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The Clinical Establishments (Registration & Regulation) Act mithun kherde


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The Clinical Establishments (Registration & Regulation) Act mithun kherde

  1. 1. The Clinical Establishments(Registration & Regulation) Act, 2010
  2. 2. Did we Need it????????
  3. 3. Let us look into HISTORY of the new beginning…….
  4. 4. CONSTITUTIONAL PROVISIONS• The preamble to the Constitution of India coupled with the Directive Principles of State Policy strives to provide a welfare State with socialist patterns of society. It enjoins the State to make the “improvement of public health” a primary responsibility.• Articles 38,42,43 and 47 of the Constitution provide for promotion of health of individuals as well as health care.
  5. 5. Regulation relating to medical profession• There exists legislation with respect to licensing of medical professionals such as doctors, nurses, dentists and pharmacists with a view to control their entry into the market• Statutory regulatory councils have been established to monitor the standards of medical education, promote medical training and research activities, and oversee the qualifications, registration, and professional conduct of doctors, dentists, nurses, pharmacists, and practitioners of other systems of Medicine such as Ayurveda, Yoga, Unani, Siddha and Homeopathye.g.Indian Nursing Council Act, 1947,Indian Dentists Act, 1948Pharmacy Act, 1948Indian Medical Council Act, 1956,Indian Medicine Central Council Act, 1970,Homeopathy Central Council Act, 1973,
  6. 6. Directive from the National Human Rights Commission – 1996• Much later, in 1996 the death of Ina Raja in a private hospital due to medical negligence was reported to the NHRC. The Commission directed the Govt. of India, MCI and the Delhi Govt. to examine:1) Registration of private hospitals after ensuring availability of minimum facilities2) Monitoring to ensure availability of facilities,3) Framing of regulations,4) Violation to be made a cognizable offence,5) Shifting of non-conforming hospitals that are health hazards from nonconforming areas.
  7. 7. Resolutions of the Central Council 5th Conference of Health & Family WelfareThe Central Council of Health and Family Welfare in its 5th Conference held in January 1997 had resolved that: -a) States may enact laws to provide for registration of only those private hospitals that have minimum facilities for different forms of treatmentb) Monitoring mechanisms should be developed by the State to ensure that the facilities and services created in private and voluntary sector hospitals continue to be available and are maintained at the desired levelc) Private Hospitals in non-confirming areas that are posing health hazards may be considered for shifting to other areasd) The accreditation system would however, require to be studied
  8. 8. Legislations by StatesAs ‘ health’ is a state subject, some State legislation had been brought out by UTs/States quite early such as:1) Bombay Nursing Homes Registration Act, 1949 (Annexure V)2) The Andhra Pradesh Private Medical Care Establishments Act, (Annexure VI)3) Delhi Nursing Homes Registration Act, 1953 (Annexure VII)4) Orissa Clinical Establishment (Control and Regulation) Act, 1991 (Annexure VIII)5) Punjab State Nursing Home Registration Act, 1991 (Annexure IX)6) Manipur Nursing Home and Clinics Registration Act, 1992 (Annexure X)7) Sikkim Clinical Establishments, Act 1995 (Annexure XI)8) Nagaland Health Care Establishments Act, 1997 (Annexure XII)9) Madhya Pradesh Clinical Establishments Regulation Act. (Annexure XII-A) It is also gathered that some more States such as Rajasthan, Karnataka and Haryana have drafted the regulatory legislations
  9. 9. Issues relating to enforcement, effectiveness and implementation• Out datedness of existing legislations• Ineffective implementation• Absence of rules• Ineffective content of rules• Non-coverage of other private institutional providers• No uniformity in standards
  10. 10. From the analysis of past we come to know that there were age old concerns in the health care service delivery• How to bring down cases of negligence??• How to improve health care quality??• How to regulate health care service delivery??• How to ensure minimum standards of facilities and services in health care throughout the country??• How to regulate systematic collection of information from gigantic private health care sector??• Despite many State Legislatures having enacted laws for regulating health care providers, the general perception was that current regulatory process for health care providers in India was inadequate or not responsive to ensure health care services of acceptable quality and prevent negligence.
