Legal issues and Ayurveda

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There are some basic laws which are to be followed by every profession. Most of the Ayurveda professional are not aware about these legal points. These includes- Conduct& Etiquette, ethics, advertisements, manufacturing of medicine for own patients, clinical registration act 2012, insurance and ayurveda, Bio-medical waste etc.

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Legal issues and Ayurveda

  1. 1. Legal issues with reference to Ayurveda practitioners
  2. 2. About • Most of the Ayurveda practitioners are not aware about the basics of legality with reference to their profession. I tried to put most common points for our young as well as senior practitioners. • This presentation is a part of eLecture series of ayurvedvishva.com started by Vaidya Manish Joshi,Nasik.(http://ayurvedvishva.com/e_sambha sha/e_sambhasha.php ) • References can be browse by their respective links for in depth reading.
  3. 3. Dr. Surendra Chaudhary B.A.M.S,PGDHFWM(NIHFW) Medical Officer former, District Ayurveda &Unani Officer, Gautambudh Nagar(Noida) dr.surendra.chaudhary@gmail.com 09810004259 3
  4. 4. NATURE OF ISSUES • Generalized and Pan Indian in nature – Applicable to all practitioners everywhere – Registration with CCIM • State wise – Registration with state board – Renewal of registration – Change of address – Additional qualification • Local bodies – Professional tax, registration with C.M.Os etc Continued…… 4
  5. 5. NATURE OF ISSUES • Related to Drugs and cosmetics act – Drug manufacturing for clinic – Preparing medicine, expiry dates • Related to CCIM act – Code of conduct, issuing of medical certificates etc – Electing CCIM members • Other rules and regulations – Health , forest, education, police departments • Regulatory bills Clinical establishment bill Medical manpower and establishment safety bill • Insurance and Ayurveda 5
  6. 6. Registration • State board – Renewal – Change of address – Additional qualification – Identity cards • CCIM – Mandatory/optional/advisable – Advantage/disadvantage – Know your CCIM registration 6
  7. 7. Registration-CCIM Know your registration • www.ccimindia.org> Central register> Ayurveda Search field- • select state • department (Ayurveda) • fill your state registration number • Enter your state registration keeping all field empty ? 7
  8. 8. Central registration 8
  9. 9. More on central registration • http://www.authorstream.com/Presentation/ Surendra1955-1815731-central-registration- ccim/ • http://www.slideshare.net/drsurendrachaudh ary/central-registration 9
  10. 10. Start your clinic • Own premises Residential/commercial • Rented premises Rent agreement with all clause of annual increment and payment of local bodies taxes • Shared chamber Collection of fees, sharing of revenue and mode of payment 10
  11. 11. Clinic in residential area legal or illegal ? • “I am of the considered view that the professional establishment of a doctor cannot come within the definition of commercial activity,” ruled justice Suresh Kait. Delhi high courts-2nd july 2012 • “Commerce is that activity where a capital is put into work, there is risk of profit or loss. Only if the activities are undertaken for production or distribution of goods or for rendering material services, it comes under the definition of commerce. There is fundamental distinction between professional activities and commercial activities,” • http://imaetawah.weebly.com/uploads/5/7/5/1/5751407/drchugvs mcd-clinicnot_commercial-delhihc.pdf 11
  12. 12. Noida Case • NEW DELHI: The Supreme Court has asked NOIDA administration to ensure that no poly clinics or nursing homes are permitted in the residential area of the Capital's satellite town and the same are allowed only in its earmarked commercial areas. • A bench of justices Swatanter Kumar and Ranjana Prakash Desai, however, said doctors can run their individual clinics in the residential areas, but the same should be purely on outpatient basis. 12
