A proposal by Baba Ramdev's Patanjali Research Foundation Trust to begin trials of its Ayurvedic medicines on COVID-19 patients has prompted Congress leaders to seek a probe into the district administration's response.
Former chief minister Digvijaya Singh said he was surprised after reading reports which claimed that Indore District Collector Manish Singh gave the nod to Patanjali without the approval of the country's Drug Controller.
Manish Singh rubbished claims that he had approved Patanjali's proposal. "Confusion is being spread in this regard," the bureaucrat said.
"I am sure Collector Indore was blissfully unaware of these guidelines. I would request him and GOMP not to treat citizens of Indore as Guinea Pigs to oblige some one close to The Powers That Be. The orders should immediately be withdrawn," Digvijaya Singh tweeted on May 23.
"There are Guidelines for approval of new drug, and this guideline is based on regulatory requirement for drug approval in India as prescribed under Drugs and Cosmetic Act and Rules made there under and its various amendments," he added.
The Congress veteran also said there is a certain legal protocol under the Drug Controller General of India only after which a drug can be tested on humans.
"Has Patanjali taken approval for its products from DCGI? If not then have they not violated the Law? Shouldnt they be held responsible and be prosecuted?
"When I checked with senior officials of GOMP I was told that GOMP has not given any permission to Patanjali to give Drugs for trials to Corona patients in Indore. I spoke to Collector Indore and he promised to look into it," he tweeted.
State Congress spokesperson Neelabh Shukla sought a high-level probe into the matter.
"The district administration has no authority to either sanction or scrap any proposal for clinical trials on COVID-19 patients," Shukla said.
An official said the May 19 proposal by the Haridwar- based organisation was to test the "effect on resistance, boosting immunity and curative ability" of the drug.
Some activists and local Congress leaders claimed the district administration gave its nod to the Patanjali proposal in a hush-hush manner, but withdrew it after reports about it appeared in a section of media.
A day after Patanjali submitted the proposal, Ramdev told Madhya Pradesh Chief Minister Shivraj Singh Chouhan that Ayurvedic medicines gave "good results" on virus patients.
Anurag Varshney, vice president of the Patanjali Research Institute, had sought permission from the Mahatma Gandhi Memorial Medical College Dean Jyoti Bindal to conduct the controlled clinical trials.
Bindal said she forwarded Patanjalis proposal to principal secretary of the state medical education department for clearance. It has not been cleared so far, she added.
An NGO, Jan Swasthya Abhiyan Madhya Pradesh, wrote to the Union Ministry of Health and Family Welfare, Drug Controller General of India, Indian Council of Medical Research and AYUSH Ministry demanding to look into the alleged administrative sanction to Patanjali's proposal.
"Media reports said the district Collector approved the proposal for clinical trial of some Ayurvedic medicines of the Patanjali group on COVID-19 patients but later quashed it," the NGO's co-convenor Amulya Nidhi said.
Patanjali Ayurved's Managing Director Acharya Balkrishna told PTI that there is a need to understand the company does not want to undertake any new experiment or trial of Ayurvedic treatment regime on COVID-19 patients in Indore.
"Our proposed treatment regime for this pandemic is based on traditional Ayurvedic medicines already being used by millions of people. We want to prove this treatment methodology globally through scientific evidence," he said.
"We are going by the book for documentation of this scientific process. Multinational companies and other vested interests are behind raking up a controversy unnecessarily.
They don't want to see Ayurvedic advancements," he said.
First Published: IST