Manual on Doctors and Law Narendra Malhotra, Shashi Goel, RN Goel
INDEX
ABCDEFGHIJKLMNOPQRSTUVWZ
A
Accident and emergency departments 279
reporting 72, 76
Acute febrile illness 123
Admission register 86
Advertising 27
Advisory committee 76
Amputation of wrong limb 279
Ancillary laboratory facilities 204
Anejaculation 208
Anemia 123
Anesthesia 279
Animal waste 77
Annual report 71, 76
of activities financed under fund 290
Appeal against orders of district forum 265
national commission 267
state commission 266
Application for authorization 69
permanent registration 225
provisional certificate of registration 224
registration of hospital 137
sterilization operation and consent form 125
Appointment of commission of enquiry 257
substitute 26
ART procedures 192
Artificial insemination with donor semen 206
husband's semen 206
Assisted reproductive technology 190
procedure 205
rules 144, 191
Authority for registration 223
Autoclave room 203
B
Back-up power supply 205
Basic information 169
Biomedical waste 69, 73, 77
Blood dyscrasia 123
Brainstem death certificate 134
Bronchial asthma 123
C
Cancellation of registration 226
Cardiac, pulmonary, cardiopulmonary transplantation 143
Central
Consumer Protection Council 267
Pollution Control Board 78
Certificate of medical officer 126
permanent registration 226
registration 101, 139, 151, 193
surgeon 127
Chemical waste 77
Chronic liver disease 123
systemic disease 123
Clinical establishments Act 217
Code of conduct 120, 315
Color coding 78
and type of container for disposal of biomedical waste 78
Composition of joint state councils 246
Congenital bilateral absence of vas deferens 208
Consent for artificial insemination or intrauterine 154
freezing of embryos 156
oocyte retrieval/embryo transfer 158
surgical extraction of sperm 157
treatment 270
Consent form 82
for donor of oocytes 163
sperm 164
Constitution and composition of central council 237
state councils 245
of special courts 303
Consumer disputes redressal agencies 263
means 262
Protection
Act and Medical Profession 259
councils 267
rights 259
Criminal negligence 275
Cryopreservation 209
D
Death penalty for certain offences after previous conviction 301
Decisions of court 53
Declaration of doctor conducting ultrasonography 107
pregnant woman 107
Deficiency means 262
Denial of sterilization 126
Details of frozen embryos 173
Dimethyl sulfoxide 209
Disallowing of registration 226
Discarded medicines and cytotoxic drugs 77
Disobedience of direction, obstruction and refusal of information 229
Display of certificate of registration 224
information for filing objections 225
registration numbers 23
District forum 263, 264
Doctor-patient relationship 268
Duties and obligations of doctor 269
of physician in consultation 25
to public and paramedical profession 26
E
Ectopic pregnancy 214
Education regulations 240
Embryo donation 208
Embryology laboratory complex 204
Emergency care 270
Employees of authority 232
Endometriosis 207, 212
Endorsement 30
by ART clinic 153, 155, 156-158, 162, 163
Entry of additional qualifications 254
Establishment of National Council 219
Euthanasia 28
Evasion of legal restrictions 23
Executive committee 239, 248
Exposure of unethical conduct 23
F
Failure of communication 280
Findings of district forum 265
Form of application for approval of place under clause (b) of section 4 80
registration or renewal of registration of infertility/ART clinic 144
certificate recommended for leave or extension or communication of leave and for fitness 36
consent 108
Format for medical record 37
Freezing of embryos 209
semen 209
Fresh application for permanent registration 226
Functions of national council 221
G
Gamete intrafallopian tube transfer 207
Gonadal dysgenesis 208
H
Heart disease 123
History of ovarian hyperstimulation syndrome 208
Hostile uterine cervix 206
Human anatomical waste 77
rights 28
Hypertension 123
I
Iatrogenic ovarian failure 208
Idiopathic infertility 207
In vitro culture media 210
fertilization 199
and embryo transfer 206
Incorporation of central council 238
state councils 246
Indian Council of Medical Research 191
medical register certificate 8
Indications for embryo donation 209
for oocyte donation 208
of ICSI with ejaculated spermatozoa 207
in vitro matured oocytes 208
surgically extracted sperm 208
Infertility of immunological origin 207
Information on oocyte donor 167
semen donor 165
surrogate 169
Inheritable genetic disorder 209
Insemination with husband's semen/sperm 154
Inspection of registered clinical establishments 227
Inter-state agreements 245
Intracytoplasmic sperm injection 199, 207, 214
Intrauterine insemination 197
with donor semen 155
with either husband's or donor semen 206
Issue of duplicate certificate of registration 255
J
Jaundice 123
Jurisdiction of
District Forum 264
National Commission 266
State Commission 266
K
Kidney transplantation 143
L
Laying of rules 233, 235
Liquid waste 77
M
Maintaining good medical practice 22
professional autonomy 30
Maintenance and preservation of records 314
Maintenance of laboratories 205
medical records 22
National Register of Clinical
Establishments 228
records 76
State Register of Clinical Establishments 228
Medical
Council of India 13
emergencies 278
research 29
termination of pregnancy Act 87
regulations 80, 94
Meetings of advisory committees 119
Microbiology and biotechnology waste 77
Micromanipulation of gametes and embryos 214
Microsurgical epididymal sperm aspiration 208