  13. 13. The Clinic • "A clinic simplicitor can be run by a doctor within such area as already specified, in his or her residence. This clinic would mean one as per the bye-laws. • "To put the matters beyond ambiguity, we clarify that the doctor can have his clinic with a table, a bed to examine the patient and such facilities which may be necessary to provide first aid. A dentist may have a dental chair in his clinic. Under this head, neither a polyclinic nor a nursing home can be run in the residential area. • "We also direct that no doctor would be permitted to run a polyclinic or a nursing home in the garb of a clinic," the apex court said. • May-7, 2012 • http://articles.economictimes.indiatimes.com/2012-05-07/news/31610700_1_nursing-homes-residential-areas- clinic 13
  14. 14. CODE OF CONDUCT CCIM 14
  15. 15. Advertisement • It is improper for a practitioner of Indian medicine to use an unusually large sign board and write on it anything other than his name, qualifications obtained from a University or a statutory body, titles and name of his speciality. The same should be on his prescription papers. • It is improper to affix a sign-board on a chemist's shop or in places where he does not reside or work. • Advertisement through hoarding and tour programmes shall be unethical. 15
  16. 16. Advertisement Cont… • Solicitation of patients directly or indirectly either personally or by advertisement in the news paper, by placards or by distribution of circular cards or hand bills by a practitioner of Indian medicine is unethical. • A practitioner Shall not make use of or aid or permit others to make use of him or his name and/or photograph as subject of any form or manner of advertising or publicity. This provision shall not apply to authors of purely medical literature written for the advancement of the profession and science. 16
  17. 17. What can be advertise • Practitioner may issue a formal announcement in the Press one-insertion in one or more papers, regarding the following :- (a) On starting practice; (b) On change of type of practice; (c) On change of address; (d) On temporary absence from duty; (e) On resumption of practice; (f) On succeeding to another practice. 17
  18. 18. Conduct& Etiquette Practitioners of Indian Medicine ( Standards of Professional Conduct, Etiquette and Code of Ethics) Regulations, 1982 PART- II PROFESSIONAL CONDUCT AND ETIQUETTE DUTIES AND OBLIGATIONS OP PRACTITIONERS OF INDIAN MEDICINE TO-WARDS PATIENTS AND PUBLIC http://ccimindia.org/cc_actregulations_1982.html 18
  19. 19. Part-II towards patient & Public 1. Character of the Practitioners of Indian Medicine 2. Duties of practitioners of Indian medicine towards their patients 3. Practitioner's responsibility 4. Patience, delicacy and secrecy 5. Prognosis 6. The patient must not be neglected 7. Upholding the honour of the profession 8. Engagement for an obstetric case 9. Practitioner as a Citizen 10. Public Health 19
  20. 20. Part-III TOWARDS ANOTHER PRACTITIONER • Dependence of practitioners on each other,- • Compensation for expenses • Consultation to be encouraged • Consultation for patients benefit • Punctuality in consultation • Conduct in consultation • Statement to patient after consultation. • Treatment after consultation • Visiting another practitioner's cases • Patient referred to specialists 20
  21. 21. PART IV CODE OF ETHICS 1. Advertising 2. Nomenclature of qualification-It shall be compulsory for a practitioner of Indian medicine to affix the correct degree or diploma before or after his name. 3. Payment for professional services- "No cure, no payment“ 4. Rebates and commission 5. Evasion of legal restriction 6. Professional certificates, reports and other documents 7. Register of medical certificate issued by practitioner 21
  22. 22. PART-IV DISCIPLINARY ACTION • Adultery, improper conduct and/ or having adultery and improper relations with patient • performing on enabling unqualified person to perform an abortion or any illegal operation for which there is no medical, surgical or psychological indication;  A practitioner of Indian medicine shall not issue certificates of efficiency in Indian Medicine to unqualified or non-medical person. – The foregoing does not apply so as to restrict the proper training and instruction of bonafide students, legitimate employees or practitioners, midwives, dispensers, surgical attendants, or skilled mechanical and technical assistants under the personal supervision of practitioners). 22
