HOW INDIA REGULATES ITS MEDICINE? AN OVERVIEW OF THE PREVALENT MEDICINAL LAWS OF THE COUNTRY by-Siddharth Alok
Medicine has been a field of utmost diligence and even though so many centuries have passed, this profession still holds its merit and authenticity. In India, the medicinal field is denoted by the names of the famous physicians- Charaka and Sushruta. The major medical fields of Ayurveda and Siddha mark their origin in India itself. Study of Medicine being the most captivating field for the youth of India, is also subjected to certain legal frameworks and obligations. This growing demand of law back-boning the medical field lead India into framing Bioethical Jurisprudence for the country. The first legal registration and recognition for the same was brought by the enactment of ‘India Medical Council of India Act,1933’ and the constitution of the Medical Council of India’2. The framing of ‘The Bombay Medical Practitioners Act of 1938’ and the ‘Commissioning of Hospitals Act’3 also worked as a catalyst for the betterment of the Medicos. Presently, there are various other laws pertaining to the governing of hospitals, practitioners/ other employees, sale and storage of the drugs, license and permissions, public and environmental health, etc. It gives us an insight of how these things which provide the doctors and the people so much of ease invite for a legal eye! However it is important to formulate laws for every limb of the medical field in India so that it can become more promising and efficient.
In this paper, we are going to explore the laws related to medicine and its techniques of it. We further diagnose the upcoming requirements of medicine laws. Here, we try to come up with some suggestive measures to make it more vigorous in nature.
Keywords:Medicinal Law, Bioethical Jurisprudence, Hippocratic Oath, Practitioners, Public/
Environmental Health, Medical Tourism, Robotics/ Artificial Intelligence.
Human culture is formulated on the basis of honesty, integrity, ethical society, respect, the pursuit of excellence, civic duty, accountability, and loyalty. Since the dawn of civilization, it has been established through trial and error that society, and particularly the medical profession, can only exist and prosper if certain standards of conduct are observed and followed, led by ethical, moral, legal, and social values of the land. In India, the component states and territories administer a universal healthcare system. Every state’s constitution is changed to include “increasing the level of nutrition and the standard of living of its people, as well as improving public health” as one of its key responsibilities. Non-compliance with the law may result in monetary fines, imprisonment, or both, depending on the appropriate authority. But, with the new emerging branches of the medical field and its everyday evolving speaks volumes about how certain new sets of legal codes will be required to maintain the harmony between proper- functionality, governance and changing contemporary times in persuasion to the ancient and modern ‘Indian Medicinal System.’
IMPORTANCE OF THE FIELD OF MEDICINE IN INDIA
“Combating excess is a contemporary manifestation of a much older desire to avoid doing harm when we try to help or heal.” – Dr. Fiona Godlee
‘Help or Heal’ as segregated from the above quote , is nothing but the relatively and primarily the utmost responsibility of a person who is an associated Medical Practitioner. It this ideology to which the Medicos wholeheartedly swear by ,and time to time fulfil their duty.
There is no doubt if we say that Medicine is one of the most widely accepted field for both the Indian parents and their offspring. In every Indian household we witness a kid who’s ultimate aspiration is to become a successful Doctor. The importance and values which a person associated with this field receives, indeed speaks volumes about the deep-rooted love for the profession and how highly the society thinks of it.
In India the commencement of this glorious field of Medicine is associated with the two famous Ancient Indian Scholars namely, Sushruta and Charaka.
Sushruta was an Ancient Indian Physician who had contributed majorly to the Medical Field in
about 7th Century. He himself is known as the “Founding Father of Indian Medicine” and most importantly the “Father of Plastic Surgery”as he was the first physician to have performed such surgery and eventually this surgery of his has led to the creation of the “Cosmetic Surgery” branch of Medicine.
Sushruta’s work on the subject (Medicine) is laid down in his three treatises- ‘SushrutaSamhita’. This is book is considered to be the oldest text in the world on plastic surgery and is highly regarded as the ‘Great Trilogy of Ayurvedic Medicine.’
The middle treatise of this SushrutaSamhita is the ‘CharakSamhita’. As the name itself suggests this Samhita was laid down by the other renowned physician of Ancient India- Charaka. Charaka marks his presence at the time of ‘ Kanishka’s’ (Ancient Ruler) regime. This great Indian Physician is said to have contributed a lot to the field of Ayurveda and it is now that we see how widely this approach of Medicine is being accepted and worked upon on International levels.
INDIA- HOME TO THE AYURVEDA AND SIDDHA SYSTEMS OF MEDICATION
Ayurvedic medicine is among the oldest medical systems in the world. Dating back to the Vedic period of India.
