Baba Ramdev-owned Patanjali Ayurved on Wednesday claimed that AYUSH ministry has allowed it to manufacture and distribute its “Coronil kit", aimed to help in treating covid-19. “As per the AYUSH ministry, Patanjali is allowed to manufacture and distribute its Divya Coronil Tablet, Divya Swasari Vati and Divya Anu Taila across India, as per the manufacturing licences granted by State Licencing Authority, Ayurvedic and Unani services, government of Uttarakhand," Yoga Guru Baba Ramdev said in a press conference on Wednesday.
The AYUSH ministry had on Tuesday said Patanjali Ayurved will not be able to sell its medicine with claims of curing covid-19 and with labels of covid-19. Patanjali Ayurved claimed that Coronil had cured within a week all covid-19 patients who took part in a trial. Following the claim, Union AYUSH ministry pulled up Patanjali stating that it cannot sell the drug till it is examined by the ministry. Ayurveda department of Uttarakhand said that the firm had only applied for a licence to manufacture an immunity booster, and not a cure for covid-19.
“It may be ensured that on the package and label displayed on the medicines (Divya Coronil Tablet and Divya Swasari Vati), no claim for the cure of covid-19 should be mentioned," the drug policy section of the AYUSH ministry said in an email to the Uttarakhand licencing authority.
“The advertisement and the publicity of the drugs should be ensured in accordance with the relevant provisions of the Drugs and Magic Remedies Act," it added. The Uttarakhand AYUSH department reportedly has given an approval to Coronil as an immunity booster, issuing a licence to manufacture three medicines and allowed clinical trial under the rules as well.
Ayurvedic drug licences and controlled clinical trials are two different streams. All manufacturing and distribution licences for Ayurvedic medicines are granted on the basis of their reported traditional uses; clinical studies are then conducted on those medicines in some cases, Ramdev said.
Patanjali Divya pharmacy obtained licence approval for Divya Coronil Tablet and Divya Swasari Vati based on their traditional reported use, and has now connected those with modern research based clinical findings, Ramdev claimed.
Patanjali Research Institute, Haridwar, and National Institute of Medical Sciences and Research (Nims) University, Jaipur, jointly conducted randomized, placebo-controlled, double-blinded clinical trials on covid-19 positive patients.
The trial was approved by Institutional Ethics Committee (IEC) and duly registered at Clinical Trial Registry–India, Patanjali said. The positive outcomes of this clinical trial were disclosed to the nation on 23 June, 2020. In this trial, 95 patients (in the age group 15-65 years, both males and females, asymptomatic or with mild to moderate symptoms) participated after giving their written consent. 45 patients were treated with Patanjali medicines and another 50 patients given placebo formulations.
The covid-19 patient group that received Patanjali medicines showed 67% recovery in 3 days and 100% recovery in 7 days of treatment, that is, all 45 patients become covid-19 negative, Ramdev claimed.
Besides, blood serum levels of C-reactive proteins (CRP), Interleukin-6 (IL-6) and TNF alpha cytokines were also detected to be significantly lower in patients who recovered from covid-19 after taking Patanjali's medicines, than in the placebo group.