There are some basic laws which are to be followed by every profession. Most of the Ayurveda professional are not aware about these legal points. These includes- Conduct& Etiquette, ethics, advertisements, manufacturing of medicine for own patients, clinical registration act 2012, insurance and ayurveda, Bio-medical waste etc.
2. About
• Most of the Ayurveda practitioners are not aware
about the basics of legality with reference to their
profession. I tried to put most common points
for our young as well as senior practitioners.
• This presentation is a part of eLecture series of
ayurvedvishva.com started by Vaidya Manish
Joshi,Nasik.(http://ayurvedvishva.com/e_sambha
sha/e_sambhasha.php )
• References can be browse by their respective
links for in depth reading.
4. 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……
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5. 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
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6. Registration
• State board
– Renewal
– Change of address
– Additional qualification
– Identity cards
• CCIM
– Mandatory/optional/advisable
– Advantage/disadvantage
– Know your CCIM registration
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7. Registration-CCIM
Know your registration
• www.ccimindia.org>
Central register>
Ayurveda
Search field-
• select state
• department (Ayurveda)
• fill your state registration number
• Enter your state registration keeping all field empty ?
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9. More on central registration
• http://www.authorstream.com/Presentation/
Surendra1955-1815731-central-registration-
ccim/
• http://www.slideshare.net/drsurendrachaudh
ary/central-registration
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10. Start your clinic
• Own premises
Residential/commercial
• Rented premises
Rent agreement with all clause of annual increment
and payment of local bodies taxes
• Shared chamber
Collection of fees, sharing of revenue and mode of
payment
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11. Clinic in residential area
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/drchugvs
mcd-clinicnot_commercial-delhihc.pdf
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12. 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.
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13. 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. Under this head, neither a
polyclinic nor a nursing home can be run in the residential area.
• "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
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15. Advertisement
• It is improper for a practitioner of Indian
medicine to use an unusually large sign board
and write on it anything other than his name,
qualifications obtained from a University or a
statutory body, titles and name of his speciality.
The same should be on his prescription papers.
• It is improper to affix a sign-board on a
chemist's shop or in places where he does not
reside or work.
• Advertisement through hoarding and tour
programmes shall be unethical.
15
16. Advertisement Cont…
• Solicitation of patients directly or indirectly either
personally or by advertisement in the news paper, by
placards or by distribution of circular cards or hand bills
by a practitioner of Indian medicine is unethical.
• A practitioner Shall not make use of or aid or permit
others to make use of him or his name and/or
photograph as subject of any form or manner of
advertising or publicity. This provision shall not apply
to authors of purely medical literature written for the
advancement of the profession and science.
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17. What can be advertise
• Practitioner may issue a formal announcement in
the Press one-insertion in one or more papers,
regarding the following :-
(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.
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18. Conduct& Etiquette
Practitioners of Indian Medicine ( Standards of
Professional Conduct, Etiquette and Code of
Ethics) Regulations, 1982
PART- II
PROFESSIONAL CONDUCT AND ETIQUETTE DUTIES
AND OBLIGATIONS OP PRACTITIONERS OF INDIAN
MEDICINE TO-WARDS PATIENTS AND PUBLIC
http://ccimindia.org/cc_actregulations_1982.html
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19. Part-II
towards patient & Public
1. Character of the Practitioners of Indian Medicine
2. Duties of practitioners of Indian medicine towards
their patients
3. Practitioner's responsibility
4. Patience, delicacy and secrecy
5. Prognosis
6. The patient must not be neglected
7. Upholding the honour of the profession
8. Engagement for an obstetric case
9. Practitioner as a Citizen
10. Public Health
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20. Part-III
TOWARDS ANOTHER PRACTITIONER
• 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
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21. PART IV
CODE OF ETHICS
1. Advertising
2. Nomenclature of qualification-It shall be compulsory
for a practitioner of Indian medicine to affix the
correct degree or diploma before or after his name.
3. Payment for professional services- "No cure, no
payment“
4. Rebates and commission
5. Evasion of legal restriction
6. Professional certificates, reports and other
documents
7. Register of medical certificate issued by practitioner
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22. PART-IV
DISCIPLINARY ACTION
• Adultery, improper conduct and/ or having adultery and
improper relations with patient
• performing on enabling unqualified person to perform an
abortion or any illegal operation for which there is no
medical, surgical or psychological indication;
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).
