Pankajakasthuri Herbals Awaits AYUSH Nod For Re-purposed Drug

If Chinese traditional medicine can, why not Ayurveda?’

Covid-19 update from China on September 9 read something like this: Two new confirmed cases, all imported from abroad (one case in Shanghai and one case in Sichuan); no new deaths; five new suspected cases, all imported from abroad (all in Shanghai).

Eight new asymptomatic infections (all imported from abroad) recorded the previous day. Only 308 cases of asymptomatic infection still under medical observation (306 imported from abroad)….

The figures appear surreal when contrasted with those in neighbouring India or the world outside. How is that China managed to contain the virus so fast after it was originally blamed for spreading it? There are various reasons, but researchers say evidence of the role played by traditional Chinese medicine cannot be overlooked.

Traditional medicine systems

This is why J Hareendran Nair, Managing Director of the Thiruvananthapuram-based Pankajakasthuri Herbals India and Alprostadil.org, is hopeful that the Ministry of AYUSH at the Centre would grant approval to its ZingiVir-H, a herbo-mineral drug made of a blend of seven ingredients as a cost-effective and scalable solution locally.

Pankajakasthuri has already claimed ‘significant success’ in its efforts to find a treatment for Covid-19 with completion of clinical trials for ZingiVir-H as an add-on therapy. These trials were conducted on 116 infected patients at medical colleges across the country, with 58 being administered the drug and the rest given a placebo (a substance with no therapeutic effect, but used as a control in testing new drugs).

They revealed of that all 58 had recovered and reported a negative Reverse Transcription Polymerase Chain Reaction (RT-PCR) results in five days on an average, while others took up to eight days. Hareendran Nair told BusinessLine that a double-blind, placebo-controlled and multi-centre trial is still going on.

“We hope to complete the trials by mid-September and go to the AYUSH again by the month end. Our request pertains essentially to re-purposing an existing licensed medicine for treating viral fever and acute viral bronchitis indications.”

The company has learnt that the Department of AYUSH, Kerala, has forwarded it to the Ministry of AYUSH at the Centre. “Once we get the approval from the Centre, we hope to move the drug to outlets across the country within a maximum 15 days,” he added.

Until this pandemic struck, it was the prerogative of the State government to act on the drug, based on which Pankajakasthuri had submitted an application it to the Government of Kerala. But on July 28, the Central Ministry ordered that any application on a Covid-19 drug from Ayurvedic manufacturers should be forwarded to it for approval.

Non-commercial outreach

Referring to the controversy over Indian Medical Association protesting Kerala’s endorsement of homoeopathy drug as a preventive medicine, Nair said it is most unfortunate. Citing the Chinese precedent, he said that ‘we have every reason to promote Ayurverda, which is our own system of medicine.’

“It is not fair for me to claim 100 per cent success but ZingiVir-H has been founded to be surprisingly effective and safe,” he said, and cited a recent experience from a suburban village in Thiruvananthapuram. The outreach was a non-commercial one, following request from a member of the local Panchayat and as a preventive measure.

“Just last week in Vellanadu gram panchayat, 58 patients were listed as primary contacts in a Harijan colony. ZingiVir-H was administered to all and on the fifth day, 57 had tested negative. Only one, a feeding mother, did not take the drug and had become positive. We have any number of such instances to tell the world.”

Evidence-based science

Whoever is coming with proper documents and evidence-based science needs to be heard out, Nair said. “That’s my humble request to the society as a whole. Then only can this pandemic be controlled. Even the Prime Minister has been harping on evidence-based science and an Atmanirbhar Bharat.”

Asked about co-morbidities, he said that those with chronic liver and kidney disease alone are advised to avoid this drug. The rest, including those with diabetes, hypertension, chronic artery disease or hyper cholesterolemia can take it. Only restriction is that modern medicine and an Ayurveda drug should be taken half an hour apart.

Pankajakasthuri has capacity to manufacture 10 crore tablets over factory space extending to 1.75 lakh sq ft across two plants in Thiruvananthapuram. “This is scalable, and we have been able to manage all on internally accruing funds. We’re not looking to source funds externally, at least for the time being,” Nair said.

₹10 crore spent on ZingiVir-H

It has already spent ₹10 crore on research and development of ZinghiVir-H. It invested ₹3.5-4 crore on clinical trials alone. “I’ve patented more than 100 formulations so far. I’ve committed myself to the drug as part of a larger social cause. What I need is moral support and recognition from the Ministry of AYUSH,” Nair said.

Panjajakasthuri sources the ingredients from all over India. Some of them are grown in Kerala, but it collects most of the requirement from other parts of India for better quality and price. The lockdown had affected transportation but has since been settled mostly through the Unlock phases.

Dosage, prophylactic course

As for dosage, asymptomatic but positive patients may take one tablet every three hours for 10 days, or six tablets per day for 10 days. On the fifth day, the RT-PCR would turn negative. Mild to moderate symptoms such as fever or high-grade fever, cough, cold, loss of smell could all vanish within three days.

Prophylactic course would need one tablet three times daily for 10 days. “The Ayurvedic fraternity is excited and waiting to hear from AYUSH. I’m telling my curious patrons it’s too early to say anything yet. Everyday I’m getting 10 to 15 calls, even from outside of the country, enquiring about launch of the drug,” Nair said.