6 Regulatory Framework for ASU Drugs
Regulatory Framework for ASU Drugs Major Milestones Crossed
180
Improving Quality Control and Enforcement - Current developments and future prospects
182
Legal Status of Cross Practice
184
Annexures :
Annexure-I: Letter of Secretary, UP to all the CMOs regarding harassment faced by the ISM practitioners in the State
194
Annexure-II: Court order on the issue of Inter-disciplinary Cross-practice in UP
195
Annexure-III: Ministry of Health & Family Welfare’s notification regarding practice of Gynaecology & Obstetrics and Diagnostic Ultrasonography by ISM Graduates
197
Annexure-IV: Himachal Government’s circular allowing ISM practitioners to use modern medicines
198
Annexure-V: Directorate of ISM, J&K Circular regarding “Prescription of Allopathic Medicine by AYUSH Doctors”
199
Annexure-VI:Proposal of J&K Department of ISM to notify the use of essential allopathic medicine by AYUSH doctors
200
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6 Regulatory Framework for ASU Drugs Introduction Post Independence, when India had to confront new challenges of manufacturing quality pharmaceuticals within in the country, the Drugs Act 1940 was enacted. It was only in 1964 that Cosmetics was brought under the purview of the Act. In 1964, the Drugs & Cosmetics Act (DCA) was further amended to insert definitions for Ayurveda, Siddha, and Unani(ASU) drugs. In 1982, a Schedule of Authoritative books was notified with a view to giving legal recognition to “AnubhutiYog” (experience-based ASU medicine) and also for defining “Patent & Proprietary” (P&P) ASU Medicine. Chapter IV of Drugs and Cosmetics Rules (DCAR) lays down regulations for synthetic compound-based drugs (generally referred as allopathic drugs) while Chapter IVA of DCAR provide regulations for ASU drugs. It would appear that the latter provisions began to be implemented only in 1983 when the Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) was first constituted to advise the Central and State Governments on technical matters arising out of Chapter IVA. Broadly speaking, Chapter IVA provides that licenses can be obtained from the licensing authorities under the State Governments. The only difference between “patent proprietary medicine” and “classical medicine” is the requirement to strictly adhere to the classical texts in the case of classical medicine. This stipulation was in the wisdom of the Parliament, based on a history of safe usage
over thousands of years since the formulations had undergone years of examination by the Vaidyas and needed no further proof to be licensed for manufacture. However, in the case of P&P ASU drugs, the formulations could be “tweaked” to make them different and special. But a specific license had to be obtained for deviating from the classical text while ensuring that the ingredients in any case were the same as listed in the ancient texts; also the processing methods were similar to those in the authoritative texts. Thereby alterations promoted by private sector manufacturers also received legal recognition. Challenges that beset ASU Drug Manufacture and Sale Lack of enforcement to check the quality of ingredients used as well as gaps in the fulfilment of the procedures as prescribed in the classical texts remain major shortcomings. Since no sale licence is required, shops can stock medicine, oils and a diverse range of formulations and these products can be obtained over the counter without any prescription. This leaves everything in the hands of manufacturers and not all among them show due diligence. Although there are some 9000 licensed units in the country just 10 manufacturers account for almost 85 percent of the sales. The regulations for maintaining safety and quality control apply to all manufacturers but these are often ignored because of the knowledge that State enforcement is weak.
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Major Milestones Crossed Major Milestones relating to ASU drugs Several major initiatives have been taken by the Department of AYUSH, Government of India and are being listed below as they represent a commitment to improving the quality of ASU
drugs. It is important to note that many of these amendments and initiatives have been undertaken at the behest of industry, and most of them are on the lines of measures applicable to the pharmaceuticals industry, but modified to fit the ASU drugs sector.
Schedule of Regulatory Milestones Crossed S.No. 1. 2.
Steps/Initiatives Provision of exemption in the labelling and packing provisions was made with an amendment in the Drugs & Cosmetics Rules, whereby ASU drugs could be labelled as per the requirements of the country to which they were exported. This was for facilitating export. Good Manufacturing Practices (GMP) notification was introduced to strengthen quality control of ASU medicines, both by the drug manufacturers and licensing authorities. GMP provisions prescribe the requirements of infrastructure, hygiene, man power, and related aspects to maintain quality control. (2000)
3.
In order to improve the quality of production and testing facilities for ASU&H drugs in the public sector, a Centrally Sponsored Scheme (CSS) was implemented to strengthen State Pharmacies and Drug Testing Laboratories. (2001)
4.
Standards for the manufacture, sale or distribution of ASU drugs were prescribed through an amendment in the Drugs & Cosmetics Rule 168. (2002)
5.
Regulatory provisions for recognition of laboratories for testing ASU drugs and raw materials were made under the Drugs & Cosmetics Rules. Notification was made for laying down the qualifications of the State Licensing Authorities for ASU drugs. Essential Drug lists of Ayurveda, Siddha and Unani were published to facilitate standardized supply of medicines to government dispensaries and hospitals. (2003)
6. 7. 8.
Joint inspections were initiated by the representatives of Central Government and State Licensing Authorities for granting recognition to the Drug Testing Laboratories under the Drugs & Cosmetics Rules. (2004)
9.
