1. आयुवेर्द कौशलम 2018
िविधक आयुवेर्द
Legal issues with reference to Ayurveda practitioners
Dr. Surendra Chaudhary
President
Vishwa Ayurveda Parishad U.P.
4Th June 2018
3. NATURE OF ISSUES
• Generalized and Pan Indian in nature
– Applicable to all practitioners everywhere
– Registration with CCIM
• State wise
– Registration with state board
– Renewal of registration
– Change of address
– Additional qualification
• Local bodies
– Professional tax, registration with C.M.Os etc
Continued……
4. NATURE OF ISSUES
• Related to Drugs and cosmetics act
– Drug manufacturing for clinic
– Preparing medicine, expiry dates
• Related to CCIM act
– Code of conduct, issuing of medical certificates etc
– Electing CCIM members
• Other rules and regulations
– Health , forest, education, police departments
• Regulatory bills
Clinical establishment bill
Medical manpower and establishment safety bill
• Insurance and Ayurveda
5. REGISTRATION
• State board
– Renewal
– Change of address
– Additional qualification
– Identity cards
• CCIM
– Mandatory/optional/advisable
– Advantage/disadvantage
– Know your CCIM registration
10. CLINIC IN RESIDENTIALAREA
LEGAL OR ILLEGAL ?
• “I am of the considered view that the professional
establishment of a doctor cannot come within the
definition of commercial activity,” ruled justice Suresh
Kait. Delhi high courts-2nd july 2012
• “Commerce is that activity where a capital is put into
work, there is risk of profit or loss. Only if the activities
are undertaken for production or distribution of goods or
for rendering material services, it comes under the
definition of commerce. There is fundamental distinction
between professional activities and commercial activities,”
• http://imaetawah.weebly.com/uploads/5/7/5/1/5751407/drchugvsmcd-
clinicnot_commercial-delhihc.pdf
11. NOIDA CASE
• NEW DELHI: The Supreme Court has asked NOIDA
administration to ensure that no poly clinics or nursing
homes are permitted in the residential area of the
Capital's satellite town and the same are allowed only
in its earmarked commercial areas.
• A bench of justices Swatanter Kumar and Ranjana
Prakash Desai, however, said doctors can run their
individual clinics in the residential areas, but the same
should be purely on outpatient basis.
12. THE CLINIC
• "A clinic simplicitor can be run by a doctor within
such area as already specified, in his or her residence.
This clinic would mean one as per the bye-laws.
• "To put the matters beyond ambiguity, we clarify that
the doctor can have his clinic with a table, a bed to
examine the patient and such facilities which may
be necessary to provide first aid. A dentist may
have a dental chair in his clinic.
• "We also direct that no doctor would be permitted to
run a polyclinic or a nursing home in the garb of a
clinic," the apex court said.• May-7, 2012
• http://articles.economictimes.indiatimes.com/2012-05-07/news/31610700_1_nursing-homes-residential-areas-clinic
24. SUCCESS MANTRA
• Faith and Confidence-No over confidence
• Knowledge- Ayurveda, Medical Science
• Hunger for updating
• Good English communicating skills
25. SUCCESS MANTRA
• Know your limitations and strengths
• Never be master of all
• Never criticise fellow physicians-whatsoever
is the reason
• Patients are loyal until they are getting relief-
physically and financially
26.
27. ONLINE PRESENCE
• Web Page
• Blogging
• Location mapping
• Social Media-Google plus
• Professional social sites- Linkedin
• Professional service providers- lybrate, Practo
30. ADVERTISEMENT
• Sign board and write on it
• Sign-board on other places.
• Advertisement through hoarding and tour
programmes.
• News papers, hand bills
• Use of Patients name or Image
31. WHAT CAN BE ADVERTISED
(a) On starting practice;
(b) On change of type of practice;
(c) On change of address;
(d) On temporary absence from duty;
(e) On resumption of practice;
(f) On succeeding to another practice.
