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Judgment
Heard Shri Bhanudas Kulkarni, learned Counsel for the Indian Medical Association - respondent No.10. He was assisted by Dr. Nikhade, the
Chairman of Mucormycosis Task Force established by the local authorities. We have also heard him. Perused the affidavit filed by the Indian Medical
Association - respondent No.10, with the assistance of Shri Bhanudas Kulkarni and Dr.Nikhade.
The affidavit is very enlightening and it clears many a doubt about the prevalence and spread of fungal infections. It not only deals with the types of
fungal infections but also the causes, symptoms, precautions to be taken and the medicines presently available for effectively tackling these infections.
It also contains good suggestions. We are of the view that if the suggestions given in this affidavit are considered seriously and implemented by all the
hospitals, private and government, presently treating the Covid patients and also patients with fungal 3 26smpil4.20 infections, there will be
considerable reduction in prevalence and spread of the fungal infections. Simultaneously, the State Government as well as the Central Government
need to take the issue of shortage of drugs available for treating the fungal infections seriously.
Although, now it is well known that raw- materials used for manufacturing these drugs which are Amphotericin B (Lipid Complex) and
Amphotericin (Liposomal) are imported for their bigger part, if effective steps are taken by the Central Government for their import, it would amount
to valuable service rendered to Indian Society. After all, such invaders; fungii are the invaders; require speedy action and they do not wait for anybody
to respond to them. It's not the case that once they raid a house i.e. body of the patient, they would lie dormant and wait for the house owner to make
his preparations and then have a word or duel of resistance wih them. The response to be given in such situations is akin to a response given in a war
like situation. Unless quick action is taken, destruction is inevitable and it is with this view and such concern that we urge the Central Government as
well as the State Government to take immediate steps for increasing the production capacity of Indian manufacturers which are involved in producing
these drugs. Whatever help is needed by them, must be made available by the Central Government and the State Government forthwith. The entire
State machinery, if required, can be 4 26smpil4.20 pressed into service for increasing of the production capacity without any further delay. We hope
that the Central Government as well as the State Government will initiate urgent measures on this front and bring badly required relief to the patients
struggling for survival because of these infections.
So far as Nagpur is concerned, affidavit of Indian Medical Association - respondent No.10 brings on record seriousness of the issue of fungal
infections. In Nagpur city, as of 29th May, 2021, number of patients suffering from Mucormycosis is 1584 and out of these patients 830 patients have
been operated so far. It means that more than 50% of the affected patients have undergone surgery as part of treatment given to them. The data
further shows that out of 1584 patients, eye exenteration which, in common terms, is known as surgical removal of eye ball, has taken place in 74
cases and so far 69 patients have succumbed to Mucormycosis. These are extremely alarming figures especially when it is acknowledged by the
experts that Mucormycosis infection and other fungal infection caused by fungus Candida Auris are rare. It appears from these figures that in Nagpur
city this is no longer a rare fungal infection, that it has already become common, and it has assumed a form of an epidemic.
There have also been reports coming from different parts of the country which are equally alarming so far as fungal infections due to fungus 5
26smpil4.20 Aspergillosis and the other fungus Candida Auris are concerned. So, if immediate measures are not taken, these infections, though
internationally stated to be rare infections, may take on a severe form of an epidemic in India.
These are the reasons why we have been repeatedly saying that the Central Government and State Government, and additionally, community of
experts in India and also Indian Society in general start taking effective measures for restricting the spread of fungal infections. These measures
would be of maintaining of individual cleanliness and hygiene through improvement of immunity levels by remaining on good diet and also keeping
contributing ailments like Hyperglycemia, diabetes and the like under control to making available in sufficient quantities drugs required for treating
these infections. The affidavit of respondent No.10 also speaks of these drugs. Two of them, Amphotericin B (Lipid Complex) and Amphotericin B
(Liposomal) have already been referred to by us. The other one is Echinocandian. As stated earlier, it will have to be ensured by the Central
Government as well as the State Government, at all costs, that these three drugs, which are presently considered to be effective answer to the
invading fungi remain in adequate supply.
