Rajasthan Health Minister Raghu Sharma has said that Baba Ramdev didn't take permission from the State Govt for conducting the clinical trials for a drug launched by his company that claims to cure the COVID-19 disease.
Raghu Sharma said that the State Govt had not received any proposal for clinical trials for the drug, nor had they have given any permission to anyone in this regard.
He warned, “Human trials cannot be carried out without permission of the state government. Those conducting clinical trials without government permission are misleading the people & strict action will be taken against them".
Regarding Ramdev’s claim, Sharma said that Ayurvedic medicines could act as immunity boosters but claiming a cure without permission of the Ayush ministry was not acceptable.
Baba Ramdev had on Tuesday claimed that his team of researchers at Patanjali Ayurved had found a medicine to cure Coronavirus. Ramdev said clinical trials had been conducted along with the National Institute of Medical Sciences (NIMS) University in Jaipur.
NIMS director Dr Anurag Tomar said that all the necessary approvals for the clinical trials had been taken & permission from CTRI was taken before the trials were conducted.
The Ayush ministry has asked Baba Ramdev to provide details about the medicine & to stop advertising the products.
Sharma warned that if anyone was found selling the Baba Ramdev’s claimed medicine for curing Covid-19, strict action will be taken against that seller.
The minister further said that a gazette notification issued on June 21, 2020 by the Centre under the Drugs & Cosmetics Act, 1940 & 1945, says that no one can sell any Ayurvedic drug for Covid-19 without permission from the Ayush ministry.
In a statement, Sharma said that “If anyone is found selling any drug for curing Covid-19, strict action will be taken against the seller as per the law".
He said that the Rajasthan Govt is complying with the guidelines of the Union health ministry, the Ayush ministry & the Indian Council of Medical Research (ICMR) in treatment of Covid-19 patients.
Sharma said if anyone wants to conduct clinical trials, these have to approved by the scientific advisory bodies & institutional ethics committee. He added that after the proposal to conduct clinical trial is registered with Clinical Trials Registry India (CTRI), the sample size should be adequate & the trials have to be as per guidelines of Ayush ministry & ICMR & has to be done as per the biomedical & health research guidelines.
Sharma said that “The human participation has to be as per ICMR’s national ethical guidelines, & participation by registered Ayush doctors has to be ensured".
Regarding NIMS, the Rajasthan minister said that suspected Coronavirus patients had been kept there in institutional quarantine for a few days. “How could clinical trials be conducted on them when it was not clear whether they were infected with the coronavirus?”
On Baba Ramdev’s allegations that patients on whom clinical trials were conducted had recovered in 7 days, Sharma said in normal course too, patients are recovering in 7 days.
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