Regulatory requirements for private clinics

Tuesday, November 6, 2012

by Dr S K Joshi

A former Soldier, Doctor, Health Administrator

A clinic may be defined as a place of professional practice with facilities for outdoor consultation and treatment during scheduled hours by one or more physicians and staff and equipment essential for the services provided. It may or may not have the facilities for limited investigations specific to the scope of services provided.

Dr Surinder Kumar Joshi

A large percentage of the population, in rural as well as urban areas, is dependent on private clinics and, therefore, the quality of healthcare services provided by them is very important. At present there is no system of registration of private clinics by health authorities in India. The Clinical Establishments (Registration and Regulation) Bill, 2007 is still pending in the parliament.

Presently, the operation of private clinics is being governed by the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 and certain other legislations as outlined below.

1. Registration/Requirement of Licenses

•          Registration with health authorities is not mandatory for private clinics but the clinic will be subject to inspections in case of any complaints. If and whenever the Clinical Establishments (Registration and Regulation) Bill, 2007 is passed by the parliament and implemented by the states, registration of all clinics (Private/Public) of all systems of medicine will become mandatory;

•          Registration with the municipal authorities (Delhi Shops and Establishments Act, 1954);

•          Recognition for usage of narcotic drugs (Delhi Narcotic Drugs (Amendment) Rules, 2002;

•          Authorisation for generation of Bio-Medical Waste, if treating 1,000 or more patients per month;

•          Permit for procurement/usage of spirit;

•          Registration under the Medical Termination of Pregnancy (MTP) Act 1971, the Pre-Natal Diagnostic Techniques (PNDT) Act, 1994, as applicable.

2. Regulations Related to Employment of Staff

•          Employment of staff (Doctors, Nurses, Pharmacists) only after proper credentialing;

•          Prevention of sexual harassment of women at work place (Judgment of the Supreme Court of India (SCI) in Sakshi Vs the Union of India and Others);

•          Responsibility of employer for safety of employees (Delhi High Court Judgment in Ms XYZ Vs Shanti Mukund Hospital, Delhi and Punjab & Haryana High Court Judgment in Jasbir Kaur Vs the state of Punjab);

•          Rules governing the employment of staff (Delhi Shops and Establishments Act, 1954);

•          Immunisation / other measures for protection of staff from Occupational Health hazards.

3. Sign Boards

 

•          Rules for the size, contents and correct place for sign boards (IMC Regulations 2002).

 

4. Information to be displayed at the Clinic

•          Certificate of registration of clinic with the municipal authorities;

•          IMC/SMC registration certificate (IMC Regulations, 2002);

•          Charges for consultation and other procedures/services (IMC Regulations 2002);

•          Clinic timings, closed days (Delhi Shops and Establishments Act, 1954).

5. Documents to be maintained by the Clinic

•          Registration of the clinic with the municipal authorities (Delhi Shops and Establishments Act, 1954);

•          Record of employment of adults, letters of employment issued and hours of work;

•          Maintenance of record of patients treated (IMC Regulations 2002) and a register of medico-legal cases (MLCs);

•          Maintenance of a register of medical certificates issued;

•          Copies of medical certificates issued;

•          Registration certificates of doctors/nurses/pharmacists with the State Medical Councils (SMCs);

•          Professional qualifications (degrees/diplomas) of the staff;

•          Record of consumption of Morphine (if applicable) (Delhi Narcotic Drugs Rules, 2002);

•          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);

6. Issue of any medical certificate, notification, document or report, which is untrue, misleading or improper is a misconduct and punishable offence (IMC Regulations 2002, Section 197 of Indian Penal Code);

7. Regulations Related to Treatment of Patients

•          Valid consent for examination/investigation/treatment/research procedure (or informed refusal of consent), as applicable (IMC Regulations, 2002);

•          Confidentiality of privileged communication, as far as permitted under the law;

•          Life saving treatment of emergency cases (SCI Judgment in Parmanand Katara Vs Union of India, and The Delhi State CDRC (Consumer Disputes Redressal Commission) Judgment in the case of death of NB Sub K L Guliani);

•          PNDT Act 1994, Conduct of Euthanasia (SCI Judgment in Aruna R Shanbaug Vs Union of India & Others, March 2011), MTP Act 1971 and IPC sections 312-315, 318;

