NEWS in INDIA is running thick and fast that BABA RAMDEV and Acharya Balkrishna promoted PATANJALI Group, a US $ 2.5 Billion (Nu 187.5 Billion / INR 187.5 Billion) Enterprise which is spread across in its portfolio from Consumer Goods to Ayurvedic Herbal Products has made sensational claims of COVID cure via purported Ayurvedic formulation CORONIL. The Group subsidiaries include Paridhan Ruchi Soya (Acquired) and Herboved Inc.
There is a World-wide movement to find a cure for COVID-19, the most deadly infection faced by mankind post the era of Spanish Flu caused by the H1N1 influenza A Virus starting February 1918 and subsiding only in April 1920 which infected 500 Million people (then 1/3rd of the World Population) in 4 consecutive waves. Today, as we go to the story of the Wuhan, China, originated COVID-19 (CORONA SARS n-Cov 2019 or simply Novel CORONA Virus 2019) declared a pandemic in March 2020 and previously as emergency in December 2019 by WHO. Albeit the first infections seems to have happened as early as November 2019.
Today, 9.24 Million Cases have been reported World-wide with 477,000 deaths. INDIA is at 4th spot with 456,000 cases and 14,476 deaths and still rising, with the fear of staggered waves emerging in different time dimensions especially across the populous states of Uttar Pradesh, Bihar, Madhya Pradesh, etc. Maharashtra with the highest cases 136,000 cases and 6,283 deaths albeit being the top infected is showing signs of recovery and controlling the virus with highest testing and better medicare management.
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It is at this juncture that the 1.38 Billion population INDIA is keenly awaiting break-through medication and a possible effective, ethical, safe and secure Vaccine for its population. At the same time till the long process of Vaccine delivery, intermediate drugs that could have possible impact for a cure are under the various phases of trial starting with the Animal Trials and then the Human Trials, a mandatory process for approval of any drug and / or vaccine.
In INDIA, the key bodies responsible for the same are ICMR (Indian Council of Medical Research), DCGI (Drug Controller General of INDIA), both under the Central Ministry of Health and Family Welfare (MoHFW), Government of INDIA, and Department of Bio-Technology under the Ministry of Science & Technology, Government of INDIA, for the Vaccine approvals.
For the Ayurveda, a separate Ministry of AYUSH (The Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) has been established by the Government of INDIA, which along with the body ICMR is responsible for giving any approval for Herbal / Ayurvedic formulations.
Post the announcement by BABA RAMDEV himself of the sensational use of COVID cure find with CORONIL, it took barely any time for the Ministry of AYUSH, Government of INDIA, to distance itself from the claims and the ICMR feigned any knowledge of the same. The claim made by Patanjali was that they have an approval for Ayurvedic formulation, CORONIL, received from CTRI (Clinical Trials Registry- India), body under the ICMR, and that 280 patients were tried for its efficacy claiming that CORONIL could cure many in 3 days and most in a weeks time and that too with 100% results.
Almost refuting these claims of BABA RAMDEV and Patanjali, Ministry of AYUSH asked Patanjali to stop advertising CORONIL Drug within hours of its launch. But a defiant CEO, Acharya Balkrishna, claimed protocol was followed and the Drug has approval. However, it is now known that CORONIL or any of its variants with similar name was cleared only as an Energy Booster and has no clearance as a cure for CORONA as quoted by a source in the knowledge of the matter. Also, the tests were conducted on young and healthy patients and not on the high risk segment such as the elderly or those with comorbidities. The numbers too seem to be far less than the 280 claimed and it is only 45 patients who have been on trial for the “Energy Booster”. Further, the findings for the Clinical Trail have neither been peer reviewed or published in any reputed medical journal which is mandatory and any results claimed are of interim nature and only pertaining to its being an Energy Booster and not a COVID cure.
The National Institute of Medical Sciences (NIMS), Jaipur, Rajasthan, INDIA, conducted the Clinical Trails on behalf of Patanjali. As per sources to this Author, Dr. Ganpat Devpura, Professor and Head of Department, Clinical Trials – Department of Medicine, at NIMS, began the trials on 23rd May 2020 to check the impact of CORONIL on COVID-19 patients.