  23. 23. The punishment • The appropriate authority-the State Board or the State Council • May issue a letter of warning or • May direct the removal altogether or for specified period from the register the name 23
  24. 24. Prescription letter head XYZ Clinic Dr. ABC General physician and surgeon XYZ Clinic 123, street – place, telephone XYZ Clinic Dr. ABC, B.A.M.S….. Contact number Timings- In case of emergency 24
  25. 25. DRUGS AND COSMETICS ACT FROM 25
  26. 26. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 • An Act to control, the advertisement of drugs in certain cases, to prohibit the advertisement for certain purpose of remedies alleged to possess magic qualities and to provide for matters connected therewith. • The Act defines drugs and registered medical practitioners besides defining magic remedy. According to Act the Magic remedy includes a talisman mantra kavacha, and any other charm of any kind which is alleged and possess miraculous powers for or in the diagnosis, cure, mitigation treatment or prevention of any disease in human beings or animals or for affecting or influencing in any way the structure or any organic function of human beings or animals. • Unless prescribed by registered medical practitioners or after consultation with the Drugs and Cosmetics Act 1940, no person or company, shall take any part in the publication of any advertisement referring to any drug that is used for: a) the miscarriage in woman, b) maintenance or improvement of the capacity of human beings for sexual pleasures, c) correction of menstrual disorder in women, and d) the diagnosis, cure, mitigation, treatment or prevention of any disease. • No person or company will take part in advertisement which give false impression or makes a false claim for the drug or mislead the people. Whosoever contravenes any of the provision of this Act shall be punishable with imprisonment extended to six months or with fine, or with both for first time conviction. It may extend to one year imprisonment or with fine or with both on subsequent convictions. 26
  27. 27. The diseases (54) 1. Diabetes 2. Uterus diseases 3. Disorder of menstrual flow 4. Prostatic gland disorders 5. Female disease (in general) 6. Obesity 7. Rheumatism 8. Forms and structure of the female breast, 9. Gall bladder stones 10. Kidney stones 11. Bladder stones 12. Leucoderma 13. Sexual impotence 14. Stature of person 15. Sterility of women 27
  28. 28. Common advertisements
  29. 29. Common advertisements
  30. 30. Common advertisements
  31. 31. Ayurveda exploited!!!!!!
  32. 32. Action Taken • Herbal oil ads: Govinda tells FDA he was unaware of laws • Mid-Day.com | Updated: August 23, 2012 12:40 IST • Mumbai: Last month, the Food and Drug Administration (FDA) had filed 67 complaints at police stations across the state under various sections of the Drugs and Magic Remedies (Objectionable advertisements) Act, 1955. These include complaints against advertisements of products such as 'Sandhi Sudha plus', 'Step up herbal oil' and 'Power Prash', which are promoted by leading Bollywood stars.
  33. 33. Advertising Standards Council of India contravened the provisions of the Drug & Magic Remedies Act • Naaz India Company: Naaz Fat Cut Granuals and Naaz Hair Up Oil's - 'stops hair fall', 'provides successful cure of baldness'. • Sagar Dispensary's - 'Dr. S.A. Ali is an expert in STD'. 'Treats patients with problems like less sperms, impotence & provides complete and permanent cure', 'our successful treatment has cured lakhs of disheartened patients and given them new life'. • Anant -'provides successful cure of male infertility', 'internal weakness', 'premature ejaculation erectile dysfunction', 'childlessness', 'skin disease', 'psoriasis and tumour in breast'. • Sarkar Dispensary's advertisement claimed that it 'is the Best Ayurvedic clinic of 2011' • IPSA Labs: Eraser Ayurvedic Skin Cream's advertisement claimed that it 'is a mixture of 8 essential herbs which removers every kind of spots from your face and skin'. • Stammering Cure Centre advertisement claimed that the centre 'Partha Bagchi (world leader in stammering cure since 22 years) cures stammering in 12 days.‘ • GM Pharmacy: Sadabahar Sugar Free's advertisement claimed that 'Sadabahar sugar free is a diabetes killer powder', 'most effective medicine in diabetes'.