Standard requirements of space and technical manpower were prescribed prior to grant of approval for carrying out testing of ASU drugs. Use of excipients was permitted with specific conditions and permissible limits to improve the quality and shelf life of ASU drugs. Many of them are currently manufactured on an industrial scale and distributed across the country. Rule 169. Administrative orders were issued to the State Governments and Drug manufacturers for arranging for batch to batch testing of heavy metals in export-oriented ASU herbal ASU medicines. (This was subsequent to an article published in the Journal of American Medical Association (JAMA) about the presence of heavy metal contents in Ayurveda products, and concerns raised on the safety of herbal ASU medicines). (2005)
10. 11.
12.
Pharmacopoeia Laboratory for Indian Medicine (PLIM) was notified under the Drugs & Cosmetics Rules to function as Central Drugs Laboratory. PLIM is the Appellate Laboratory for the purpose of testing ASU drugs. (2006)
13.
A Technical Committee was set up to examine applications seeking Central Government’s permission for conducting clinical trials on ASU medicines. (This remained a temporary measure only. The committee did not continue and its working was objected to by several firms). Pharmacopoeial standards of multi-ingredient Ayurvedic formulations were developed and published for the first time, in the Ayurvedic Pharmacopeia of India. (2007)
14.
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15.
16. 17. 18.
19.
20. 21. 22.
23. 24.
25. 26. 27. 28.
29. 30. 31. 32. 33. 34.
Drugs & Cosmetics Rules were amended to provide for maintenance of records of raw materials used by licensed ASU drug manufacturing units in preceding financial year. (This was to get manufacturers to provide annual data on consumption of raw herbs and materials with a view to generate data on utilization as well as demand and supply aspects to maintain sustainability). Framework for issue of WHO-GMP certification of ASU drugs was finalized. Administrative orders were issued prescribing permissible limits of heavy metals, aflatoxins, pesticide residues and microbial load in Ayurvedic drugs. Administrative orders issued banning the use of misleading prefixes and suffixes in classical and patent ASU medicines. Later certain exemptions were also issued. (This order in effect prevented branding of classical medicine which the PI feels has impacted adversely on R&D and the “look and feel” of classical medicine.) (See Part I, Chapter on Drugs for a detailed critique on branded drugs). (2008) Guidelines for manufacturing of Mineral and Herbo-mineral formulations notified vide amendment in Schedule ‘T’ of Drugs & Cosmetics Act. (Supplementary GMP requirements were introduced specifically for the manufacturers of metallic preparations of ASU drugs that need to undergo purification as per the authoritative texts. This was an additional measure to ensure safety and quality of ASU drugs). Voluntary quality certification scheme for AYUSH products was started in collaboration with Quality Council of India (QCI). (2009) Shelf life/date of expiry for ASU medicines notified under Drugs & Cosmetics Rule 161 (B). (This was a long standing demand from consumers and was advised by Consumers Affairs Ministry as providing information on the durability of products has become a consumer right). Guidelines for issue of manufacturing license to various types of Patent & Proprietary (P&P) ASU drugs notified listing documents required in support of efficacy and safety. (This broadened the scope of and permitted P&P drugs to use extracts based on ethanol and solvents. A new category called ASU Cosmetics and Supplements was introduced) List of poisonous substances used in ASU systems of medicine was amended through Schedule E-1 of Drugs & Cosmetics Act. Pharmacopoeia Commission for Indian Medicine (PCIM) was set up to accelerate the pharmacopoeia work of ASU drugs. (The Pharmacopoeia Commission is run by scientists who lay down standards for ASU medicines and related aspects, on lines similar to Indian Pharmacopoeia Commission for Allopathic drugs). (2010) Research Councils were directed to register all clinical trials on ASU & H drugs under Clinical Trial Registry of India (CTRI). Ayurveda, Siddha and Unani Drugs Technical Board (ASUDTAB) was reconstituted. (2011) Notification of draft rules regarding the mandatory mention of botanical names and plant parts on the labels of ASU medicines. Good Clinical Practice (GCP) guidelines for ASU drugs were approved by Department of AYUSH. Initiatives in the Pipeline Provision of Retail Sale license for ASU drugs containing poisonous raw materials (as per Schedule E-1) has been initiated on the recommendation of Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB). (This move was proposed many times in the past) Legal ban on misleading use of prefix or suffix in ASU medicines has been initiated. This prevents the branding of classical medicine. (The PI feels that branding ought in fact to be encouraged. See part I of the Status Report-Chapter on Drugs). Regulatory provision introduced for mandatory compliance to GCP to conduct clinical trials on ASU drugs. Notification of model laboratory practices for testing of ASU drugs initiated. Review of shelf life of ASU drugs initiated to rectify ambiguities between the formularies and the legal provisions. Amendment of the lists of authoritative texts of Ayurveda, Siddha and Unani listed under the First Schedule of the Drugs & Cosmetics Act undertaken. (2012)
*(Remarks in parentheses are the PI’s views and do not constitute an official point of view).
