Updated: March 2, 2021 2:31:38 pm
Maharashtra Home Minister Anil Deshmukh Tuesday (February 23) said the sale of Coronil, which Yoga guru Ramdev’s Patanjali group claims is medicine for Covid-19, will not be allowed in the state “without proper certification from competent health organisations like WHO, IMA and others”.
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Deshmukh wrote on Twitter, “The IMA has questioned the said ‘clinical trials’ of Coronil & WHO refuted the false claims made by Patanjali Ayurveda for giving any certificate regarding its effectiveness for Covid19 treatment. Launching such a drug hurriedly and being endorsed by two senior Central Union Ministers is highly deplorable. Selling of Coronil without proper certification from competent health organizations like WHO, IMA and others will not be allowed in Maharashtra.”
The #IMA has questioned the said ‘clinical trials’ of #Coronil & WHO refuted the false claims made by #Patanjali Ayurveda for giving any certificate regarding its effectiveness for #Covid19 treatment. (1/2)
— ANIL DESHMUKH (@AnilDeshmukhNCP) February 23, 2021
This is the latest in a series of controversies Coronil has been involved in.
So what is the row over Coronil, and what was the “WHO certification scheme” cited by Patanjali?
Patanjali’s claim on Coronil
On February 19, Ramdev, at a press meet, said Coronil had received certification from AYUSH Ministry as a drug that can be used as “supporting measure in Covid-19” and as an immuno-booster.
The press meet was attended by Union Transport Minister Nitin Gadkari and Union Health Minister Harsh Vardhan, a qualified doctor who is also chair of World Health Organization’s (WHO) Executive Board. At the event, Harsh Vardhan said: “During British colonial times, Ayurveda should have been recognised, its knowledge publicised… Unfortunately, we had to wait till Independence to do that… The Rs 30,000-crore industry for Ayurvedic products which grew at 15-20% per year is growing at 50-90% after Covid.”
In a press statement released that day, Patanjali said: “Coronil has received the Certificate of Pharmaceutical Product (CoPP) from the Ayush section of Central Drugs Standard Control Organisation as per the WHO certification scheme.” Calling Coronil “an evidence-based medicine to fight Covid-19”, Patanjali said under the CoPP, the drug can be exported to 158 countries.
— WHO South-East Asia (@WHOSEARO) February 19, 2021
The WHO, however, distanced itself from the product the very same day. Without taking names, WHO South-East Asia wrote on Twitter, “WHO has not reviewed or certified the effectiveness of any traditional medicine for the treatment of COVID-19”.
As social media erupted with criticism of Patanjali’s “false claims”, group CEO Acharya Balkrishna clarified that their certificate had come from the Government of India, and not WHO. “We want to clarify to avoid confusion that our WHO GMP compliant COPP certificate to Coronil is issued by DCGI, Government of India. It is clear that WHO do not approve or disapprove any drugs. WHO works for building a better, healthier future for people all over the world,” he tweeted.
We want to clarify to avoid confusion that our WHO GMP compliant COPP certificate to Coronil is issued by DCGI, Government of India.
It is clear that WHO do not approve or disapprove any drugs.
WHO works for building a better, healthier future for people all over the world. pic.twitter.com/ZEDPdWy0tg
— Acharya Balkrishna (@Ach_Balkrishna) February 19, 2021
What is the WHO certification scheme for drugs?
The WHO indeed does not “approve or disapprove” drugs. According to the UNO body, the “role of WHO in the area of medicines regulatory support is two-fold. One aspect relates to the development of internationally recognised norms, standards and guidelines. The second aspect relates to providing guidance, technical assistance and training in order to enable countries to implement global guidelines to meet their specific medicines regulatory environment and needs.”
Its certification scheme is for finished pharmaceutical products, and is a voluntary agreement among various countries.
According to the WHO, the scheme is an “administrative instrument that requires a participating Member State (a certifying country), upon application by a commercially interested party (the applicant company), to certify/attest to the competent authority of another participating Member State (the recipient country) that:
- A specific pharmaceutical product is authorised for marketing in the certifying country, or if not, the reason why authorisation has not been accorded;
- The manufacturing facilities and operations conform to good manufacturing practices (GMP) as recommended by WHO.”
Has IMA questioned Coronil, as Deshmukh claims?
The Indian Medical Association (IMA) had on February 22 criticised the “blatant lie of WHO certification” made by Patanjali Ayurved, and demanded an explanation from Harsh Vardhan for endorsing it.
“Being a Health Minister of the country, how justified is it to release such falsely fabricated unscientific product to people of the whole country and how ethical was it to promote the product in unethical, wrong and false ways,” the IMA statement said.
The association also pointed out that as per the code of act of the Medical Council of India, no doctor can promote any drug, “whether for compensation or otherwise, any approval, recommendation, endorsement, certificate, report or statement” and said that it was “surprising that the Minister himself is promoting the drug (Coronil)”.
After the Delhi Medical Association defended Vardhan, Dr J A Jayalal, IMA’s national president, said the Health minister should come out with a statement that he is not endorsing the sale of Coronil as a curative medicine for Covid-19.
The IMA has also sought clarifications on the timeline for the clinical trial of Coronil, and what procedures were followed for the trials.
Patanjali had claimed last year too that Coronil could cure Covid-19, but the government had allowed it to sell the product only as an “immunity booster”.
The company had claimed in June last year that its trials on “mild to moderately ill patients” were successful, and showed “100 per cent recovery of patients within seven days”.
“Some people feel research is a monopoly of those who wear a suit and tie. They think a saffron-wearing sanyasi has no right to do any research. What sort of untouchability and intolerance is this?” Ramdev had then said.
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