Dr. AKB Sadbhavana Mission School of Homoeo Pharmacy vs The Secretary, Ministry of AYUSH & Ors.

REPORTABLE

IN THE SUPREME COURT OF INDIA CIVIL APPELLATE JURISDICTION

CIVIL APPEAL NO. 4049 OF 2020 (arising out of SLP (C) No. 15293/2020 Diary No. 19638 of 2020)

DR. AKB SADBHAVANA MISSION SCHOOL OF HOMEO PHARMACY ...APPELLANT(S)

VERSUS

THE SECRETARY, MINISTRY OF AYUSH & ORS. ...RESPONDENT(S)

J U D G M E N T

ASHOK BHUSHAN, J.

The application seeking permission to file

special leave petition is allowed.

Leave granted.

2. This appeal has been filed by the appellant

Dr. AKB Sadbhavana Mission School of Homeo Pharmacy

aggrieved by the part of Division Bench judgment of

Kerala High Court dated 21.08.2020 passed in Writ Signature Not Verified

Petition (C) No.9459 of 2020.

Digitally signed by Nidhi Ahuja

The appellant, who was Date: 2020.12.15 17:57:02 IST Reason:

not party in the writ petition feeling aggrieved by 2

certain directions issued by the High Court have come

up in this appeal.

3. We need to notice the contents and prayers of the

writ petition filed in the Kerala High Court by

respondent No.4 (proforma respondent). The writ

petition was filed by respondent No.4, an Advocate

praying for writ of Mandamus or for any other writ or

order directing the Secretary, Department of AYUSH,

Government Secretariat, Trivandrum to ensure that the

Homeopathic practitioners are immediately allowed to

perform in accordance with the Exhibit-P1

notification (Guidelines dated 06.03.2020 issued by

Secretary, Department of AYUSH (Ministry of Ayurveda,

Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa and

Homeopathy) (AYUSH, New Delhi).

4. The petitioner’s case in the writ petition is

that petitioner is an ardent admirer of the

Homeopathic medicine system, which system of medicine

in India is controlled and regulated by the Ministry

of AYUSH. The petitioner pleaded that to control the 3

spread of Coronavirus (COVID-19), notification dated

06.03.2020 was issued by the Secretary, Ministry of

AYUSH to the Chief Secretaries of all States in which

notification, it was pointed out that interventions

under AYUSH systems have been varyingly used for

making an effective public health response in similar

situations faced in many States/Union Territories

earlier. The petitioner’s grievance was that State

of Kerala and the Secretary, Department of AYUSH,

Government Secretariat, Trivandrum did not take steps

to implement the advisory dated 06.03.2020 whereas

many other State Governments have taken steps much

earlier. The petitioner pleaded that Homeopathic

system would have been absolutely able to control the

spread of COVID-19 through its immunity boosting

medicines. Petitioner further stated in the writ

petition that if the Homeopathic medicines had been

distributed earlier in highly affected pockets and

particularly to those under isolation and quarantine,

the explosive situation had not happened, which has

happened in the State of Kerala. The only prayer

made in the writ petition are to the following

effect:-

4

(i) To issue a Writ of Mandamus or any

other Writ or Order directing the

third respondent to ensure that the

Homeopathic practitioners are

immediately allowed to perform in

accordance with the Exhibit P-1

notification.

(ii) To grant such other reliefs as this

Honourable Court deems fit and

proper in the facts and

circumstances of the case.

5. The Division Bench of the High Court disposed of

the writ petition by judgment dated 21.08.2020. The

High Court in its judgment has extracted advisory

dated 06.03.2020 of the Government of India, Ministry

of AYUSH, the Government Order dated 08.04.2020 and

21.04.2020 issued by Government of Kerala and after

noticing the aforesaid, the High Court disposed of

the writ petition. In paragraphs 13 and 14 of the

judgment, the High Court has stated as follows:-

“13. It is the case of the petitioner that Exhibit-P1 has not been implemented by the State of Kerala, whereas it is the 5

submission of learned Senior Government Pleader that Government has approved the action plan of Homeo Department for giving Homeo medicines as prophylactic. However, the target population was not intended to include COVID-19 patients or their contacts or those people, under quarantine. Advisory of the Ministry of AYUSH is being followed by the Government and tablets are given free of cost to those persons as immunity boosters. As per the State Medical Protocol, COVID-19 affected persons should not be treated by anybody other than the Government and those authorised by the Government. As per the medical protocol of the Government, doctors practising in AYUSH medicines are not supposed to prescribe any medicines, stating that it is curative for COVID-19 disease. However, as per the advisory, there is nothing prohibiting the qualified medical AYUSH practitioners to prescribe immunity booster mixture or tablets, as suggested by the Ministry of AYUSH, Government of India, New Delhi. When the Central as well as State Governments have approved prescription of certain mixtures and tablets, as immunity boosters, qualified medical practitioners in AYUSH can also prescribe the same, but only as immunity boosters.