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Improving Quality Control and Enforcement - Current developments and future prospects Regulations that Relate to Safety and Efficacy of ASU Medicine With the resurgence of interest in Ayurveda and Indian systems of medicine, there is an increasing need to refer to not just the profile of the ingredients but to satisfy the consumer about the safety and efficacy of the drugs. On the one hand the D&C Act 1940 does not prescribe the need for any safety studies or clinical studies in respect of ASU drugs; on the other nothing can be taken for granted simply because it claims to follow what has been stipulated. The manner in which laboratory testing can be refined and modernised has been dealt in detail in Part I in the Chapter on Drugs. Introduction of New Categories under the D&C Act Particular reference needs to be made to the sixth amendment to the Drugs and Cosmetics Rules issued in 2010 elaborating guidelines for issue of licence of different kinds of ASU products. Categories intended to promote good health, paediatric formulations, cosmetic and toilet preparations, as well as extracts were mentioned as separate categories for the first time. Although it was specified that the conditions relating to safety studies and experience or evidence of effectiveness would need to be as specified, such requirements do not appear to have been spelt out. In the case of cosmetic and toiletry preparations, it was specified that safety studies were to be undertaken in case the formulation contained any of the ingredients mentioned in schedule E (1). (Poisonous substances) In respect of extracts of medicinal plants (dry or wet) no requirement for safety studies or for
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experience/evidence of effectiveness studies have been laid down but in the case of new indications other than those mentioned in the list of books and if the extracts are other than hydro/hydro-alcohol-based, acute chronic, mutagenicity and teratogenicity studies have been asked to be conducted. It has also been indicated that the standard protocol should include the concepts of Anupan, Prakriti and Tridoshas as published by the Central Research Councils. Strengthening the Regulatory Mechanisms for Enforcement The Mashelkar Committee (2003) and the Ayurveda, Siddha, Unani Drugs Consultative Committee (ASUDCC) chaired by the Drugs Controller General of India (DCGI) while recommending the need to strengthen the regulatory mechanism at central and state levels suggested the creation of a Central Drug Controller for AYUSH. With this the Central Government would assume a significant role in enforcing the regulatory provisions prescribed under Drugs and Cosmetic Act 1940 and the rules there under. Accordingly, the Department moved a proposal in 2010 to set up a Central Drug Controller for ASU & H Drugs. The EFC chaired by the Secretary (Expenditure) is reported to have approved the proposal. Thereafter the Department of Expenditure was approached for creation of posts and infrastructure. The Department of Expenditure has sought clarifications and it is understood that the matter remains under process. Guidelines for Clinical Research Considerable cloudiness covers the requirement to follow protocols for clinical trials as well as the level of trials needed for ASU drugs. For the first time the ICMR issued AYUSH specific ethical guidelines for biomedical research in human
subjects in the year 2000 and revised them in 2006. The guidelines suggest the composition of an institutional Ethics committee but there is little specificity about when exactly Phase-I, Phase-II and Phase-III trials are needed. Also the ICMR committee perhaps did not recognize that for ASU drugs with long usage, Phase I to III studies which apply primarily to Synthetic New Chemical Entities (NCE’S) may not be required. The categorization of ASU drugs into different categories as given in the ICMR guidelines does not synchronize with the way ASU drugs are listed in the pharmacopoeias or used in practice. The result has been that the ICMR guidelines have generally remained on paper. ASU research as well as practice has been guided by the protocols drawn up by the Scientific Advisory Committees of the Government Research Councils or as Sub Committees under ‘Ayurveda Siddha Unani Drugs Technical Advisory Board (ASUDTAB)’
undertaken by private manufacturers. There, therefore exists no final position on what is needed for ASU drugs clinical research. A number of papers based on clinical trials carried out by companies like Himalaya and Dabur have been published in leading international journals. Hence the adoption of acceptable standards can be learnt from the way the private companies have successfully published their research in high impact journals including international publications. Some details are given in the Chapter on Cotemporary Ayurveda. It is interesting to note that five sub-committees had been set up under the ASUDTAB with different terms of reference. The five subcommittees and their terms of reference can be summarized as under: Terms of references
1. Subcommittee to examine Schedule “Z’ and other relevant notification
Introduction of Schedule ‘Z’ in Drugs & Cosmetics Rules 1945 – related to requirement & guidelines for permission to manufacture ASU drugs for sale or to undertake clinical trials
2. Subcommittee to evaluate the proposed Retail Sale License for ASU drugs
Introduction of Retail sale license for ASU medicines containing Schedule E (I) drugs (poisonous substance) of the Drugs & Cosmetics Rules 1945
3. Subcommittee to review the Model Laboratory Practices for testing of ASU drugs
Amendments in Drugs & Cosmetics Rules, 1945, for introduction of Schedule-T-1 related with “Good Laboratory Practices & Requirements of premises &equipments for testing of ASU Drugs”
4. Subcommittee to amend Frame the Amendment of the list of authoritative books in the First First Schedule of Drugs & Schedule of Drugs & Cosmetic Act, 1940 with details of writer, Cosmetics Act, 1940 for the publisher, year of publication etc. list of Authoritative ASU books 5. Subcommittee to examine shelf life of ASU Medicines
Review of shelf life of Siddha and Ayurvedic drugs mentioned in respective formularies and under Rule 161-B, 2 (ii) of the Drugs & Cosmetics Rules to harmonize the shelf life of drugs to rectify ambiguities between Formularies and legal provisions.
The template which has been used for the preparation of the proposed Schedule Z has been modelled on Schedule Y for allopathic drugs. For the first time safety studies and evidence of effectiveness studies are proposed to be specified and exactly when and in what circumstances Phase I, Phase II and Phase III are needed have been planned to be included.