  11. 11. Who were concerned??• General public• Government• Professional associations• Private providers• Agencies financing health care• Human Rights Commission• Judiciary• Others
  12. 12. ULTIMATE OBJECTIVE SET BY GOVERNMENT• Creation of a national registry of healthcare establishments• Comprehensively and efficiently managed regulatory system• Maintenance of minimum standards and their periodic review This led to THE NEW BEGINNING of regulation
  13. 13. The Clinical Establishments (Registration & Regulation) Act, 2010 In order to move forward with the understanding of the act, we need to get familiarised with few terms:• REGULATION• REGULATION OF CLINICAL ESTABLISHMENT• LICENSURE• CERTIFICATION• ACCREDITATION
  14. 14. The Clinical Establishments (Registration & Regulation) Act, 2010 REGULATION• Regulation seeks to ensure quality, accountability, protect the consumers and control costs as well as the distortions created by market forces REGULATION OF CLINICAL ESTABLISHMENT• There are several actors involved in the regulatory process namely, the health care professionals, managers, ministry of health, commercial interests, NGOs, community and consumer groups amongst others
  15. 15. The Clinical Establishments (Registration & Regulation) Act, 2010 LICENSURE a government administered mandatory process thatrequires healthcare institutions to meet established minimumstandards in order to operate CERTIFICATION a voluntary governmental or non-governmental processthat grants recognition to healthcare institutions that meetcertain standards and qualifies them to advertise services or toreceive payment or funding for services provided
  16. 16. The Clinical Establishments (Registration & Regulation) Act, 2010 ACCREDIATION a process by which a government or non-government agency grants recognition to healthcareinstitutions that meet certain standards that require continuousimprovement in structures, procedures or outcomes. It isusually voluntary, time-limited and based on periodicassessments by the accrediting body, and may, likecertification, be used to achieve other desirable ends such aspayment or funding.
  17. 17. Definition of clinical establishment• (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 recognized 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, and shall include a clinical establishment owned, controlled or managed by:• Government or a department of the Government;• a trust, whether public or private;• a corporation (including a society) registered under a Central, Provincial or State Act, whether or not owned by the Government;• a local authority; and• a single doctor
  18. 18. Coverage & Applicability Coverage• All clinical establishments including diagnostic centres and single doctor clinics, across all recognized systems of medicine in both the public and private sector.• Only exception is in case of clinical establishments of the Defence Forces Applicability• States of Arunachal Pradesh, Sikkim, Mizoram, Himachal Pradesh and all Union Territories• Such other States which adopt this Act by resolution passed in this behalf under clause (1) of article 252 of the Constitution.
  19. 19. Institutional Mechanisms to beestablished under the Act Central/National Council of Clinical Establishments State Council / Union Territory Council of Clinical Establishments District Registering Authority
  20. 20. National Council for Clinical Establishments Ministry of Health & Family Welfare Directorate General of Health Services (DGHS) DGHS subordinate offices all over the countrya) Director-General of Health Service, MOHFW, ex officio, who shall be the Chairperson;b) Four representatives out of which one each to be elected by the(i) Dental Council of India constituted under section 3 of the Dentists Act, 1948;(ii) Medical Council of India constituted under section 3 of the Indian Medical Council Act, 1956;(iii) Nursing Council of India constituted under section 3 of the Indian Nursing Council Act, 1947;(iv) Pharmacy Council of India constituted under section 3 of the Pharmacy Act, 1948;c) Three representatives to be elected by the National council of Indian Medicine representing the Ayurveda, Siddha and Unani systems of medicine constituted under section 3 of the Indian Medicine National council Act, 1970;d) One representative to be elected by the National council of Homoeopathy constituted under section 3 of the Homoeopathy National council Act, 1973;
  21. 21. National Council for Clinical Establishmentse) One representative to be elected by the National council of the Indian MedicalAssociation;f) One representative of Bureau of the Indian Standards constituted under section3 of the Bureau of Indian Standards Act, 1986;g) Two representatives from the Zonal Council set-up under section 15 of theStates Reorganisation Act, 1956;h) Two representatives from the North-Eastern Council set-up under section 3 ofthe North-Eastern Council Act, 1971;i) One representative from the line of paramedical systems excluding systemsthat have been given representation under clause (b);j) Two representatives from National Level Consumer Group to be nominated byCentral Government;k) One representative from the Associations of Indian Systems of Medicinesrelating to Ayurveda, Siddha and Unani to be nominated by the CentralGovernment;l) The Secretary-General of the Quality Council of India, ex officio.
