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Judgment
On the conspectus of what we had observed in our earlier orders, the following issues are discussed at the hearing of these petitions yesterday and
today:
(i) Paediatric treatment
(ii) Mucormycosis
(iii) Shortage of Toculizumab in treatment of Covid-19;
On behalf of the State Government, Mr. Kumbhakoni, learned Advocate General has filed affidavit of Dr. Sadhana M. Tayde dated June 10, 2021.
Mr. Anil Singh, learned Additional Solicitor General has also filed an additional compilation of documents. We take up the above issues:
(i) Pediatric On behalf of the State Government, it is pointed out that a pediatric task force is appointed by the Government Resolution dated May 25,
2021. It is stated that the task force has conducted meetings of private practice health staff in rural areas and Asha workers. Also specific protocols
are being prepared by the Task Force for the pediatric age group. In the meantime, the protocol prepared by the Central Government in this regard is
being followed. Dr. Sadhana Tayade in her affidavit has stated that on 7th June, 2021, the Hon'ble Chief Minister had organized a video conference
program of which there was a live telecast on Facebook/You Tube, in which members of Pediatric Task Force gave information and guidance about
the treatment to be administered to children in the wake of the proposed ""third wave"". It is stated that such program was attended by about 65,000
Asha workers, 3000 Block facilitators and about 2000 medical officers including District Health officers and Taluka Health Officers. The role of all
such workers and their responsibilities were discussed and appraised. A power point presentation was prepared for the said program, the copy of
which is placed on record. We have perused the power point presentation. It appears to be an exhaustive presentation, providing all necessary
information as regards the steps to be taken to prevent children from getting infected by Covid-19 and those who are affected. We are, however, of
the opinion that wide publicity ought to be given to a concise version of the power point presentation in the print and electronic media. We would urge
the TV channels as a part of their social obligation to consider providing adequate time slots for its telecast, when such information can be noticed, by
the parents and the children and the family members. An endeavour in this regard be made to telecast such information at least 4 to 5 times a day, till
the dark clouds of children getting infected vanishes.
Dr. Sadhana Tayade has also stated that in regard to the availability of children's beds in pediatric wards in rural areas, the pediatric task force has
informed that there shall be no separate pediatric hospital in the State, however, beds for pediatric patients would be reserved for all Covid treatment
facilities in the following proportion:
a) Covid Care Centre - 15% of the existing beds
b) Dedicated Covid Health Centre - 10% of existing beds
c) Dedicated Covid Hospital - 5% (Expandable to 10%) of the existing beds.
Mucormycosis
In regard to mucormycosis, the State has pointed out that admittedly it is serious but rare fungal infection caused by group of molds called
Mucormycetes. It is informed that a person gets such disease by coming in contact with fungal spores in the environment. It is stated that the
observance reveals that incidence of Mucormycosis is increasing in Covid-19 patients called as Covid Associated Mucormycosis (CAM). It is stated
that Mucormycosis is found in Covid- 19 patients having high blood sugar, use of steroids in high doses for longer duration, prolonged ICU stay and
pre-existing morbidities such as cancers, organ transplant etc. The treatment of mucormycosis involves combination of surgical debridement followed
by antifungal medicine such as Inj. Amphotericin B. Debridement is procedure involving thoroughly cleaning the infected surface and removing callus,
necrotic and dead tissue, foreign debris etc. As on June 7, 2021, total diagnosed patients of mucormycosis are 6287 out of which 518 deaths, 1695
discharged and 4033 under treatment. Total 41 patients left the hospital during treatment against medical advise. It is stated that after the increase in
the incidence of Covid Associated mucormycosis, following precautionary measures were taken:
a) All the doctors treating the Covid-19 patients are informed to keep watch on blood sugar of Covid-19 patients during treatment and atleast 3 weeks
after discharge.
b) Steroids are being used judiciously and lowest possible does and for minimum duration considering clinical condition of the patient.
c) Increase in availability of Debridement Facility in Government and Private Sector. As of now, facility for debridement is available in 592 hospitals in
State. Out of these, 76 private hospitals are covered under Mahatma Jyotiba Phule Jana Arogya Yojna which provides free treatment to MJPJAY
beneficiaries.
d) Increase in availability of Inj. Amphotericin B in all districts of State.