The qualifications, training and experience of clinical investigators, the responsibilities of the sponsor and investigator, a requirement to report unexpected serious adverse events, informed consent, responsibilities of the ethics committee, maximum dosage levels, measurement of drug activity, therapeutic confirmatory trials and post marketing trials are some of the features which
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have been included in the template. Despite efforts the PI could not get an authentic account of the progress made. Conclusion and Recommendations It is apparent that for the first time an effort is being made to have evidence of safety and efficacy and to fulfill meet requirements that are considered necessary to protect the consumer and keep him informed. While the steps initiated are laudable it has also to be seen how far the sub-committees will modify or augment the template. The final adoption of the rules would probably take several months more. It is hoped that in the process wide consultations would be held with all stakeholders before new measures are put in place. In order to get a counter view, the meetings should be notified for stakeholders to attend as observers who can then give their suggestions in writing. Alternately the meetings should be video-taped and put on the internet. Ultimately, the aim is for ASU medicines to reach a larger clientele, which is becoming increasingly discerning and conscious about safety and quality. The position of Drugs Controller for AYUSH needs to be created with the full complement
of supporting staff at the earliest. At least one percent of the drugs in the market should be subjected to intense scrutiny and the outcomes publicized and if serious shortcomings are found, licences should be suspended and cases should be prosecuted. The work of the State licensing and enforcement authorities needs to be monitored constantly. This is a very weak link despite all the legal changes. Most of the state governments appoint the Drug Inspectors (Ayurveda) from the available list of Ayurvedic medical officers except in states like Delhi and Kerala. There ought to be a separate recruitment rules and standards or specialization prescribed for the drug inspectors who look after ASU medicine. This should be adopted on an all India basis which will strengthen the reputation for quality of Ayurvedic drugs. Clinical research needs to be promoted by giving generous grants to encourage more people to take an interest in this area. There should be much greater encouragement given to publishing papers in high impact journals. Regular support should given to the few journals that have set up independent editorial boards and are trying to maintain high standards.
Legal Status of Cross Practice Practice of Modern Medicine by ASU Doctors Medical practice being on the concurrent list of the Constitution, both Central as well as State Governments can pass laws on the subject. Ordinarily if the State law conflicts with the Central Law, the Central Law will prevail. The following major Central and State laws have been passed over the years: -
The Medical Council Act, 1956 which regulates modern system of medicine (MCI Act).
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-
The Indian Medicine Central Council Act, 1970 which regulates the Indian systems of medicine including Ayurveda, Siddha and Unani systems of medicine (IMCC Act).
-
The Homeopathic Central Council Act, 1971 which regulates practice of homeopathic medicine (HCCA Act).
-
The Drugs & Cosmetics Act, 1940 and Rules there under with a special Chapter IV A for ASU drugs.
Most State Governments have also passed laws in respect of ASU medical practitioners. All such laws have schedules attached which list the qualifications and degrees/ diplomas which would entitle practitioners to practice a particular branch of medicine. The Medical Council Act, 1956 lists the degrees and diplomas which are recognized for practicing allopathic medicine. Likewise the Medical Councils at the State level specify the maintenance of the State medical registers, set the standards for observance of medical ethics and enumerate what constitutes medical practice and malpractice. Recognition to medical colleges of Ayurveda, Siddha and Unani medicine is however granted only by the Central Government on the recommendations of the Central Council for Indian Medicine CCIM which includes Ayurveda, Siddha and Unani Medicine. A major issue that the Courts have had to deal with is that of cross practice. Can an Ayurvedic practitioner prescribe allopathic drugs? The most relevant case on this issue is that of Mukhtiar Chand and Ors v State of Punjab.1 In Mukhtiar Chand v State of Punjab, the primary question before the Supreme Court was “who may prescribe allopathic medicine?” This case raises questions of general importance and practical significance; questions relating not only to the right to practice the medical profession but also to the right to life that includes the health and wellbeing of a person. The controversy in this case was triggered by the issuance of a notification by some State Governments under clause (iii) of Rule 2(ee) of the Drugs and Cosmetics Rules, 1945, which defines a “Registered Medical Practitioner.”
Under such notifications the Vaidyas/Hakims claimed the right to prescribe allopathic drugs covered by the Drugs and Cosmetics Act, 1940 (D&C Act). Furthermore, Vaidyas/Hakims who had obtained degrees in integrated courses claimed the right to practice the allopathic system of medicine. It is necessary to understand what Rule 2(ee) means in the context of cross practice. This provision defines “registered medical practitioner” as a person: i)
Holding a qualification granted by an authority specified or notified under Section 3 of the Indian Medical Degree Act, 1916, or specified in the Schedules to the Medical Council Act, 1956; or
ii)
Registered or eligible for registration in Medical Register of a State meant for the registration of persons practicing the modern scientific system of medicine (excluding the homeopathic system of medicine); or
iii)
Registered in a Medical Register (other than a register for the registration of homeopathic practitioner) of a State, who although not falling within subclause (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 purposed of the Act.