Minimum physical infrastructure requirement for infertility clinic 192
requirement regarding staff in infertility clinics 192, 198
Ministry of Health and Family Welfare Government of India 94, 144
Mode of declarations 242
elections 238, 247
Model form of informed consent 281
Monetary penalty for non-registration 229
Multiple gestations 214
N
Narcotic drugs and psychotropic substances 294
Act 282
consultative committee 289
National
Commission 264, 266
council for clinical establishments 219
fund for control of drug abuse 289
Non-obstructive azoospermia 208
O
Oath of secrecy 188
Obligations to sick 24
Observation of hon’ble Supreme Court 40
Obstructive azoospermia 208
Offences and penalties 295
Officers of
Central Government 288
State Government 289
Oligozoospermia 206
Oocyte cryopreservation 210
donation 208
donors 171, 172
embryo record 173
Operation theater 203
Opinion form 83
Ovarian disorders 213
hyperstimulation syndrome 215
tissue cryopreservation 210
Ovulation induction 208
P
PAN application 1
Partial zona dissection 207
Passport application 3
Payment of part of fees to central council 257
professional services 23
Pelvic infection, adhesions or mass 123
Pharmacy Act, 1948 236
Polycystic ovary 208
Power of
Central Government 232
to permit, control and regulate 291
seizure and arrest in public place 309
State Government 233, 293
Preconception and prenatal diagnostic techniques Act 314
Premature ovarian failure 208
Preparation and maintenance of register 249
Preservation of organs 141
President and vice-president of central council 238
state council 247
Presumption of culpable mental state 303
Primary germ cell failure 209
infertility clinics 196
Professional negligence 274
secrets 274
Prohibition of certain operations 290
Provisional certificate 224
Proxy consent 278
Public information 120, 196, 315
Publication of expiry of registration 225
Q
Qualifications for entry on first register 250
subsequent registration 250
Quality of consumables used in laboratory 205
R
Record of use of donor gametes and surrogates 172
room 202
Register of clinical establishments 228
Registration and standards for clinical establishments 222
for clinical establishments 223
in central register 242
of hospital 141
of pharmacists 249
of research center using human embryos 149
Rejection of application for registration or renewal of registration 102, 152
Renewal of registration 141, 194, 225, 314
Results of screening of semen donors 171
Retrograde ejaculation 208
Room for embryo transfer 204
S
Scrutiny of applications for registration 253
Secondary infertility clinics 197
Selection criteria for
ART procedure 192, 212
gamete intrafallopian transfer 213
Semen analysis report 175
collection room 203
donors 172
processing laboratory 203
Severe nutritional deficiency 123
Sex determination tests 31
Signing professional certificates, reports and other documents 31
Solid waste 77
Sperm cervical mucus penetration test 197
Spontaneous abortion 214
Staff remuneration and allowances 239, 248
State commission 263, 265
consumer protection council 267
council of clinical establishments 222
pharmacy councils 245
Substitute consent 278
Subzonal insemination 207, 214
Surrogate mothers 172
T
Term of office and casual vacancies 239, 247
Tertiary infertility clinics 198
Testicular spermatozoa 207
Thyrotoxicosis 123
Transplantation of human organs act 130
rules 140
liver and other abdominal organs 143
Treatment of oligozoospermia 196
Tubal disease 212
embryo transfer 207
ligation 122
Tuberculosis 123
Type of container 78
U
Unethical acts 27
Unexplained infertility 206, 212
Use of donor oocytes and donor embryos 213
Uterine disorders 213
V
Validity of provisional registration 224
registration 194
Verification of application 225
Violation of regulations 30
Vitamin deficiency 123
W
Waste category 78
Z
Zygote 191
×
Chapter Notes

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1Manual on DOCTORS AND LAW2
3Manual on DOCTORS AND LAW
Second Edition
Editors RN Goel MBBS DGO DA DCH Founder Fellow Indian College in Medical Ultrasound Fellow Guide Indian College of Maternal Child Health Treasurer SAFOG 2013 Vice President Indian Federation of Ultrasound in Medicine and Biology Vice President UP Nursing Home Association Vice President Agra Obs/Gyne Society Secretary Agra Chapter Indian Menopause Society Secretary Agra Nursing Homes Association Executive Member ISPAT Narendra Malhotra MD FICOG FICMCH Professor Dubrovnik International University Dubrovnik, Croatia Director Rainbow Hospital Agra, Uttar Pradesh, India Shashi Goel BSc LLB MA (USSR) PhD in Journalism (Moscow) President Balaji Kalyan Kendra (NGO) Director Balaji Oxford Center for Personality Development Agra, Uttar Pradesh, India Foreword Sanjay Gupte PK Shah
4
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This book has been published in good faith that the contents provided by the editors contained herein are original, and is intended for educational purposes only. While every effort is made to ensure accuracy of information, the publisher and the editors specifically disclaim any damage, liability, or loss incurred, directly or indirectly, from the use or application of any of the contents of this work. If not specifically stated, all figures and tables are courtesy of the editors. Where appropriate, the readers should consult with a specialist or contact the manufacturer of the drug or device.