As observed in our earlier orders, the only drug administered for the treatment of mucormycosis is Inj. Amphotericin B of which there is severe
short supply. It is stated that considering the acute shortage of this drug, following measures are taken to streamline the supply:
i) Considering shortage of Inj. Amphotericin B in all states, Government of India has
given quota of Amphotericin B to each State, which includes the name of manufacture and number of vials allotted.
ii) Once the Gol communication is received, manufacturers are contacted, purchase orders are issued and they are requested to supply the medicines
at the earliest.
iii) Distribution of Amphotericin B through private medical stores is completely stopped.
iv) All the Amphotericin B made available to State is purchased by Public Health Department and supplied to all Government and Private Hospitals
except in MCGM areas.
v) In MCGM area, Amphotericin B is directly purchased by MCGM.
vi) As on today, purchase order of 3677000 vials of Amphotericin B, 50 mg is issued to various manufactures. Out of these, 92898 are received and
distributed to districts.
Learned counsel for the petitioner has also raised serious concern in regard to the consequence of the non-availability of this drug for patients in its
dire requirement. On the earlier occasions, we were informed that Haffkine Bio-Pharmaceuticals was to manufacture and make available by today
40000 vials, however, such availability, as informed by Mr. Kumbhakoni is now postponed. We wonder as to why an aggressive approach to import
such medication from various countries on the globe, was not adopted and more particularly from such countries in which there is a possibility of a
high production and demand for such drug is not such, as in our country.
Be that as it may, we would urge the Central Government to have a re-look at the allocation of such drug as far as the State of Maharashtra is
concerned and make it available to its maximum, so that the needy patients who are in large number, do not suffer for want of such medication. We
also note from the statement as placed on record by Mr. Anil singh titled 'Allocation of Amphotericin B Inj. on 9th June', that such allocation is totally
insufficient to meet the demand of such drug for the 6287 patients, suffering mucormycosis. We may note that in a short period of last 4 days, about
82 persons suffering from mucormycosis have expired, which in our opinion, is an alarming figure requiring urgent supply of such drug. We are
informed by learned counsel for the petitioner that the maximum number of cases of mucormycosis in the State are in Mumbai, Thane, Pune, Solapur,
Kolhapur and Nashik. This situation, in our opinion, requires an immediate and an emergent attention requiring a concentrated supply of such drug at
places where it is so required.
We may also observe that there has to be some flexibility or free play in the joints in the rigid allocation of the quotas of drugs. It has to be a
dynamic mechanism, which is absolutely need based and which would cater to a situation of easy and immediate availability of the drug at the
hospitals where such drug is in urgent need for the ailing patients. We accordingly direct that in present situation, the State Government as also the
Central Government consider adopting a dynamic mechanism. This be undertaken for the State of Maharashtra on/or before the adjourned date of
hearing. We are also seriously concerned with the adequate and rational distribution of this drug within the State. Hence, we direct the State
Government to evolve a mechanism by appointing nodal officers who can manage procuring of such drug from either the Central system or the State
supplies. Such nodal officer be appointed in each of the districts/places in which there are large number of patients suffering from mucormycosis.
Our deepest intention in making such observations and issuing such directions is considering the helplessness of the patients who are left wandering
in search of this drug and with an intention that no patient should suffer from want of medication. We, accordingly, leave it to the wisdom of the
authorities to bring out the best possible mechanism, which would cater to the present needs and meet the urgent situation in regard to availability of
such medication. Tocilizumab
In regard to the drug Tocilizumab, learned counsel for the petitioners have stated that the situation in regard to the supply of this drug is also not
different from that of 'Amphotericin B'. Dr. Joshi, on behalf of the Indian Medical Association, has informed that this drug is administered to the
Covid-19 patients as a second line of treatment, when a sustained treatment of Dexamethasone would not work. In this situation, according to him, the
only drug which would be required to be administered would be Tocilizumab. In regard to the availabiltiy of this drug, the current mechanism, in our
opinion, is far from satisfactory. It is clear that the requirement of this drug would continue till the Covid-19 pandemic continues. It is high time that the
Central Government and State Government consider taking a decision to have buffer stock and secure such drug from all possible sources globally.
Dr. Sadhana Tayade on behalf of the State Government has stated in her affidavit that orders were placed on Cipla as referred to in a statement
annexed to her affidavit as Exhibit-AR4 (Page 468). We find that these orders are dated May 01, 2021 and May 05, 2021, the quantity of the order
was also too meager, i.e. 200 and 210 respectively. Such orders relate to a position as existed a month back. We would require the State Government
to place on record data for the last one month and the latest position in this regard and also appraise us as to the quantity of this received and what is
currently the exact demand for such drug, in the State of Maharashtra. The directions as issued by us above in regard to Amphotericin B shall also
equally apply in regard to supply of this drug so that it is made available to the needy patients.
We, accordingly adjourn the hearing of these petitions to June 16, 2021 to enable the UOI and State Government to respond on the issues as noted
by us in the present order.