1 W.P. 3321/2011 IN THE HIGH COURT OF JUDICATURE AT BOMBAY APPELLATE SIDE, BENCH AT AURANGABAD WRIT PETITION NO. 3321/2011 Dr. Ajay Tejraj Oswal,, Age : 43 years, Occu. Medical Practitioner, R/o Bungalow No. B-1, Sumangal Park, Opp. To Sant Eknath Rang Mandir, Osmanpura, Aurangabad. ...Petitioner. Versus 1 Joint Director of health Service, Maharashtra State, Government Dental College Building, 4th Floor, St. George Hospital Campus, P.D. Mello Road, Mumbai-01. 2 Director of Health Services, Maharashtra State, Government Dental College Building, 4th Floor, St. George Hospital Campus, P.D. Mello Road, Mumbai-01. 3 The State of Maharashtra, through its Secretary, Health Department, Mantralaya, Mumbai. ...Respondents. Mr. V.J. Dixit, Senior Counsel I/b Mr. Ankush N. Nagargoje Advocate for the petitioner. Mrs. R.K. Ladda, A.G.P. for respondents Nos. 1 to 3. CORAM : A.V. NIRGUDE, J. DATED : 21st July, 2011. ORAL JUDGMENT: 1. Rule. Rule is made returnable forthwith. 2. By consent of learned counsel for both the parties, the petition is taken for final hearing. 3. This writ petition filed under Articles 226 and 227 of 2 W.P. 3321/2011 Constitution of India, takes exception to the two orders dated 01/04/2011 and 11/04/2011 passed by competent authority established under the provisions of “The Transplantation Of Human Organs Act, 1994” (Henceforth referred to as “the Act”), preventing and affecting the petitioner’s right to practice medicine. The petitioner is Medical Practitioner. He is a Surgeon. Since 1999 he has been performing kidney transplantation surgeries. He has been providing his services to various hospitals as free lance surgeon. He used to visit and perform surgeries at Aditya Birla Hospital, Pune and “Suretech Hospital”, Nagpur prior to the impugned orders. 4. On 26th November, 2010 a team comprised of Dr. Bhavani the head of the department of urology & Department of Surgery, Bombay and Dr. Mohan Jadhav, who is a Govt. Officer who is appointed as “the appropriate authority” under the Act, visited Aditya Birla Hospital, Pune. They found that the petitioner had been visiting this hospital for performing the surgeries. They noticed that the petitioner’s name as a surgeon of the hospital was not mentioned when the hospital sought registration under the Act. They therefore, issued a show cause notice to the hospital as to why its registration should not be cancelled. Similar show cause notice was given to Suretech hospital, Nagpur on the same ground that the petitioner and one more Surgeon were allowed to perform surgeries in that hospital. After submission of explanations etc the impugned orders mentioned above were passed. The orders inter alia specifically mentioned that the petitioner was not recognized for performing the kidney transplantation operation and therefore he should not be allowed to perform such operations in the above named hospitals. The order also cancelled the registration of 3 W.P. 3321/2011 the hospitals. The petitioner is concerned with only that part of the order which adversely affected him. The question that arises for consideration is “whether the petitioner or any medical practitioner required specific recognition from the appropriate authority appointed under the Act for performing surgeries in the registered hospital? 5. In order to answer this, one must peruse the above mentioned act and the rules made thereunder. The relevant provisions of the Act are mentioned below. Section 2. Definitions : In this Act unless the context otherwise requires: (b) “Appropriate Authority” means the Appropriate Authority appointed under section 13; (g) “hospital” includes a nursing home, clinic, medical centre, medical or teaching institution for therapeutic purposes and other like institution; (n) “registered medical practitioner” means a medical practitioner who possesses any recognized medical qualification as defined in clause (h) of section-2 of the Indian Medical Council Act, 1956, and who is enrolled on a State Medical Register as defined in clause (k) of that section; S.10. Regulation of hospitals conducting the removal, storage or transplantation of human organs : (1). On and from the commencement of this Act: (a) no hospital, unless registered under this Act, shall conduct, or associate with, or help in, the removal, storage or transplantation of any human organ; (b) no medical practitioner or any other person shall conduct, or cause to be conducted, or aid in conducting by himself or through any other person, any activity relating to the removal, storage or transplantation of any human organ at a place other than an place registered under this Act; and (c) no place including a hospital registered under sub-section (1) of section 15 shall be used or cause to be used by any person for the removal, storage or transplantation of any human organ except for therapeutic purposes. (2). Notwithstanding anything contained in sub-section (1), the eyes or the ears may be removed at any place from the dead body of any donor, for therapeutic purposes, by a registered medical practitioner. Explanation: For the purposes of this sub-section, “ears” includes ear drums and ear bones. 