32.
33.
34.
35. CONDUCT & ETIQUETTE
Part II-TOWARDS PATIENT & PUBLIC
Part III-TOWARDS ANOTHER PRACTITIONER
PART IV-CODE OF ETHICS
PART IV-DISCIPLINARY ACTION
Payment for professional services- "No
cure, no payment“Rule-27
36. CONSULTATION/REFERRAL
• Dependence of practitioners on each other
• Compensation for expenses
• Consultation to be encouraged
• Consultation for patients benefit
• Punctuality in consultation
• Conduct in consultation
• Statement to patient after consultation
• Treatment after consultation
• Visiting another practitioner's cases
• Patient referred to specialists
41. MUST HAVE
• Record of patients- electronically or otherwise
• Record of treatment, medical certificates
• Record of medicine purchased
• PAY INCOME TAX and see the benefit!!!
42. Documents to be maintained @ the Clinic
• Registration of the clinic with the municipal/health authorities (State
legislation)
• Record of employment of adults, letters of employment issued and
hours of work;
• Maintenance of record of patients treated
• Maintenance of a register of medical certificates issued;
• Copies of medical certificates issued;
• Registration certificates of doctors/paramedics with the Respective
State Councils
• Professional qualifications (degrees/diplomas) of the staff;
• Account of money receipts and expenses (Income Tax Act, 1961);
• Authorisation for generation of Bio-Medical Waste and record of
category wise waste generated (BMW Management Rules, 1998);
• Professional indemnity insurance cover of an appropriate amount
(Insurance Regulatory and Development Authority Act, 1999);
45. ISSUING OF EFFICIENCY
CERTIFICATE
✓ A practitioner of Indian medicine shall not issue
certificates of efficiency in Indian Medicine to
unqualified or non-medical person.
– The foregoing does not apply so as to restrict the proper
training and instruction of bonafide students, legitimate
employees or practitioners, midwives, dispensers, surgical
attendants, or skilled mechanical and technical assistants under
the personal supervision of practitioners).
47. THE DRUGS AND MAGIC REMEDIES
(OBJECTIONABLE ADVERTISEMENTS)
ACT, 1954
• The Act defines drugs and registered medical practitioners
besides defining magic remedy. According to Act the Magic
remedy includes a talisman, mantra, kavacha, and any
other charm of any kind which is alleged and possess
miraculous powers for or in the diagnosis, cure, mitigation
treatment or prevention of any disease in human beings or
animals or for affecting or influencing in any way the
structure or any organic function of human beings or
animals.
• False advertisement
• Draft Notification by AYUSH
48. THE DISEASES (54)
1. Diabetes
2. Uterus diseases
3. Disorder of menstrual flow
4. Prostatic gland disorders
5. Female disease (in
general)
6. Obesity
7. Rheumatism
8. Forms and structure of
the female breast,
9. Gall bladder stones
10. Kidney stones
11. Bladder stones
12. Leucoderma
13. Sexual impotence
14. Stature of person
15. Sterility of women
54. In order to curtail malpractices in the advertisement of
AYUSH drugs, the Ministry of AYUSH has signed a MoU
with the Advertising Standards Council of India (ASCI).
Addressing the cases of misleading advertisements with
respect to Ayurveda, Yoga and Naturopathy, Unani, Siddha
and Homoeopathy drugs, treatments and related services,
ASCI will comprehensively monitor these advertisements
across print and electronic media.