22
23. The punishment
• The appropriate authority-the State Board or
the State Council
• May issue a letter of warning or
• May direct the removal altogether or for
specified period from the register the name
23
24. Prescription letter head
XYZ Clinic
Dr. ABC
General physician and surgeon
XYZ Clinic
123, street – place, telephone
XYZ Clinic
Dr. ABC, B.A.M.S….. Contact number
Timings-
In case of emergency
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26. The Drugs and Magic Remedies
(Objectionable Advertisements)
Act, 1954
• An Act to control, the advertisement of drugs in certain cases, to prohibit the advertisement for
certain purpose of remedies alleged to possess magic qualities and to provide for matters
connected therewith.
• 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.
• Unless prescribed by registered medical practitioners or after consultation with the Drugs and
Cosmetics Act 1940, no person or company, shall take any part in the publication of any
advertisement referring to any drug that is used for:
a) the miscarriage in woman,
b) maintenance or improvement of the capacity of human beings for sexual pleasures,
c) correction of menstrual disorder in women, and
d) the diagnosis, cure, mitigation, treatment or prevention of any disease.
• No person or company will take part in advertisement which give false impression or makes a false
claim for the drug or mislead the people. Whosoever contravenes any of the provision of this Act
shall be punishable with imprisonment extended to six months or with fine, or with both for first
time conviction. It may extend to one year imprisonment or with fine or with both on subsequent
convictions.
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27. 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
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32. Action Taken
• Herbal oil ads: Govinda tells FDA he was
unaware of laws
• Mid-Day.com | Updated: August 23, 2012 12:40 IST
• Mumbai: Last month, the Food and Drug
Administration (FDA) had filed 67 complaints at
police stations across the state under various
sections of the Drugs and Magic Remedies
(Objectionable advertisements) Act, 1955. These
include complaints against advertisements of
products such as 'Sandhi Sudha plus', 'Step up
herbal oil' and 'Power Prash', which are promoted
by leading Bollywood stars.
33. Advertising Standards Council of India
contravened the provisions of the Drug & Magic Remedies Act
• Naaz India Company: Naaz Fat Cut
Granuals and Naaz Hair Up Oil's -
'stops hair fall', 'provides successful
cure of baldness'.
• Sagar Dispensary's - 'Dr. S.A. Ali is an
expert in STD'. 'Treats patients with
problems like less sperms, impotence
& provides complete and permanent
cure', 'our successful treatment has
cured lakhs of disheartened patients
and given them new life'.
• Anant -'provides successful cure of
male infertility', 'internal weakness',
'premature ejaculation erectile
dysfunction', 'childlessness', 'skin
disease', 'psoriasis and tumour in
breast'.
• Sarkar Dispensary's advertisement
claimed that it 'is the Best Ayurvedic
clinic of 2011'
• IPSA Labs: Eraser Ayurvedic Skin
Cream's advertisement claimed that
it 'is a mixture of 8 essential herbs
which removers every kind of spots
from your face and skin'.
• Stammering Cure Centre
advertisement claimed that the
centre 'Partha Bagchi (world leader in
stammering cure since 22 years)
cures stammering in 12 days.‘
• GM Pharmacy: Sadabahar Sugar
Free's advertisement claimed that
'Sadabahar sugar free is a diabetes
killer powder', 'most effective
medicine in diabetes'.
34.
35. 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
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36. 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
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37. Self preparation of medicine
• No manufacturing license required
• Can prepare and dispense for own patient
• Marketing ?
• Distribution
• Overseas supply
37
39. The Clinical Establishments
(Registration & Regulation) Act, 2010
• The Act is for the Registration and Regulation of the clinical
Establishments in the country and for matters connected
therewith
• Act passed by Parliament in August 2010 and notified on
1st March, 2012.
• National Council under the Act notified on 19th March,
2012 and Central Rules notified on 23rd May, 2012
• Model State Rules have been circulated to the States/UT’s.
• Ministry has requested the Chief Ministers to adopt and
implement the Act.
• Highest priority of Govt. for implementation and
monitored by the PMO.
