedents Cited

Court's Reasoning and Analysis

Holding and Implications

Registrar (Judicial), High Court Of Judicature Of Bombay v. Union Of India And Others

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