Jaipur: Health department issues notice to NIMS for conducting Covid-19 clinical trials

JAIPUR: The state health department has issued a notice and sought reply from NIMS Hospital for conducting clinical trials on Covid-19 patients without informing the state government and the Centre. Based on these clinical trials, Patanjali Ayurveda Ltd has claimed to have produced the "first and foremost ayurvedic remedy", ‘Coronil’, for mitigating corona virus-induced mild and moderate clinical signs and symptoms.
Health minister Raghu Sharma said that no one has applied for permission for this drug and no permission had been granted by the state government for the same. NIMS officials have refuted the charges and claimed that they had all the required permissions to conduct the clinical trials.
The minister said as per a notification issued by the Centre on April 21, under the Drugs and Cosmetic Act, no Ayurvedic medicine can be sold as a medicine for Covid without the permission of AYUSH ministry. “Appropriate action will be taken against the seller of ayurvedic medicines as Covid drugs,” said Sharma.
Reacting to Ramdev’s ayurvedic medicine, he said that it can be used as an immunity booster. The claim that the medicine can treat Covid patients cannot be accepted until the AYUSH ministry gives it permission.
He said that human clinical trials cannot be conducted in the state without the permission of the state government. He said action would be taken against such people who try to mislead the public.
“We will initiate an investigation, if required, if they have violated norms. We will take legal action against them as per law, if they have violated norms,” said Dr K K Sharma, director (health), health department.
The health department said that more than 400 Covid patients had been admitted to NIMS Hospital for treatment. “We have taken cognisance of media reports published about the clinical trials of ayurveda medicine for Covid patients. We are not aware about the clinical trials. We came to know about it only through media reports. Taking it on a serious note, we have issued notice to the NIMS Hospital. Without informing the state government and the Centre, clinical trials have been conducted,” said Dr Narrottam Sharma, chief medical health officer, Jaipur (I).
The health department has given hospital authorities three days to reply. The department will also investigate if consent was taken from patients for being part of clinical trials.
A joint press release was issued by Patanjali Research Institute, Haridwar, and the National Institute of Medical Sciences (NIMS) University, Jaipur, on Tuesday to launch the drug claiming that ‘Coronil’ is the "first and foremost ayurvedic remedy for mitigating coronavirus-induced mild and moderate clinical signs and symptoms".
“This herbal remedy is basically a combination of 'divya swasari vati', 'giloy ghan vati', and 'ashwagandha' extract along with 'divya anu taila'. The aforementioned treatment modalities have shown significant results within a time span of 3-7 days as far as minimising the virus load is concerned,” they claimed in the press release.
The release also claimed that a clinical trial was successfully conducted on 95 patients, divided into placebo and treatment groups. Patients were checked for Covid viral load, Interleukin 6 (IL-6), and HS-CRP levels on the first, third, and seventh day. In the placebo group, a recovery of the viral load was detected at 52% on day 3, and 65% on day 7.
In the treatment group, the viral load recovery was 69% on day 3 and 100% on day 7. A similar substantial recovery was also determined for the clinical parameters such as IL-6 and HSCRP levels. For these parameters, the recovery in the treatment group was higher and statistically significant as compared to the placebo group, the release claimed.
When contacted, NIMS officials claimed that they had all the permissions required for the clinical trial -- randomised placebo-controlled trials (RCT) related to the ayurvedic medicine -- in Jaipur. “All the prerequisites were fulfilled including the ethical approval of Clinical Trial Registry India (CTRI) (Reg. No.—CTRI/ 2020/ 05/025273),” they claimed in the release.
Meanwhile, a social activist, Dr Sanjeev Gupta, has also filed a complaint at Gandhi Nagar police station. “At a time when Covid has been declared as an epidemic, conducting clinical trials on Covid patients without permission from ICMR, the Centre, drug controller of India, ministry of health is a legal offence,” said Dr Gupta in his police complaint.