14. We also make it clear that if any qualified doctor practising AYUSH medicine, makes any advertisement or prescribes any drugs or medicines, as a cure for COVID-19 disease, except those specifically mentioned in Annexure-I advisory to Exhibit-P1 D.O. letter dated 6.3.2020, it is open for the respondents to take appropriate action under the provisions of the Disaster Management Act, 2005, and the orders of the Governments, both Central as well as the State, issued from time-to-time. Only those tablets or 6

mixtures shall be given as immunity booster and not as cure for COVID-19.

AYUSH medical practitioners are further directed not to violate the Government Order dated 6.3.2020. In this regard, Medical/Police Departments are also directed to monitor the action of AYUSH medical practitioners.

Writ petition is disposed of accordingly.”

6. The appellant, who was not party to the writ

petition, has filed this appeal and the reasons given

for filing this appeal by the appellant as stated in

paragraph 4 of the application seeking permission to

file special leave petition, are as follows:-

“4. It is respectfully submitted that the Hon'ble High Court had not issued any notice either to Ministry of AYUSH, Government of India or to Homoeopathy doctors or its organisation before passing the impugned order. Homoeopathy Doctors are treating all patients who come for treatment. As is well known, most of the Covid-19 patients, are asymptomatic and therefore such blanket orders will cause grave prejudice to the Homoeopathy doctors, who treat the patients. The direction to take action under the Disaster Management Act is very harsh and the said order has been passed without hearing the doctors, who are affected by such orders. The Writ Petition has been filed by a lawyer, who is an ardent follower of homoeopathy medicine. The prayer was to implement the direction passed by AYUSH on 06.03.2020. The Hon'ble High Court unfortunately went beyond the pleadings and made observations which will 7

affect the profession of Homoeopathy doctors. It is pertinent to mention here that many of the State Governments have been prescribing Homoeopathy medicines as an immunity booster. Even the Health Minister, Government of Kerala had given a press statement that Homoeopathy medicines are very good for prevention of Covid-19. In the State of Gujarat, the Government itself had prescribed the homoeopathy medicines for its citizens.”

7. The appellant is aggrieved by the directions of

the High Court contained in paragraph 14 only. The

High Court in its judgment dated 21.08.2020 itself

has extracted the G.O. dated 21.04.2020 of the

Government of Kerala where Government of Kerala was

pleased to approve the action plan outlining the

Homeopathy Strategies for prevention and management

of COVID-19 in Kerala. It is now useful to refer to

the G.O. dated 21.04.2020, which has been quoted in

the impugned judgment, which is to the following

effect:-

“GOVERNMENT OF KERALA Abstract

AYUSH Dept. – COVID-19 - Action Plan outlining the Homeopathy Strategies for Prevention, and Management of COVID-19 in Kerala – Approved - Orders issued.

------------------------------------------

AYUSH(B) DEPARTMENT 8

G.O.(Rt)No.161/2020/AYUSH Dated, Thiruvananthapuram, 21/04/2020

------------------------------------------ Read:- 1. Letter No. DHTVM/2606/2019-P2 dtd. 13.04.2020 of the Director of Homeopathy.

ORDER

In the circumstances explained by the Director of Homeopathy vide letter read above, Government are pleased to approve the Action Plan outlining the Homeopathy Strategies for prevention and management of COVID-19 in Kerala as appended to this order.

(By order of the Governor) Bhooshan V.,”

8. We have heard Shri Venkita Subramoniam, learned

counsel for the appellant and Shri Tushar Mehta,

learned Solicitor General of India for the

respondent.

9. An affidavit has been filed on behalf of

Ministry of AYUSH to which rejoinder has also been

filed. The appellant being aggrieved only with

directions in paragraph 14 and no relief having been

claimed by the appellant against the State of Kerala, 9

we have not issued notice to respondent Nos. 2 and 3

and we proceeded to decide this appeal after hearing

the learned counsel for the petitioner as well as

learned Solicitor General of India for the

respondent.