55. ASCI upholds complaints against 193
advertisements out of 290 in February
Healthcare: - Total of 154 ads complained against
• Dr. Dassan’s Life Care Ayurvedic Herbal Treatment and Research Centre (Kidney)
• OPTM HealthCare Private Limited
• IPSA Labs Pvt Ltd (Arodent Ayurvedic Gum and Dental Paste): “Pyorrhoea ke liye
Brahmastra”,
• Shri Kalyan Ayurvedashra M-Cure Leucoderma,Safed Dag Mitao Abhiyan
• Berry Skin Care (Leuco Kit)-Only brand delivery, with optimal mixture of herbs
that ensures therapeutic outcome
• Vaidya Ashwani Kumar-Cure Leukoderma /Vitilig
• Abhay Ayurvedic Pharmacy
• Ayurnava Kerala Ayurvedic Treatment Centre:“Best Authentic Kerala Ayurvedic
Treatment centre in Gurgaon”
• Sagar Malik Ayurveda: The advertisement’s claim, “Cure damaged knee without
operation”
• Lifespan Wellness Pvt. Ltd (Lifespan Diabetes Clinic): “We treat Diabetes”
56. More………..
Naveen Clinic-Solves sex problem
Arogyam Ayurvedic Allergy Hospital-Freedom from Asthma,All the problems were
cured from the root in 4 months
Dr. Balvinder Singh Waliya-Permanent cure for masculine weakness
Dr. Madhu Varanasi Super Speciality-Getting cured totally from cancer is possible
Dr. Samrat’s Clinic-Increases height,Sexual
Dr. Yogesh Kayakalp Hospital-Successful treatment for obesity, blood pressure,
diabetes (sugar), paralysis
Ganga Ayurvedic Clinic
Rishi Ayurved Dawakhana-Get rid of obesity in one month
Roshan Clinic
Atrivarad Multispecial ITY Ayurved Centre-100%
https://goo.gl/1z8cQt
57.
58.
59.
60. EXPIRY DATE
Duration Description
One year All eye drops and arka
Two years Churna and kwath churna, Ghrit,tooth-powder and tooth paste,
Varti, Swet parpati, Nasal and ear drops, Doophan-inhaler
Three years Gutika containing kashtha aushdhi, avleha, taila, lep -churna,
lep -gutika, lep malhar, ghanvati, capsule made of gelatine
containing kashtha aushadhi, syrup, Khand,Granules and Paka.
Five years Hard gelatine capsule containing kashtha aushadhi with
ras,bhasma and kajjali, nag,vang and tamra bhasma.
gugglu,lavan, kshars and drava.
Ten years Lauh and Mandoor
No expiry Pishti&Bhasma,Ras, Asava ,Airshtha, Kupipakva Rasayan, Swarn-
rajat-loh-mandure,abhrak-godanti-shankh bhasma
Important Pishti and bhasma start solidifying after five years and need one
or two put before reusing
61. EXPIRY DATE
Duration Description
One year Arka
Two years Churna and kwath churna, Ghrit,tooth-powder and tooth paste,
Varti, Swet parpati, Eye,Nasal and ear drops, Doophan-
inhaler,Extract
Three years Gutika containing kashtha aushdhi, avleha, taila, lep -churna,
lep -gutika, lep malhar, ghanvati, capsule made of gelatine
containing kashtha aushadhi, syrup, Khand,Granules and
Paka.Parvahi Kwath
Five years Hard gelatine capsule containing kashtha aushadhi with
ras,bhasma and kajjali, nag,vang and tamra bhasma.
gugglu,lavan, kshars and dravak.
Ras yog having Kashth aushadh with rs,upras&bhasm
Ten years Lauh and Mandoor Parpati,Pishti&Bhasma,Ras, Asava ,Airshtha,
Kupipakva Rasayan-containing only ras/upra/bhasm, Swarn-
rajat-loh-mandure,abhrak-godanti-shankh bhasma
No expiry
62. ALCOHOL CONTENTS
S.No. Name of the drug Maximum size of
packing
1. Karpur Asava 15 ml.
2. Ahiphenasava 15 ml.
3. Margamadasava 15 ml.
4. Mritsanjivani Sura 30 ml
5. Mahadraksasav 120 ml
63. SELF PREPARATION OF MEDICINE
• No manufacturing license required
• Can prepare and dispense for own patient
• Marketing ?