  34. 34. Expiry date Duration Description One year All eye drops and arka Two years Churna and kwath churna, Ghrit,tooth-powder and tooth paste, Varti, Swet parpati, Nasal and ear drops, Doophan-inhaler Three years Gutika containing kashtha aushdhi, avleha, taila, lep -churna, lep - gutika, lep malhar, ghanvati, capsule made of gelatine containing kashtha aushadhi, syrup, Khand,Granules and Paka. Five years Hard gelatine capsule containing kashtha aushadhi with ras,bhasma and kajjali, nag,vang and tamra bhasma. gugglu,lavan, kshars and drava. Ten years Lauh and Mandoor No expiry Pishti&Bhasma,Ras, Asava ,Airshtha, Kupipakva Rasayan, Swarn-rajat- loh-mandure,abhrak-godanti-shankh bhasma Important Pishti and bhasma start solidifying after five years and need one or two put before reusing 35
  35. 35. Alcohol contents S.No. Name of the drug Maximum size of packing 1. Karpur Asava 15 ml. 2. Ahiphenasava 15 ml. 3. Margamadasava 15 ml. 4. Mritsanjivani Sura 30 ml 5. Mahadraksasav 120 ml 36
  36. 36. Self preparation of medicine • No manufacturing license required • Can prepare and dispense for own patient • Marketing ? • Distribution • Overseas supply 37
  37. 37. THE CLINICAL ESTABLISHMENTS ACT 38
  38. 38. The Clinical Establishments (Registration & Regulation) Act, 2010 • The Act is for the Registration and Regulation of the clinical Establishments in the country and for matters connected therewith • Act passed by Parliament in August 2010 and notified on 1st March, 2012. • National Council under the Act notified on 19th March, 2012 and Central Rules notified on 23rd May, 2012 • Model State Rules have been circulated to the States/UT’s. • Ministry has requested the Chief Ministers to adopt and implement the Act. • Highest priority of Govt. for implementation and monitored by the PMO. 39
  39. 39. 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, 40
  40. 40. Coverage • All clinical establishments - including diagnostic centres and single doctor clinics, across all recognized systems of medicine in both public and private sector. (exception: establishments of the Armed Forces) 41
  41. 41. Bio-waste management Law • Bio-medical waste means any solid and/or liquid waste including its container and any intermediate product, which is generated during the diagnosis, treatment or immunization of human beings or animals in research or in the production or testing • Consisting entirely or partly of human or animal tissue, blood or other body fluids, excretions, drugs or other pharmaceutical products… 42
  42. 42. Bio-waste management-Ayurveda • Blood from raktamokshan, ksharsutra • Needle, syringe out of local anasesthesia • Residual oil of panchkarma • Vomit and sanitation product 43
  43. 43. Bio-waste management Law • SMC(Surat municipal corporation)-TNN May 10, 2013, has been carrying out surprise inspections in hospitals, clinics and nursing homes to check to check their bio-medical waste disposal mechanism. At least 186 hospitals, nursing homes and clinics were covered on Thursday. Four private hospitals, namely 21st Century Hospital run by Dr Purnima Nadkarni and Dr Pooja Nadkarni, Ayush Hospital run by Dr Ghanshyam Patel 44
  44. 44. Insurance and Ayurveda • The Insurance Regulatory and Development Authority (IRDA) has issued a notification informing the inclusion of the Indian System of Medicines in the mediclaim insurance policy. As per the notification, the insurance coverage to Ayush treatments has been facilitated through the regulation 5(1) of the IRDA (Health Insurance) Regulations, 2013 45
  45. 45. Professional Indemnity Policy For Doctors And Medical Practitioners a) Legal liability as fixed by courts in India to pay compensation. b) Defence costs and expenses. This means all costs, fees and expenses incurred with the prior consent of the insurer in the investigation, defence or settlement of any claim made against the insured, provided the claim falls within the ambit of the policy. • The amount of payment under (a) and (b) will not exceed the amount insured for in the policy under the limit of Any One Accident (AOA) in respect of any or all claims made against the insured arising out of Any One Accident. 46
  46. 46. Premium Premium chargeable depends on the: • Risk group of doctor Limits of indemnity selected Ratio of limits • Depending on exposure, the proposer has to fix two limits of indemnity under the policy: • Any One Accident (AOA)Any One - Year (AOY)AOA and AOY can be in ratio of 1:1 or 1:2. • Premium-Varies between 0.30 per thousand rupees and 3.00 per thousand rupees depending upon (a) Category of Doctor and (b) AOA : AOY ratio chosen.  AOA - Any One Accident  AOY - Any One Year 47