  22. 22. Functions of National Council of Clinical Establishments• Compile and publish a National Register of clinical establishments within two years from the date of the commencement of this Act;• Classify the clinical establishments into different categories;• Develop the minimum standards and their periodic review;• Determine within a period of two years from its establishment, the first set of standards for ensuring proper healthcare by the clinical establishments;• Collect the statistics in respect of clinical establishments;• Perform any other function determined by the Central Government from time to time.
  23. 23. State Council of Clinical Establishmentsa) Secretary, Health ex officio, who shall be the Chairman;b) Director of Health Services — ex officio member-secretary;c) Directors of different streams of Indian Systems of Medicine -ex officio members;d) One representative each to be elected by the executive committee of-i. State Medical Council of India;ii. State Dental Council of India;iii. State Nursing Council of India;iv. State Pharmacy Council of India;e) Three representatives to be elected by the Executive of the State Council or Union Territory Council, as the case may be, of Indian Medicine representing the Ayurveda, Siddha and Unani systems of medicines;f) One representative to be elected by the State Council of the Indian Medical Association;g) One representative from the line of paramedical systemsh) Two representatives from the State level consumer groups or reputed non- governmental organizations working in the field of health
  24. 24. Functions of the State Council• Compiling and updating the State Registers of clinical establishment;• Sending monthly returns for updating the National Register;• Representing the State in the National Council;• Hearing of appeals against the orders of the authority;• Publication on annual basis a report on the state of implementation of standards within their respective States.
  25. 25. District Registering Authority• The State Government shall, by notification, set-up an authority to be called the district registering authority for each district for registration of clinical establishments, with the following members:• District Collector - Chairperson• District Health Officer – Convenor• Three members with such qualifications and on such terms and conditions as may be prescribed by the Central Government.
  26. 26. Condition for registration Every clinical establishment shall fulfil the following conditions:• Meet the prescribed minimum standards of facilities and personnel• Maintain records and reporting as prescribed• Provide staff and facilities as may be required to stabilize emergency medical condition of any individual
  27. 27. Procedure for registration• Application in the prescribed Performa along with prescribed fee to be made to district registering authority.• Application can be filed in person or by post or online.• If any clinical establishment is in existence at the time of the commencement of this Act, an application for its registration shall be made within one year from the date of the commencement of this Act• A clinical establishment which comes into existence after commencement of this Act, shall apply for permanent registration within a period of six months from the date of its establishment.
  28. 28. Provisional registration• The registering authority within a period of ten days from the date of receipt of application, shall grant a certificate of provisional registration in such form and containing such particulars and such information, as may be prescribed.• The authority shall not conduct any inquiry prior to the grant of provisional registration.• The authority shall, within a period of forty-five days from the grant of provisional registration, shall publish (as per prescribed manner) all particulars of the clinical establishment so registered provisionally.• The certificate of registration shall be displayed in a conspicuous place by the CE• The provisional registration shall be valid to the last day of the twelfth month from the date of issue of the certificate of registration and such registration shall be renewable.• Provisional registration shall not be granted or renewed beyond: Period of two years from date of notification of standards in case of establishments which came into existence after commencement of this Act but before notification of the standards Period of two years from the date of notification of the standards for clinical establishments which come into existence after the commencement of this Act but before the notification of the standards; and Period of six months from the date of notification of standards for clinical establishments which come into existence after standards have been notified.
