Ramdev and the Coronil claim: Patanjali treading on thin legal ice, but enforcement gaps might let yoga guru get away with COVID 'drug'
Patanjali Ayurved is treading on thin legal ice with regard to the true effect of the drug compared to what is claimed. Considering the widespread adverse impact that could result from reliance upon an ineffective drug during a deadly pandemic, the question also arises as to whether the usual standard of approval of new drugs is sufficient for the present situation or whether a different standard has to be adopted despite the urgent need for a remedy.
As the world looks for solutions for the pandemic that has held us hostage for the last few months, and threatens our way of life for at least the next few, Patanjali Ayurveda Ltd on Wednesday launched an Ayurvedic medicine – named Coronil, and claimed that it's a cure for COVID-19 .
The news was met with skepticism from some quarters who, cognizant of the rigorous and time consuming process by which comprehensive clinical trials are conducted and new drugs are innovated, felt that the drug being touted by Patanjali Ayurveda did not meet those standards.
Soon enough the AYUSH Ministry of the Government of India issued a statement denying any knowledge of the scientific study claimed by Ramdev's Patanjali and said that advertisement of any such medicine is covered under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
In response Patanjali Ayurveda doubled down on its assertion claiming that it was merely a “communication gap” with the government authorities, and further stated that they had in fact received approvals from Clinical Trials Registry – India (CTRI) for the Clinical Trials and that they had conducted the study with NIMS Jaipur.
Separately, the License Officer of the Uttarakhand Ayurved Department released a statement that they only approved a license for immunity booster, cough and fever and not as a cure for COVID-19 .
Guidelines for development of ayurvedic drugs
The AYUSH ministry in 2018 had issued detailed guidelines for clinical research in the Ayurveda, Siddha, Unani and Homeopathic systems. The AYUSH Ministry, in its notification of 21 April, sought to plug the gap in the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 which do not provide specific procedures for conducting clinical trials in Ayurveda, Siddha, Unani, Homoeopathy drugs.
The ministry declared that the clinical trials for new drugs in these systems for COVID-19 would have to be conducted as per the AYUSH guidelines or guidelines of the ICMR.
While it remains to be seen as to whether Patanjali Ayurveda can substantiate its claim on successful clinical trials and the approvals, it is important to consider what the effect of a false advertisement could be in legal terms.
Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940 did not originally contemplate the regulation of Ayurvedic medicines. It is only by the insertion of Chapter IVA in the Act (with effect from 1969) that some regulatory arrangements for AYUSH medicines were made.
Section 33E of the Drugs and Cosmetics Act deems an ayurvedic drug to be “misbranded” if the label, container or anything accompanying the drug contains a false claim about the drug and the sale of such misbranded drugs is prohibited. Sale of a misbranded drug or a drug without a valid license is punishable by imprisonment up to one year.
Drugs and Magic Remedies Act
Section 4 of the Drugs and Magic Remedies Act prohibits the publication of any advertisement which makes a false claim for the drug or gives a false impression about the true character of the drug. Contravention of this section is punishable by imprisonment of up to six months the first time the person is held guilty and up to one year for each subsequent conviction.
Efficacy of the legislations
The track record of the Drugs and Magic Remedies Act has been sketchy at best.
The Department Related Parliamentary Standing Committee on Health and Family Welfare in its 95th report in 2016 identified two major weaknesses in the enforcement system of the Drugs and Magic Remedies Act in the context of Ayurveda, Siddha, Unani, and Homoeopathic medicines.
First, the licensing authority at the level of the states was stated to be weak. Second, there was no definition of a new drug. As a result, the only requirement for granting license for a new drug was the production of proof of safety and efficacy of a drug which could even be an article on the efficacy of the drug. It is to remedy this situation that the AYUSH ministry formulated the new guidelines mentioned above.
The Committee also recommended further amendments to the Drugs and Magic remedies act, to enhance the powers under the Act, to make it more effective. While a draft amendment bill had been published in February 2020, enhancing the punishment to two years and making other changes has not yet been enacted and brought into effect.
In this scenario, Patanjali Ayurved is treading on thin legal ice with regard to the true effect of the drug compared to what is claimed. Considering the widespread adverse impact that could result from reliance upon an ineffective drug during a deadly pandemic, the question also arises as to whether the usual standard of approval of new drugs is sufficient for the present situation or whether a different standard has to be adopted despite the urgent need for a remedy.
The author is a lawyer practicing in the Supreme Court and other courts and tribunals in Delhi