DR.

RAM MANOHAR LOHIA NATIONAL

LAW UNIVERSITY

2019

Health and medicine law

“Regulatory requirements for private clinics w.r.t. Clinical Establishment

Act, 2010”
SYNOPSIS

SUBMITTED TO: SUBMITTED BY:

Dr. Prem Kumar Gautam Utkarsh kumar Prajapati

Assistant professor (Law) Enroll no. - 150101151

Dr. Ram Manohar Lohia 8th Semester

National Law University,

Lucknow.
INTRODUCTION and OBJECTIVE

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.
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.
Section 11 of the Clinical Establishments (Registration and Regulation) Act, 2010 compels that no person or
institute shall run a clinical facility unless it has duly registered in agreement with the provisions of the Act.
The government of India, the Ministry of Health and Family Welfare published the Application format for
Permanent Registration of Clinical Establishments which demands the applicant to provide information such
as facility information, types of service, a method of medicine, etc.

Objective of the project is to find out the regulatory requirements for private clinics as per the Clinical
Establishments Act, 2010.

TENTATIVE CHAPTERIZATION

1- Introduction
2- Registration/Requirement of Licenses
3- Regulations Related to Employment of Staff
4- Information displayed and documents to be maintained at the clinic
5- Regulations Related to Treatment of Patients
6- Submission of Reports/Returns to Health Authorities
7- Regulatory framework for digital health
8- Conclusion
9- References
RESEARCH QUESTIONS

 What is CEA, 2010 as per India?

 How is CEA, 2010 dealing with private clinics in Indian states?
 How is it important in present national scenario?
 How major is the impact been till now?

RESEARCH METHODOLOGY

The research methodology used in this project is purely doctrinal, this means the data and information used in
the project are collected through pre published sources. Sources used in the project to get the detailed data is
collected from magazines, books and e-sources.

RESOURCES REFERRED

1- https://www.nhp.gov.in/national_eHealth_authority_neha_mtl
2- https://www.indiamedicaltimes.com/2012/11/06/regulatory-requirements-for-private-clinics/
3- https://www.dr-hempel-network.com/health-policies-in-india/clinical-establishments-in-india/
4- https://www.downtoearth.org.in/news/health/why-is-private-healthcare-opposing-the-clinical-
establishments-act-59766