  29. 29. Permanent registration• Application for permanent registration would be made in such form and accompanied by such fees, as prescribed• Along with form, the CE shall submit evidence of having compiled with the prescribed minimum standards as per prescribed manner• Information submitted by CE shall be displayed for information of public at large and for filing of objections, if any for a period of 30 days before processing for final grant of permanent registration• In case of objections, the same shall be communicated to CE for response within a period of 45 days
  30. 30. Cont……• Permanent registration shall be granted only when a CE fulfils the prescribed standards for registration by the Central Government• The certificate of permanent registration shall be valid for a period of 5 years from date of issue• Cancellation of registration, would occur at any time, if the conditions for registration are not compiled and show cause notice would be issued to the CE• Authority after cancellation of registration for reasons to be recorded in writing, may restrain immediately the CE.
  31. 31. Inspection and power to enter• The authority or its designated officer shall have right to undertake an inspection of any registered establishment and its work through a multi-member inspection team• Results of the inspection shall be communicated to the establishment and after ascertaining the opinion of the establishment shall advise upon action to be taken• The authority or its designated officer has the power to enter, with prior notice to the establishment, if there is any reason to suspect that the clinical establishment is carrying on without registration
  32. 32. Appeals• Any person, aggrieved by an order of the registering authority refusing to grant or renew a certificate of registration or revoking a certificate of registration may, in such manner and within such period as may be prescribed, can refer an appeal to the State Council• Provided that the State Council may entertain an appeal preferred after the expiry of the prescribed period if it is satisfied that the appellant was prevented by sufficient cause from preferring the appeal in time.
  33. 33. Penalties• Whoever contravenes any provision of this Act shall, if no penalty is provided elsewhere, be punishable for the first offence with fine which may extend to ten thousand rupees, for any second offence with fine which may extend to fifty thousand rupees and for any subsequent offence with fine which may extend to five lakh rupees.• Whoever carries on a clinical establishment without registration shall, on first contravention, be liable to a monetary penalty up to fifty thousand rupees, for second contravention with a monetary penalty which may extend to two lakh rupees and for any subsequent contravention with a monetary penalty which may extend to five lakh rupees.• Whoever knowingly serves in a clinical establishment which is not duly registered under this Act, shall be liable to a monetary penalty which may extend to twenty-five thousand rupees.• Whoever wilfully disobeys any direction lawfully given by any person or authority empowered under this Act to give such direction, or obstructs any person or authority in the discharge of any functions which such person or authority is required or empowered under this Act to discharge, shall be liable to a monetary penalty which may extend to five lakh rupees.
  34. 34. Salient Features of the Clinical Establishment Act 2010• Comprehensive definition of Clinical Establishments: Includes all types and kinds of health care providers Includes Indian Systems of Medicines and Homeopathy• Typology: Allows for categorization and classification of establishments- public / private; single doctor to hospitals and laboratories and others• Database generation: Provision for generation of reliable and comprehensive database for all types of clinical establishments in the country• Defines standards: for operation, using participatory approach and ensure uniformity across all establishments• Ensure transparency: through online registration system• An accountable, time-bound system: The Act places the entire process of registration and the data of clinical establishments in the public domain, making it mandatory for every district registering authority, the State Government and the Central Government to compile, publish and maintain in digital format a register of clinical establishments within a period of two years of its establishment.
