Originated due to zoonoses the SARS-COV-2 virus has no doubt posed a big challenge to human intelligence. It is only natural for scientists and physicians from all branches of modern and traditional or CAM medicine to deliberate on the medical side of the new dreadful disease COVID 19. Each one, be it a virologist, medical doctor, AYUSH doctor or herbal healer wants to contribute to the process of healing. In India where medical pluralism is very well accepted and practiced, debates are unavoidable. The dreadful nature of the unknown disease, increasing fatalities, deaths of treating doctors and paramedical staff and helplessness to find a quick cure in spite of the so-called ultra-modern technology at hand, has put everyone in a fix.
Since March we have been reading research articles in scientific journals giving diverse and sometimes completely contradictory findings. All the peer-reviewed journals have opened their free publication channels to facilitate quick access to the data coming from various action researches from all over the world. Leading newspapers are giving news of drugs being tested for COVID -19. Almost every week renowned scientists from all streams of science and medicine including AYUSH, are giving webinars on emerging disease and probable treatment options. World Health Organization (WHO) also has to make decisions based on the newer data, which may contradict to its previous stand in some cases.
The governments of all sufferer nations have accelerated the process of clinical trial permissions for the repurposing of known drugs that are being tested to treat and also prevent COVID 19. In India, the Ministry of Health and Family Welfare (MoHFW) and the Ministry of AYUSH (MoA) published advisories in the last week of March 2020 regarding diagnosis and prevention. Along with social distancing and mechanical preventive measures like masks and frequent handwashes, MoA advised a few selected herbal and herbomineral formulations which are known immunomodulators; in the form of kadha or tablets to achieve immune homeostasis. This step is based on the Ayurvedic concept of Rasayana, whereby natural strength of the body is optimized for self-protection against any type of infection be it bacterial or viral.
At the beginning of April, ICMR revised its guidelines where the use of oxygen therapy, fluid management, empirical antibiotics, and symptomatic life-saving measures like glucocorticoids was suggested. It also suggested the treatment of Hydroxychloroquine (HCQ) (200 mg BD )and Azithromycin (500 mg OD) for 5 days for patients with severe disease. Immediately afterward MoHFW together with Ministry of Science and Technology and announced the schemes through DST / DBT. MoAYUSH also decided to give impetus to research of known or new drugs to combat the disease in the public-private partnership model. Proposals for such trials were invited under the extramural research scheme (EMR) from MoA on April 21. It is clearly mentioned that the trial of any Ayurvedic formulation should be done with scientific rigor. It means that the drug should have prior evidence of efficacy, clearance from the Institutional Review Board/ scientific committee, approval of the Institutional Ethics Committee, the clinical trial should be registered in the Clinical Trial Registry of India (CTRI database), and must have state FDA license for manufacture and sale.
The modern pharmaceutical industry harnessed the opportunity and followed required steps like taking permission from competent authorities (DCGI) for trials of already FDA approved drugs like HCQ, remdesivir, favipiravir and for COVID -19 patients. Recently, tocilizumab and itolizumab have been added as off-lable drugs to test in patients having moderate to severe disease. Research for quick yet accurate diagnostic kits and a preventive vaccine is also ongoing with mixed outcomes.
Ayurvedic drug manufacturers wanted to contribute their share in the management of the disease. Many pharmacies came up with the known Rasayana combinations with a preventive approach. Over 2000 proposals were received for the EMR scheme within the stipulated time frame of about 2 weeks.
Owing to the fluid dynamics of the situation arising out of COVID -19 caused by SARS-CoV-2, the apex bodies like WHO and ICMR are compelled to rely upon new data coming up from researches happening around the world. They had to go back and forth in terms of advisories or suggestions depending on the reliability of the data coming to them. The HCQ trials were halted by NIH and HCQ was dropped by WHO from the multiarm solidarity trial due to no harm but no use for prevention and reduction in mortality. Similarly, Tocilizumab is promising but yet to prove safety and specific efficacy in COVID-19. The vaccine trials at Oxford have shown promising results in terms of production of antibodies and stimulation of T cells however, the scientists are not yet convinced about long-lasting immunity and the studies are continued. Most of these studies are published in indexed journals like Lancet or JACM.
