Laws around Homeopathy in India: Be aware of Quacks

India has seven recognised systems of medicine, one of which is Homoeopathy. People historically rely on alternative systems of medicine in India, which has even resulted in the growth of the system, with practitioners picking the medicine system without adequate qualifications. The outcome is due to the failure to have a proper regulation supported by the people’s ignorance. People must know who is quack and not just be led by the practice’s popularity. Homoeopathy originated outside India, founded 200 years ago by Dr. Samuel Hahnemann. The history of homoeopathy in India dates to the early 19th century when Dr John Martin Honigberger, a disciple of Dr Samuel Hahnemann, introduced the practice in 1810. His successful treatment of Maharaja Ranjit Singh of Punjab in 1839 with the homoeopathic remedy Dulcamara led to the Maharaja’s support, fostering Homeopathy’s growth in India. The philosophy of Homeopathy resonated with Indian cultural beliefs, particularly the “Law of Similars,” recognised by ancient Hindu physicians. Dr Mahendra Lal Sircar became the first Indian homoeopathic physician, and his influence encouraged others to adopt the practice. Dr. Rajender Lal Dutt, considered the Father of Indian Homeopathy, further advanced the field. In 1847, Surgeon Samuel Brooking established the first Homeopathic Hospital in Tanjore, South India, solidifying the practice’s presence there. Homeopathy continued to flourish, becoming integral to India’s healthcare system. The ‘Calcutta Homeopathic Medical College’, the first homoeopathic medical college, was established in 1881. In India, it is quite a widespread practice on which many rely, and therefore, its practice must be duly regulated.

Are you visiting a doctor who is qualified as a Homeopath?

The practice of Homeopathy in India has a rich history and has become an essential part of the healthcare system in India. However, the popularity has also led to the growth of unqualified practitioners, leading to the adequate regulation necessary for people to rely on alternative medicine safely. In 1995, the Department of Indian Systems of Medicine and Homeopathy (ISM&H) was established under the Ministry of Health and Family Welfare, later renamed the Department of AYUSH. In 2014, the government made AYUSH an official ministry responsible for regulating the education, research, and development of Ayurveda, Yoga, Unani, Siddha, and Homeopathy. The National Commission for Homeopathy, previously known as the Central Council of Homeopathy (CCH), is the autonomous body regulating homoeopathic education and practice. However, CCH was later superseded by the National Commission for Homeopathy, which was responsible for maintaining high-quality education in Homeopathy.

People must be aware of the qualifications of their healthcare providers and not just rely on the popularity of a particular practice. To become a qualified Homeopathic doctor in India, one needs to have completed 12th grade in the Science stream, pass the Ayush NEET exam, obtain admission to a Homeopathic Medical college, pass it, complete four and a half years of academic study plus a one-year rotary internship, obtain a BHMS degree, and apply for registration with the state Homeopathic Board.

The Homeopathic pharmacy in India was initially regulated under the Drug and Cosmetic Act of 1940 and its associated Rules from 1945. Over the years, numerous developments have formally recognised Homeopathy as an alternative medicine system. In 2024, the Ministry of AYUSH introduced the Draft Drugs (Amendment) Rules 2024, which proposed significant changes, including mandatory adoption of good manufacturing practices for homoeopathic drugs.

What is required to become a Homeopathic doctor:

1. 12th pass with Biology
2. Ayush NEET Qualified
3. Get admission to a Homeopathic medical college
4. Registered with the National Commission for Homeopathy.
5. Completed four and half years of academic and One-year rotary Internship
6. Get a BHMS degree and apply for registration in the state Homeopathic Board.

Courses such as MD (Hom-Pharmacy), MD (Hom-Practise of Medicine), and MD (Homeopathic) (Materia Medica) can be taken at the postgraduate level. These courses last three years. The Homoeopathic doctor is allowed to use the title of doctor. There is no course for MBBS doctors in India wanting to learn and practice homoeopathy legally. However, MBBS doctors are entitled to admission to the M. F. (Hom) course conducted by the Royal London Homoeopathic Hospital, Greenwell Street, London.

Ideally, homoeopaths should operate as full-time practitioners, and patients should be able to ask about the length of training and the institute from which they see doctors. 

