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Legislations

CEA, 2010 – A Step Towards Controlling Unregulated Clinics

The health care industry is a critical industry across all the sectors. The testing laboratories, multi-specialty hospitals, consulting doctors, super specialty surgeries- all forms of medical services are expanding expeditiously in our country. But a blistering pace of expansion of unqualified clinics has been a cause of concern for the government.

The Clinical Establishments (Registration and Regulation) Act, 2010 has been enacted by the Central Government for compulsory and authentic registration so that all clinical establishments can be regulated. This aims to achieve the minimum necessary standards for all medical facilities and services. 

The act covers all forms of clinical establishments including both therapeutic and diagnostic ones being run in public or private sectors. Only the clinical establishments run by the armed forces are excluded. The act has specified guidelines for a standardized treatment – both specialty and super specialty. It recognizes both allopathic and AYUSH form of treatment.

This act would help in maintaining a digital registry of all clinical establishments at all the three levels- National, State and District level. It aims at putting a stop on all unqualified practitioners by the implementation of mandatory registration. The quality of health care would be improved by prescribing minimum standards for facilities ensuring all the conditions of registration are complied with, like compliance to standard treatment guidelines, maintenance of records etc. The compulsory registration will also help in better management of emergency medical conditions. The act says that details of rates charged have to be prominently displayed at a conspicuous place in local and in English language. These rates shall be determined by the central government from time to time in consultation with the state governments.

Heavy penalties ranging from Rs. 10,000 to 5 Lakhs will be levied if any provision is violated. 

All the test reports prepared by the prescribed qualified persons in registered testing laboratories need to write a disclaimer saying that these results are only for the use of medical practitioners. They are not allowed to give medical diagnosis. They are not allowed to state any medical opinion or interpretation of the test results. In case it is necessary to state the interpretation of the results, the report must bear signatures of a qualified medical doctor who shall only be responsible for that interpretation in the report. 

The Ministry of Health and Family Welfare released a notification on 14th February, 2020 specifying further regulations for the lab technicians which are: –

1. The laboratory technicians are not allowed to sign the test results. After obtaining the prescribed qualifications and training experience, he/she can conduct some specific tests but these shall be signed by qualified signatory authority of the laboratory.

2. The minimum qualification for lab technician is – Diploma in Medical Laboratory Technology (DMLT) or Bachelor of Science (B.Sc.) Medical Laboratory Technology (MLT) or Master of Science (M.Sc) Bio-chemistry or Micro-biology from a recognized university or institution.

3. It is mandatory to conduct periodic health checkups and vaccination of the staff.

4. In case a special test is conducted, it is mandatory to have a specialist of that subject in the lab (full time or part time or outsourced basis). Special test includes all test excluding the routine basic tests of biochemistry, hematology, or medical microbiology (example- fasting sugar, blood group, blood pressure etc.), some examples of special tests are biopsies or cytology.

Numerous efforts are being taken to curb the rapid growth of those clinical establishments which are not run by suitable qualified medical professionals. These efforts would result in a systematic collection of information creating a database for good quality health care sector. It would also help in appropriate policy formulation in the future. The effort would cut down extremely costly treatments and sub-standard healthcare.

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