In the Mukhtiar Chand v State of Punjab case, non-allopathic doctors sought to reinforce their right to prescribe allopathic medicine on the strength of notifications issued and under (iii) above and to restrain interference with this right. Similar issues also arose in various other high courts. Finally all the cases reached the Supreme Court. The Apex Court observed
1. (1998) 7SCC 579
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that Rule 2(ee) only defines the expression ‘registered medical practitioners’ and does not provide as to who can be registered. Therefore, the Court read the notification in consonance with laws regulating and permitting medical practice and held that the benefit of Rule 2(ee) and the notifications issued would be available in those States where the privileges to practice modern medicine (such as in Maharashtra) is conferred upon by the State law for the time being in force, applicable to medical practitioners of Indian medicine registered in the State. The Supreme Court also held that the right to prescribe drugs in a concomitant right to practise a system of medicine. In another Apex Court decision, Subhasis Bakshi v West Bengal Medical Council & Ors2 the Court reiterated that State Governments were at liberty to decide the qualifications that would permit prescription of allopathic and other medicines in the State. The other issue before the court was whether the right to issue prescriptions or certificates could be treated as a part of this right. The Court relying on the Mukhtiar Chand case held that the right to prescribe drugs and the right to issue certificates is a concomitant to the right to practise medicine. This case dealt with a situation where the West Bengal Government had allowed certain diploma holders to practise modern medicine to a limited extent in rural areas. However, in the PoonamVerma vs. Ashwin Patel3, the Supreme Court made an offquoted observation: “A person who does not have the knowledge of a particular system of medicine but practices in that system is a quack and a mere pretender to medical knowledge or skill, or to put it differently, a charlatan.” 2. (2003) 9 SCC 329 3. (1996) 4 SCC 332 4. AIR 2003 Karnataka 388
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In this case, a registered Homoeopathy doctor prescribed Allopathic medicines to PoonamVerma’s husband. His defence was that he had received instructions in modern system of medicine (Allopathy), and after the completion of his course, he had worked as Chief Medical Officer at a well-known allopathic clinic. The Court went on to observe that no person can practise a system of medicine unless he is registered either under the Central Indian Medical Register or the State Register to practise that system of medicine; and only such persons as are eligible for registration and possess recognized degrees as specified under the concerned Central and State Acts may so practice. The mere fact that during the course of study some aspects of other systems of medicine were studied does not qualify such practitioners to indulge in the use of other systems. In the PoonamVerma case, the Court held that the doctor was registered only to practise Homoeopathy. He was under a statutory duty not to use other systems of medicine. He trespassed into a prohibited field and was liable to be prosecuted under Section 15(3) of the Indian Medical Council Act, 1956. His conduct also amounted to actionable negligence for injury caused to his patient by prescribing allopathic drugs. While the above cases dealt with the situation where ISM practitioners were practising Allopathy, an equally important issue that needs to be addressed is whether allopathic doctors can prescribe and practise Ayurveda and other forms of Indian medicine. Interestingly, in the case of Akhtar Hussain Delvi (Dr.) vs. State of Karnataka4 a registered
Allopathic medical practitioner sought the right to prescribe drugs and medicine of Ayurvedic origin, which had been accepted by professionals practising Allopathic medicine pursuant to clinical and other tests. The High Court observed that under the Indian Medicine Central Council Act, 1970 only those who possess the medical qualifications specified in Second, Third or Fourth Schedule of the Act or are enrolled in the State Register of Indian Medicine have the right to practise Indian medicine. The Petitioner had neither acquired such a qualification nor passed the qualifying examination under the concerned State Act, and was therefore, not entitled to prescribe Ayurvedic medicine. This runs counter to the present practice (which is increasing of late) whereby modern medicine doctors prescribe Ayurvedic medicine once they are convinced by data based on clinical trials, the knowledge of which is imparted by medical representatives hired by drug manufacturers, exactly as is done by modern pharmaceutical companies. The Court cases and judgements have not set the controversy at rest because enforcement is weak and there is unsureness about Court judgements and intermittent executive orders. Occasionally, the associations of modern medicine doctors urge for action against those who resort to modern medical practice but this peters off. The numerical strength and clout of the non Allopathic AYUSH doctors is quite substantial and they have the sympathy of policy makers (political and bureaucratic). Different States have been taking different stands and also changing them from time to time, which leaves a big difference between the de facto and the de jure position. Maharashtra State seems to have taken the lead in trying to bring the subject into sharper focus something no other state has done until now.
State-wise Policies on Cross-pathy practice Maharashtra The State Government of Maharashtra has recently declared that the Maharashtra Medical Practitioners Act, 1961 will be amended to include that Ayurveda, Homeopathy and Unani practitioners would soon be able to legally prescribe allopathic medicines in Maharashtra provided they complete a one-year course in pharmacology. The government also plans to allow them to practise Allopathy after passing a one-year course. This decision by the Maharashtra Government has caused unrest among the Allopathic doctors in the State who argue that they spend five years acquiring an MBBS degree which enables them to practise and prescribe Allopathic medicine and it would not be right to allow Ayurvedic doctors to practise and prescribe Allopathic medicine after a mere one-year course. The Indian Medical Association (IMA) is planning to challenge the decision taken by the Maharashtra Government in the courts. It would be interesting to see how the court addresses this issue, especially after various decisions have been announced that reflect a view that a medical practitioner needs to be trained in a particular system of medicine in order to practice that system. The question that would need an answer is whether a oneyear course in pharmacology is sufficient to suggest that a person is trained in that medical system. The official version recounted to the PI by the Director Ayurveda of Maharashtra State Dr. K.R. Kohli, himself an Ayurvedic doctor is recapitulated below. The responses answer the itemized issues raised by the PI. Cross-Pathy Practice to be allowed after undergoing the related Pharmacology Courses. 1. What triggered the initiative In Maharashtra, Ayurvedic doctors registered