4 W.P. 3321/2011 S.13. Appropriate Authority:- (1). The Central Government shall appoint, by notification, one or more officers as Appropriate Authorities for each of the Union territories for the purposes of this Act. (2). The State Government shall appoint, by notification, one or more officers as Appropriate Authorities for the purposes of this Act. (3). The Appropriate Authority shall perform the following functions, namely: (i) to grant registration under sub-section (1) of section 15 or renew registration under sub-section (3) of that section; (ii) to suspend or cancel registration under sub-section (2) of section 16; (iii) to enforce such standards as may be prescribed, for hospitals engaged in the removal, storage or transplantation of any human organ; (iv) to investigate any complaint of breach of any of the provisions of this Act or any of the rules made thereunder and take appropriate action; (v) to inspect hospitals periodically for examination of the quality of transplantation and the follow-up medical care to persons who have undergone transplantation and persons from whom organs are removed; and (vi) to undertake such other measures as may be prescribed. S.14. Registration of hospital engaged in removal, storage or transplantation of human organs :- (1). No hospital shall commence any activity relating to the removal, storage or transplantation of any human organ for therapeutic purposes after the commencement of this act unless such hospital is duly registered under this Act. Provided that every hospital engaged, either partly or exclusively in any activity relating to the removal, storage or transplantation of any human organ for therapeutic purposes immediately before the commencement of this Act, shall apply for registration within sixty days from the date of such commencement: Provided further that every hospital engaged in any activity relating to the removal, storage or transplantation of any human organ shall cease to engage in any such activity on the expiry of three months from the date of commencement of this Act unless such hospital has applied for registration and is so registered or till such application is disposed of, whichever is earlier. (2). Every application for registration under sub-section (1) shall be made to the Appropriate Authority in such form and in such manner and shall be accompanied by such fees as may be prescribed. (3). No hospital shall be registered under this Act unless the Appropriate authority is satisfied that such hospital is in a position to provide such specialised services and facilities, possess such skilled manpower and equipments and maintain such standards as may be prescribed. 5 W.P. 3321/2011 S.24. Power to make rules:- (1). The Central Government may, by notification, make rules for carrying out the purposes of this Act. 6. Utilising powers to make rules, Central Government has enacted rules under the Act by name Transplantation of Human Organs Rules, 1995 out of which, following rules are relevant for our discussion. Rule 2. Definitions 2. (e) the Registered medical Practitioner, as defined in clause (n) of section 2 of Transplantation of Human Organs Act, 1994 includes an allopathic doctor with MBBS or equivalent degree under the Medical Council of India Act. Rule: 7. Registration of hospital 1. An application for registration shall be made to the Appropriate Authority as specified in Form 11. The application shall be accompanied by a fee or rupees one thousand payable to the Appropriate Authority by means of a bank draft or postal order. 2 The Appropriate Authority shall, after holding an inquiry and after satisfying itself that the applicant has complied with all the requirements, grant a certificate of registration as specified in Form 12 and shall be valid for a period of five years form the date of its issue and shall be renewable. 3. Before a hospital is registered under the provisions of this rule, it shall be mandatory for the hospital to nominate a transplant co-ordinator. Rule 9. Conditions for grant of certificate of registration : No hospital shall be granted a certificate of registration under this Act unless it fulfills the following requirement of manpower, equipment, specialized services and facilities as laid down below;- A. General Manpower Requirement Specialised Services and Facilities: 1. 24 hours availability of medical and surgical, (senior and junior) staff. 2. 24 hours availability of nursing staff, (general and speciality trained). 3. 24 hours availability of Intensive Care Units with adequate equipments, staff and support system, including specialists in anaesthesiology, intensive care. 4. 24 hours availability of laboratory with multiple discipline testing facilities including but not limited to Microbiology, Bio-Chemistry, pathology and Hematology and Radiology departments with trained staff. 5. 24 hours availability of Operation Theatre facilities (OT facilities) for planned and emergency procedures with adequate staff, support system and equipments. 6. 24 hours availability of communication system, with power backup, 6 W.P. 3321/2011 including but not limited to multiple line telephones, public telephone system, fax, computers and paper photo-imaging machine. 7. Experts, (other than the experts required for the relevant transplantation) of relevant and associated specialties including but not limited to and depending upon the requirements, the experts in internal medicine, diabetology, gastroenterology, nephrology, neurology, paediatrics, gynaecology, immunology and cardiology etc. should be available to the transplantation center. B. Equipments: Equipments as per current and expected scientific requirements specific to organ or organs being transplanted. The transplant center should ensure the availability of the accessories, spare-parts and back-up/maintenance/service support system in relation to all relevant equipments. C Experts and their qualifications: a. Kidney Transplantation M.S. (Gen.) Surgery or equivalent qualification with three years post M.S. training in a recognized center in India or abroad and having attended to adequate number of renal transplantation as an active member of team. b.Transplantation of liver and other abdominal organs M.S. (Gen.) Surgery or equivalent qualification with adequate post M.S. training in an established center with a reasonable experience of performing liver transplantation as an active member of team. c. Cardiac, Pulmonary, Cardio-Pulmonary Transplantation M.Ch. Cardio- thoracic and vascular surgery or equivalent qualification in India or abroad with at least 3 years experience as an active member of the team performing an adequate number of open heart operations per year and well-versed with Coronary by-pass surgery and Heart- Valve surgery. d. Cornea Transplantation M.D./M.S. ophthalmology or equivalent qualification with one year post M.D./M.S. Training in a recoginsed hospital carrying out Corneal transplant operations.] 