Manual on Doctors and Law
First Edition: 2013
9789350904923
Printed at
5Foreword
In today's atmosphere of importance of legalities in medical practice, it is highly desirable for a medical practitioner to know the laws, which are applicable to him/her in practice.
I would like to compliment Dr RN Goel for preparing a concise collection of the bare Acts applicable to medical practitioners and various forms and documents, which are associated with these Acts. This will serve as a ‘Ready Reckoner’ for an average medical practitioner who would desire to keep it on his desk for quick reference. Its always said that ignorance of laws is no excuse and this is proved beyond doubt by the sufferance of doctors under the Preconception and Prenatal Diagnostic Techniques (PCPNDT) Act. So friends, it is time to wake up and learn what the legislations of our country expects of us. This will lead to safety and hopefully peace in our everyday practice.
I again compliment the authors for their helpful endeavor !!
Sanjay Gupte MD DGO FICOG LLB FRCOG
President FOGSI 2010
Member Central Supervisory Board of PCPNDT Act
Member Ethics Committee, Medical Council of India
Chairman Ethics Committee of Maharashtra Medical Council
National Coordinator, National Eclampsia Registry
Ex-Honorary Associate Professor, BJ Medical College, Pune
National Consultant in Medicolegal and Ethical Issues in Obst and Gynec
Director, Gupte Hospital and Center for Research in Reproduction,
PG Institute for Gynec and Obst
Mumbai, Maharashtra, India6
7Foreword
It gives me immense pleasure to write foreword for the book Manual on Doctors and Law, edited by Dr RN Goel, Dr Narendra Malhotra and Dr Shashi Goel. All Obstetricians and Gynecologists must know laws related to the practice. It would help avoid unnecessary medicolegal problems related to our field.
The book covers all the important Acts, such as MTP Act, PCPNDT Act, ART Act, Clinical Establishment Act, Consumer Protection Act, Tubal Ligation, etc. All the editors have done an excellent job in making this book very informative. I am sure this excellent reading material will help our colleagues know and understand law related to the field of Obstetrics and Gynecology.
I congratulate the editors for their wonderful efforts.
PK Shah
MD FCPS FICOG FICMU FICMCH DGO DFP
Immediate Past President, FOGSI
Professor
Department of Obstetrics and Gynecology
Seth GS Medical College and King Edward Memorial Hospital
Mumbai, Maharashtra, India8
9Preface
The classical concept of doctor-patient relationship born in the golden days of family physicians has undergone drastic change because of dramatic advancement in medical technology, availability of sophisticated imaging system, high tech electronics and preponderance of new diseases. With the immense strides in technology, health care has emerged as a profitable sector attracting investors from varied background in our country. Seeing the vast privatization of health sector, Government and Ministry of Health laid down certain rules, regulations, Acts, etc. for this sector. Where doctor has to fulfil so many forms, undergo so many registrations, of which a doctor may not be aware of and faces problem at any stage of his practice. So, it is must for every doctor to know and follow these rules and regulations to avoid further complications.
This book (manual) is an effort to aware medical practitioners about the rules, regulations, Acts and right legal procedures to start their practices.
Hereby, we have provided the Performas of all the forms, which a doctor or a clinical establishment has to fulfil before starting medical practice in India. This manual contains all forms and bare Acts concerning to medical practitioner.
Hope this manual will be a great guideline to Indian doctors.
RN Goel
Narendra Malhotra
Shashi Goel1011121314
15Introduction
  • This book (manual) is a compliance of all the laws and Acts, which govern medical doctors
  • Every country has different laws for practicing medicine and in India, we have laws, which govern and regulate medical practice
  • We have provided to you all the forms, a doctor or a clinical establishment has to fulfil before they start medical practice in India
  • The manual has all forms and also bare Acts
  • We are pleased to present this manual and hope it will make useful reading to all doctors of India.