•          Rules for issue of prescriptions (IMC Regulations, 2002);

•          Maintenance of Medical Records of the patients treated for a period of three years and as per the format vide Appendix 3 to the IMC Regulations, 2002;

•          Reporting of Medico-Legal cases to the police;

•          Reporting of occurrence of occupational diseases;

•          Responsibility for ensuring safety of patients (Judgment of Punjab High Court in Jasbir Kaur Vs the State of Punjab);

•          Rights of patients;

•          Privacy of patients during consultation, examination and treatment;

•          Professional indemnity insurance cover of an appropriate amount (Insurance Regulatory and Development Authority Act, 1999);

•          Laws applicable to medical negligence — Vicarious Liability, Respondeat Superior, Indian Contract Law, Tort law, Consumer Protection Act, 1986, Indian Penal Code sections (52, 80, 88, 89, 92, 93, 274-276, 284, 304-A, 336, 337, 338 and 376-D).

8.  Drug and Cosmetics Act 1940, Drugs (Control) Act 1950, Narcotic Drugs and Psychotropic Substances Act 1985, Drugs and Magic remedies (Objectionable Advertisements) Act, 1954, Pharmacy Act, 1948.

9. Submission of Reports/Returns to Health Authorities

•          Cases of notifiable diseases as applicable in the state (Section 371, Delhi Municipal Corporation Act);

•          Report of cases of food poisoning, if required by Municipal Health Authorities (Prevention of Food Adulteration Act, 1954);

•          Incidence of needle stick injuries;

•          Annual report under BM Waste Management Rules, 1998 (if applicable);

•          Reports on the MTPs carried out;

•          Reports on the USG abdomen (abdominal ultrasonography) done on the pregnant women.

10. Safe disposal of infectious/hazardous waste generated at the clinic (BMW Management Rules, Environment Protection Act 1986, IPC Section 269, 270).

11. Prohibition of unethical activities, such as soliciting patients directly or indirectly, by a physician, a group of physicians, or by institutions or organisations by advertising, self-promotion or self-aggrandizement; use of touts for procuring patients; giving/offering or receiving rebates, gifts, commissions, cutbacks or kickbacks in return for referral or procurement of patients etc (IMC Regulations, 2002).

12. Prohibition of Smoking in Public Places Rules, 2008, Fire Safety Regulations, Financial Regulations: Income Tax Act, Value Added Tax (VAT) Act, Central Sales Tax Act, etc.

13. State laws for prevention of vandalism/violence against medical service staff and institutions.

Note: 1. All of these regulations may not be applicable to every clinic.

2. Delhi Laws quoted above may be substituted by the relevant state laws.

Dr S K Joshi (MBBS, MHA, DNB, QMAHO, MIPHA, MAHA) is a Hospital Administrator and author of books (“Quality Management in Hospitals”, “Law and The Practice of Medicine” and “Safety Management in Hospitals”), and many articles on professional issues. Dr Joshi is an Assessor for NABH (National Accreditation Board for Hospitals and Healthcare Providers) Accreditation of hospitals. He is also a life member and past president of Renukoot Branch of IMA. Presently, he is working as a Consultant and a Visiting Faculty for postgraduate medical courses. Email: skjoshi1948@yahoo.com Mobile: 9871582005

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32 Comments »

Comment by Dr.C.Srinivasa raju
2012-11-06 18:44:14

Respected Dr S K Joshi,
Namaste.
Excellent article sir.
Regarding NABH parameters and insurance company empannelment requirements, small hospitals doesn’t cope and unable to fulfill. only big corporate hospitals can thrive in these circumstances,which will result in corporatization and escalation of health care cost and raise of insurance premiums. unless we allow and encourage the small establishments in health care delivery, vast number of clinics and small hospitals will be wiped out from the scene and those big hospitals will rule the roost.
for our country,which has varied expansive demographics, few big corporate hospitals couldn’t provide universal health care in time. the same situation like in U.K and USA, where long waiting periods and protracted appointments for even tiny proedures,will repeat in our country in future.
Sir,Is it necessary and practically implementable these regulations in all areas of our country? majority of doctors of small clinics and small hospitals belonged to the rural areas and c-class towns feels these utopian regulations,especially the structural floor-space parameters are not practically implementable and even if they do so,economically not viable. stipulatory parameters like human resources,equipment can be provided but not structural space and bed strength.
in the present days,day care surgery is practiced even in small centers in general surgery,OB&GYNIC.
For ENT & EYE hospitals,20 beds are not necessary. but the NABH still asking for Minimum 20 beds to get accreditation. unless we have large number of beds, small hospitals don’t get empanelment of insurance companies.
all regulatory mechanisms aim for quality care ,but they should involve,utilise and have partnership of all types of health care providers to suit the needs of our country.