  35. 35. Salient Features of the Clinical Establishment Act 2010Establishment of a National Council, an all encompassing, multi-member body representing :1. Medical council of India2. Dental Council of India3. Nursing Council of India4. Pharmacy Council of India5. Indian Medicines representing the Ayurveda, Siddha, Unani and Homoeopathy systems6. Indian Medical Associations7. Bureau of Indian Standards8. Zonal Councils set up under the States Re-organisation Act, 19569. North Eastern Council10. Consumer Group amongst othersThe National Council: through a consultative process would discharge following duties:• Classify clinical establishments into different categories• Determine minimum standards• Carry periodic review, compile, maintain and update a national register of clinical establishments.
  36. 36. Salient Features of the Clinical Establishment Act 2010• Role assigned to State Government:1. Designate the DHO or the CMO as district registering authority for registration of clinical establishments;2. Compile and maintain State Register• Role assigned to Central Government:1. Shall maintain digital All India Register, (an amalgam of the State / UT Registers )2. Publish in the public domain• Provisional & Permanent Registration: Allows for provisional registration, which is simply a process of self declaration, with no inspection. After notification of standards (which is within 2 years of the enactment of the Act), permanent registration would be undertaken• Time-bound development: The Act seeks to ensure time bound programme for development of standards and their subsequent enforcement• Mandatory to provide emergency care: Mandatory for every clinical establishment to provide treatment to stabilize the emergency medical condition of any individual brought to such establishment• Respecting People’s Right to Information: Details of charges, facilities available would be prominently displayed at a conspicuous (easily visible) place at each establishment
  37. 37. Salient Features of the Clinical Establishment Act 2010• New entrant: No person shall carry on a clinical establishment unless it has been registered in accordance with the provisions of the Act• Existing oldies: Clinical establishments already in existence may be allowed for provisional registration to carry out their business. There shall be no prior enquiry for provisional registration But the authority shall have power to make enquiry in accordance with such rules as may be prescribed.• Clinical establishment having provisional registration shall fulfil the standards which may be notified for the purpose• Duration & Renewal of Provisional Registration: certificate shall not be granted or renewed beyond a period of two years from the date of notification of standards for establishments that come into existence before commencement of the Act• Permanent Registration: any clinical establishment may apply for permanent registration & and shall pay such fee as may be prescribed by the State Government
  38. 38. Salient Features of the Clinical Establishment Act 2010• Power to inspect: The authority shall have power to inspect a registered clinical establishment Any person aggrieved by an order of the registering authority shall prefer an appeal to the State Council• Power to cancel registration: Authority shall have power to cancel the registration of the clinical establishment which fails to comply with the conditions prescribed by the Central Government• This watch dog has Teeth to Bite: If any person contravenes any, provisions of the proposed legislation or any rules made there-under, he shall be punished with fine and wide ranging penalties
  39. 39. Government perceived benefits of The Clinical Establishment Act 2010Facilitate :• determination of standards• improve quality service delivery• need and evidence based policy formulation• resource allocation• community empowerment• ease of administration• good governance
  40. 40. Government perspective• The Act requires that the registration would be at a committee level headed by a collector level official and assisted by a health official.• The registration would be non-transferable and in the event of change of ownership, one will have to apply for a fresh certificate.• The applicants and facilities would be verified physically for their compliances with the Act by the government authorities.• Only then, would the permanent registration be issued.• Healthcare providers will be required to display the registration certificate so that it is visible to citizens and patients visiting the establishment.
  41. 41. The policy makers perspective According to government sources there is no data of how many healthcare centres operate in various states. Making registration mandatory for all medical establishments will help the administration compile data on healthcare service providers. The Clinical Establishment Bill also aims to fix any loopholes in the existing Acts. It will ensure that issues such as ethics, infrastructure, quality management and bio medical waste are tackled. The Act would also help in strict implementation for often flouted norms.
  42. 42. CONSUMER PERSPECTIVE• Unprecedented consumer empowerment due to the provisions of the law• Minimum requirement of staff numbers to attend to the patient needs• General and medical and especially emergency facilities to stabilise the medical condition of a patient in case of a life threatening condition• Maintenance of records; this would keep the data current and real time for the authorities• An expected positive effect on the cost cutting/ price control
  43. 43. CRYING DOCTORS!!!!!!!!!!!
