The Health Department, Government of Haryana, issued the Haryana Clinical Establishments (Registration and Regulation) Amendment Rules, 2019 (“Amendment Rules”), which is amending the Haryana Clinical Establishments (Registration and Regulation) Rules, 2018 (“Principal Rules”).
The Amendment Rules is effective 10.12.2019.
We have analysed the amendments vis-à-vis the Principal Rules, through the following table:
| Principal Rules | Amendment Rules | Implication |
| Rule 10A – Not Present | Rule 10A – Provisional or permanent certificate for clinical establishment as specified in sub-clause (ii) of clause (c) of section 2 of the Act.-
(1) The applicant shall apply to the authority for provisional certificate either in person or by post or through web based online facility along with necessary information in a format as per Annexure 1 and a fee of five hundred rupees.
(2) The provisions of sub-rule (2) to sub-rule 8 of rule 9 shall mutatis mutandis apply to an application submitted under sub-rule(1) above.
(3) The applicant shall apply to the authority for permanent certificate in person or by post or through web based online facility with the necessary information filled and with evidence of having met the requirements of minimum standards for different categories of clinical establishment in a form prescribed by the National Council (available at www.clinicalestablishment.gov.in) along with a fee of two thousand rupees.
(4) The provisions of sub-rule (2) to sub-rule (8) of rule 10 shall mutatis mutandis apply to an application submitted under sub-rule (3) above.
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The procedure of obtaining provisional / permanent certificate for clinical establishments other than bedded facilities was not explicitly provided under the Principal Rules. The Principal Rules provided for procedure to obtain provisional / permanent certificate for clinical establishments having specified number of beds only.
Interestingly, the Amendment Rules, has now inserted a new Rule, stating the procedure for obtaining provisional / permanent certificate for the following type of clinical establishments as covered under Section 2(c)(ii) of the Clinical Establishments (Registration and Regulation) Act, 2010:
(c) “clinical establishment” means— (i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognised system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not; or
(ii) a place established as an independent entity or part of an establishment referred to in sub-clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated or not.
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| Annexure 9 – Not Present | Annexure – 9 – Monetary penalties for non- registration of clinical establishment as specified in sub-clauses(ii) of clause (c) of section 2 of the Act.
1st Contravention – Rs. 5,000/- 2nd Contravention – Rs. 20, 000/- |
In light of this amendment, the penalties for non-registration of above mentioned class of clinical establishments is also prescribed through a newly inserted Annexure 9.
The prescribed penalties are as follows;
1st Contravention – Rs. 5,000/- 2nd Contravention – Rs. 20, 000/-
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In addition to the above amendments, the provision references for the following Annexures have also been modified to bring in it’s scope the present set of clinical establishments:
| Annexures | Principal Provision References | Amended Provision References |
| Annexure 1 – Application Form for Provisional Registration of Clinical Establishments | Rule 9 (1) | Rules 9(1) and 10A(1) |
| Annexure 2 – Acknowledgement of Provisional Registration of Clinical Establishment | Rule 9 (2) | Rules 9(2) and 10A(2) |
| Annexure 3 – Provisional Certificate for Registration of Clinical Establishment | Rule 9 (3) | Rules 9(3) and 10A(2) |
| Annexure 4 – Duplicate Certificate for Clinical Establishment | Rule 9 (7) | Rules 9(7) and 10A(2) |
| Annexure 5 – Acknowledgement Registration of Clinical Establishment | Rule 10(2) | Rules 10(2) and 10A(4) |
| Annexure 6 – Permanent Certificate for Registration of Clinical Establishment | Rule 10 (3) | Rules 10(3) and 10A(4) |
| Annexure 7 – Duplicate Certificate for Clinical Establishment | Rule 10 (7) | Rules 10(7) and 10A(4) |
| Annexure 8 – Display of registration status for filing objections | Rule 10(8) | Rules 10(8) and 10A(4) |
Source: Health Department, Government of Haryana
