The Clinical Establishments (Registration and Regulation) Act, 2010 is a central legislation enacted by the Government of India.
Aim: To provide a system of registration and regulation of all clinical establishments in the country with a view to prescribe minimum standards of facilities and services.
It applies to both public and private clinical establishments, across all systems of medicine including Ayurveda, Siddha, Unani, Homoeopathy, Allopathy, etc.
DEFINITION OF CLINICAL ESTABLISHMENT
According to the Act:
A Clinical Establishment includes:
Hospitals
Nursing homes
Clinics
Sanatoriums
Day care centres
Laboratories, diagnostic centres
AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy) establishments
OBJECTIVES OF THE ACT
Ensure registration of all clinical establishments.
Standardize healthcare facilities across systems.
Prescribe minimum standards for services and infrastructure.
Promote transparency and accountability in healthcare.
Provide accessible, affordable, and quality health services.
KEY FEATURES OF THE ACT
Mandatory Registration:
All clinical establishments must register with the district registering authority.
Minimum Standards:
Prescribes minimum infrastructure, human resources, equipment, and records for services.
Digital Health Records:
Maintenance of electronic records of every patient is mandated.
Penalties:
Penalty imposed for non-registration or non-compliance.
National & State Council Formation:
National Council for Clinical Establishments
State Council for Clinical Establishments
Exemption:
Establishments run by the Armed Forces are exempt.
APPLICABILITY OF THE ACT
Applicable to all clinical establishments in the states and union territories that have adopted this Act by passing a resolution under Article 252 of the Constitution.
As of now, several states like Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, etc., have adopted the Act.
RELEVANCE TO AYURVEDA PRACTITIONERS
Ayurvedic clinics, hospitals, and Panchakarma centres fall under the ambit of this Act.
Mandatory for Ayurveda doctors to register their clinical establishment.
Must comply with minimum standards set by the Central/State authorities.
Ensures legal protection and credibility to qualified Vaidyas.
LEGAL AND ETHICAL ASPECTS (AGADATANTRA PERSPECTIVE)
The act aids in preventing quackery and malpractice.
Ensures professional ethics, hygiene, and patient care standards.
Promotes Ayurvedic toxicology (Visha Chikitsa) by recognizing and regulating such centers.
RELEVANT SANSKRIT REFERENCES
From Charaka Samhita (Vimana Sthana 8/89):
"न चैकचिकित्सकः सर्वान् रोगान् साधयेत्।"
Na chaika chikitsakaḥ sarvān rogān sādhayet.
(One physician alone cannot treat all diseases – stresses the importance of specialization and systematic practice.)
From Sushruta Samhita (Sutrasthana 36/10):
"विशुद्धा चिकित्सा भवनानि सर्वविधायिनीः भवन्ति।"
Viśuddhā cikitsā bhavanāni sarvavidhāyinīḥ bhavanti.
(Proper clinical establishments contribute to comprehensive treatment.)
From Ashtanga Hridaya (Sutrasthana 1/7):
"स्थानं कालो दृव्यं यश्च युक्तिः चिकित्सितस्य च।"
Sthānaṁ kālo dravyaṁ yaśca yuktiḥ cikitsitasya ca.
(Success in treatment depends on place, time, medicine, and physician’s method – highlights importance of suitable clinical setting.)
MODERN FORENSIC AND TOXICOLOGICAL RELEVANCE
Forensic Responsibility: Proper record maintenance as per CEA helps in medico-legal cases.
Chain of Custody in Poisoning Cases: Registered establishments are responsible for documentation and sample preservation in poisoning cases.
Medical Negligence: Adherence to prescribed standards reduces the chances of litigation under IPC Sections 304A, 337, 338.
Consumer Protection Act: Ensures patient rights and facilitates grievance redressal.
Disaster Management: Registered clinical establishments are coordinated in health emergencies like pandemics, poisoning outbreaks, etc.
BENEFITS OF THE CLINICAL ESTABLISHMENTS ACT
Promotes uniformity in healthcare service delivery.
Enhances public trust in Ayurvedic and other traditional medicine systems.
Protects genuine practitioners from imposters and quacks.
Encourages modernization and scientific validation of traditional practices.
Useful in toxicological emergencies where timely referral, standard treatment, and documentation are crucial.
CHALLENGES AND LIMITATIONS
Lack of awareness among rural practitioners.
Resistance due to fear of regulatory burden.
Infrastructure cost for small Ayurveda clinics.
Incomplete implementation in non-adopting states.
SUGGESTIONS FOR BETTER IMPLEMENTATION
Conduct awareness campaigns and training programs.
Provide financial aid and tax exemptions for AYUSH clinics.
Involve Ayurvedic councils in standard-setting.
Encourage integration with modern toxicological protocols.