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in Schedule A, B & A-1 appended to the Maharashtra Medical Practitioners Act of 1961 have been declared as eligible to practise the modern system of medicine to the extent of the training they received in the system by a Notification dated 25th November 1992. Similarly, Unani Doctors registered under Schedule D of the Maharashtra Medical Practitioners Act of 1961 have been permitted to practise modern system of medicine to the extent of training they received in the system. There was a continuous demand from Homoeopathic doctors in the State to allow them the practice of modern system since last more than 20 years. Moreover several surveys have indicated a very poor doctor population ratio in Maharashtra which is approximately 1:1213 which is much lower than many other States. The fact remains that most of the rural population and slums in the cities and metros is being catered by primarily Homoeopathic and Ayurvedic doctors. Most of these doctors practising in rural areas as of today also practice modern system of medicine irrespective of the legal propriety of doing so. Many times such doctors have also been taken to the consumer courts. During almost every Assembly session, questions were being raised by the several MLAs and MLCs about not allowing Allopathic practice by doctors of the Indian Systems of Medicine -specially when adequate number of Allopathic doctors were on one hand not available and on the other most of them do not want to serve in the rural areas. It was during the last Monsoon Session (2012) that the Hon’ble Minister of Medical Education & Drugs announced that an Ordinance would be issued to allow Practitioners of other systems to practise the stream in which they undergo Certificate Course of Respective Pharmacology, which is planned to be
188 Status of Indian Medicine and Folk Healing
conducted by the Maharashtra University of Health Sciences. 2. Important milestones in Decision Making In the year 2009, the Government had set up a Committee under the chairmanship of Vaidya Kuldip Raj Kohli with representatives from Director Medical Education & Research, Maharashtra University of Health Sciences and a few prominent Homoeopathy Doctors. This committee studied various State and Central Acts, various judgements including the Mukhtiar Chand v/s State of Punjab of Supreme Court of India, Poonam Verma v/s Ashwin Patel of Supreme Court of India, the report submitted by the Committee headed by Director of Medical Education & Research Dr. Ganeriwal in 1997, the opinion given by the then Advocate General Shri C J Sawant in 1997, the opinion given by the then Advocate General Sh. Gulam Vahanvati in 2001 and the opinion of the National Law School given on the Poonam Verma Case referred by Department of AYUSH in 2006. This Committee recommended that the pharmacology of Modern Medicine should be taught to Homoeopathic doctors and then relevant changes may be made in the Bombay Homoeopathic Act, Indian Drug & Cosmetic Act and a notification be issued on similar grounds as was issued for Ayurvedic &Unani Doctors in the state of Maharashtra. Very recently also, an opinion was sought from Advocate General Shri Ravi Kadam who in his opinion dated Aug 25, 2010 stated that ‘Central Council pf Homoeopathy Act, 1973 protects the privileges provided by the State Acts.’ This provision enables the State Government to provide the privilege of using allopathic medicines to Homoeopathic doctors. He had suggested that to enable such doctors to practise Allopathy they need to have a Comprehensive training for Homoeopathic
doctors and the course be called “Certificate in Clinical pharmacology”. Now that several opinions had been sought, the Health Minister of Maharashtra replied on the floor of the House that a Certificate Course in Pharmacology of all disciplines of Medicines, i.e., Modern Medicine/Ayurved/ Homoeopathy/Unani would be started for doctors of other streams to allow cross pathy practice and that parallelly necessary amendments in the relevant State Acts would be made to facilitate the practice of the newly learnt subject. To work out the details of this scheme, a Committee has been setup to devise syllabus, duration of the courses, the fee structure and other related issues. The Committee is headed by Director Ayurved with Director Medical Education and the Vice Chancellor of Maharashtra University of Health Sciences as members besides a few members of the respective Councils. 3. The Expected Outcome, Risks & Benefits of the Initiative The outcome of this will be that doors will be open for all doctors of Modern Medicine/ Ayurved/Unani/Homoeopathy to learn other streams of medicine and this will create a mutual respect amongst all systems of medicine. But primarily, the goal would be to enable the population living in rural areas and the urban slums to have access to welltrained doctors which would reduce the risk of complications that could have arisen because of indiscriminate use of modern medicine without the doctor having knowledge of that discipline. The medical manpower available in the State has to be utilized optimally for achieving the targets of several national
programmes. The doctor population ratio will greatly improve as there are around 60000 Homoeopaths and 58000 Ayurvedic doctors in the State. Risks: Maharashtra Medical Council has already declared that they will oppose the move. Present Status: Maharashtra Government has sought legal opinion from the Law and Judicial Department of the State and also from the Advocate General. The matter was reported to be under active consideration (October 2012). Uttar Pradesh In Uttar Pradesh, the stated policy does not allow ISM practitioners to practise Allopathy. The case that is often relied upon is that of Mehboob Alam v State of Uttar Pradesh and Ors5, which was heard in the Allahabad High Court. In this case, a Unani practitioner was prescribing Allopathic medicines and it was held by the court that he was not eligible to do so as his qualifications did not match those which are listed in the First Schedule of Indian Medical Council Act and neither was he enrolled on the State Medical Register under the same Act. This case clearly stated that doctors holding a qualification in Indian Medicine and registered with the Indian Medicine Board cannot prescribe Allopathic drugs and registered doctors must confine themselves to the branch in which they were qualified. During 2012 in a legislative assembly meeting of Uttar Pradesh, the Parliamentary Affairs Minister Mohammad Azam Khan said “The government cannot allow Bachelor of Ayurvedic Medicine and Surgery (BAMS)