Apart from Ayurveda India is a birth-giver of the Siddha style of Medication which marks its origin centuries ago and in present is being practiced in the Indian state of Tamil Nadu. This medication believes that the five basic elements- Earth, water, fire, air, and sky are in the food we eat, ‘Humours’ of the human body, and herbal, animal, or inorganic chemical compound, used as therapies for treating diseases.
These systems of medicine in India have been practiced for centuries and have undoubtedly provided for a stronger base for the foundation of the current Medical System but this field was first subjected to some Laws ( In form of obligations ) by the Greek physician- Hippocrates.
WHAT WAS THE ‘HIPPOCRATIC OATH’AND IT’S RELEVANCE TO THE PRESENT MEDICINAL SYSTEM OF INDIA?
“Apollo Physician and Asclepius and Hygieia and Panacea and all the Gods and Goddesses, making them my witnesses, that I will fulfill according to my ability and judgment this oath and this covenant.” 4
Written above is the most important and primary pledge that according to the Hippocratic Oath had to be taken by the Medical Practitioners.
This oath is akind of moral and ethical code attributed to the Greek physician Hippocrates. It has been adopted as a guide by Medical Professionals throughout the ages and is still used in the graduation ceremonies of many medical schools.
Apart from all the available translations of this oath, its central meaning remains the same, and it is- It prohibits lethal drugs, acts of impropriety or corruption, inclusive of seduction of men and women, etc. It advocates for the patient’s privacy and concludes with the oath-takers need to strive for the deserving respect.
“I will do no harm or injustice to them.”- this is the most inspiring and most important statement of the oath as it addresses to the harm and injustice that can be caused to the patient in social aspects.
LOSING ITS RELEVANCE
(Oath of Ethics)-
The Concluding Piety of the oath says that :
“If I fulfill this path and do not violate it, may it be granted to me to enjoy life and art, being honored with fame among all men for all time to come; if I transgress it and swear falsely, may the opposite of all this be my lot.”
Though still today, we face and swear by both old and new deities, including one which is perhaps the most powerful and capable of extremes of good and evil than any of the counterparts has to be ‘Money’. Presently, we often face problems that are intensely relevant to modern-day research and care and which perpetually did not exist at the time of the oath. Mostly, these problems are directly or indirectly connected with the two broader factors: a) Universality of health care accessibility and; b) Affordable costs.5
This oath was primarily for the male practitioners but in this era of equitable rights and a Artificial Intelligence ( Robotics) taking over the World this oath in its narrower approach deems to be seconded.
FOUNDATION OF MODERN-DAY MEDICAL SYSTEM AND THE LAWS WHICH HELP INDIA IN REGULATING IT.
Earlier there was no such thing as a Hospital. A Scholar of Science ( Physician) used to visit his patients in their own residences in their time of need. It was the World War Era that led to the construction of Nursing Houses, which in contemporary times are the new Multi-Specialty Hospitals.
Being a departure from how they used to function earlier these Hospitals, their manpower, drugs, practitioners, equipment used, etc. are all subjected to certain Legal frameworks and have certain limitations attached to their functioning.
Further, this act was followed by the laying down the ‘Bombay Medical Practitioners Act 1938’ and this act by itself paved the way for the establishment of the most important statute relating to the Indian Medicinal field and i.e; ‘Commissioning of the Hospitals Act’.
ROLE OF DIFFERENT LAWS THAT INDIA ABIDES BY TO REGULATE ITS MEDICINE
- Commissioning of the Hospitals
These are the rules that ensure that hospital facilities are safe for public use, provide the bare minimum of infrastructure for the type and level of workload expected, and are subject to regular inspections to assure compliance.6
b)Law Governing the Qualification and Conduct of the Practitioners
These are the rules that ensure that the hospital’s employees are qualified and authorised to perform certain tasks within certain limits of competence and in accordance with standard codes of conduct and ethics. Their credentials can be verified by registering councils, and the councils can take appropriate action against them if they engage in professional misconduct.7
c) Laws pertaining to Sale, Storage of Drugs, and Safe Medication
We have certain laws like- The drugs and Cosmetics Act, 1940 and Amendment Act, 1982, Pharmacy Act, 1948, The Narcotics and Psychotropic Substances Act, etc. which control the usage of drugs, chemicals, blood products, the eccentric coating on the medicines, prevention of misuse of drugs, sale of licensed drugs, etc. They monitor the packaging and shipment of drugs as well just to prevent it from adulteration and provide for punitive action against the offenders.