  44. 44. WHY ARE DOCTORS CRYING? The Indian Medical Association (IMA) has strongly opposed the Clinical Establishments (registration and regulation) Act, 2010. It stated that the act will only escalate the cost of treatment and adversely affect small and medium size hospitals. Take an example of Maharashtra-• A progressive state like Maharashtra does not need such an act. The existing Bombay Nursing Home Act is good enough and health indices of Maharashtra speak volumes about good health practices.• The provisions in the act are such that small hospitals giving treatment by charging very low fees will have to be closed down.• This Clinical Establishment Act will only help in widening the differences between the doctors and the consumers.
  45. 45. WHY ARE DOCTORS CRYING?• According to the new act, doctors will have to take a no- objection certificate from all neighbours living near the clinic.• Also, doctors will have to issue a daily prescription audit, which is almost impossible. If a doctor does not register or fails to show necessary papers, he will be fined Rs 5 lakh• This act will have an adverse effect on the patients and is just a way of bringing corporate and costly hospitals in the country• Many Indian doctors practicing abroad and now because of this act this number will increase.
  46. 46. WHY ARE DOCTORS CRYING?• Since clinics, hospitals and private nursing homes would have to be registered with the state government, the doctors claimed that it would encourage inspector raj in the state. Helps create more corruption in the form of Inspections , checking etc.• One of the doctors said that there are so many points in the Act which needs to be relooked. Even for a single mistake, a doctor will have to pay a fine if caught first and second time. Third time, the registration of the doctor will be cancelled.• it is just to kill medical profession..what about sub standard doctors who graduate or post graduate just by giving fat donations in private college owned by these politicians & there after start looting people to gain it back..this act will provide a big platform to earn for such ill minded doctors & then this medical quacks will increase & will over come the real good doctors.
  47. 47. WHY ARE DOCTORS CRYING? An example from USA• In emergency situation, a patient should be provided treatment whether he is capable of paying or not.• The government, however, refused to pay and the insurance companies too refused to pay.• In such circumstances, who will pay for the treatment of the patient?????
  48. 48. WHY ARE DOCTORS CRYING? The overall impression about the Act was viewed with some introspection and apprehension from some quarters. Some medical bodies felt that single doctor clinics may receive different handling as they may not be able to keep pace with the situation in view of their size of work. This law is more suited to big government institution and corporate private healthcare providers. Attending emergencies in small clinics may be an issue, which needs further elaboration. This may also lead to double registration fees if both systems exist parallel. The Act may encourage license raj in medical practice
  49. 49. WHY ARE DOCTORS CRYING? Doctors under the Indian Medical Association’s (IMA) banner have approached the Delhi High Court to stay the implementation of the Act. This act came along at the time when the doctors were already protesting against couple of other Government proposals on regulating the medical profession and addressing the rural requirement for doctors. The doctors made a serious point when they seek discussion and clarity on norms that govern them. Contrary to popular perception, the medical fraternity is not averse to regulation, they say in their defence. Dissecting the Act, they say, a doctor is required to “stabilise” a patient before sending her across to the nearest referral hospital, failing which he or she could face a non-bailable warrant.
  50. 50. WHY ARE DOCTORS CRYING? On the face of it, it is a much needed, pro-patient move by the Government. Scratch the surface, and complexities emerge. The definition of “stabilise” is unclear. Besides, it is not realistic to expect a regular family physician to be equipped with ventilators and so on. The equipment is expensive, and if individual doctors were to invest in such equipment, who shares their cost, they ask. And while the Act’s efforts to regulate all clinical establishments is a good move, to expect all clinics to be at least 500 sq.-ft, for instance, is practically impossible in expensive cities such as Mumbai, where real- estate costs are prohibitive. If a doctor has that kind of money, he wouldn’t need to practice, quips a general practitioner in South Mumbai. He asks, who pays for this?