5. AIR 2001 ALL 371
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doctors to do the work of MBBS doctors and provide Allopathic treatment. It’s not possible. If such a thing is done, there will be no need for MBBS studies.” He was reported in media reports to have been replying to an adjournment notice given by some Congress members who asked the government to grant permission to BAMS doctors to provide Allopathic treatment like MBBS doctors.6 The National Integrated Medical Association of Uttar Pradesh, however, advocates the integration of modern scientific medicine and traditional medicine like Ayurveda, Siddha and Unani. Sh. Jagjit Singh, Secretary, Government of Uttar Pradesh had written a letter dated 24.2.2003 (Annexure-I) to all the Chief Medical Officers of UP by which Ayurvedic/ Unani Medical Practitioners registered with UP Indian Council Board had been authorised to prescribe Allopathic drugs. He had referred to Section 29 (1) and Section 29 (2) of the UP Indian Medicine Act, 1939 and had also directed all the CMOs restraining them from taking any coercive steps against Ayurvedic/Unani Doctors. It stated that the Supreme Court has directed prosecutions of unregistered doctors and not registered practitioners in Indian Medicine prescribing Allopathic medicines. But in view of Dr. Mehboob Alam v/s State of UP writ petition no. 5896 of 2000, the Allahabad Court said that this Government order dated 24.2.2003 has become nonest and must not be acted upon. In an order dated 6.7.2004 it stated that “Any inter-disciplinary transgression is prohibited.”(Annexure-II) Tamil Nadu The Siddha system of medicine originated in
Tamil Nadu and is almost entirely confined to that State. There have been several instances when the Madras High Court has addressed the issue of cross practice among practitioners. One of the important cases that the Madras High Court dealt with is that of Dr. Abdul Janeer v Jaleed Ahmed Siddiqui.7 In this case, the Madras High Court restrained ISM practitioners from practising the Allopathic system. Passing the order, Justice K K Sasidharan had held that the police could take action against those who practise the modern system without possessing the qualification. Following this order, the State police started a widespread crackdown on ISM practitioners for practising Allopathy. Perturbed by the police action, the Siddha practitioners and others are reported to have approached the High Court, and Justice FM Ibrahim ruled that the registered practitioners in Siddha, Ayurveda, Homoeopathy and Unani were eligible to practice surgery, obstetrics and gynaecology, anaesthesiology, ENT, ophthalmology, etc. and said penal action against such practitioners should be dropped immediately. After the order was announced, the State government wrote to the State police that institutionally qualified and registered practitioners of Ayurveda, Siddha and Unani could practise their respective systems with modern scientific medicines including surgery, gynaecology & obstetrics, anaesthesiology, ENT, ophthalmology, etc. based on their training and teaching in the course. This was based on Section 17 (3) B of the Indian Medicine Central Council Act, 1970. Later, the Tamil Nadu branch of the Indian Medical Association (IMA) appealed against
6. No permission to Ayurvedic doctors in UP to practice allopathy http://post.jagran.com/no-permission-toayurvedic -doctors-in-up-to-practise-allopathy-1340165346 7. AIR 2010 MAD 178
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the verdict before the High Court and the case is still pending with the court. Punjab Besides the Mukhtiar Chand case, in the Gurvinder Kaur8 case, the Punjab State Consumer Disputes Redressal Commission observed that a BAMS doctor cannot prescribe Allopathic drugs. It is said that BAMS doctors were not qualified to treat patients like Gurvinder Kaur and by doing so they had committed an act of grave negligence. Punjab follows the principle that a practitioner needs to be registered in a particular medical register of the State in order to practise that particular system of medicine. However, the Punjab Government announced that it would set up “five super speciality Ayurveda Centres, besides recruiting 200 Ayurvedic doctors, in its endeavour to promote the Ayurvedic system of medication and treatment”. This was announced at a function organized by the All-India Integrated Medical Association (AIIMA), in association with Punjab Ayurvedic Medical Services Association.9 Himachal Pradesh Reliance was placed on a circular issued by the Government of India, Ministry of Health and Family Welfare dated 1 September 2011 in which the practice of gynaecology and obstetrics and the use of diagnostics and ultrasonography had been clarified to all States and UTs. The letter states that those who had qualifications included in the second scheduled to the IMCC Act, 1970 were competent to pursue modern technological innovations for example radiology, ultrasonography,
ECG in their clinical practice on the basis of their teaching and training as notified by the CCIM on 6.1.2009. It was emphasized that this should not violate the provisions of the Prenatal Diagnostic Techniques (Prohibition of Sex Selection Act, 1994) and the Medical Termination of Pregnancy Act, 1971. (Annexure-III). This circular makes no mention of conducting hysterectomy operations or of delivering babies by C-Section which was apparently being taught and performed at the RGGPG Ayurvedic College, Paprola in Himachal Pradesh. On a practical note it must be recognized that the hospital is located in hilly terrain and once people bring patients, there is no nearby place where they can be asked to go especially at night. Medical interventions were, therefore, being carried out within the competence of the treating doctor which included performing operations. The State authorities were aware of this which amounts to giving tacit approval although not stated specifically in a Government order. The PI was separately provided with a circular dated 26th of September 1980 issued by the Government of Himachal Pradesh according to which the Vaids and Hakims could use modern medicine drugs. It stated that all the Vaids and Hakims registered under Himachal Pradesh Ayurvedic and Unani Practitioners Act, 1968 can prescribe modern medicine drugs in Himachal Pradesh for the purpose of Drugs and Cosmetics Act (Annexure-IV). It was stated during discussions that this notification had never been rescinded or modified. There was also a claim that the government was supplying a few essential modern medicine drugs to the Ayurvedic dispensaries as a