How well-regulated is the Homeopathic System of Medicine in India? 

In India, the regulation of Homeopathic pharmacy began with the Drug and Cosmetic Act of 1940 and its associated Rules from 1945. Over the years, several key developments led to the formal recognition of Homeopathy, an alternative medicine system based on the principle of “like cures like”.

• 1948: The Government of India constituted the Homeopathic Inquiry Committee to explore the system’s potential, which submitted its report in 1949.

• 1952: Homeopathy started gaining recognition in various states, with some state governments extending recognition through suitable enactments.

• 1960: The Government of India officially recognised Homeopathy as a system of medicine, following establishing an advisory body, the Homeopathic Pharmacopoeia Committee.

• 1973: A significant milestone was reached with the passage of a national central act that recognised Homeopathy. This led to the constitution of the Central Council of Homeopathy (CCH), a statutory body under the Ministry of AYUSH. The CCH was tasked with setting minimum standards for education in Homeopathy at both graduate and postgraduate levels. The CCH also approved colleges offering these courses.

• 1975: The establishment of the Homeopathic Pharmacopoeia Laboratory marked another critical step. This laboratory later became the nucleus for the Central Council for Research in Homeopathy, further solidifying the infrastructure supporting Homeopathic education and practice in India. 

New Developments

On February 2, 2024, the Ministry of AYUSH introduced the Draft Drugs (Amendment) Rules, 2024, proposing significant changes:

1. GMP Compliance: Licenses for manufacturing homoeopathic medicines will only be issued after fulfilling GMP requirements under Schedule M1. Good Manufacturing Practices (GMP) Compliance under homoeopathy in Indian law refers to guidelines and regulations that ensure the quality, safety, and efficacy of homoeopathic medicines. These guidelines are designed to regulate the manufacturing process of homoeopathic products to maintain consistent quality standards. In India, GMP for homoeopathy is governed under the Drugs and Cosmetics Act of 1940 and its associated rules. GMP compliance in homoeopathy under Indian law is governed by a robust regulatory framework established by the Drugs and Cosmetics Act of 1940 and the accompanying Drugs and Cosmetics Rules of 1945. These regulations, particularly Schedule M-I, set out specific provisions and requirements for the manufacturing, selling, and distributing homoeopathic medicines. Compliance with GMP involves several critical requirements, including maintaining manufacturing premises that are well-designed, hygienic, and equipped with proper ventilation, lighting, and cleanliness standards. A comprehensive quality control system must be in place to test raw materials, in-process products, and finished products, ensuring the medicines meet all required specifications. Detailed documentation at every stage of the manufacturing process is essential for maintaining traceability and accountability. Personnel involved in manufacturing must be adequately trained in GMP practices, including hygiene, equipment handling, and safety procedures. The manufacturing equipment must be regularly maintained and calibrated to ensure consistent production quality, with stringent measures to prevent contamination. Additionally, homoeopathic medicines must be stored and packaged appropriately to maintain their potency and stability, with packaging designed to protect the products from environmental factors like light, moisture, and temperature changes. Regulatory oversight is a crucial aspect of GMP compliance, with authorities such as the Central Drugs Standard Control Organization (CDSCO) and State Drug Control Departments conducting periodic inspections of manufacturing facilities. Manufacturers must obtain and maintain a license from the appropriate regulatory authority, contingent on meeting GMP requirements. Proper product labelling is also a key component, with homoeopathic products required to be labelled according to the standards set by the Drugs and Cosmetics Rules, 1945, including details such as the medicine’s name, potency, batch number, manufacturing date, expiry date, and storage instructions. Additionally, adherence to the Homeopathic Pharmacopoeia of India (HPI) standards for the quality and composition of homoeopathic medicines is a fundamental GMP requirement. The importance of GMP compliance must be balanced. It ensures that homoeopathic medicines are high quality and safe for consumption by minimising the risk of contamination, mix-ups, and errors during production. By adhering to GMP standards, manufacturers play a critical role in protecting public health, ensuring that the medicines produced are effective and free from harmful substances. Moreover, GMP compliance is necessary for obtaining and retaining manufacturing licenses and for exporting homoeopathic medicines to other countries requiring adherence to international quality standards. In summary, GMP compliance under Indian law for homoeopathy involves strict adherence to quality control measures, proper documentation, and regulatory oversight to ensure the safety and efficacy of homoeopathic medicines.
2. GMP Certificate: Newly introduced Rule 85BB mandates a valid GMP certificate for manufacturing units, renewable every five years.
3. Loan Licenses: Rule 85BA requires a loan license application fee of Rs. 2,000 for single-ingredient medicines and Rs. 200 per combination product.
4. Redefinition of Homeopathic Medicines: The amendment redefines homoeopathic medicines, expanding the criteria and including references to the Homoeopathic Pharmacopoeia of India.
5. New Homeopathic Medicines: New medicines, including combinations not previously listed in official pharmacopoeias, will be regulated and defined as new for four years post-approval.
6. Increased Fees and Perpetual Licenses: Application fees and licenses are now perpetual, with a self-declaration required every five years.
7. Regulatory Process: Sales and distribution licenses must be issued within two months, and the amendment mandates online application processing via the e-Aushadhi portal.
8. Inclusion of International Standards: The draft rules include the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia as standards for imports and manufacturing.
9. Expanded Definitions: The amendment provides detailed definitions for registered homeopathy, Ayurveda, Siddha, Sowa-Rigpa, Unani practitioners, and proprietary medicines.