Central Government has placed on record some information regarding the steps taken by it for procuring the raw-material from abroad in the pursis
6 26smpil4.20 dated 2nd June, 2021 filed on record today. On going through the pursis, it becomes clear that information contained in this pursis is no
more than what was stated in the earlier pursis. The earlier pursis vaguely referred to the efforts of the Central Government by making general
statements like steps are being taken to procure so many number of vials without giving details of exact steps taken. More or less the present pursis
dated 2.6.2021 is same. The only improvement is that it is stated that the expected production of Amphotericin B from the existing five manufacturers
is likely to increase in June, 2021 to 255114 vials and 102000 vials are expected to be produced more in June, 2021. It is orally submitted that the
reference to June, 2021 is generally a reference to the end of June, 2021. In the pursis a chart of allocation of this drug made on some of the dates of
May 2021 is also given. However, it is not known as to how many and how these allocations have been made, whether randomly or by considering the
case load in State of Maharashtra.
Whatever be the method adopted for making allocations, the fact remains that the State of Maharashtra and in particular city of Nagpur having very
high prevalence of Mucormycosis infection remain in crying state for Amphotericin B. Inspite of having so many patients in the State, major part of it
is in Nagpur, patients are not getting enough number of vials per day for the treatment because of deficit allocation and short supply of Amphotericin
B to 7 26smpil4.20 State of Maharashtra. Many patients have lost some or the other organ of their body, many patients have even lost their eyes and a
sizable number of patients is dead. This is a situation which can be improved if there is sensible allocation of Amphotericin B to the State of
Maharashtra. This is already known to the Central Government. But, the steps that it has to take or it must take, considering the fundamental duty of
the State and also the concept of welfare State in the Directive Principles of State Policy, the response appears to be not on the expected lines. Of
course, we are not saying that no steps have been taken and there is no response from the concerned officials. But, the fact is that till date, response
has not appeared so far on record of this case. At the same time, we reiterate that as the patients are losing lives due to these dreaded infections,
urgent steps and urgent relief are required. This is a sort of war like situation for the State of Maharashtra and in particular city of Nagpur, which calls
for rapid response and mighty one. We hope that these entreaties would be positively answered by the Central Government and if not, further loss of
lives of a few more patients, unfortunate as it may be, may be a fait accompli.
In such a serious situation, some public spirited importers from Nagpur have come forward to extend their helping hands. However, they have
highlighted their problem in importing of the raw-material 8 26smpil4.20 required for manufacturing of the aforestated drugs. According to them, if
these hurdles are cleared, they being the private importers who are willing to make the raw-material available to the Indian manufacturers, our society
will substantially save itself from its present crisis. One of such private importers, Unijules Life Sciences Limited, has sent a letter to this Court which
is dated 31 st May, 2021. It is produced before the Court by the learned Amicus Curiae. It is taken on record. It is marked ""G1"" for identification. This
letter also refers to similar difficulties faced by another interested importer namely Ms. Arco Lifesciences (I) Pvt. Ltd. On going through this letter, it
appears that major hurdles that these interested importers are facing are in respect of the delay occurring at the level of Drugs Controller General of
India (DCGI) in granting registration to the private players.
Of course, in the pursis dated 27.5.2021 filed by the Central Government, it is already stated that in order to augment production, DCGI has
actively co- ordinated with the industry for identification of the manufacturers of alternate drugs and expeditious approval of new manufacturing
facilities. But the pursis dated 27.5.2021 does not say anything about the expeditious grant of registration to the Indian importers. In the letter 'G-1', a
request has been made by these two interested importers that procedure for obtaining registration of DCGI for 9 26smpil4.20 making import of the
drugs or raw material required for production of drugs within India should be done away with atleast during the pandemic situation and the Authority
to grant permission for import of the drugs and/or raw material for drugs be delegated to the Food and Drugs Administration of individual States. We
request the Central Government to actively consider the prayers made in the letter 'G-1', a copy of which be supplied to the learned A.S.G.I. A
decision in this regard, we direct, be taken on or before the next date and the outcome thereof be placed before this Court latest by the next date. We
are hopeful that some solution in this regard will be found out by the Central Government as the goal of this Court is in communion with the object of
the Central Government, with the patient being at the centre of focus.
So far as the suggestions given in the affidavit of respondent no.2 are concerned, we request the Indian Medical Association, Vidarbha Hospital
Association and also the State Government to consider them seriously and device a procedure for improving the state of cleanliness and hygiene in the
hospitals, the state of awareness amongst the patients, doctors, nursing staff and all concerned and establish an effective and regular machinery for
keeping check on all the hospitals; Government or Private, as regards the conditions of cleanliness and hygiene in those hospitals.
