Transcript Slide 1

Dr. JAYAKRISHNAN.A.V.
CO ORDINATOR,
Committee for Medicine & Law
State Secretary, IMA Kerala
 TOO MANY LAWS GOVERNING THE HEALTH
SECTOR
 HEALTH CARE PROVIDERS FEEL THAT THE
SECTOR IS OVER REGULATED
 LAW MAKERS AND ADMINISTRATORS FEEL THAT
THE SECTOR IS UNREGULATED
(i) Medical Education: This topic again encompasses a
number of issues right from recognition of
qualifications, recognition of educational institutions,
the courses of study, right of admission and various
other aspects concerning rights of medical students,
etc.
(ii) Entitlement to medical practice and the limitations
of the same: What does a given degree entitle you to
practise? Can an allopathic doctor prescribe
Homeopathic medicines, etc.
(iii) Control over medical practice: Machinery which will
ensure the enforcement of the laws referred to above.
(iv) Obligations of doctors and medical ethics: The
obligations of doctors to other doctors, to patients and
to the society are codified in the code of medical
ethics.
(v) Medical malpractice laws: These deal with
malpractice and negligence and the machinery to
bring doctors to book such as Medical Councils,
Consumer Courts, etc. A small part of medical
malpractice accompanied by the unethical conduct is
covered under the medical council acts while the rest
falls under the tort law, criminal laws and the
consumer protection act
(vi) Drug dispensation and Drug laws: These are covered
under the acts for pharmacists and the
pharmaceuticals.
(vii) Control over hospitals and Nursing Homes
 MCI ACT
 UNIVERSITIES ACT
 OTHER COUNCILS
 recognition of educational institutions
 the courses of study
 right of admission
 various other aspects concerning rights of medical
students, etc.
 Medical degrees
 MCI Act
 Trainings and certificates
 Encroacment & quackery
 Medical council
 Government control
 Protocols and guidelines
 Standard practice
 Advancements
 Trial & experiments
 Trade or profession
 Self regulation
 Ethics and law
 Individual Vs Institution
 a) Consumer Dispute Redressal Agencies.
 b) Medical Council of India and Dental Council of
India.
c) Civil Courts.
d) MRTP (Monopolies and Restrictive Trade
Practices Commission)
e) Public Interest Litigation.
f) Sections of Indian Penal Code, 1860 (Criminal
courts)
 g)Other Agencies
 (i)Human Rights Commission (ii)Vanitha
Commission (iii) Lok Adalat
 Magic remedies act
 Drugs and cosmetics act 1945
 Nursing homes registration act of various states
 Clinical establishment act
 CPA act Passed in 1986
 Medical profession introduced in 1995 following
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supreme court verdict in V.P.shantha Vs IMA case
Jacob Mathew case, Martin D’Souza case and Nikhil
superspeciality case
(i) lata culpa, gross neglect
(ii) levis culpa, ordinary neglect, and
(iii) levissima culpa, slight neglect.
 To do scientific analysis regarding CPA cases
 To find out possible solutions
Amendments, expert panel, capping of compensation,
special fund etc.
 Proceed with legal measures
 No practitioner should be booked under the provisions
except under extraordinary circumstances
 The provisions has to be clearly defined
 Although MCI is called the regulatory body, it has
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limited regulatory role
NOC for medical colleges decided by the state govt.
Syllabi modified by respective universities
No financial and administrative autonomy
Overlap of portfolios with other councils and agencies
Nominated representatives outnumber elected ones
Representation from states erratic and not according
to the number of registered practitioners
 For Registration and regulation of clinical
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establishments.
State council
District authority of registration
Provisional and Permanent registration
Cancellation
Penalties
 Appeals and Revision
 Grievance Redressal
 Inspection and Power to enter
 PROVISIONAL For One year
 PERMANENT
For 3 years
issued only after inspection and minimum
standards are met.
institution will be categorised.
 Registration can be cancelled for various reasons
envisaged in the act.
 Penalty ranging from 50,000 to 5,00,000
Appeals and revision
Appeals to the council
Revision by government
Grievence redressal
Council to set up a grievence redressal mechanism to receive complaints against the
establishment.
Inspection and Power to enter
The council, the authority or an authorised person can inspect/ enter the clinical
establishment at any time.
 The participating associations unanimously resolve that
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proposed Clinical Establishments bill is irrelevant and not
required for our state.
However the associations agreed on the following points
Registration of clinical establishments and maintenance of
appropriate standards are necessary.
Govt regulation through licensing process is not required.
The state council should have a representative character of
stake holders.
 The institution may conform to the prescribed standards
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through independent accreditation agencies and this should be
adequate for registration without inspection by Govt agencies.
State level council is adequate. District authority is not
necessary.
A minimum of 5 yr period should be given to the institutions to
achieve the standards.
This state authority should provide a single window for all
legislations and regulations.
The stabilization clause is unrealistic and should be deleted.
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 The act should include provision for promotion of clinical
establishments.
 The penalty clauses and complaint cell should be deleted.