10. Learned counsel for the appellant contends that

the directions issued by the Division Bench of Kerala

High Court in paragraph 14 to take actions against

Homeopathic doctors, who prescribe any drug as a cure

for COVID-19 disease should be proceeded with under

the provisions of Disaster Management Act, 2005 was

uncalled for and beyond the scope of the writ

petition. Learned counsel submits that even the

Government of India advisory dated 06.03.2020

permitted COVID-19 like illness to be managed by

AYUSH systems. The advisory itself permits

Homeopathy to be used as preventive, prophylactic,

symptom management of COVID-19 like illnesses and add

on interventions to the conventional care. The High

Court has erred in confining right of Homeopathic

medical practitioners to prescribe only as immunity 10

booster, which direction is not in accord to the

Guidelines dated 06.03.2020.

11. Learned counsel for the appellant submits that

guidelines for Homeopathic practitioners for COVID-19

has been issued by Government of India, Ministry of

AYUSH, which clearly permits medical practitioners,

which permission from local health authorities and

Medical Superintendent of the hospital to prescribe

medicines for COVID-19. When the guidelines issued

specifically permits treatment of COVID-19 patients,

the High Court erred in observing that Homeopathy

practitioners can only prescribe medicines as

immunity booster. It is submitted that the direction

issued by the High Court in paragraph 14 has made

vulnerable the Homeopathic practitioners from being

proceeded with under Disaster Management Act, 2005

and actions by police and other medical staff, which

is demoralising the practitioners of Homeopathy.

12. Shri Tushar Mehta, learned Solicitor General of

India appearing for Ministry of AYUSH, Government of 11

India has submitted that Government of India keeping

in view the unprecedented and unforeseen precarious

situation caused by COVID-19, the Ministry of AYUSH

decided to augment and strengthen the COVID -19

medical response of the country by using the

traditional healthcare system of the country, which

includes AYUSH Organisation, Homeopathic practices as

well as Unani practices. Learned Solicitor General

of India has referred to advisory dated 06.03.2020,

which covers the field and he has also referred to

the guidelines issued by Government of India. Shri

Mehta has referred to the affidavit filed on behalf

of Ministry of AYUSH. He submits that Homeopathy

practitioners are permitted by the Ministry of AYUSH

to prescribe medicines as (i) preventive and

prophylactic; (ii) symptom management of COVID-19;

(iii) add on interventions to the conventional care.

13. We have considered the submissions of the learned

counsel for the parties and have perused the records. 12

14. The advisory dated 06.03.2020 issued by the

Ministry of AYUSH has been relied by the learned

counsel for the appellant as well as learned

Solicitor General and was also extensively extracted

by the High Court in its judgment. The advisory

dated 06.03.2020 contains the object of AYUSH

systems. It is useful to extract following (relevant

of Homeopathic only), which is part of advisory dated

06.03.2020:-

“i. Preventive and prophylactic:

xxxxxxxxxxxxxx

Homoeopathy:

Arsenicum album 30, daily once in empty stomach for three days. The dose should be repeated after one month by following the same schedule till Coronavirus infections prevalent in the community.

In one of the studies Arsenic album as one of the constituents in a formulation affected HT29 cells and human macrophages. Also, it showed SNF-KB hyperactivity (reduced expression of reporter gene GFP in transfected HT29 cells), tTNF-a release in macrophages. More over, Arsenic album is a common prescription in the cases of respiratory infections in day to day practice.

ii. Symptom management of COVID-19 like illnesses 13

xxxxxxxxxxxxxx

Homoeopathy

Various medicines which found to be effective in treating flu like illness are Arsenicum album, Btyonia alba, Rhus toxico dendron, Belladonna Gelsemium Eupatorium perfoliatum. All these medicines should be taken in consultation with qualified physicians of respective AYUSH systems.

iii. Add on Interventions to the conventional care

xxxxxxxxxxxxxx

Homoeopathy

Medicine mentioned Symptom management of COVlD-19 like illnesses under subhead Homoeopathy can also be given as add on to conventional care.

All these medicines should be taken in consultation with qualified physicians of respective AYUSH systems.

15. The above clearly indicate that Ministry of AYUSH

specifically permits use of Homeopathy for following

three ways:-

(i) Preventive and prophylactic;

(ii) Symptom management of COVID-19 like illness;

(iii) Add on interventions to the conventional

care.

14 16. We may further notice the specific averments made

by Ministry of AYUSH in its affidavit dated

23.11.2020 regarding what is permitted to the

Homeopathy Medical Practitioner as per Ministry of

AYUSH. Paragraph 16 of the affidavit sworn on behalf

of the Ministry of AYUSH is as follows:-

“16. In addition to the above, it is respectfully reiterated that Ministry of AYUSH has clearly permitted the homeopathic medical practitioners to prescribe the chugs, as mentioned in the guidelines, as an add-on drug to the conventional treatment for patients who have been tested Covid positive and are undergoing conventional treatment.

