India’s Minister for Health and Family Welfare, Dr Harsh Vardhan recently endorsed Patanjali’s Coronil, which claimed not only to be WHO-certified, but also “evidence-based”. This claim was hastily denied by the Twitter account of WHO South-East Asia, and the entire incident was slammed by the Indian Medical Association.
Aside from the discussion on WHO’s role in approving Coronil, and the appropriateness of the Union Health Minister endorsing a private company’s products, it is necessary to examine Coronil’s claim as an “evidence-based” (or scientific) drug, particularly since, according to Patanjali itself, Coronil has received the Certificate of Pharmaceutical Product from the Ayush section of Central Drugs Standard Control Organisation.
Ayurveda May Work, But It’s Not Scientific
Too often, the line between what is scientific and what is not scientific gets blurred in India. If it works, it must be scientific. But that is not, and never has been, the ambit of science. The test is not whether something works, the test is whether it has been shown to work.
The argument here is not that Ayurveda is ineffective, or that it is in any way a scam. The argument is that Ayurveda is unscientific. I agree that Ayurveda may well be effective for those who believe that it works. I cannot, however, concede that Ayurveda is scientific.
What then does it mean to be scientific? In its simplest form, that which follows the scientific method is scientific. The scientific method is the basis for science and the foundation on which all scientific discoveries are made. It is a step-by-step enquiry, which involves making observations, formulating hypotheses, testing the hypothesis through rigorous and carefully controlled experimentation, and examining the conclusions.
If the experiment results support the hypothesis, then the observations and methodology must be made available to peers and the public to review the conclusions. If the experiment results reject the hypothesis, then a new hypothesis may be formulated, and the process repeated.
Medicines Must Be Safe AND Efficacious
Even when developed in India, ‘western’ medicine, must follow a similar rigorous multi-step experimental process to demonstrate a host of characteristics and demonstrate a simple hypothesis: that the given medicine is safe and efficacious. The dual objectives of safety and efficacy, while essential separately, must be seen together.
A medicine must be effective against the indication it is prescribed, while also ensuring that it does not cause something even more harmful in the process. There is no wisdom in developing medicine that is not both, safe and efficacious. Safety without efficacy gives us salt water, and efficacy without safety gives us cyanide pills.
If a car is demonstrated by the R&D department of the automobile company to reach a top speed of 200kmph, but they have failed to test the airbags or any other safety feature, I might be purchasing a very fast time bomb. If the same R&D department develops quality airbags, but has not run tests on the engine, I could end up with an expensive cushion.
In addition to the safety/efficacy combo, medicines and vaccines must be tested to determine various other characteristics such as
immunogenicity (the ability of the medicine to provoke an immune response in the body),
pharmacokinetics (the movement of the drug inside and then out of the body, or how the body affects the drug),
pharmacodynamics (the exact mechanism of action of the drug within the body, or how the drug affects the body),
method of ingestion etc.
Indian Law Mandates a Rigorous Process of Trials
These characteristics are determined at the end of a rigorous process which consists of multiple steps and phases, in accordance with Indian law. The Indian regime for testing and approval of drugs and vaccines is governed by the Drugs and Cosmetics Act, 1940; the Drugs and Cosmetics Rules, 1945; and the New Drugs and Clinical Trials Rules, 2019. This same set of laws, i.e. the Drugs Act, the Drugs Rules and the Clinical Trial Rules govern the manufacturing, testing, approval, sale, stocking and marketing of pharmaceutical drugs as well as homeopathic, ayurvedic, unani medicines, and cosmetic products.
When governing pharmaceutical drugs, the provisions of the Clinical Trial Rules (Second Schedule) mandate that the proposed product is first characterized in a lab to determine its molecular structure and other physical characteristics. It is then subject to pre-clinical trials, or animal trials. It is only after the results of the pre-clinical ie animal trials are scrutinized and reviewed that approval for “clinical trials”, ie trial on humans is provided by the Drugs Controller General of India.
The human trials themselves are done in three phases, with each phase incorporating a larger number of trial subjects, culminating in phase-III trials, involving large groups of people.
Any New Medicine’s Long Road to Final Approval
Clinical trials must follow strict criteria to be considered valid. Clinical trials must be ‘controlled’, i.e. all studies must involve a ‘control group’ of subjects who are provided a ‘placebo’ (which could either be a fake harmless substitute, or the prevalent medicine against which the new medicine is being tested). Controlled trials must further be randomized, which means who receives the new medicine and who receives the placebo must be a selection made at random.
Studies must further be ‘blind’, where the test subjects are not told whether they are receiving the new medicine or the placebo. Studies may even be double-blind, where the researchers themselves are not made aware of which subject received the new medicine and which subject received the placebo.
The process of the testing is at all times overseen by the Drugs Controller, India and various government committees under the Ministry of Health and Family Welfare, as well as independent ethics committees.
Results from each stage are put before various government authorities from time to time, and approvals are sought for continuation of the study from the government at various stages of the medicine’s development.
Only when the regulatory body is convinced that not just the final product, but also each step that led to the final product was properly conducted, is the final approval for commercial manufacture, sale and marketing provided to the pharmaceutical company.
Different Rules For Ayurveda, Unani or Siddha Medicine
In contrast, Ayurvedic, Siddha or Unani medicine, which fall under the legal regime of the same central act as pharmaceutical drugs, i.e. the Drugs and Cosmetics Act, are tested on only two criteria: faithfulness to the recipe as provided in traditional texts, and hygiene of the premises where such drugs are manufactured. Where the Clinical Trial Rules dealt with clinical drugs, Part XVI of the Drugs Rules deals with Ayurvedic drugs.
Rule 157(1) of Part XVI requires the premises to be hygienic, and Rule 158B(1)(A) requires the product to be “manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine”. No other testing criterion has been made mandatory for Ayurvedic, Siddha or Unani drugs under Indian law.
Ayurvedic, Siddha or Unani drugs are not tested to ensure their safety, they are not tested to ensure their efficacy, they are not tested to determine their immunogenicity, pharmacodynamics, pharmacokinetics, or any of the myriad physical and chemical characteristics and benchmarks that clinical medicines are tested upon under the Drugs Act in India.
In fact, Rule 158B of the Drugs Rules explicitly states that safety studies and proof of effectiveness are not required. The only thing that is required under Rule 158B is that the medicine must be as described in published literature. Schedule I of the Drugs Act lists 58 books of Ayurveda, 25 books of Siddha and 14 books of Unani medicine. As long as the medicine proposed to be sold finds mention in any of these books, it has absolutely no need for any tests regarding safety, or to prove effectiveness.
Traditional Medicine Must Undergo Clinical Trials For Its Own Sake
The assumption being that since knowledge of these drugs has been received from the Ayurveda, they are already known to be safe and efficacious. We need run no further tests. The difference between “received knowledge” and “evidence-based knowledge” is not that one works and the other doesn’t. The difference is that “evidence-based knowledge” can be challenged and tested and re-tested and modified and even rejected. “Received knowledge” must be accepted as it is. Testing of Ayurvedic medicines is not then unnecessary, it is unthinkable. This is codified in Indian law. However, good clinical trial practices should not be seen as anathema to traditional medicine.
Instead, the scientific method is an opportunity for India to share its wealth of knowledge and wisdom with the world and with science.
It is difficult to understand why Indian law would discourage inquiry into the subcontinent’s treasure trove of medical literature. We live in the land of Charak and Sushrut, but we must recognise that we no longer live in the times of Charak and Sushrut. Testing of Ayurvedic, Siddha and Unani medicine through the lens of the scientific method will turn the forcibly unquestionable to truly unquestionable.
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