  47. 47. ??????????????? Right to practice Modern Medicine
  48. 48. Right to practice Modern Medicine • New Delhi, June 17: Doctors of ayurveda and three other systems of medicine may be legally permitted to prescribe modern medicine under a controversial proposal from the Union health ministry that has angered sections of modern medics. 49
  49. 49. Right to practice Modern Medicine 50
  50. 50. Right to practice Modern Medicine - RULES -PART I -PRELIMINARY 2. Definitions.___ [(ee) “Registered medical practitioner” means a person__ (i) holding a qualification granted by an authority specified or notified under section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or (ii) registered or eligible for registration in a medical register of a State meant for the registration of persons practising the modern scientific system of medicine 7excluding the Homoeopathic system of medicine; or (iii) registered in a medical register, 1other than a register for the registration of Homoeopathic practitioner, of a State, who although not falling within sub-clause (i) or sub-clause (ii) is declared by a general or special order made by the State Government in this behalf as a person practising the modern scientific system of medicine for the purposes of this Act; or (iv) registered or eligible for registration in the register of dentists for a State under the Dentists Act, 1948 (16 of 1948); or (v) who is engaged in the practice of veterinary medicine and who possesses qualifications approved by the State Government;] • 51
  51. 51. Important examples 52
  52. 52. 53
  53. 53. YES • Amendments in state boards  Maharashtra  Andhra Pradesh  Himachal Pradesh  Tamil Nadu  Haryana, Delhi--?????? Uttar Pradesh! • Gazette notification • Any other circular or order from competent authority • Now it will be only appropriate that the Union health ministry takes a decision of allowing all ISM practitioners to practice allopathy in rural areas all over the country until the current shortfall of MBBS doctors is overcome.
  54. 54. Legal aspects of allopathic hospitals employing AYUSH practitioners Dr M C Gupta (Advocate) MD (Medicine), LLM http://www.aalatimes.com/2012/05/07/legal-aspects-of-allopathic-hospitals-employing-ayush-practitioners/ • Are there any laws or guidelines with respect to the role of practitioners of Indian systems of medicine employed as medical officers in hospitals which deal only and solely with allopathic medicine? What is the status in the event of an error? — Dr Gladstone D’Costa, Voluntary Health Association of Goa • The practice of employing AYUSH practitioners in hospitals is common in many private hospitals. This is illegal and has been commented as follows by the National Consumer Commission:  “When a patient is admitted in a hospital, it is done with the belief that the treatment given in the hospital is being given by qualified doctors under the Indian Medical Council Act, 1956. It is not within the knowledge of the relatives of the patient that the patient is being treated by a Unani specialist. We hold that it is clear deficiency in service and negligence by the hospital for leaving the patient in the hands of a Unani doctor… As laid down by the Apex Court in the above case (Jacob Mathew Vs. State of Punjab), we feel it is high time that hospital authorities realize that the practice of employing non-medical practitioners such as Doctors specialized in Unani system and who do not possess the required skill and competence to give allopathic treatment and to let an emergency patient be treated in their hands is a gross negligence.” In Prof P N Thakur Vs. Hans Charitable Hospital, NC, 16 August 2007
  55. 55. AYURVEDIC DOCTOR IS FINED 15 LAKH RUPEES BY HON>SUPREME COURT ON APRIL 5, 2013. http://www.advocatekhoj.com/library/judgments/announcemen t.php?WID=3336 57
  56. 56. Landmark judgments • Dr. Mukhtiar Chand & Ors vs The State Of Punjab & Ors on 8 October, 1998 http://indiankanoon.org/doc/484509/ • Poonam Verma vs Ashwin Patel & Ors on 10 May,1996 http://www.indiankanoon.org/doc/611474/ 58
  57. 57. Right to practice Modern Medicine • Obstetrics cases • Immunization • Storing allopathic medicine • Prescription 59
  58. 58. Thanks ! Can follow me at • http://www.scribd.com/surendra_chaudhary_2 • in.linkedin.com/pub/dr-surendra chaudhary/11/705/4ab/ • https://www.facebook.com/dr.surendra.chaudhary • http://www.authorstream.com/MyUploaded- Presentations/All • http://www.slideshare.net/drsurendrachaudhary/ My cases on Ayurveda and related topics • http://www.ayurvedaconsultants.com/caseallauthor.aspx?ivalue=1435 60

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