The AYUSH ministry said that it has asked the State Licensing Authority to provide copies of the license and product approval details of the medicine.

Baba Ramdev co-founder of Patanjali Ayurved
news Coronavirus Wednesday, June 24, 2020 - 15:00

Patanjali did not mention that it was developing a drug for coronavirus, the State License Authority for Ayurveda of the Uttarakhand government said, according to ANI. Patanjali’s application reportedly stated that it was for an immunity booster and for cough and fever, based on which a licence was issued.

“We'll issue them a notice asking how they got permission to make the kit,” the official said.

This comes after the AYUSH ministry said that it has asked the State Licensing Authority to provide copies of the license and product approval details of the Ayurvedic medicines being claimed for the treatment of COVID-19.

Patanjali was advertising its Ayurved-based 'Coronil and Swasari', medicine which they claimed to be a cure for COVID-19.

Ramdev claimed that Ayurved-based 'Coronil and Swasari' medicine have shown 100% favourable results during clinical trials on COVID-19 infected patients except those on a life support system, the AYUSH Ministry sought from the company detailed report on composition, testing and other data of the drugs.

"We conducted a clinical case study and clinical controlled trial, and found 69% patients recovered in 3 days and 100 patients recovered in 7 days," Ramdev had claimed. 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.

It has however now been found that the clinical trials were conducted on 120 patients who were asymptomatic and mildly/moderately symptomatic between the ages 15 to 80 years. The trial excluded severely symptomatic patients, those with Acute Respiratory Distress Syndrome (ARDS) and those who had a life expectancy less than 1 year due to other comorbid conditions.

Patanjali, he said, had started to work on corona medicines in December 2019.

After the medicine was publicised, the AYUSH ministry had asked the company to stop advertising or publicizing its claims of corona cure drug until the issue is examined by the ministry.

Under the ministry's guidelines for drug development of ayurvedic formulations, state licensing authority grants licenses for manufacturing any Ayurvedic, Siddha or Unani medicine.

The government notification bars companies from advertising a ‘cure’ without government approval.

Acharya Balkrishna, MD of Patanjali, said the Modi government is one that promotes Ayurveda and communication gap has been bridged.  "We have 100% fulfilled standard parameters of Randomised Placebo Controlled Clinical Trials and information about the same has been communicated to the AYUSH Ministry," he said.

The company also released an 11-page reply it sent to the AYUSH Ministry that detailed composition of medicines; IEC clearance and CTRI registration; and protocol sample size and result data of the study.

"The trial was being conducted and registered with Clinical Trial Registry of India (CTRI)," it said in the response.

With inputs from PTI

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