ISSUE
The matter titled Mani Kumar v. State of Uttrakhand & Ors was filed as Public Interest Litigation in the Uttrakhand High Court alleging misrepresentation on behalf of Patanjali Ayurved Ltd. in as much as they not having sought approvals for the trials conducted with relation to Coronil tablet. The Petitioner also alleged that Patanjali was wrongfully advertising the Coronil Tablet as a cure for Covid-19 Coronavirus. The Petitioner sought for issuance of a writ in the nature of Mandamus to ban the medicine launched by Patanjali; to take strict action against Patanjali and to award the cost of the Petition to the Petitioner.
THE ARGUMENTS
The Uttrakhand High Court was pleased to issue notices to the Respondents vide Order dated 01.07.2020. Subsequently, Patanjali Ayurved Ltd. filed its appearance and further sought time to file a Counter Affidavit. The same was duly done by Patanjali and arguments ensued.
After a course of lengthy arguments being heard by the Hon’ble Court, the Petitioner then sought time to file an affidavit seeking to withdraw the Petition however, the Petitioner ended up filing a Rejoinder Affidavit seeking to justify the action of the Petitioner. At the same time, the Petitioner also filed a Misc. An application seeking to implead yet another agency as a Respondent.
FINAL ORDER
Finally, the Hon’ble Court vide its Order dated 07.08.2020 dismissed the PIL filed by the Petitioner after having not found a prima facie case against the Respondents and also imposed costs of Rs. 25,000 on the Petitioner. The Hon’ble Court specifically observed the failure of the Petitioner to present a bona fide case against Patanjali along with the presentation of incorrect facts by the Petitioner. The Hon’ble Court also rightfully held that Patanjali was able to counter each and every allegation levelled by the Petitioner and even backed it up with cogent evidence.
A bare extract of the Order dated 07.08.2020 is as follows :
“Each one of the contentions of the Petitioner has been negated by the Respondents and the State agencies that the sixth Respondent is not a manufacturer of the product. On merits, we find absolutely no reasons to entertain this Petition. Incorrect facts have been narrated.
…
Under these circumstances, while accepting the apology of the Petitioner, party-in person, the Petition is dismissed as withdrawn. We deem it just and appropriate that a proper message is sent to those persons misusing public interest. We deem it necessary that the Petitioner, party-in-person, be directed to pay costs of Rs. 25,000 with the Registry of this Court within a period of one week…”
While interviewing about this case with the Partner Athena Legal adv. Simranjeet responded to the queries of INDIAN LAW WATCH
Q1. Congratulations to the legal team of Athena Legal being lead by Mr Kailash Vasudev (Sr. Advocate) along with an Athena Legal Advocate-Simranjeet Singh (Partner, Athena Legal) and also Advocates Mr Sanjay Shandilya and Advocate Mr Ramji Srivastav. What was the greatest challenge while defending this matter? How do you see the impact of this order outside the state of Uttarakhand?
Response: There was no specific challenge, however, the media attention that the issue generated had to be kept in mind.
The impact of this order, in our opinion, will be significant. As the parties to the PIL were the relevant authorities that were involved in the process of the grant of the license. As you would know the license was granted by the concerned department of State of Uttarakhand, it correctly points out that we had applied for the license, which was duly granted to us and thereafter the Ministry of Ayush letter is self-explanatory. At all time our client had acted as per applicable law prior to the grant of the license and even subsequent to it.
The product was only sold after following all applicable guidelines and recommendations of the relevant authorities. Thus, the same would be a crucial aspect when the same issue is dealt with in a different jurisdiction.
Q2.The respondents and the state agencies have negated each one of the contentions of the Petitioner as recorded in the court judgment. So after this legal outcome in favour of Coronil, what are the important takeaways of the judgment for people at large in India?
Response: It is clear that on the merits of the issue at hand we have been absolved of any wrongdoing on our part. The details of the ayurvedic formulation and its testing at NIMS, Jaipur were duly brought to the knowledge of the Ministry of Ayush.
