Coronavirus | Patanjali Ayurved Baba Ramdev told to stop advertising anti-COVID-19 drug
Yoga Guru Baba Ramdev addresses to the media during the event of launch of 'Coronil' and 'Swasari' ayurvedic medicines, claimed by Patanjali Ayurved to cure coronavirus disease, in Haridwar on June 22, 2020.
Centre seeks details on the formulation to verify claims.
Hour after yoga guru Baba Ramdev unveils an Ayurvedic medicine — ‘Swasari and Coronil’ — on Monday, claiming that clinical trials on COVID-19 affected patients had shown favourable results, the Central government asked to the Patanjali Ayurved Limited to stop the advertisement of the drug and sought details on its claimed “successful trial and cure”.
In a statement issued by the Ministry of the Ayush on the claims made by Haridwar (Uttrakhand) based Patanjali Ayurved in treating COVID-19, the Ministry noted that it was took cognisance of the news being recently flashed on its drug by the company. All the Facts of the claim related to the drugs and details of the stated scientific study are not known to the Ministry, the statement said.
List of the details
Patanjali Ayurved asked to provide, at the earliest all details of the name and composition of the medicines being claimed as successful in COVID-19 treatment; hospital(s) / site(s) where the research study was conducted; the sample size, protocol, Institutional Ethics Committee clearance, Clinical Trials Registry-India (CTRI) registration, and results data of the study, and to stop publicising/advertising such claims till the issue had been duly examined.
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The Ministry also requested the concerned State Licensing Authority (CSLA) of the government of uttarakhand to provide copies of the license and the product approval details of Ayurvedic medicines being claimed as useful in the treatment of COVID -19.
Regulated by Act
The concerned Ayurvedic drug manufacturing company has been informed that such advertisements of drugs. We also know that Ayurvedic medicines are regulated under the provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and also the Rules thereunder and the directives issued by the Central Government in the wake of Corona virus outbreak. The Ministry had also issued a Gazette Notification on April 22, 2020 stating the requirements and the way or manner in which research studies on COVID-19 with Ayush interventions/medicines should be undertaken,’’ the Ministry said.
‘100 patients’
Scientists associated with the trial said they had not published the results. Dr. Abhishekh Sharma, Assistant Professor of Medicine, National Institute of Medical Science (NIOMS) and those who supervised the trial he said that 100 patients, who had tested positive for the virus, were recruited for the trial. Of them, 60 were given the medicine and five dropped out midway. The remaining 60 were administered a placebo.
“68% of the 44, when we tested on the third day, we were found clear of the virus and half of those on the placebo recovered,”also said Dr. Sharma. That works out to 32 of those on the treatment tested negative, and 26 of those on placebo tested negative.
No other details on the profiles of the Corona virus positive persons — the degree of sickness in those who went for the trial, their age, whether they were on other medication prior to enrolment — were immediately available.
Clinical trial registry
After check on the clinical trial registry, where all the trials must be registered, showed that a wide spectrum of patients were solicited. Also They were “asymptomatic, moderately symptomatic, mildly symptomatic, and those aged 15-85”. The main aim of the study was to check the status of patients at day 4, day 7 and day 14, and whether they had also improved immunological parameters due to medicine. The medicine regime involved are the Tablet pure tulsi Extract (500 mg), Tablet Pure Ashwagandha Extract (500 mg), Anu Taila (nasal drop), Tablet Swasari Ras (500 mg) and Tablet Pure Giloy Extract (500 mg), according to information on the clinical trial website.
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