 
Comment by Editor
2012-11-07 00:03:51

Dear Dr Joshi
Nice to go through the mail on regulation of private medical establishment in the country.
This is to inform you that Karnataka is the first state in the country to implement the Private Medical Establishment Act which in turn regulates the private medical clinics in the state from 2009 and it is being implemented in the state from nov 2009.It includes all the suggestions made by you.I think it is wise to copy similar Act to be implemented in other states also.
Yours sincerly
Raju.v.
Project Director (RCH) Retd.
[In an email to editor@aalatimes.com]

 
Comment by Dr pramod
2015-03-09 12:01:13

Wanted to know about permission/s required for establishment of dental clinics from state government or municipality.and list of that act/rules /authorisations.

 
Comment by dr.Saritha
2015-03-28 13:21:33

Wanted to know about the documents or registrations required to start a dental clinic in panchayat area in Maharashtra

 
Comment by ady
2015-04-08 18:48:32

Need u r expert opinion
do we need drug licence in a nursing home for
pharmacy to give medicine to patient.

 
Comment by ved anand
2015-05-28 21:22:01

Wanted to know , If it is not necessary to disclose the Fees of an doctor owns clinic or hospitals in haryana and other state of India .I think it should be mandatory for all to disclose all fees as well service charges otherwise it is going so much black money .?

 
Comment by Priya
2015-08-10 16:00:45

Dear Sir

I want to know that “Is it necessary to register hospital on the name of Doctor only ? Does non-medico can start a hospital and hire a doctors on call? please guide me on these matter.

 
2015-08-11 20:43:27

I want to know that “Is it necessary to register hospital on the name of Doctor only ? Does non-medico can start a hospital and hire a doctors on call? please guide me on these matter.

 
Comment by Fadhlurahman
2015-08-24 13:02:47

Hi All, I want to know rules and regulations for the formation of a specialized maternity hospital in Kerala, also require guidelines and approvals need to take for the formation of hospital.

 
Comment by pritam yadav
2015-09-22 00:37:11

hi there..i had the same query but didn’t get the answer.Please help me with the same if u got the answer.
plz do reply me on yadavpritam0@gmail.com

 
Comment by Dr.R.Paul Raj.
2015-10-12 13:30:08

hello Sir,I was working in a private medical college coming under minority status as assistant surgeon.I was suspended two months back for no valid reason and an enquiry was conducted and in that i was proved not guilty.But the management is keeping quiet even without giving the enquiry report or subsistance allowance.How should I proceed further? Which forum I should approach,legaly and professionaly?

 
Comment by Vikash
2015-10-27 11:21:03

There is only one nursing home with ICU and ICCU in darbhanga district of bihar R B MEMORIAL . The hospital is iso certified but u can’t imagine the scenario how patients are dealt here. I am surprised that ICCU is having mosquitoes and flies. The patients are treated like animals. Even nowadays the animals are cared better. I have tried to raise my concern but I was told my patient will be referred from here if I query about anything. No rules no regulations.

 
Comment by Sanjeev Verma
2015-11-20 13:36:53

Dear Sir,

Want to know what regulations to be followed to open an corrective lenses store.

How can i sell corrective lenses. Do i need to be an optician or I can sell it openly.

Regards

Sanjeev

 
Comment by Dr Sandeep khetarpal
2016-01-16 11:12:19

For which states Hospital not need to get medical registration certificates (in which states its not mandatory).

regds.

