The Clinical Establishments (Registration & Regulation) Act, 2010

1. The Clinical Establishments (Registration & Regulation) Act, 2010 Prasanth K S, NHSRC, National Health Mission, New Delhi

2. Why? • Lack of authenticated data regarding the number and nature of Clinical Establishments • Absence of registration requirements for Clinical Establishments even when shops cannot be started without registration

3. Ambit • Registration • Regulation • Clinical Establishments (including single doctor clinics and diagnostic centres) • Minimum standards • Facilities and Services • All recognized systems of Medicine • Public and Private • Exception – Clinical Establishments of Defense forces

4. Uses • A reliable database for clinical establishments • Categorize and classify types of clinical establishments • Policy formulation & resource allocation • Helps government in obtaining data for various public health interventions (e.g. outbreak management) • Provide for emergency medical management • Transparency – data kept in public domain • Bringing in uniform standards (consultative process)

5. Salient features • National council – to classify clinical establishments and determine standards • Provisional registration – based on self declaration • Permanent registration • National registry of Clinical Establishments

6. Provisional registration • Application by post, in person or online • All applicant establishments get registration – 10 days time (Validity – 1 year – renewable ) • No enquiry prior to registration • Establishment to display the certificate • Publication of registered establishments – within 45 days • Duplicate certificate if original lost / damaged / mutilated • Certificate non-transferable

7. Provisional registration • Change of ownership – to be informed • Change of category / location / ceasing to function – surrender / apply afresh • Publishes – expired establishment list • Application for renewal of registration – 30 days (late – enhanced fees)

8. Time limit for Provisional registration / renewal 2 years* Renewal 2 years* 6 months* * From the date of notification of standards

9. Permanent registration • Application + submit evidence of standards complied • Filing objections from public (30 days) • Response to objections (45 days) • Next 30 days – allow / disallow (with reasons) • Validity 5 years • Application for renewal – 6 months • Disallowed establishments can apply after rectifying deficiencies

10. Post registration • Show cause notice – (3 months) if conditions for registration not complied with or management punished • Breach of provisions – cancel registration (if no appeal or appeal dismissed) • Power to inspect establishments – action to be taken – action taken report to be submitted by establishment • Grievance - appeal to State council

11. Register of Clinical Establishments • State Authority – 2 years – register of Clinical Establishments in digital format • National register of Clinical Establishments in digital format • Updating 15th of every month – data of the previous month

12. Penalties* • 10,000 to 50,000 to 5 lakhs (first, second and subsequent offence) • Running Clinical Establishments without registration - 50,000 to 2 lakhs to 5 lakhs (first, second and subsequent offence) • Staff working in a Clinical Establishment which is not registered – 25,000/- • Evidence taking – power to summon & enforce attendance of a person • Covers company / Government department etc. as well • * depending on category / size / type

13. Appropriate authority (5 members)* • District collector (Chairperson) • District Health officer (Convener) • Superintendent of Police / City Police Commissioner • Local Self Government representative • Professional Medical Association representative * Read with Central rules

14. Thanks