10 26smpil4.20
About City of Nagpur, there is already a task force set up by the Divisional Commissioner; but presently the scope of this task force appears to be
confined to only Mucormycosis infection. We direct the Divisional Commissioner and other concerned Authorities to expand the scope of this task
force to all fungal infections and this shall be done with immediate effect. We also direct the Divisional Commissioner, Nagpur, Collector Nagpur and
Commissioner, Nagpur Municipal Corporation to extend all the help to make available the requisite man power and paraphernalia for increasing the
check-ups and survey of all the hospitals in Nagpur city in order to find out any deficiency, lacunae, and other incidental factors which contribute to
spread of fungal infections. The task force, upon completing such survey and check-ups, shall report to this Court appropriately within next two
weeks.
The Divisional Commissioner has already filed an affidavit regarding the Companies situated in Vidarbha having unspent CSR funds. The affidavit
also gives list of Companies which had shown their willingness to make their contributions and the Companies which are unwilling. This affidavit has
been filed about two weeks ago and we are not aware of the present position till date. It is not known as to how many of the willing Companies have
actually sent their contributions. We must point out here that there are specific provisions made in the Companies 11 26smpil4.20 Act, 2013 for dealing
with such unwilling, defaulting and non-responsive Companies. The relevant provisions are contained in Section 136 of the Companies Act and also in
some other Sections. The Divisional Commissioner of Nagpur and Amravati and also Collectors of all the districts in Vidarbha region shall do well to
make a thorough study of these provisions of law and invoke them against the erring Companies by resorting to the procedure prescribed in the
Companies Act, 2013. If any directions in this regard are required, detailed factual position be placed before this Court so that appropriate decision can
be taken by this Court in this regard. It shall be done on or before the next date, if required.
Learned Government Pleader has placed on record letter dated 1.6.2021 received from National Thermal Power Corporation Ltd., Mouda. It is
marked as 'G-2' for identification. It states that as per the direction given by this Court, the NTPC, Mouda is contributing CSR/CD fund to the tune of
Rs. Three Crores for Covid-19 treatment and management. This amount will be transferred in the account of Collector, Nagpur by issuing a cheque in
the name of District Collector, Nagpur. It is informed at the bar by the Law Officer, Collector Office, Nagpur that as per the instructions received by
him from N.T.P.C., the cheque for Rs. Three Crores will be issued to the District Collector, Nagpur within seven days from today. That means by the
next date this amount 12 26smpil4.20 would have been received in the fund reserved for Covid-19 treatment and management. The Collector, Nagpur
shall report to this Court receipt of the said cheque by him accordingly.
By the order passed on 17.5.2021, we have directed that the work orders to be issued for setting up of Oxygen generation plants at Lata
Mangeshkar hospital and Shalinitai Meghe hospital be put on hold. Now, both these hospitals have made their responses over the issue. The affidavit
filed by them is quite reflective about this. Mr.A.A.Naik, learned Counsel appearing for both these institutions states that there can be a via media
insofar as Lata Mangeshkar hospital is concerned, but he makes a request for allowing the tender process to go ahead for Shalinitai Meghe hospital.
As regards Lata Mangeshkar hospital, the proposal is that since this hospital is attached to N.K.P. Salve Institute of Medical Sciences and Research
Centre and since this college is suffering loss on account of inability of its students to pay the fees, which springs forth from the State Government not
crediting to their accounts the amount of fees they are entitled to receive from the State Government, the hospital is not in a position to make any
investment on its own for setting up of Oxygen generation units. Accordingly, it is submitted that if the State Government reimburses atleast 50% of
the outstanding amount of fees to the students, the issue would be resolved immediately.
13 26smpil4.20
Learned Government Pleader, based upon what is stated in the letter dated 31/5/2021 marked as ""G- 3"" for identification submits that as more
funds were diverted for dealing with Covid-19 pandemic, no funds are presently available for reimbursing the fees of the students under the various
Scholarship Schemes.
Considering the response of the State Government, we are of the view that at least to the extent of making available funds for Covid cause, the
State Government can always release some amount by way of reimbursement of the College fees of the students so that some money will resultantly
come to the College, which could be ultimately spent for Covid cause. Therefore, we direct the State Government to release amount of Rs.2.5 crores
to the students of the College, i.e., N.K.P. Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur by way
of reimbursement of their College fees under the Scholarship Scheme, by crediting the proportionate amounts to the accounts of each of the students,
a list of which shall be submitted by the said College and Hospital to the State Government on or before 05/06/2021 in order to facilitate and expedite
the process of crediting of the said amount to the respective accounts of the said students. The State Government shall release the said amount within
two 14 26smpil4.20 weeks from the date of submission of the list of the eligible students to it by the said College and Hospital. The said College and
Hospital on its part shall refund whatever amount that would be presently spent from out of the funds made available by MOIL for setting up the
oxygen generation plant at Lata Mangeshkar Hospital within a period of four weeks from the date of the crediting of fees to respective accounts of
the students by the State Government. The State Government shall inform the College and also this Court the date on which the said amount has been
released accordingly. We further direct that the amount spent for setting up oxygen plant from out of CSR funds shall be refunded by the College,
which shall be credited to the District Covid Fund by the Collector within four weeks of relase of Rs.2.5 crore by Government and which shall later on
be used for Covid cause.