 
Comment by Dr Vini Vivek
2016-02-12 12:27:39

Sir, can you please tell me regarding what all certificates are needed to start an eye clinic with laser center.
Also a psychiatric clinic

 
Comment by dr renuka
2016-03-27 11:44:55

how to register a dental clinic.?
how to get a permission letter in municipal office

 
Comment by Raju rao
2016-04-19 18:58:25

Sir,want to know what regulation r needed to start a private clinic in mp,and is it necessary to get a clinic registration with the state government.

 
Comment by i need a doctor
2016-05-23 09:31:59

Sir my need a doctor in my clinic male / female doctor plc contact 09667217023

 
Comment by chintan shah
2016-06-10 11:49:18

Hello sir,I want to know list of private hospitals in India so can you please provide me any website that I can refer to the same thank you

 
Comment by ronald benjamin
2016-06-11 14:10:50

sir i would like to know about clinic opening rules and regulations, i mean is it realy no ned any noc from apartment association ,bcz we are 49 fly living in big appartment and down builder is going to start a clinic ans beded hospital so sir i woul like to know its allowed or not to open clinic as wel beded hospital,
tnx,

 
Comment by Dr Asra shaesta
2016-06-12 10:39:39

Hi sir I would like to know about rules and regulations to open a dental clinic under non Medico authority so is it necessary to submit a license in municipality

 
Comment by Paramjit singh
2016-08-09 18:54:09

Can I open a dental hospital/clinic in DDA multi storey residential colony in a residential flat?

 
Comment by Dilip Yadav
2016-09-15 23:33:45

Respected honorable Sir
I want to know that yow much a person qualify to open a private hospital and how I should get it registered

 
Comment by Hitesh Dabhi
2016-12-05 07:18:31

Dear Sir,

I would like to know , After course of nurshing we are authorise to open madical store or not ?

 
2017-05-04 13:18:55

Please guide me on what permissions and licences are required to start a OPD Clinic in a city in Goa.

 
Comment by Swapnil shinde
2017-06-26 14:11:35

Hi, i am swapnil shinde from pune.
I was admited in hospital for kidney stone treatment.
Doctor told me to do sonography.
As per doctor proper guidance i have done sonography, they have given simple bill receipt,but it is mandatory to take vat bill from Clinic.
Plz do rpy on Swapnil.shinde807@gmail.com

 
Comment by vivek
2017-06-26 22:51:32

Hi,
If someone wants to offer the start Stem Cell Procedure for Face Lift to the dermatologists, what are the regulatory requirements ?
Can you suggest some consultant or way out?

 
Comment by Balveer mehra
2017-12-12 10:51:24

डिअर सर,

मैं जानना चाहता हूँ की हमारे आर्गेनाइजेशन के कुछ क्लीनिक गाँव में ( मध्य प्रदेश के कई गाँव में ) चलाये जा रहे थे लेकिन न्यू क्लिनिकल एक्ट के बाद उन्हें बंद कर दिया गया क्युकी वह क्लीनिक नर्स/सिस्टर्स द्वारा चलाये जा रहे थे यं में डॉक्टर्स की नियुक्ति नहीं की गयी थी

क्रप्या के बताये की उन क्लिंच्स को फिर से कैसे चालू किया जा सकता हे

धन्यवाद्

बलवीर मेहरा
भोपाल, मध्य प्रदेश

 
Comment by Kavita
2018-02-26 11:22:39

required doctor for our clinic

 
Comment by Dr.Chandra Mohan
2018-04-07 00:48:17

Is hospital registratio necessary for practicing? I am an orthopaedic surgeon practising in Telangana. The hospital rules are so cumbersome and bribery has become the stipulated criteria for registering. Small flaws are blown out of proportion. I am registered with the Bihar medical council and I have been asked to register in the state medical council. Is it mandatory to register in each state I practice?
Fire safety criteria has become another deterrant for registration? How will small town doctors practice?

 
Comment by Akash
2018-04-18 09:55:39

If I want to partner with a path lab to collect samples at my clinic so that my patients do not have to go to a lab, and as a part of the partnershipo if i take a part of the fee collected for path tests. Is it legal?

 
Comment by Dr M Saravanan
2018-07-22 22:04:08

I am a Paediatrician in Madurai.I totally agree. Lots of red tape process involved. The system needs to be transparent and needs improvement to make things easier for practioners

 
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