Initially about 100 patients were enrolled for the study divided into 2 groups of 50 each. Around 45 of these patients were administered the Ayurvedic Drug while the remaining 50 were placed in the Placebo Group (no treatment) as 5 patients refused to consent for these trials. It is claimed that on Day3, 69% of the patients or 13 Number who were given the Ayurvedic Drug purportedly turned COVID-19. While around 50% or 25 in numbers in the placebo group also turned negative in the same period. It is further claimed that by the 7th Day, everyone who were given the medicine were cured while 65% or 33 in numbers of the Placebo Group also recovered.
However, this study is yet to be published or peer reviewed, thereby both by virtue of the quantum and qualitative aspect of the sample size, this can be construed only as an interim study and cannot qualify as proof of success without further trails on moderate and severely infected patients. Further such results have to be published and peer reviewed. CORONIL, according to Patanjali, has the core ingredients of Ashwagandha (Withania somnifera), Giloy (Tinospora Cordifolia) and Tulsi (Ocimum Tenuiflorum) which are all known Ayurvedic Herbs used in the day to day life by several Indians and thereof not any innovation. There is also no evidence of any Patent Application for CORONIL as then its full ingredients would be in disclosure and public domain. The IPR Laws demands that Patent should be mandatorily registered for any medication being used for emergency or pandemic in particular as it is of severe nature and needs to protect the safety and security of the patients at large.
It may be noted that there are several leading Ayurvedic Entities in INDIA and the famous amongst them being VAIDYARATNAM (Ashtavaidyan Thaikkattu Mooss) and The Arya Vaidya Sala, Kottaikal, who are famous, ancient Namboodiri Family run Ayurveda Family Entities from Kerala and their products are well accepted. In addition, leading companies such as Dabur, Zandu, Himalaya, Lever Ayush of Hindustan Uniliver Limited and Ayur Herbals are some of reputed Ayurvedic Herbal Companies in INDIA who have yet to make any such product claims while many of them are in the Domain of finding immunity enhancers and boosters as well as conducting study of possible impacts on COVID patients.
Further, it is mandatory that such results must be in substantial number with phases of trail that starts from Animal Trial and then moves to Human Trial with sample sizes 250 to 300 ; 500 to 750 and 750 to 1000 in 3 stages of approval. This was completely missing as then it can be opened up for a mass trial on more than 5000 candidates. All this can only be done after proof of efficacy, safety, security, study on side effects and publishing and peer review of the entire outcome in reputed journals as deem fit by the Medical Fraternity World-wide failing which the claims become more or less BOGUS
As per the provisions of The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Rules thereunder as well as the Directives issued by the Indian Government in the wake of COVID outbreak, any such claims contrary to proper process and procedure of approval and announcement in public is tantamount violation of the said Act. Patanjali and BABA RAMDEV find themselves exactly in violation of this Act as well as the Emergency Provisions of the Government of INDIA on COVID-19 and have more or less registered a FALSE CLAIM especially when the approval is set to be for the use as a limited ENERGY BOOSTER purpose. The claim that it is a COVID treatment and cure thereby becomes violatory on several grounds including spreading false claims, wanton misinformation spread, putting public at risk as well as the violation of the provisions of The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Emergency Provisions of the Government of INDIA on COVID-19. While it openly stands in violation of the International Drug Control procedures of the WHO, USFDA and other bodies including the National Body, ICMR.
Also, it must be noted and the Government of INDIA must be careful that this unproven and lofty claims of CORONIL should not end up crossing the border into Friendly Countries such as BHUTAN as that could simply jeopardize the interest of INDIA and the common people who access such stuff due to border infiltration through distribution networks that are now far and wide for Patanjali. Now, it is to be seen whether the Government of INDIA takes suo-motto cognizance of these violations and there is a clear cut case of proceeding against Patanjali on these grounds.
PROF. A G IYER
Editor-in-Chief – MARKENOMY
Author – INDIAN BRANDished & BHUTAN BRANDished
E : [email protected]
Mumbai, INDIA ; Wednesday, 24th June 2020