Patanjali Coronil approved as supporting measure in treating COVID-19: MoS Health
Dehradun: After the issue of Coronil's effectiveness in COVID management stirred up major controversy, the State Licensing Authority of Uttarakhand has granted a license to Coronil to be used as a supporting measure in the management of COVID-19 without claiming cure. The decision was taken following the advice of a review committee set up by the AYUSH ministry, the Lok Sabha was informed on Friday.
Patanjali had introduced Ayurveda-based Coronil on June 23 last year, when the pandemic was at its peak. It had to face severe criticism for apparently lacking scientific evidence regarding its efficacy.
PTI reports that Minister of State for Health Bharati Pravin Pawar, in a written reply, said the Interdisciplinary Technical Review Committee (ITRC) set up by the AYUSH ministry reviewed the application submitted by the Patanjali Research Foundation Trust for "updating the AYUSH license for Divya Coronil tablet" from 'immunity booster' to 'medicine for COVID-19'. The committee suggested that the tablet may be used as a supporting measure in Covid management, she said.
"The application titled 'Updating AYUSH license for Divya Coronil tablet from Immunity booster to Medicine for COVID-19' submitted by Patanjali Research Foundation Trust, Haridwar, Uttarakhand to this Ministry, was placed before the ITRC on October 27, 2020 for examination of the applications/claims on patent and propriety (P&P) ASU&H medicines with new indications or repurposing of licensed P&P, ASU&H medicines for COVID-19," Pawar said in her reply.
"The ITRC reviewed the study and it was suggested that it may be used as a supporting measure in Covid. The State Licensing Authority was also informed that Coronil tablet may be used as a supporting measure in the management of COVID-19 without claiming cure," she added.
The MoS was responding to a question on whether the Centre has upgraded the license for Patanjali Ayurved's Coronil from an "immunity booster" to a "supporting measure" in treating COVID-19 and the details thereof along with the data/studies based on which such an upgrade was approved.
Explaining the rules under which such approval was granted, Pawar said the regulatory provisions for granting license and approval of Ayurvedic, Siddha, Unani and Homoeopathy drugs are prescribed under the Drugs and Cosmetics Act, 1940 and Rules 1945. The Section 3(a) and Section 3(h) define all Ayurvedic, Siddha, Unani medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of diseases or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in the First Schedule.
"The State Licensing Authority Uttarakhand has granted the license of drug Coronil after examination of the application submitted by the applicant. The State Licensing Authority Ayurveda, Government of Uttarakhand was informed that Coronil tablet may be used as supporting the measure in the management of COVID-19 without claiming cure," the minister added.
Previously Medical Dialogues reported that Patanjali Ayurveda brewed controversy after it claimed that its Coronil tablet had received certification from the Ayush Ministry as a medicine supporting COVID-19 treatment as per the World Health Organization's certification scheme.
Reacting to Patanjali Ayurveda's claims of Coronil being a curative against coronavirus, the Indian Medical Association (IMA) pointed out that the Central Drugs Standard Control Organisation (CDSCO) has not given permission for the use of Coronil for the treatment of Covid-19.
IMA filed for an RTI to know if the Central Drug Standard Control Organisation (CDSCO) has issued any license for the use of Coronil in the treatment of COVID-19. In response, CDSCO informed the association that they are not the concerned authority to grant certification for such medications as it comes under the ambit of state licensing authorities. Finally, now, the State Licensing Authority of Uttarakhand has granted permission to Coronil to be used as a supporting measure.
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