d)Laws Governing the Safety of Patients, Public, and Staff within the Hospital Premises
The Indian Fatal Accidents Act 1955, The Radiation Surveillance Procedures for the Medical Application of Radiation 1989, Insecticide Act 1968 are certain laws that deal with the safety of facilities and services against any accidental hazards that may endanger the lives and liability of management for any violation.
e)Licences required for establishment of a Hospital
It is not easy to construct a hospital anytime and anywhere! Some licenses initially under the- ‘Registration under societies registration Acts’, ‘Inspection for electrical installations/substation’ and ‘NOC from local municipal offices any By-law.’ The hospital administrator should be aware of the licenses that are essentially required and renew them as and when required.
f) Laws governing to Medico Legal Division
These are the laws which govern the doctor patient relationship, which can be subjected to legal consequences of breach of contract and negligence.
g) Laws governing the Employment and Management of the Manpower & Practitioners
We have laws like the Bombay Labour Welfare Fund Act 1953, Employee Provident Fund and Miscellaneous Provision Act 1952, Equal Remuneration Act 1976, ESI Act1948 and 1950 that regulate the employment of manpower, salaries/benefits, service rules, and the system of redressing any grievances or disputes that arise under this.
HOW EFFICIENT ARE THESE LAWS IN GOVERNING THE PRESENT MEDICAL SYSTEM?
The government can revive public health regulation by updating and wisely implementing public health legislation, involving stakeholders, and enhancing public understanding of current rules and their enforcement mechanisms through concerted efforts.
It can not be denied that these laws have backboned the medical system of the country and hence makes it so respectable and efficient in its approach but the question that arises is whether can the same set of laws be fulfilling enough to cast a legal eye over the other two limbs this auspicious field i.e. first of ‘The emerging Medical Tourism Sector’ and the other limb inclusive of the soon to be used ‘Artificial Intelligence/Robotics’ for consultations and surgeries.
- MEDICAL TOURISM– Health-related travel, sometimes known as “medical tourism,” has a long and illustrious history. Its current incarnation signals the emergence of a globalized for-profit healthcare system. Although patients have the freedom to travel and seek treatment at international medical centers, medical tourism has a number of worrisome aspects. Diverting public healthcare investments to the private sector in order to serve medical tourists distributes public resources to international patients at a time when India’s public healthcare system is failing to provide primary healthcare to its own
Keeping in mind the emerging sectors and evolution of the Field of Medicine in India, it can be rightly concluded that we need more legal and ethical codes to properly monitor and govern the working of the medicine as
“The importance of the medical field in today’s way of living cannot be underestimated simply because there seems to be a continuing advancement in the complexity and severity of many diagnosed medical maladies. It’s not like before when you can put Mexican blankets over a loved one with fever, make them drink plenty of water, and be confident that they will regain their strength the succeeding day. Today, even the slightest inclination that there are symptoms, however minor, are already treated with a barrage of diagnostic medical steps to try to determine if there is an underlying problem that needs a more targeted medical solution. Doctors go to great lengths to try to discover the potential causes behind each symptom so that patients are always aware of their medical conditions at any given time.”- Tim Catherine.
The sooner the authorities in India would work on formulating certain legal provisions catering to the needs of an hour (with respect to the medical field) the better it would be. The pace at which the field of medicine is evolving and raging is a cue enough to suggest that the time has come to move out of that Quintessential, Archaic, and Conventional style of Medicine and explore the new and broader aspects of the same. In this era and time, a world without doctors is hard to imagine, and any institute or functional body not being back-boned by a Legal/Ethical back-boning is even more horrifying!
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- Indian Systems of Medicine: A Brief Profile- NCBI
- Runnels, Vivien& Turner, Leigh. (2011). Bioethics and transnational medical travel: India, “Medical Tourism”, and the globalisation of healthcare. Indian journal of medical 8.42-4.10.20529/IJME.2011.014.
- Medicine and law- NCBI
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1 LL.M Candidate at CNLU
2 1933; with affiliation to the ‘Ministry of Health and Family Welfare.’
3Co-extensive to the ‘Clinical Establishments Bill’ and ‘Governments Buildings Act.’
4 Gilbert Berdine, The Hippocratic Oath and principles of Medical Ethics
5HagopKantarijan and David P. Steensma- Relevance of the Hippocratic Oath in the 21st century. https://ascopost.com/issues/october-15-2014/relevance-of-the-hippocratic-oath-in-the-21st- century/#:~:text=These%20two%20issues%E2%80%94health-care,and%20social%20injustice
6 RD Associates Risk management. https://rdassociatesriskmanagement.wordpress.com/2017/01/06/laws- applicable-on-doctors/