The Ministry vide its letter dated 30th June 2020 clearly stated that the licensee had initiated necessary activities for the management of COVID-19 appropriately and further allowed Patanjali Research Foundation Trust to continue clinical trials as per the Ministry of Ayush Notification no. L11011/8/2020/AS dated 21st April 2020, which was specifically issued in relation to COVID-19.
Thus it can be stated that the Clients business philosophy of always seeking to adhere to the applicable law and act in accordance was the very basis of all their actions.
Q3. According to the General Guidelines for Clinical Evaluation of Ayurvedic Interventions issued by the Ministry of AYUSH, it is necessary to register with the Clinical Trials Registry – India (CTRI) before beginning any clinical trials. What is the correct factual position regarding Coronil on this?
Response: Yes, in this context April 21, 2020, letter of the Ministry of Ayush is very important which stated the process that needs to be followed and spells out the necessity for developing such ayurvedic formulations for the benefit of the public at large.
However, the correct position with regard to CTRI registration can be explained with a little perspective on the stand of the Ministry of AYUSH. The Ministry released several circulars and notifications at the beginning of March-April 2020 to utilize the potential of Ayurvedic Formulations for COVID management.
The Ministry vide its Notification dated 21st April 2020 laid out the methodology for the scientists to carry out research and made certain conditions which were to be followed mandatorily while carrying out the said research.
Response: The Licensee carried out the research as mandated by the said Notification and duly registered with CTRI as well as followed all other applicable conditions.
In view of our strict compliance with the government-mandated notification, the Ministry of Ayush stated that we had acted in accordance with the notification.
On the CTRI registered trials, it is relevant to mention that the same was conducted in collaboration with NIMS, Rajasthan (independent third party). The results of the trials were successful and clearly showed that the said ayurvedic formulation assisted the patients suffering from COVID-19, therefore the Ministry allowed us to continue the trials, which are still on-going. The results as it is were made available to the public for their knowledge and technical know-how at the launch of the Coronil Medicine.
Q4. At the end of the win in this litigation, what is the best way to describe Coronil for people at large-immunity booster or cure for COVID-19? What are the steps being taken by Patanjali to enlighten the public at large about it?
Response: It is pertinent to mention that the Licensee has followed the process as mandated by law and has not deviated from it. The bonafide is further established by the fact that all the relevant details of the tests were duly made available to the relevant authorities as and when they sought it and also informed to the public at large.
However, as per the directions of the Ministry of Ayush, we are only referring to the said product at the present time as an immunity booster for COVID management which is backed up with a robust data set from the clinical trials duly conducted as per the govt Notifications.
As soon as the clearance was granted by the Ministry of Ayush, the same facts as narrated herein-above were duly brought to the knowledge of the public at large via a press conference.
Q5. In a series of events and turns faced by Coronil medicine since its launch by Patanjali, whether there was a change of campaign, if yes then whether or not the same was in any manner hit under section 4 of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954?
Response: I cannot delve much into the said campaign as I am not dealing with their marketing operations. However the client was clear from the very beginning to ensure that all plausible efforts be made to help the general public during this god-awful pandemic, the same started with them being one of the biggest donors in the COVID-19 related PM CARES fund with a donation of 25 Crores and continued with the immense research carried out by the Patanjali Research institute to make a formulation, duly tested under robust trials, as per the procedure prescribed by the law. Further, the herbal ayurvedic formulation that has been termed as CORONIL can be accessed by the masses at large at a relatively low price.
Further in light of the Ministry of Ayush holding our trial to be conducted as per the relevant notification and more so in view of the fact that the same has also given us an approval to go ahead with further research and trials. In our opinion, we are not at all being hit by Section 4 of the Drugs and Magic Remedies Act, 1954.
Q6. What is the legal difference in terms of labelling between ‘COVID management’ and ‘COVID treatment’?
Response: The Clients are following the directions of the Ministry of Ayush and thus have sold our product for COVID management.
Therefore, we want to put the controversy to rest and not be dragged into a debate on terminology. Further and in specific consideration of the fact that the said issue is sub-judice before other Hon’ble Courts of competent jurisdiction, it wouldn’t be correct on our part to state anything further except for what the ministry has allowed us.