Common people unaware of the scientific jargon needed a specific direction and a 'to do' advice from authoritative figures and government bodies, at such chaotic times. People also tend to behave believing their own experience and wisdom. For improving general immunity against any infection, advice for use of vitamins D, E, C, and minerals like Zinc and variety of herbal teas, nutritious foods etc. mushroomed in media. Many commoners and physicians in India consumed HCQ on their own for prophylaxis when the ICMR document never mentioned it as prophylactic. This attitude is no different than practicing vaidyas advising people to maintain good health and immunity through lifestyle modifications and known well studied drugs like Turmeric, Tinospora, Ashwagandha and Indian Basil, Ginger, and their combinations.
Amidst these events, the Coronil controversy flared up due to the public announcement of 'Corona Kit' made by Patanjali Divya Pharmacy. While many modern pharma industries are making the above mentioned medicines, selling those, and earning profits why Patanjali should not be allowed to do the same, was a hot debate in various circles of Ayurveda. At such confusing times principles of the Ayurvedic science act as guiding lamps to lead everyone to the right path.
Guiding principles in the Brihattrayee recommend the following when a vaidya faces an unknown disease or condition:
- The diagnosis of new disease (anukta vyadhi) should be arrived at based on the standard framework (doshadhatumala, nidanpanchak).
- The drugs or formulations which are known to be beneficial in similar conditions should be selected.
- The drugs should be administered and the patient should be monitored carefully for a particular duration. If the desired effect is not observed, then the medicine should be changed.
- When consistent and assured results are obtained, then the findings with justifications should be documented in a specific format and presented before experts (vidvatparishad ~ peer review process). The submission should be examined and discussed by learned scholars for acceptance.
- After acceptance, it can be confirmed as standard treatment protocol (pramanit chikitsa) for that particular disease (anukta vyadhi).
- After confirmation one can manufacture and sell the medicine for that particular new disease.
In the 21st century, Ayurvedic medicine must abide by the law of the country. For Ayurvedic medicine, there are two routes, classical drugs and proprietary drugs. Classical drugs need not give proof of efficacy by way of clinical trials for conditions mentioned in the Ayurvedic classics. Proprietary drugs must give evidence of efficacy by following GCP guidelines for ASU drugs published in 2013 and following specific conditions in the amendment of 2018. The state licensing authority approves the drug for its label claim based on the trial data, which is registered in the registry for the specific disease or condition.
The Corona kit contains 3 medicines. Coronil tablet made from known herbs but a new combination, Shwasari tablet, which may have been already registered and licensed by Divya pharmacy and Anutaila is a licensed classical formulation for nasal application. The news reported that the 3 drugs together cure COVID -19 based on the trial results wherein 69 percent were cured by day 3 and the rest by day 7; which was conducted at the National Institute of Medical Sciences, Jaipur. The company also said that the new formulation Coronil was licensed and the trial was registered in CTRI.
Coronil is a proprietary drug where the application for license did not mention COVID -19 or corona virus. It is mentioned as an immunity booster. The trial is registered in Jaipur but the media reported that it was tested on patients from Delhi, Ahmedabad and Meerut. In the CTRI form, the number of patients mentioned is 50 whereas the media reports different numbers from 120 to 250. These facts highlight misinformation and if correct, a serious issue of scientific misconduct and ethics. The trial inclusion criteria mention mild to moderate cases whereas results are advertised as a cure for COVID-19 patients which interprets severe cases as well, which can be labeled as objectionable misconduct. Further, the data and results are not analyzed and published in scientific journals as per the guidelines. The sequence of events neither comply with the guiding principles of Ayurvedic science nor abide by the law of the country. Hence, in spite of huge potential, it attracted controversy.
Such incidences point to the gap between true scientific spirit and commercial approach practiced by both; traditional medicine and biomedicine alike. Any misdeeds not only malign the image of the company which engages itself in such practices but also bring a bad name to the great medical science Ayurveda. Thankfully, a few thinkers like Prof. Madhulika Banerji of Delhi University, Dr. Kalantri from Sevagram medical college, and Dr. Bhavana Prasher from CSIR have condemned the attitude of exploitation of science for short term gains and supported the ethical, rational practice of Ayurveda.
Hence in times of conflicts, one should always remember the verse from Charaksamhita which guides the practitioner and I quote " A vaidya should use his intellect and guiding light of the shastra appropriately to achieve success in material life".
शास्त्रं ज्योतिः प्रकाशार्थं दर्शनं बुद्धिरात्मनः|
ताभ्यां भिषक् सुयुक्ताभ्यां चिकित्सन्नापराध्यति||
(च. सू. ९/२४)
ताभ्यां भिषक् सुयुक्ताभ्यां चिकित्सन्नापराध्यति||
(च. सू. ९/२४)