International Framework

The regulation of homoeopathy varies widely across the world, reflecting different levels of acceptance, legal frameworks, and integration into national healthcare systems. Here’s an overview of how homoeopathy is regulated in various regions:

In Europe, Homoeopathy is well-established in countries like Germany and Switzerland, where it is integrated into the healthcare system and regulated under the same laws as conventional medicine, with treatments often covered by health insurance for medically qualified practitioners. In the United Kingdom, however, Homoeopathy has faced significant scrutiny, leading the National Health Service (NHS) to largely cease funding homoeopathic treatments following recommendations from the NHS and the National Institute for Health and Care Excellence (NICE). While Homoeopathic products remain available in the UK, they must be clearly labelled as lacking scientific evidence of efficacy. Spain and Italy have also moved toward stricter regulation of homoeopathy, with Spain working to restrict its use and Italy requiring homoeopathic products to be registered and authorised by the national drug agency with specific labelling requirements. In North America, the United States regulates homoeopathy through the Food and Drug Administration (FDA), which mandates that homoeopathic products meet certain standards, although they are not subjected to the same rigorous testing as conventional drugs. In 2016, the FDA proposed stricter regulations to ensure that homoeopathic products are safe and properly labelled, but the efficacy of these treatments remains a topic of debate. In Asia, homoeopathy is not widely practised or officially recognised in China, where Traditional Chinese Medicine (TCM) is the dominant form of alternative medicine.

Meanwhile, in Australia, homoeopathy is under scrutiny, with minimal support from the public healthcare system. The National Health and Medical Research Council (NHMRC) has concluded that there is no reliable evidence to support homoeopathy’s efficacy, prompting calls for tighter regulations and the removal of homoeopathic products from pharmacy shelves. Overall, while homoeopathy is well-regulated and integrated into healthcare systems in some countries, it faces significant challenges and declining support in others, especially in regions with greater scientific scepticism.

Homoeopathy Pharmacy

German brands dominate the Indian Homeopathic market. However, Indian brands are not far behind, and several Indian manufacturers have rapidly moved up the value chain and formed a formidable competition to them.

According to a recent survey conducted by the Dabur research organisation, the market size of the homoeopathic industry in India is estimated to be ₹600 crores, representing a 14% share of the total Indian system of medicine and homoeopathy. The sector comprises registered homoeopathic practitioners, both institutionally and non-institutionally qualified, manufacturing units or pharmacies involved in producing homoeopathic medicines and products, and both government and non-government research institutes or councils, which may be privately owned or government-run. Additionally, the industry includes hospitals and dispensaries dedicated to homoeopathic care.

How does MCI define the Quacks?