In view of above, in part modification of our order dated 17/5/2021, we allow the District Collector to issue the work order to W-2-E Engineering
Private Limited, Noida (U.P.) for setting up Oxygen generation plant at Lata Mangeshkar Hospital, Nagpur, suject to condition of refund of the money
spent for this purpose in the manner and in the time laid down in earlier paragraph.
As regards Shalinitai Meghe Hospital, Mr. Naik, learned Counsel makes a statement, on instructions, 15 26smpil4.20 that the Management of this
Hospital is planing to set up Oxygen generation plant from out of its own funds and therefore it would no longer be requiring any outside help for that
purpose. However, he submits that there are some bills pending with the Civil Surgeon which need to be cleared by him and amount thereof be paid to
the Hospital by the State Government.
As the Management of Smt. Shalinitai Meghe Hospital does not require any outside assistance for setting up oxygen generation plant, there would
be no need for issuing work order for setting up such plant at this Hospital. However, the place where such work order is to be executed can always
be changed and accordingly we direct the Collector, Nagpur to consider the change of place of execution of the work order which could be AIIMS,
Nagpur. A decision in this regard may be taken appropriately by the District Collector, Nagpur on or before the next date.
About pendency of bills and payment thereof by the State, we direct the Civil Surgeon, Nagpur and also the District Collector, Nagpur to verify the
same and if it is found that those bills are really pending, the same be cleared and money thereof be paid in accordance with law to Smt. Shalinitai
Meghe Hospital, as expeditiously as possible, preferably within two weeks from the date of the order, unless the bills are not in accordance with the
relevant rules.
16 26smpil4.20
Mr. D.M. Kale, learned Counsel for the MSETCL informs, on instructions and as stated in the latest submission dated 01/06/2021, that CSR
Committee would take its decision about allocation and release of CSR funds for Covid cause in Nagpur. This submission, however, does not give any
date within which the CSR Committee would be taking its decision. Mr. Kale, learned Counsel submits, on instructions, that the CSR Committee
would take the decision as and when it would meet and its meeting would be held as soon as possible. He also submits that a policy decision has
already been taken for release of such funds, and therefore, not much time would be required by the Committee in taking its decision in the matter.
Considering the submissions which are quite vague at present and also considering the situation of emergency, we direct that the CSR Committee
of MSETCL shall take its decision on the subject on or before the next date and place the same before this Court.
Mr. Bhandarkar, learned Amicus Curiae has raised a very pertinent question about the delay in sending the samples of drugs alleged to be spurious
for their testing to Central Drugs Laboratory. According to him, once a drug is suspected to be spurious one, immediate steps must be taken for 17
26smpil4.20 getting it tested by the competent authority as every such drug has its own shelf life, which is of short duration and therefore if the
samples of such drugs are not sent before their respective expiry dates, the testing will be futile exercise. The Joint Commissioner, FDA shall make
his appropriate response on the issue.
Hon'ble Shri Justice M.G. Giratkar (Retired) Member of Grievance Committee has telephonically informed the Registrar (Judicial) of this Court
that he has some difficulty in continuing to be a Member of the Committee and therefore he has made a request for his being relieved of the
responsibility.
Considering the personal difficulty expressed by the Hon'ble Shri Justice M.G.Giratkar (Retired), the learned Member of the Committee, we direct
that he stands relieved of the responsibility with immediate effect. In his place, we direct, Mr. M.N.Pote, District Judge (Retired), Nagpur be taken up
as a Member of the Grievance Committee.
In our earlier order, we had already directed the Collector, Nagpur to requisition 400 cylinders from the office or godown of a closed company at
Kamptee and this order has been complied with. However, it has come on record that now out of these 400 cylinders, 200 cylinders could not be used
as they are presently out of order. It is stated at the bar by 18 26smpil4.20 learned Government Pleader that these 200 cylinders are repairable. We,
therefore, direct that they be repaired as soon as possible and in any case within two weeks from the date of the order.
Stand over to 09/06/2021 at 02:30 p.m.