CORONIL exposing drug development process/approval in India?

CORONIL exposing drug development process/approval in India?

CORONIL has launched in India from Patanjali and no formal authority is aware on this on 23 Jun 2020. Paid media showing live coverage of launching of CORNIL and friends and family members celebrated. Main stream media does not know anything about clinical trials or drug development process as we know their main focus would be on religions, Indo-Pak thats it. Hence main stream media did not ask any relevant questions to Baba ji who sits in laboratory with raw materials and as usual media did not involve any relevant panelist.

On 23 Jun 2020 evening, AYUSH ministry finally informed (after launching and completing of this coverage )that this scientific study are not known to ministry and asked Patanjali to stop this advertisements of Ayurvedic drugs and are regulated under the provision of Drugs and Magic Remedies Act 1954 and rules thereafter and the directives issued by the central government in the wake of COVID outbreak. Patanjali Ayurved Ltd has been also asked to provide the earliest details of the name and composition of medicines being claimed for COVID treatment, sites, where the research study was conducted for COVID-19, protocol, sample size, IEC approval, CTRI registration and results of the study sites and also asked to provide licensing authority of Uttarkhand Government to provide copies of license and product approval details being claimed for treatment of COVID-19.

This research has raised so many questions on Indian Drug Regulatory authority which clearly allows anyone can come and claim and do the marketing without proper approvals and no one is here to stop there. This kind of research reminds of Nuremberg code few principles.

• The experiment should be designed and based on the results of animal experimentation and knowledge of the natural history of the disease or other problem under study that anticipated results will justify the performance of the experiment.
•  No experiment should be conducted where there is an priori reason to believe that death or disabling injury will occur, except perhaps in those experiments where the experimental physicians also serve as subjects.
• Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death.

CORONIL Raised below questions

1. Which authority has approved this study and on what basis ?what were the documents submitted? while looking at documents which circulates in social media shows that they just informed to AYUSH ministry on clinical trial conduct which can not be considered as approval.
2. Any clinical trials results should be released and peer reviewed but no one has seen published anywhere.
3. Institutional Ethics Committee seems to be not registered with CDSCO which is mandatory. and if you look at Ethics Committee approval letter which seems to be without member list like who attended that meeting, what documents reviewed for that meeting, IEC seal is missing, when documents were submitted to IEC and nothing is traceable thus how should we consider as IEC approved study. We also want to know the Standard Operating Procedure (SOP) of IEC.
4. CTRI registration- Baba Ramdev claimed in all media channels that Patanjali has registered this trial under CTRI and he considers it as approval? somebody should explain him what is registration and approval.
5. Baba Ramdev claimed that they have conducted trials in different cities like Delhi, Ahmedabad, Jaipur, Merut however if you look at the CTRI which only speaks about NIMS Jaipur.
6. Secondary Sponsor is NIMS Jaipur as per CTRI (Clinical Trial Registry India) where NIMS IEC approved the trial and study conduct at NIMS Jaipur which means it raises questions on "conflict of interest". Conflict of Interest should be declared publicly.
7. Date of first enrollment was 29 May 2020 as per CTRI, outcomes need to be measured for at least 14 days after beginning therapy. Patanjali launched this drug and announcing efficacy on 23 June 2020 and as per CTRI they are still recruiting for patients.
8. As per CTRI, Trial design involved use of Placebo, as per ICH GCP placebo control group does not imply that the control group is untreated. In many placebo-controlled trials, the new treatment and placebo are each added to a common standard therapy which is not available in COVID19.
9. Did Principal Investigator give current standard of care (supportive therapy) for COVID19 or not (for the patients who needed therapy). if not then there is major ethical issue
10. Blank Informed Consent Document (ICD) should be thoroughly checked where Patanjali claims to use of Placebo in trial.
11. This study enrolled 120 COVID mild and moderate ill patients and looked at viral clearance and decrease in IL-6 levels as endpoints. IL-6 the indicator of severe inflamation and cytokine storm is unlikely to be elevated early in these patients. how would drug impact it? complete mechanism of actions is required to prove this.
12.  Patanjali bypassed DCGI, clinical trial regulations, ethics and even they launched event on live TV as promotion gimmick.

Concerns are very clear now and we as public are not expecting negligence in medical research, medical ethics in 2020 where we are claiming to be "Viswa guru" on another side. Ministry of Health and Family Welfare should look into this and take appropriate actions. I also urge government officials to audit this study at the earliest to prevent further damage.

Reference:

1) No particular reference as all claims are made in social media and TV (attached below)

2) Drugs and Cosmetics Act 1940

3) Central Drugs Standard Control Organization

4) Indian Council of Medical Research