• Distribution
• Overseas supply
64. OTHER BILLS TO DISCUSS
THE CLINICAL
ESTABLISHMENTS ACT
BIO-WASTE MANAGEMENT ACT
FIRE AND SAFETY
SAFETY FOR MEDICARE
PERSONS IN U.P.
65.
66.
67. OTHER LAWS
• Bio-waste management-Ayurveda
• Blood from raktamokshan, ksharsutra
• Needle, syringe out of local anasesthesia
• Residual oil of panchkarma
• Vomit and sanitation product
• Punishment
68.
69.
70.
71. G.S.T.
Category G.S.T
1. Health Services Nill
Medicine*
2. Classical Medicine 5%
3. Proprietary Medicine 12%
*Annual turnover up to 22 lakh exempted
72. INSURANCE AND AYURVEDA
• The Insurance Regulatory and Development
Authority (IRDA)’s regulation 5(1) of the
IRDA (Health Insurance) Regulations, 2013
• Professional insurance
76. GUIDELINES FOR
REIMBURSEMENT/ SETTLEMENT
A. Central or state government Hospitals
B. NABH accredited Ayurvedic Hospitals
C. Teaching hospitals attached to CCIM
recognised ayurvedic colleges
D. Ayurvedic hospitals having registration with
government authorities, minimum 15 beds, 5
registered and qualified ayurveda doctors,
adequate qualified & trained paramedical staff,
dedicated therapy sections and maintaining daily
records
77. SALIENT FEATURES
Treatment duration from 1-35 days
1-7 days
• Constipation,Pain in anal region, Itching around anus,Burning
sensation ,Prolapse of mass from anus,Bleeding from anus Pus from anus
14-25 days-
• Pakshaghata- Paralysis,Hemiplegia, Hemiparesis…etc
Treatment cost- Rs.340 to 10,000
• Pre and post procedure cost will be chargeable @ Rs 75 per day
• 25%hike of the above rates shall be applicable for the treatment taken in
NABH accredited hospital or any other hospital located in metropolitan
city
• Room rent etc shall be chargeable as per norms of the insurance
company insurance policy
78. PROFESSIONAL INDEMNITY POLICY FOR
DOCTORS AND MEDICAL PRACTITIONERS
The cover granted under the policy provide indemnity for legal liability to
third party arising out of errors and omissions or negligence in
professional service rendered by the insured
A. Records to be maintained
B. The Insured shall keep an accurate record containing all relevant particulars
and shall allow the Company to inspect such record. The Insured shall within one
month after the expiry of each period of insurance furnish such information as
the Company may require.
C.Establishment must be registered with the local competent authority in
compliance of all statutory rules/regulations relating to your establishment
OPD
1.No. of patients actually treated in the previous year
2.No. of patients estimated to be treated in the proposed year
Any procedures carried out under general anaesthesia unless performed in a
hospital
80. DELIVERY & MTP
• Notification issued by Ayush wrt Ayush Haryana
• Notification by MOHFW- 19-2-2014
81.
82.
83. LEGALASPECTS OF ALLOPATHIC HOSPITALS
EMPLOYING AYUSH PRACTITIONERS
DR M C GUPTA (ADVOCATE) MD (MEDICINE), LLM
HTTP://WWW.AALATIMES.COM/2012/05/07/LEGAL-ASPECTS-OF-ALLOPATHIC-HOSPITALS-EMPLOYING-AYUSH-PRACTITIONERS/
• Are there any laws or guidelines with respect to the role of practitioners of Indian systems of medicine
employed as medical officers in hospitals which deal only and solely with allopathic medicine? What is
the status in the event of an error?