There are varieties of rights given to people, by law or
recognised by law: (1)Fundamental rights given by the
constitution, (2) Constitutional rights not having
status of fundamental rights, (3) Statutory rights, (4)
Rights flowing from subordinate legislation. (5) Rights
based on case law, (6) Customary rights, (7)
Contractual rights.
Article 47
 Public health act
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The Medical Termination of Pregnancy Act and Rules
The Pre-Natal Diagnostic Techniques (PNDT) Act and Rules
Acts in Disability
Insecticides Act and Rules
Maternity Benefit Act and Rules
Narcotic Drugs and Psychotropic Substances Act and Rules
The Prevention of Food Adulteration Act, 1954
Drugs and Cosmetics Act, 1940
Bio-Medical Waste (Management and Handling) Rules, 1998
The Pharmacy Act, 1948
The Transplantation of Human Organs Act and Rules
Environmental Acts and Rules
Consumer Protection Act and Medical Profession
Mental Health Act, 1987
Food Safety and Standards Regulations
The Protection of Women From Domestic Violence Act, 2005
The Marriage Laws (Amendment) Bill, 2010
The Prohibition Of Sexual Harassment Of Women At Workplace Bill, 2010
Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011
Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011
List of Licenses and Statutory
Obligations
All
of them might not be applicable to all the Hospitals:
1. Building Permit (From the Municipality).
2. No objection certificate from the Chief Fire officer.
3. Bio- medical Management and handling Rules, 1998.
4. No objection certificate under Pollution Control Act.
5. Radiation Protection Certificate in respect of all X-ray, Cath lab and CT Scanners
from BARC.
6. Atomic energy regulatory body approvals.
7. Excise permit to store Spirit.
8. Income tax PAN.
9. Permit to operate lifts under the Lifts and Escalators Act.
10. Narcotics and Psychotropic substances Act and License.
11. Sales Tax Registration certificate.
12. Vehicle registration certificates for Ambulances.
13. Retail and Bulk drug license (Pharmacy).
14. Wireless operation certificate from Indian post and telegraphs, (if applicable)
15. Air (prevention and control of pollution) Act, 1981 and License
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Arms Act, 1950. (if guards have weapons)
Boilers Act, 1923.
Cable television networks Act, 1995.
Central sales tax Act, 1956.
Consumer protection Act, 1986.
Contract Act, 1982.
Copyright Act, 1982.
Customs Act, 1962.
Dentist regulations, 1976.
Drugs and cosmetics Act, 1940.
Electricity Act, 1998.
Electricity rules, 1956.
Employees provident fund Act, 1952.
ESI Act, 1948.
Employment exchange Act, 1969.
Environment protection Act, 1986.
32. Equal remuneration Act, 1976.
33. Explosives Act, 1884.
34. Fatal accidents Act, 1855.
35. Gift tax Act, 1958.
36. Hire Purchase Act, 1972.
37. Income Tax Act, 1961.
38. Indian Lunacy Act, 1912.
39. Indian Medical Council Act and Code of Medical Ethics, 1956.
40. Indian Nursing council Act, 1947.
41. Indian penal code, 1860.
42. Indian trade unions Act, 1926.
43. Industrial disputes Act, 1947.
44. Insecticides Act, 1968.
45. Lepers Act
46. Maternity benefit Act, 1961.
47. MTP Act, 1971.
48. Minimum wages Act, 1948.
49. National building code.
50. National holidays under shops Act.
51. Negotiable instruments Act, 1881.
52. Payment of bonus Act, 1965.
53. Payment of gratuity Act, 1972.
54. Payment of wages Act, 1936.
55. Persons with disability Act, 1995.
56. Pharmacy Act, 1948.
57. PNDT Act, 1996.
58. Prevention of food adulteration Act, 1954.
59. Protection of human rights Act, 1993.
60. PPF Act, 1968.
61. Registration of births and deaths Act, 1969.
62 .Sale of goods Act, 1930.
63.Tax deducted at source Act.
64. Sales tax Act.
65. SC and ST Act, 1989
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Act
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License for the blood bank
Companies Act, 1956
Constitution of India
Insurance Act, 1938
Transplantation of human organs
1994 and License (if applicable)
Workers compensation Act, 1923
Urban land Act, 1976
 Bhore committee 1946 Comprehensive and structured
 Mudaliar Committee 1961 public health act
Control and standardisation of institutions including
pvt hospitals
 Mukherjee committee 1966 health services
 Ajith Prasad jain committee 1968 on hospitals
 ICMR/ICSSR Committee 1981 comprehensively review
health & healthcare situation
 Working group of planning commission 1989 on ISM
and Homoeopathy
 Varadappan committee 1989
Nursing
 Committee on Subordinate legislation 10th Loksabha
1991 -1996
Comprehensive recommendations
 FEBRUARY , MARCH
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data collection, research, consultations
APRIL
meetings
MAY – JULY
Campaigning, political lobbying, legal fight
AUG – OCT
Follow up activities and meetings
NOV
Summing up