Rajasthan health minister Raghu Sharma has said that Baba Ramdev did not take permission from the state government for conducting the clinical trials for a drug launched by his company that claims to cure the coronavirus disease.
Sharma said that the state government had not received any proposal for clinical trials for the drug, nor had the they have given any permission to anyone in this regard.
“Human trials cannot be carried out without permission of the state government. Those conducting clinical trials without government permission are misleading the people and strict action will be taken against them,” he warned.
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 Covid-19. 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 and permission from CTRI was taken before the trials were conducted.
The Ayush ministry has asked Baba Ramdev to provide details about the medicine and 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 and Cosmetics Act, 1940 and 1945, says that no one can sell any Ayurvedic drug for Covid-19 without permission from the Ayush ministry.
“If anyone is found selling any drug for curing Covid-19, strict action will be taken against the seller as per the law,” Sharma said in a statement.
He said that Rajasthan government is complying with the guidelines of the Union health ministry, the Ayush ministry and 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 and 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 and the trials have to be as per guidelines of Ayush ministry and ICMR and has to be done as per the biomedical and health research guidelines.
“The human participation has to be as per ICMR’s national ethical guidelines, and participation by registered Ayush doctors has to be ensured,” said Sharma.
Regarding NIMS, the Rajasthan minister said that suspected Covid-19 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 claims that patients on whom clinical trials were conducted had recovered in seven days, Sharma said in normal course too, patients are recovering in seven days.