7. The provisions mentioned above clearly highlight the importance of a properly equipped hospital for undertaking surgical operations for transplantation of human organs. An elaborate procedure is prescribed for registration of a hospital. Unless such registration for a hospital is secured a surgical operation of transplantation of human organs there is not permissible. The Act and the Rules however do not provide individual surgeons who would undertake the surgical operations, are required to be specifically 7 W.P. 3321/2011 authorized by the appropriate authority. 8. Section 2(n) defines the term registered medical practitioner and this term is further elaborated in Rule 2 (e). This definition in fact does not show that the registered medical practitioner should be a person who has acquired a specific educational qualification, such as Master in Surgery or specialization in Urology etc.. 9. Rule 9 quoted above inter alia speaks about “experts and their qualifications” who would be employed by a registered hospital. So it is clear that at the time of registration an applicant hospital should provide the names and qualifications of the experts they would engage for the transplantation operations in their hospital. The appropriate authority's satisfaction for grant of registration also depends on this vital information. 10. The facts of this case suggest that the hospitals which are named above had not mentioned the name of the petitioner as one of the experts who would visit and perform surgeries at their establishment. At times a hospital may not get the services of any of their experts. All of them could be busy somewhere else. At such time -which could be a rare case and that too of emergency- could a registered hospital engage an "expert" who is not on their list which they had furnished at the time of registration without obtaining sanction of the appropriate authority? The other relevant but similar question is whether a registered hospital is allowed to change its team of experts without appropriate sanction of the appropriate authority? The answer to this question is in affirmative but subject to some condition. 11. As said above, each hospital at the time of registration is 8 W.P. 3321/2011 required to give a list of expert which forms their team. The appropriate authority would then examine as to whether the members of such team are sufficiently qualified, as expected under Rule 9. Rule 9-C clearly mentions that an expert would be a medical practitioner having masters of kidney transplantation (general) or equivalent qualification with three years-post master of surgery training in a recognized center in India or abroad and having attended to adequate number of renal transplantation as an active member of team. The appropriate authority thus would be able to examine qualification of each expert whose name is mentioned in the list, submitted by a hospital for registration. As said above, the petitioner’s name was not submitted as an expert attached to the hospitals in question. However, it has come on record that the petitioner’s name is already accepted as an expert of a registered hospital by name Kamal Nayan Bajaj hospital Aurangabad. A letter to that effect was issued in favour of the petitioner by appropriate authority on 02/07/1999 and is annexed to this petition Exhibit ‘B’. The position that emerges from this fact is that if an expert in this field as defined under rule 9-C is recognized as member of team of experts in a registered hospital, he would be able to perform surgical operations involving transplantation of kidney in any other registered hospital. The registered hospital has to ascertain as to whether such expert is a member of a team of experts in any other registered hospital. On ascertainment of this information, a registered hospital is able to permit such expert who is not member of their own team to perform transplantation operations in their hospital. The appropriate authority can not raise any objection to this practice. The rules referred to 9 W.P. 3321/2011 above do not prohibit an expert who is member of a team of experts of a registered hospital, from performing transplantation operation in any other registered hospital. At the same time in view of the rules referred to above an expert who is not member of a team of any registered hospital, no matter, how much experience he has in this field, is not permitted to perform transplantation operation in any registered hospital. In view of this, the petition should succeed. ORDER The writ petition is allowed. The directions contained in the impugned order that the petitioner shall not carry on transplantation operations in a registered hospital is set aside. The appropriate authority shall not prohibit the petitioner from performing transplantation operation in any registered hospital of his choice. A.V. NIRGUDE, J. ts k/2011/July21/wp3321.11/ok