Baba Ramdev the so called Mahatma or Saint is well known businessman selling his products with self acclaimed medicinal properties and with a guarantee to cure various serious ailments. This time he has jumped on with the opportunity to earn money in the name of Covid-19, medicine.

He has claimed that his medicine Coronil tablet, Swasari Vati and Anu Taila, can 100% cure Covid-19 and the same has been proven in clinical trials. No one knew about alleged clinical trials of Baba Ramdev, not even the government bodies such as Ministry of Ayush.

There are certain rules which are prescribed worldwide for clinical trials on humans; the same rules are applicable in India. Let me explain in detail that Government of India formulated New Drugs and Clinical Trials Rules 2019, under Drugs and Cosmetics Act 1940, the rules were published in Gazette of India on 19/03/2019, and it came in to operation same day.

Clinical Trial has been defined in Rule 2(j)as   in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its,- (i) clinical or; (ii) pharmacological including pharmaco dynamics, pharmacokinetics or; (iii) adverse effects, with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug.

It is important to mention that Ministry of Ayush also came out with guidelines for clinical trials namely General Guidelines for Clinical Evaluation of Ayurvedic Interventions. One can find these guidelines on this link https://www.ayush.gov.in/docs/clinical_evaluation.

According to the guidelines issued by Ministry of Ayush all clinical trials in India have to get registered them self with ICMR, as it is mandatory to register in The Clinical Trial Registry India. The enrolment is mandatory for trany medicine including Ayurvedic medicine and before enrolment of first participant for human trial. It is also pertinent to mention that before registration with CTRI, it is mandatory to seek prior approval of Ministry of Ayush as per guidelines.

The idea of registration in CTRI, is that all such trials are under public domain and available on internet site  (www.ctri.nic.in). and are regularly monitored. Now let me refer to WHO guidelines for research on traditional Medicines. These guide lines are known as General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine,

These guidelines are available at https://apps.who.int/iris/bitstream/handle/10665/66783/WHO_EDM_TRM_2000.1.pdf;jsessionid=3F17CA384FAAA5F475752B9853D2546C?sequence=1. If you go through the guidelines it prescribes detailed requirements for clinical Research and trial of Traditional medicine which includes Ayurveda. It prescribes number of tests on animals  before a medicine can be tested on humans.

The list of Observations and Examinations is provided in the guidelines. The Ministry of Ayush has also referred to WHO guidelines for clinical research. It is apparent that Baba Ramdev has not followed any guidelines nor got his alleged research registered with CTRI. It is quite surprising that without getting clearance from any government authority for research, production and marketing of drug, he himself launched the so called Covid-19 medicine.

The Third Schedule of New Drugs and Clinical Trials Rules 2019, provides complete guidelines for Clinical Trial as follows:

1. Clinical trial shall be conducted in accordance with the provisions of the Act and these Rules and principles of Good Clinical Practice Guidelines.
    
2. Clinical trial on a new drug shall be initiated only after the permission has been granted by the Central Licencing Authority and the approval obtained from the respective ethics committee.
    
3. The Central Licencing Authority shall be informed of the approval of the respective institutional ethics committee in accordance with these rules.
    
4. All trial investigator should possess appropriate qualifications, training and experience and should have access to such investigational and treatment facilities as are relevant to the proposed trial protocol. A qualified physician (or dentist, when appropriate) who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions. Laboratories used for generating data for clinical trials should be compliant with good laboratory practices.
    
5. Protocol amendments, if become necessary before initiation or during the course of a clinical trial, all such amendments should be submitted to the Central Licencing Authority in writing along with the approval by the ethics committee, if available, which has granted the approval for the study.
    
6. No deviations from or changes to the protocol should be implemented without prior written approval of theethics committee and Central Licencing Authority except when it is necessary to eliminate immediate hazards tothe trial subject or when change involves only logistic or administrative or minor aspects of the trial. All such exceptions must be immediately notified to the ethics committee as well as to the Central Licencing Authority. Administrative or logistic changes or minor amendments in the protocol should be notified to the Central.
   
   Licencing Authority within thirty days. (https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI2MQ==)

 
It is also important to mention that ICMR has also formulated guidelines for manufacturing of Ayurvedic medicines and complete procedure has been prescribed to be followed. But none of the above Guidelines, Regulations and laws were followed by Baba Ramdev. (https://www.iitm.ac.in/dpaf/nus/ICMR%20IGuidelines.pdf)
 
Now let me examine what action is required to be taken against Baba RamDev and his company Patanjali. The first and formost action should be cancellation of manufacturing licence of Patanjali under rule 84 for violation of rules 81 to 83 of New Drugs and Clinical Trials Rules 2019. The penal action can be taken under section 33 (I) (C) of Drugs & Cosmetics Act 1940, which provides maximum sentence of 5 years.

Apart from the above penal action to my mind criminal case can be registered under section 420 IPC against Baba Ramdev and his associatres for inducing general public to buy his medicine by making false declaration regarding clinical trial of hiS medicine being helpful in 100% cure of CoviD-19.
 
However power to file complaint before Metropoliton Magistrate vest with Central Government under section 33 M of Drugs and Cosmetics Act 1940, and we all know Central Government will never initiate serious action under law against Baba Ramdev. If it was any other ordinary person of this country indulging in similar activity he would have been behind bars immediately.

Written By: Hitender Kapur, Advocate