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Restriction on Patanjali’s Coronil for COVID-19 treatment claims

July 2, 2020

By Tulip De and Reetika Wadhwa

In these COVID-19 affected times, one of the renowned manufacturers for ayurvedic products in India- Patanjali Ayurved Ltd. has gathered eye-balls by launching its medicinal product– ‘Coronil tablet and Swasari vati’, claiming they can cure highly contagious disease within seven days.[1] The Government authorities have put under the impugned advertisements under scanner in order to verify the sanctity of the claims being made.

The changed situation, where several business ventures are running into losses many entrepreneurs have opted for opportunities more favourable to better handle the viral infections. There has been a rapid increase in the manufacturing of hand-sanitizers, face masks and other safety as well as hygiene equipments. Drug manufacturing businesses globally are pacing up for the quick development of an effective treatment so that COVID-19 ailments can be cured soon.

Development of medication/ vaccines amidst COVID-19

While social distancing and lockdown have served as interim measures to prevent the spread of the viral infection- COVID-19, an immediate need to develop vaccine to fight the pathogen has emerged. In India the manufacturing and commercialization of drugs are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and Rules of 1945 (hereinafter referred to as the “Drugs law”) to ensure that the products being sold comply with safe practices and are of genuine quality. Hence, before commencing the process to manufacture drugs, pharmaceutical companies are mandated under the law to procure a valid license for the same under the provisions of the Drugs law.

Advertisement of Ayurvedic products prohibited under Law

It would be relevant to mention here that the Central Government amended the Drugs and Cosmetics Rules, 1945 in the year 2018 and inserted Rule 170 which prohibits manufacturer of Ayurvedic, Sidha or Unani Drugs (ASU Drugs) from participating in advertisement of any drugs relating to use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or condition. According to Rule 170 the advertisement of ASU drugs can only be allowed with conditions.

Additionally, the provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (hereinafter referred to as “Drugs and Magic Remedies Act”) also prohibits advertisement of drugs for diagnosis, cure, mitigation, treatment or prevention of any disease, disorder without consultation with the Drugs Technical Advisory Board (Section 3 of the Drugs and Magic Remedies Act).

In the aforesaid context, the State/ Union Territories Governments are empowered to enforce legal provisions under Drugs and Cosmetics Act, 1940, Drugs and Magic Remedies Act, including imposition of fine, imprisonment of the persons responsible for misleading advertisements pertaining to ayurvedic products.

Advertisement of Patanjali’s Coronil- claiming treatment of COVID-19

Popular manufacturer of Ayurvedic products in India- Patanjali Ayurved Ltd, recently issued advertisements for its new medicine ‘Coronil and Swasari’ on June 23, 2020, wherein Patanjali claimed that clinical trials for the same have been performed on COVID-19 affected patients had shown favourable results.[2]

Restraining of advertisements

Taking cognizance of the said advertisements, the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (hereinafter referred to as “Ministry of Ayush”) had stated that the facts of the claim and details of the stated scientific study pertaining to the impugned products are not known[3].

In order to verify the claims, Patanjali Ayurved Ltd. had also been asked to provide at the earliest details of the name and composition of the medicines being claimed for COVID treatment; site(s)/hospital(s), where the research study was conducted for COVID-19; protocol, sample size, Institutional Ethics Committee clearance, CTRI registration and results data of the study (ies) and stop advertising/publicizing such claims till the issue is duly examined.

Further, the Ministry of Ayush had also directed the State Licensing Authority of Uttrakhand Government to provide copies of license and product approval details of the Ayurvedic medicines being claimed for the treatment of COVID – 19 by Patanjali.

Coronil can be sold as immunity booster and not as cure to COVID

In a recent development, the Ministry of Ayush has now issued a statement stating that Patanjali’s “Coronil” can be used as an “immunity booster” and not as a cure to coronavirus disease[4].

PIL filed in Uttarakhand High Court against Coronil

Reportedly, a PIL has also been lodged with the Uttarakhand High Court against Patanjali Ayurved Ltd., challenging its impugned medicine “Coronil” as a cure to COVID. The Uttarakhand High Court on hearing the PIL has now issued a notice to the Central Government and sought reply from the Centre on the same[5].

Criminal action

A popular Indian Daily has also reported that a complaint has been filed by a social activist, namely, Tamanna Hashmi against yoga guru Ramdev and Patanjali Ayurved Ltd, –  MD Acharya Balkrishna, before a Court in Muzaffarpur, Bihar seeking registration of FIR for offences under the Indian Penal Code, 1860 (hereinafter referred to as “IPC”), including cheating (Section 420 of IPC), criminal conspiracy (Section 120B of IPC), malignant act likely to spread infection of disease dangerous and to life (Section 270 of IPC) and intentional insult with intent to provoke breach of peace (Section 504 of IPC) on account of misleading and putting at risks the lives of several people. [6]

Thus, the clarity on the authenticity of the claims made by Patanjali Ayurved Ltd. for its drugs for treatment of COVID is still unclear, thereby giving rise to apprehension regarding their credibility in terms of health and safety of those who may consume the same for treatment of virus.

Conclusion

While human life is facing tremendous on account of the COVID-19 outbreak, urgency of medication to treat the deadly contagion has become the need of the hour. Nevertheless, the Government is taking all reasonable steps to ensure that the remedies being opted are not false or misleading based on the advertisements and claims being made by the manufacturers thereby requiring compliance to the provisions of the applicable laws while promoting the sale of novel products.

Also read:

Rise in false and misleading advertisements amid Coronavirus’

Ministry of AYUSH orders to stop advertisement of AYUSH related products

Dettol withdraws advertisement claiming soap bars to be ineffective

[1] https://www.thehindu.com/news/national/other-states/complaint-in-bihar-seeks-fir-against-baba-ramdev-over-covid-19-medicine-claim/article31905842.ece

[2] https://www.thehindu.com/news/national/coronavirus-ayush-ministry-lens-on-baba-ramdevs-covid-19-cure/article31899866.ece

[3] PIB Statement issued by the Ministry of Ayush on claims of Patanjali Ayurved regarding treatment of COVID19- https://pib.gov.in/PressReleasePage.aspx?PRID=1633690

[4] https://www.thehindu.com/news/national/patanjali-can-sell-its-drug-but-not-ascureto-covid-19-says-union-health-ministry/article31962529.ece

[5] https://www.newindianexpress.com/nation/2020/jul/01/coronil-drug-uttarakhand-high-court-issues-notice-to-baba-ramdevs-patanjali-2164088.html

[6] https://www.thehindu.com/news/national/other-states/complaint-in-bihar-seeks-fir-against-baba-ramdev-over-covid-19-medicine-claim/article31905842.ece

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