(Dr Gladstone D’Costa, Voluntary Health Association of Goa)
• The practice of employing AYUSH practitioners in hospitals is common in many private hospitals. This
is illegal and has been commented as follows by the National Consumer Commission:
✓ “When a patient is admitted in a hospital, it is done with the belief that the treatment given in the
hospital is being given by qualified doctors under the Indian Medical Council Act, 1956. It is not within
the knowledge of the relatives of the patient that the patient is being treated by a Unani specialist. We
hold that it is clear deficiency in service and negligence by the hospital for leaving the patient in the
hands of a Unani doctor…
As laid down by the Apex Court in the above case (Jacob Mathew Vs. State of Punjab), we feel it is high
time that hospital authorities realize that the practice of employing non-medical practitioners such as
Doctors specialized in Unani system and who do not possess the required skill and competence to give
allopathic treatment and to let an emergency patient be treated in their hands is a gross negligence.”
In Prof P N Thakur Vs. Hans Charitable Hospital, NC, 16 August 2007
84. YES
• Amendments in state boards
➢Maharashtra
➢Andhra Pradesh
➢Tamil Nadu
➢Uttar Pradesh
• Gazette notification
• Any other circular or order from competent authority
• Now it will be only appropriate that the Union health ministry takes a decision
of allowing all ISM practitioners to practice allopathy in rural areas all over the
country until the current shortfall of MBBS doctors is overcome.
• Madhya Pradesh Ayurvigyan parishad (sanshodhan) vidhayak 2016 and
• MPAyurvdic ,Unani tatha prakritik chikitsa vyavsai (sanshodhan)
vudhayak 2016
86. RIGHT TO PRACTICE MODERN MEDICINE
Rule 2(ee)iii
[(ee) “Registered medical practitioner” means a person__
(i) holding a qualification granted by an authority specified or notified under
section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified
in the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or
(ii) registered or eligible for registration in a medical register of a State meant
for the registration of persons practising the modern scientific system of
medicine 7excluding the Homoeopathic system of medicine; or
(iii) registered in a medical register, 1other than a register for the
registration of Homoeopathic practitioner, of a State, who although
not falling within sub-clause (i) or sub-clause (ii) is declared by a
general or special order made by the State Government in this behalf
as a person practising the modern scientific system of medicine for the
purposes of this Act;
87. LANDMARK JUDGMENTS
• Dr. Mukhtiar Chand & Ors vs The State Of
Punjab & Ors on 8 October, 1998
➢http://indiankanoon.org/doc/484509/
• Poonam Verma vs Ashwin Patel & Ors on 10
May,1996
➢http://www.indiankanoon.org/doc/611474/
88. POINTS TO DISCUSS
1.Whether Rule 2(ee)(iii) of the Drugs Rule is bad for want of
legislative competence; and are the impugned notifications
issued by the State Governments, under clause (iii) of the said
rule,declaring the categories of persons who were practising
modern system of medicine invalid in law.
2.What is the impact of Indian Medical Council Act, 1956 and
Indian Medical Central Council Act, 1970 on rule 2(ee)(iii) of
the Drugs Rules and the notifications issued thereunder? and
3.Whether the persons who have qualified the integrated
courses in Ayurveda and Unani from various universities are
entitled to practise in and prescribe allopathic medicines.
89. THE JUDGEMENT
Section 33 of the Drugs Act confers wide power on the Central Government to make rules.
Section 33, in so far as it is relevant, is reproduced hereunder : "33 Power of Central Government
to make rules.”
From what has been discussed above, we are unable to uphold the view of the Punjab and Haryana
High Court. We have perused the above said notifications issued by the State Governments and we
find that they are well within the confines of clause (iii) of rule 2(ee). Therefore, we conclude that
the said circular and the notification issued by the said State Governments declaring the categories
of Vaids/Hakims who were practising modern system of medicine and were registered in the State
Medical Registers, are valid in law.
(iii) of Rule 2(ee) what is required is not the qualification in modern scientific system of medicine
but a declaration by a State Government that a person is practising modern scientific system and
that he is registered in a medical register of the State (other than a register for registration of
Homeopathic practitioner).