8. (2008) 2 PLR 791 9. http://www.tribuneindia.com/2010/20100920/region.htm
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matter of course but this was not corroborated by others. The position was therefore far from clear at the operational level. No one was in a position to clarify the position with finality. Jammu and Kashmir The Jammu & Kashmir State reported that instructions had been issued from time to time instructing the AYUSH Medical Officers “to stick to their own pathy and no cross practice is allowed” (Annexure-V). No guidelines have been issued related to operating practices by the doctors appointed under the NRHM, nor any instructions given on what was expected by way of performance by such doctors. Likewise no guidelines had been issued relating to the combined use of Ayurveda/ Unani/Allopathic treatment on a patient. The Director ISM of J&K reported that a proposal to notify the use of essential Allopathic medicines by the AYUSH doctors was, however, under active consideration of the Health Department and had been submitted by the Directorate of Indian Systems of Medicine (Annexure-VI). However, at present no life saving Allopathic drugs are being supplied to the Ayurvedic dispensaries. On the subject of responsibilities to be fulfilled by Ayurvedic/Unani doctors functioning as single In-charges posted in the CHCs & PHCs no specific instructions were shown to the PI. However, these doctors were conducting deliveries/ postpartum and attending to emergencies at some PHCs. They were also being put on night duty/ emergency roster duty regularly particularly where modern medicine doctors were not available. Need to confront the Legal Dilemma Most State Governments declare a commitment to the development of the Indian
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systems of medicine which, apart from being an effort to preserve cultural heritage, also provides an alternative system of medical care in addition to the Allopathic system. However the dominance of the Allopathic system is all pervasive seen in the national context. The AYUSH systems tend to imitate the dominant system in structure and management. Ayurvedic manufacturers also tend to imitate the Allopathic presentation of treatment by using modern packaging and labelling which make them acceptable to the modern medicine doctors as well as to educated patients who opt for self-medication. The old practice of holistic treatment has been overtaken by “Contemporary Ayurveda”. Over the last 80 years, the Himalaya Drug Company (HDC) has focused on contemporarizing Ayurveda. The company had opted for developing products rooted in Ayurveda but “validated by modern scientific research to ensure that over time, this ancient system of medicine becomes an integral part of mainstream medicine”. Allopathic doctors routinely prescribe Ayurvedic drugs for liver related diseases and some other conditions. The question that arises is whether Allopathic doctors practising the modern system of medicines are entitled to prescribe drugs which might have originated in Ayurveda? The pre-clinical and clinical trials for new Ayurvedic drug formulations have been prescribed by the Department of AYUSH with the intention of providing appropriate evaluation methods for new formulations based on traditional systems of medicine. The problem with conducting clinical trials is that a large amount of capital is required which only major drug manufacturers can afford. Most Ayurvedic doctors feel clinical trials will probably kill the industry and circumscribe the practice of traditional medicine. The dilemmas that confront the sector are immense. The
Department of AYUSH should consider putting out an official approach on its website as even officers working in the department refer to a variety of interpretations but these are mostly self-referential. Conclusions and Recommendations The legal position of ASU practitioners practicing modern medicine needs to be confronted because it is evident that Ayurvedic doctors are maintaining the health facilities as the sole in-charges of PHCs and CHCs. They are not only prescribing Allopathic medicine but are expected to handle all the situations that arise in a health setting. The use of modern interventions and drugs including injectibles and parenterals has not been addressed upfront. If that is permitted and encouraged then the States have to use the provisions of the D&C Act to make appropriate notifications to support the practice which cannot then be confined solely to Government appointees. It would have to apply to all ISM/ AYUSH doctors that have graduated after a five-anda-half year degree course. The most balanced approach would be to allow ASU doctors to
practise modern medicine to the extent that is needed at the primary health centre level, while accepting that would need to include immediate response to emergencies, acute illnesses and routine illnesses. But they require to be trained thoroughly to handle such situations both in the public and private sector facilities. As far as private practitioners are concerned, the State should notify that ASU doctors using modern medicine need to avail of a training which equips them to handle certain non-invasive/non-surgical medical needs. Medical Colleges and hospitals may be given accreditation for conducting training and for levying a charge on each private doctor. The colleges should provide training free of cost to Government doctors. A certificate of having acquired this training to provide limited medical care to patients should be issued by a State Board and the display of the certificate made mandatory. Side by side, a list of interventions and drugs that must not be used by ASU practitioners should be listed to remove all ambiguity on the matter.
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Annexure-I
Letter of Secretary, UP to all the CMOs regarding harassment faced by the ISM practitioners in the State
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Annexure-II Court order on the issue of Inter-disciplinary Cross-practice in UP
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Annexure-III Ministry of Health & Family Welfare’s notification regarding practice of Gynaecology & Obstetrics and Diagnostic Ultrasonography by ISM Graduates
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Annexure-IV Himachal Government’s circular allowing ISM practitioners to use modern medicine
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Annexure-V Directorate of ISM, J&K Circular regarding “Prescription of Allopathic Medicine by AYUSH Doctors”
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Annexure-VI Proposal of J&K Department of ISM to notify the use of essential allopathic medicine by AYUSH doctors
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