39
40. Definition of Clinical Establishment
(i) a hospital, maternity home, nursing home, dispensary, clinic,
sanatorium or an institution by whatever name called that offers
services, facilities requiring diagnosis, treatment or care for illness,
injury, deformity, abnormality or pregnancy in any recognized
system of medicine established and administered or maintained by
any person or body of persons, whether incorporated or not; or
(ii) a place established as an independent entity or part of an
establishment referred to in sub-clause (i), in connection with the
diagnosis or treatment of diseases where pathological,
bacteriological, genetic, radiological, chemical, biological
investigations or other diagnostic or investigative services with the
aid of laboratory or other medical equipment, are usually carried
on, established and administered or maintained by any person or
body of persons, whether incorporated or not,
40
41. Coverage
• All clinical establishments - including
diagnostic centres and single doctor clinics,
across all recognized systems of medicine in
both public and private sector. (exception:
establishments of the Armed Forces)
41
42. Bio-waste management Law
• Bio-medical waste means any solid and/or liquid
waste including its container and any
intermediate product, which is generated during
the diagnosis, treatment or immunization of
human beings or animals in research or in the
production or testing
• Consisting entirely or partly of human or animal
tissue, blood or other body fluids, excretions,
drugs or other pharmaceutical products…
42
43. Bio-waste management-Ayurveda
• Blood from raktamokshan, ksharsutra
• Needle, syringe out of local anasesthesia
• Residual oil of panchkarma
• Vomit and sanitation product
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44. Bio-waste management Law
• SMC(Surat municipal corporation)-TNN May 10, 2013,
has been carrying out surprise inspections in
hospitals, clinics and nursing homes to check
to check their bio-medical waste disposal
mechanism. At least 186 hospitals, nursing
homes and clinics were covered on Thursday.
Four private hospitals, namely 21st Century
Hospital run by Dr Purnima Nadkarni and Dr
Pooja Nadkarni, Ayush Hospital run by Dr
Ghanshyam Patel
44
45. Insurance and Ayurveda
• The Insurance Regulatory and Development
Authority (IRDA) has issued a notification
informing the inclusion of the Indian System
of Medicines in the mediclaim insurance
policy. As per the notification, the insurance
coverage to Ayush treatments has been
facilitated through the regulation 5(1) of the
IRDA (Health Insurance) Regulations, 2013
45
46. Professional Indemnity Policy For
Doctors And Medical Practitioners
a) Legal liability as fixed by courts in India to pay
compensation.
b) Defence costs and expenses. This means all costs, fees
and expenses incurred with the prior consent of the
insurer in the investigation, defence or settlement of
any claim made against the insured, provided the
claim falls within the ambit of the policy.
• The amount of payment under (a) and (b) will not
exceed the amount insured for in the policy under the
limit of Any One Accident (AOA) in respect of any or all
claims made against the insured arising out of Any One
Accident.
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47. Premium
Premium chargeable depends on the:
• Risk group of doctor Limits of indemnity selected Ratio of
limits
• Depending on exposure, the proposer has to fix two limits
of indemnity under the policy:
• Any One Accident (AOA)Any One - Year (AOY)AOA and AOY
can be in ratio of 1:1 or 1:2.
• Premium-Varies between 0.30 per thousand rupees and
3.00 per thousand rupees depending upon (a) Category of
Doctor and (b) AOA : AOY ratio chosen.
AOA - Any One Accident
AOY - Any One Year
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49. Right to practice Modern Medicine
• New Delhi, June 17: Doctors of ayurveda and
three other systems of medicine may be
legally permitted to prescribe modern
medicine under a controversial proposal from
the Union health ministry that has angered
sections of modern medics.
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51. Right to practice Modern Medicine
- RULES -PART I -PRELIMINARY 2. Definitions.___
[(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; or
(iv) registered or eligible for registration in the register of dentists for a State under the
Dentists Act, 1948 (16 of 1948); or
(v) who is engaged in the practice of veterinary medicine and who possesses
qualifications approved by the State Government;]
•
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54. YES
• Amendments in state boards
Maharashtra
Andhra Pradesh
Himachal Pradesh
Tamil Nadu
Haryana, Delhi--?????? 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.
55.
56. Legal aspects 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
57. AYURVEDIC DOCTOR IS FINED 15 LAKH
RUPEES BY HON>SUPREME COURT ON
APRIL 5, 2013.
http://www.advocatekhoj.com/library/judgments/announcemen
t.php?WID=3336
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58. 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/
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59. Right to practice Modern Medicine
• Obstetrics cases
• Immunization
• Storing allopathic medicine
• Prescription
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60. Thanks !
Can follow me at
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Presentations/All
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My cases on Ayurveda and related topics
• http://www.ayurvedaconsultants.com/caseallauthor.aspx?ivalue=1435
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