  51. 51. WHY ARE DOCTORS CRYING? Having invested in a large room, a ventilator and so on, a doctor will be under pressure to recover his cost and the most likely victim will be the patient, he observes. The Act’s stiff requirements and penalties will encourage corporatisation of healthcare, as only the big corporates have deep pockets. It also opens the door to abuse of power, as authorities can penalise or shut down the clinic of a good doctor for reasons not connected with his medical expertise. The small, neighbourhood doctor will be virtually forced to shut down. Such “draconian” measures will also keep young people away from becoming doctors, says a local family physician, adding that his own children have chosen to pursue engineering, rather than follow in their father’s footsteps!
  52. 52. WHY ARE DOCTORS CRYING? On 25th June, 2012 IMA, IDA and several other professional associations of Medical fraternity had organized a nation-wide protest in the form of “Rallies” at various locations throughout the country. States like Andhra Pradesh, Punjab and Madhya Pradesh have already rejected the Clinical Establishment Act in their assemblies.
  53. 53. One size does’nt fit all India does not have a universal emergency services number or support network like the US’ 911 or the UK’s 999. And patients here are pretty much at the mercy of government- or privately run hospital emergency services that could turn out to be good, bad or downright ugly. The recently notified Clinical Establishments Act (to regulate medical centres) sought to address this concern over emergency care. A key feature in the Act is that no patient can be refused emergency treatment. The well-intended effort, though, is getting the wrong end of the scalpel, as it lays more responsibility on the neighbourhood doctor than he or she is probably equipped to handle. So while it seeks to protect the patient, the Act’s one-size-fits-all approach could end up doing quite the opposite — affecting patients and putting the small, single doctor in the dock.
  54. 54. General observation From a general perspective it is clear that CEA is a reality now and will be covering all the relevant entities as it is implemented throughout. All healthcare providers are expected to obey this statute as any other legal promulgation. As the implementation crystallises there are several beneficial possibilities. This will be allowing a formal classification, standardisation and categorisation of different healthcare institutions, based on their respective location, scale of services offered and level of specialisation creating to be a national level based registry. The mere action of creating a registry, codifying information, monitoring standards and having access to databases throws up highly exciting and useful opportunities for the agencies engaged in healthcare.
  55. 55. References:1) The Clinical Establishments (Registration and Regulation) Rules, 2010 Draft Rules for the Central Government2) Planning Commission Report: Clinical Establishments, Professional Services Regulation and Accreditation of Health care Infrastructure for the 11th Five Year Plan, Government of India3) Bhate-Deosthali P. et al Private Health Sector in Maharashtra A study of private hospitals CEHAT 20114) Bhate P. et al,Poor standards of care in small, private hospitals in Maharashtra, India: implications for public– private partnerships for maternity care, Reproductive Health Matters 2011;19(37):32–415) Dantas A . ,Mapping of urban health facilities Maharashtra, CEHAT 20116) Duggal R. THE PRIVATE HEALTH SECTOR IN INDIA -Nature, Trends and a Critique, May 20127) Jesani A.,LAWS AND HEALTH CARE PROVIDERS A Study of Legislation and Legal Aspects of Health Care Delivery,Jan 968) Gangoli L. et al ,Review of Health care in India , 20059) Nandraj S. , Unhealthy Prescriptions : The Need for Health Sector Reform in India10) The West Bengal Clinical Establishment (Registration and Regulation) Rules, 201211) Report on the Working Group on Clinical Establishments,Professional Services Regulation and Accreditation of Health Care Infrastructure For the 11th Five-Year Plan Government of India Planning Commission
  56. 56. Mithun G Kherde Bharat Thakare Manish Khichi Masters in Public Health(Health Policy, Finance & Economics) Tata Institute of Social Sciences, Deonar, Mumbai, Maharashtra