A government notification bars companies from advertising a cure without government approval. But it wasn't immediately clear if the drug can still be sold.
Talking to PTI, Ramdev
said the medicines have been developed by Patanjali Research Center, Haridwar and privately-owned National Institute of Medical Science, Jaipur following all protocols with clinically controlled trial-based evidence.
"Patanjali first conducted clinical case study and conducted clinical control trials following all protocols of drug discovery," he said.
Sidestepping questions on the drug being approved by government agencies such as ICMR, Ramdev
said clinical controlled study of these medicines was done in several cities including Delhi, Ahmedabad and Meerut and the RCT (Randomized Clinical Trial) controlled with placebo was conducted at Jaipur-based National Institute of Medical Sciences & Research.
"This was done after getting approval from Clinical Trial Registry of India (CTRI) and all other required formalities," he said. "We have followed all the parameters set up by modern science for such clinical trials."
Reacting to the announcement, the Ministry of Ayush
issued a statement saying, "Facts of the claim and details of the stated scientific study are not known" to it.
Ltd has 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," the ministry statement said.
The ministry also asked the concerned State Licensing Authority of Uttarakhand Government to provide copies of license and product approval details of the Ayurvedic medicines being claimed for the treatment of Covid -19.
Under the ministry's guidelines for drug development of ayurvedic formulations, state licensing authority grants licenses for manufacturing any Ayurvedic, Siddha or Unani medicine.
Ramdev at a launch press conference in Haridwar, where his company is based, claimed that his ayurvedic drugs have shown 100 per cent favourable results during the clinical trial.
"We conducted a clinical case study and clinical controlled trial, and found 69 per cent patients recovered in 3 days and 100 patients recovered in 7 days," he said.
According to him, this medicine is useful for prevention from Covid-19
and also for treatment.
Claiming that during the trial other complications of patients were also cured and their critical parameters were normalised, he said no infected patient lost his life during the trial.
Patanjali, he said, had started to work on corona medicines in December 2019. The Corona kit, priced at Rs 545, would be available pan India within a week. The kit will have medicines for 30 days.
Ramdev said the medicines can be ordered online through a mobile app from next Monday.
therapy suggested by Patanjali is applicable for adults ranging between 15-80 years of age whereas children are advised to take half the dosage prescribed for adults.
Patanjali's anti-Covid tablet, Divya Coronil Tablet consists of Giloy, Tulsi and Ashwagandha and is prescribed to be taken thrice a day with hot water 30 minutes after breakfast, lunch and dinner.
Medical experts, however, were not convinced by the claims.
Dr Ravi Shekhar Jha, Head of the department and senior consultant, Pulmonology, Fortis Escorts Hospital, Faridabad, said physiologically it is quite impossible that there is any medicine which can finish the viral load from the body in 5-7 days.
"These claims can be very harmful because people, instead of taking actual medical help, may start rushing to these kinds of claims which have no proven clinical trial," he told PTI.
Instead of taking actual medical help, opting for a "desi nuskha" kind of a thing is just going to result in loss of precious time in curing the disease, Jha said.
Noted city-based lung surgeon Dr Arvind Kumar said only a proper clinical trial can prove the efficacy of the medicine.
Haridwar-based Patanjali group has an estimated turnover of around Rs 10,500 crore. It had acquired debt-ridden Ruchi Soya in a corporate insolvency resolution process for around Rs 4,350 crore after competing with Adani Group.
The group is also known for venturing in uncharted areas as it had in August 2018 launched a messaging app 'Kimbho', which could not take off and is now defunct.
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