Priyanshi Srivastava
SVKM’s NMIMS School of Law, Mumbai
INTRODUCTION
Patanjali Ayurveda made a claim about developing an Ayurvedic cure for COVID-19 pandemic. The founder and managing director Ramdev and Balkrishnan announced to media that they have developed a 100% cure for covid-19 pandemic with the help of two medicines “coronil and swasari”. Patanjali issued a statement claiming that after administration of these drugs covid-19 patients become asymptotic within 3 to 15 data. They added that the ‘clinical case study’ of these drugs has been done in several cities like Delhi, Meerut, and Ahmedabad. Patanjali stated that these medicines will come in the form of coronil kit of price ₹ 545, and will be sold across India within a week. Ramdev added to his statement that this cure is “clinically controlled” to lend scientific gravity to the medicine.
However, the AYUSH Ministry has sought details about the medicine and has directed Patanjali and Ramdev to stop advertising such claims.
At the launch in Haridwar, Ramdev claimed that Coronil tablet “swaswari vati” and “anu taila” had shown 100% favorable results during the clinical trial on COVID-19 patients.
RESPONSE OF THE AYUSH MINISTRY
Taking cognizance of the news, The AYUSH Ministry in a statement mentioned, “Facts of the claim and details of the stated scientific study are not known to the ministry”. The statement says that Patanjali Ayurveda ltd has been spoken to provide at the earliest, the details of the name and composition of the medicines being claimed that will treat COVID-19; the site(s) hospital where the research study was conducted; protocol, sample size, institution ethics committee clearance CTRI registration and results in studies and to stop advertising/publicizing such claims until the issue is duly examined.
On this issue, the AYUSH Ministry has also requested the Uttarakhand State Licensing Authority to provide copies of the license and product approval details of the Ayurvedic medicines which the company has claimed will treat COVID-19.
VIOLATION OF AYUSH MINISTRY’S DIRECTIVE
On 21st April, the Ministry has imposed several conditions while giving approval for research for covid-19. According to the conditions it is mandatory for the institution to apprise about the research developments to the AYUSH Ministry.
Instead of this directive, Patanjali didn’t inform the whole process to the ministry as the AYUSH Ministry itself in its response mentioned. It was considered the unilateral declaration without prior consultation with the ministers, and hence violating the directive.
VIOLATION OF DIRECTIVE AGAINST FALSE CLAIMS OF COVID-19 CURE
The AYUSH Ministry issued a directive on 1st April, to stop and prevent the advertisement of AYUSH related claims for covid-19 cure would fall under the ambit of false claims.
The Union Ministry, on 24th march, had declared that making false claims with respect to covid-19 will be a punishable offense under the National Disaster Management Act.
VIOLATION OF DRUGS AND MAGIC REMEDIES (OBJECTIONABLE ADVERTISEMENT ACT, 1954)
This section will be relevant for the current situations.
Sec 4 of this Act discusses about :
Prohibition of misleading advertisements related to drugs, if the advertisement contains any matter which:
1. Directly or indirectly gives a false impression regarding the true characteristics of the drug.
2. Or makes a false claim for the drug
3. Is otherwise false or misleading in any material particular.
4. The violation of the Act can lead to a punishment of imprisonment up to 6 months on the first instance and 1 year for a subsequent offense. The offense under this is a cognizable offense.
PROHIBITION ON ADVERTISEMENT OF AYUSH DRUGS
In 2018 rule 170 was inserted to the Drugs and Cosmetics rules,1945 by the Central Government through an amendment. This amendment specifically prohibits the advertisement of any AYUSH drugs for the use of diagnosis, cure, mitigation, treatment and prevention of any disease, disorder, syndrome or condition, which indicates that AYUSH drugs cannot be advertised for therapeutic purposes.
The rules said:
“The manufacturer or his agent, of Ayurvedic, Siddha or Unani drugs, shall not participate in the publication of any advertisement relating to any drug for the use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome, or condition”.
VIOLATION OF DRUGS AND COSMETICS ACT RULE
It is ambiguous under what terms Drug Licensing Authority of Uttarakhand issued a license to Patanjali for the manufacture of drugs.
The AYUSH Ministry has requested the Uttarakhand State LicensingAuthority to provide copies of the license and product approval details of the Ayurvedic medicines which the company has claimed will treat COVID-19.
According to some reports it was mentioned that at the moment of application for license Patanjali mentioned that they are developing an immunity booster medicine with respect to COVID 19 rather than specifying that they are developing a cure for COVID 19.
CONCLUSION
Patanjali has committed many legal violations by publicizing and advertising such drugs that have not gone through due verification. Now an FIR is filed against Patanjali and Ramdev in the state of Bihar alleging that Ramdev has misled the people and endangered their life.