Thus in the respectful submission of the answering respondent, prescription of the medication prescribed by the Ministry of AYUSH to Covid positive patients as an add-on treatment is permitted, and therefore, any contention to the contrary stating that homeopathic medical practitioner cannot prescribe any treatment to Covid-19 positive patients, even as an add-on to conventional treatment is liable to be rejected. It is stated that the only embargo is that the said Medicines should not be administered or advertised as a cure but should be administered as preventive measure/immunity booster or as an add-on to the conventional treatment.” 15

17. It is clear from the advisory dated 06.03.2020

and the specific stand taken by the Ministry of AYUSH

as contained in paragraph 16 extracted above that

Homeopathic medical practitioners are not only

confined to prescribe Homeopathic medicines only as

immunity booster. The following observations in

paragraph 13 by the High Court does not correctly

comprehend the guidelines dated 06.03.2020:-

“13. ……………………………………When the Central as well as State Governments have approved prescription of certain mixtures and tablets, as immunity boosters, qualified medical practitioners in AYUSH can also prescribe the same, but only as immunity boosters.”

18. The High Court in the impugned judgment has

emphasised that if any qualified doctor practising

AYUSH medicine, makes any advertisement or prescribes

any drugs or medicines, as a cure for COVID-19

disease, except as prescribed in letter dated

6.3.2020, it is open to the authorities to take

appropriate action under the provisions of the

Disaster Management Act, 2005. Insofar as

advertisement by Homeopathic practitioners is

concerned, i.e., clearly prohibited by the 16

regulations framed in Section 33 read with Section 24

of Homeopathy Central Council Act, 1973 namely the

Homeopathic Practitioners (Professional Conduct,

Etiquette and Code of Ethics) Regulations, 1982. The

Regulation 6 prohibits advertisement for solicitation

of patients personally or advertisement in the

newspaper by the Homeopathic practitioners.

Regulation 6 is to the following effect:-

“6. (1) Advertising

Solicitation of patients directly or indirectly by a practitioner of Homoeopathy either personally or by advertisement in the newspapers, by placards or by the distribution of circular cards or handbills is unethical. A practitioner of Homoeopathy shall not make use of, or permit others to make use of, him or his name as a subject of any form or manner of advertising or publicity through lay channels which shall be of such a character as to invite attention to him or to his professional position or skill or as would ordinarily result in his self-aggrandisement provided that a practitioner of Homoeopathy is permitted formal announcement in press about the following matters, namely :-

(i) the starting of his practice;

(ii) change of the type of practice;

(iii) change of address;

(iv) temporary absence from duty;.

(v) resumption of practice (vi) succeeding to another's practice. 17

(2) He shall further not advertise himself directly or indirectly through price lists or publicity materials of manufacturing firms or traders with whom he may be connected in any capacity, nor shall he publish cases, operations or letters of thanks from patients in non-professional newspapers or journals provided it shall be permissible for him to publish his name in connection with a prospectus or a director's or a technical expert's report.”

19. When statutory regulations itself prohibit

advertisement, there is no occasion for Homeopathic

medical practitioners to advertise that they are

competent to cure COVID-19 disease. When the

Scientists of entire world are engaged in research to

find out proper medicine/vaccine for COVID-19, there

is no occasion for making any observation as

contained in paragraph 14 with regard to Homeopathic

medical practitioners. The homeopathy does not cure

the disease, but it cures the patients.

20. We have already noticed that the writ petition,

which was filed in the Kerala High Court only with a

limited relief for issuing direction to respondent to

implement the advisory dated 06.03.2020 issued by

Ministry of AYUSH, there was no occasion for High 18

Court to make observations and issue direction as it

has been made in paragraph 14.

21. We, however, make it clear that what is

permissible for Homeopathic medical practitioner in

reference to COVID-19 symptomatic and asymptomatic

patients is already regulated by the said advisory

and guidelines. The Government of India, Ministry of

AYUSH has also brought on record the guidelines

issued subsequent to 06.03.2020 for Homeopathy

medical practitioners for COVID-19, where Homeopathic

approach to COVID-19 has been elaborately dealt with.

The said guidelines, which has been issued after

04.04.2020 has been brought on the record as Annexure

C by the Ministry of AYUSH. The guidelines contained

following under the heading “Homeopathic approach”-

“Homoeopathic Approach

It is advised that before taking up for homoeopathic medicines for prophylaxis, Amelioration and mitigation, physician must acquaint himself of above sections.

In case of epidemics or pandemics, first approach is to follow preventive measures and educate people about general measures and to provide such interventions which will keep their immunity enhanced. 19

Homeopathy therefore recommends issuing of public notice for Genus epidemics identified by the designated experts for immunity enhancement and practitioners may suggest the same to the people and as per the Advisory issued by Ministry of AYUSH(6).