Quacks can be divided into three basic categories as per MCI:

1. Quacks with no qualification whatsoever.
2. Practitioners of Indian Medicine (Ayurvedic, Sidha, Tibb, Unani), Homeopathy, and Naturopathy, commonly called Ayush, are not qualified to practice Modern Medicine (Allopathy) but are practising Modern Medicine.
3. Practitioners of so-called integrated Medicine, Alternative System of Medicine, electro-homeopathy, Indo-allopathy, etc., terms which do not exist in any Act.

There is an acute lack of awareness amongst State Governments, the legislature(s), the judiciary and even doctors themselves regarding the threat to the nation’s health from quackery and the non-entitlement of practitioners of Indian Medicine who are practising Modern Medicine. The confusion has been compounded due to various contradictory Govt. and court orders. Hon’ble Supreme Court has ruled in Mukhtiar Chand Vs. State of Punjab (AIR 1999 SC 468) that

“A harmonious reading of Section 15 of 1956 Act (Indian Medical Council Act) and Section 17 of 1970 Act (Indian Medicine Council Act) leads to the conclusion that there is no scope for a person enrolled on the State Register of Indian Medicine or Central Register of Indian Medicine to practice modern scientific medicine in any of its branches unless that person is also enrolled on a State Medical Register within the meaning of 1956 Act.”

In another case titled (AIR 1996 SC 2111), the Hon’ble Supreme Court has defined a quack as

“A person who does not know a particular system of medicine but practices in that system is a Quack and a mere pretender to medical knowledge or to put it differently a charlatan.”

The same was reaffirmed by the Supreme Court in Civil Appeal No.3541 of2002  in Martin E D’Souza vs Mohd Ishfaq, and it was held that.

“a professional may be held liable for negligence on the ground that he did not possess of the requisite skill which he professes to have.  Thus, a doctor who has a qualification in Ayurvedic, Unani or homoeopathic medicine will be liable if he prescribes allopathic treatment….”

A reading of the above court orders will make it abundantly clear that no person other than those possessing qualifications mentioned in the First, Second and Third Schedule of the Indian Medical Council Act 1956 and registered with the State Medical Register under the provisions of Indian Medical Council Act 1956 can practice allopathic or the modern scientific system of medicine anywhere in India.

Though IMA/MCI have submitted a draft Anti Quackery Bill, the Government still needs to place it before parliament. The MCI website mentions that fake Medical Institutions distributing fake medical degrees are prospering and multiplying under the patronage of Government functionaries and politicians, and no action is taken against them even though they are reported to the government police. The drug suppliers are also giving a helping hand to quacks by supplying drugs directly and sending their medical representation to them to promote the sale of their drugs. These drug suppliers stoop down to supply drugs without cash memo also. There is no practitioner’s data bank for a common man to fall back on, leaving ordinary consumers to rely on their intellect to ensure that the doctor they are consulting is not quack. The government’s legislative agenda, including recent bills, does not list an Anti-Quackery Bill, suggesting that while the issue is recognized, it has not yet been prioritised in recent parliamentary sessions​. Given the same the role of aware public can spearhead in uprooting practice of quakes too.  

References: 

1. Ghosh AK. A short history of the development of homoeopathy in India. Homeopathy. 2010 Apr;99(2):130-6. doi: 10.1016/j.homp.2009.10.001. PMID: 20471616. https://pubmed.ncbi.nlm.nih.gov/20471616/

2. Department of Homeopathy, Government of NCT of Delhi, Origin and growth of homoeopathy in India, https://homeopathy.delhi.gov.in/homeopathy/origin-and-growth-homeopathy-india

3. Homoeopathy, https://www.dsir.gov.in/sites/default/files/2019-10/ISM_H_Intro.pdf

4. R. Sur Homoeopathic college, hospital, research centre, government of NCT Delhi(n.d) https://shmch.delhi.gov.in/en/shmch/history-homeopathy

5. IMA Anti quackery wing, Indian Medical Association (n.d), Indian Medical Association https://www.ima-india.org/ima/archive-page-details.php?pid=291

6. Who can write the prefix Dr., Medical Council of India, the executive committee, (n.d) https://ima-india.org/windata/ccima/Legal/WhocanwritetheprefixDr.pdf