Second approach is to provide homoeopathic symptomatic mitigation to affected persons. Homoeopathic medicines are also useful in the treatment of communicable diseases like Influenza Like Illness(7) (8), dengue(9), acute encephalitis syndrome(10). Several studies are also published which shows the immune modulatory potential of homoeopathic medicines in preclinical studies (11) (12) (13) (14) (15) (16). These medicines can be prescribed in an integrated manner or standalone depending on the severity on a case to case Therapeutic Aid

As a system with wholistic approach medicine were selected based on the presenting signs and symptoms of each patients (17) (18) (19) (20). The medicines given here are suggestive based on their use and studies in the past in diseases of similar presentation like COVID-19 (21) (22) (23). Patients of COVID-19 are to be treated with adjuvant Homoeopathic medicines with the permission from local health authorities and Medical Superintendent of the Hospital.

Homoeopathic doctors must follow all preventive measures (using PPEs) as are required for dealing with COVID 19 patients.

20

The remedies according to different stages of disease are given below:

Mild Disease (Symptomatic Amelioration and Mitigation Approach):

Medicines like Aconite napellus, Arsenicum album, Bryonia alba, Gelsemium sempervirens, Rhus tox. Eupatorium perfoliatum, Ipecacaucunha, Belladonna, Camphora, may be used depending upon the symptoms similarities.

Severe disease but not in critical condition:

It is defined by following criteria (Dyspnoea, respiratory frequency ≥ 30/min, blood oxygen saturation (SpO2) ≤ 93%, PaO2/FiO2 ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours)/)

 Suggested medicines are as adjuvant to Standard Management guidelines in the hospital setting only with the approval of authorities and willingness of the patient/guardian.

 The prescription is to be given only by institutionally qualified practitioner.

 Medicines like Phosphorus, Chelidonium, Veratrum Viride, Iodum, Camphora, Cinchona officinalis, Lycopodium, Ars. iod., Antim ars., Stannum met, Carbo veg., can be prescribed on symptomatic indication.

Posology 21

The medicine selected for each patient is tailored to person specific, taking into consideration, his/her mental make-up, physical symptoms, and characteristic particulars etc. In case of long term illness, besides the above mentioned factors, age, occupation, previous illnesses and life circumstance unique to that individual irrespective of the disease which he/she is suffering from, are also taken into consideration; thus the dictum “Homoeopathy treats the patient but not the disease”.

After the appropriate medicine is selected, it is essential to decide the requisite potency, dose and repetition which is imperative for optimum response and faster recovery in each case. Different types of potencies such as decimal or centesimal potencies can be employed for treatment as are required for acute diseases. However, selection of potency of the remedy is dependent on various factors like susceptibility of the patient (high or low), type of disease (acute/chronic), seat/ nature and intensity of the disease, stage and duration of the disease and also the previous treatment of the disease(24).”

22. The above guidelines make it clear that

Homeopathy has been envisaged by the Ministry as the

therapeutic aid.

22 23. The above guidelines refer to Homeopathy

medicines as medicines for prophylaxis, Amelioration

and mitigation. The guidelines, however,

specifically provides that “the prescription has to

be given only by institutionally qualified

practitioners”. The High Court in its impugned

judgment has not fully comprehended the guidelines

dated 06.03.2020 and taking a restricted view of the

guidelines and have made observations for taking

appropriate actions against the Homeopathic medical

practitioners, which cannot be approved. The High

Court, however, is right in its observation that no

medical practitioner can claim that it can cure

COVID-19. There is no such claim in other therapy

including allopathy. The High Court is right in

observing that no claim for cure can be made in

Homeopathy. The Homeopathy is contemplated to be

used in preventing and mitigating COVID-19 as is

reflected by the advisory and guidelines issued by

the Ministry of AYUSH as noticed above.

24. We, thus, observe that directions issued by the

High Court in paragraph 14 of the judgment need to be 23

modified to the extent as indicated above. It goes

without saying that Homeopathic medical practitioners

have to follow the advisory dated 06.03.2020 issued

by AYUSH Ministry as well as guidelines for

Homeopathic medical practitioners for COVID-19 issued

by Government of India, Ministry of AYUSH, as noted

above. The Civil Appeal is disposed of accordingly.

The interlocutory applications filed seeking

permission for impleadment is rejected.

......................J. ( ASHOK BHUSHAN )

......................J. ( R. SUBHASH REDDY )

......................J. ( M.R. SHAH ) New Delhi, December 15, 2020.