AYUSH Ministry initiates efforts to bring Indian traditional medicines under D&C Act 1940

With an objective to find a possible solution to the COVID-19 pandemic, the AYUSH Ministry has initiated efforts for the development of drugs based on any AYUSH system. It has also undertaken steps to recognise them under the Drugs and Cosmetic Act 1940.

Recently, the Ministry of AYUSH issued a notification, stating that there has been a surge in proposals received by the Ministry, claiming possible treatment of COVID-19. Therefore, based on consultation with CDSCO, the Ministry of AYUSH, with the approval of Minister of State Independent Charge for AYUSH has notified that scientists, researchers, clinicians of any recognised system of medicine can carry out research on COVID-19 through Ayurveda, Homeopathy systems including prophylactic measures, intervention during quarantine, asymptomatic and symptomatic cases of COVID-19, as public health research, surveys, lab-based research etc. to generate evidence.

However, the notification also mentions mandatory steps, which organisations need to comply with:

(i) The proposals should be approved by their scientific advisory bodies and Institutional Ethics Committees

(ii) If it is a clinical trial, the project should be registered with CTRI

(iii) The sample size should be based on statistical justification

(iv) Clinical research should be conducted as per AYUSH guidelines for clinical research or ICMR guidelines

(v) Compliance with relevant regulations for biomedical and health research

(vi) Compliance to Good Clinical Practice Guidelines

(vii) Compliance to National Ethical Guidelines for Bio-Medical and Health Research on Human Participation published by ICMR

(viii) Compliance with any other relevant regulations in force

(ix) AYUSH registered practitioner/expert should be part of the study team at each site

At present, there are no specific regulatory provisions available in the Drugs and Cosmetics Rule 1945, for the conduct of clinical trials of Ayurveda, Siddha, Unani and Homeopathy drugs.

Indian traditional medicines have wide potential for usage. This is evident from their longstanding use in the community, a huge number of references in ancient texts and a large number of publications in scientific journals on their phytochemical constituents, mode of action, clinical efficacy etc. But, we need to have scientific evidence on the use of any Ayurveda, Siddha or Homeopathy formulations for prevention/management of COVID-19.

Ranjit Puranik, Managing Director, Shree Dhootapapeshwar said, “It is a good enabling order indicating the Government of India’s commitment to its traditional medicinal heritage being put to use in combating this pandemic that has wrought widespread destruction, resulting in the death of many. Ayurved medicines have always been allowed to conduct clinical trials. One had to register themselves on the ICMR Clinical Trial Register after receiving approvals from Ethical Committees of respective institutions. It is important to note that Ayurved has been allowed access to citizens in quarantine facilities, COVID-19 positive cases who are asymptomatic and even cases that have displayed symptoms. This notification has pronounced confidence in the role that AYUSH traditional systems can play even in this advanced stage of COVID-19 onset.”

Speaking on the challenges, Puranik commented,” Challenges to get a correct protocol organised with little information in the public domain on COVID-19 disease aetiology will remain. True-blue scientists, in collaboration with modern medicine, hopefully, will make most of this opportunity to put Ayurved principles to test in dealing with something described in ancient texts as ‘Mahamari..’ or pandemic. Again the order has enabled if not encouraged research scholars to take such giant steps in designing sophisticated trials that address focused endpoints of benefit to COVID-19 patients. Ayurved has never been about one herb or one drug, it is always a combination of medicinal herbs and minerals used, suited to the patients, disease progressions and ability of the body to metabolise.”

He further added, “Industry and academia will come together and collaborate. Most industry members have already started receiving proposals for joint collaborations, we as a company also hope to place our experience and might in studies to follow. With this order, the Ministry of AYUSH has also paved the way to give traction to the Task Force Report which is eagerly awaited. It is hoped that the report will outline research candidates and protocols suited to combat COVID-19 and demonstrate the preventive strength of Ayurved medicines. As a company, it would be worthwhile to take such collaborations and joint efforts to fruition. The focus group of patients here are untested quarantine citizens and COVID-19 positive patients who are asymptomatic or demonstrate only mild symptoms. We look forward to being a part of immunity booster campaigns for patients in this fight against COVID-19. I believe the introduction of Ayurved medicines in this fight will be a game-changer for India and its citizens.”

Amit Agarwal, Director, Natural Remedies states, “It encourages researchers from all fields to undertake scientific evaluation/validation on use of ASU ingredients/products for management/ prevention of COVID-19. However, it does not mention anything about the source of funding for such studies. Both pre-clinical and clinical research is expensive and there is never any certainty of positive results in any research. In these tough economic times, I am not sure whether the private sector will be able to come forward, based on their own resources, to invest in such research.”

He further added, “If funding is not a constraint, I think that many effective ASU products can be made available to the people. If the government can develop some new schemes especially for the private sector (either as partial grants and/or soft loans with convenient repayment terms). There are many hidden jewels in ASU systems, which can significantly help the country in its fight against COVID-19. These need to be found out quickly validated as per modern scientific norms and made available for use as prophylactics/preventives. Overall, ASU products are divided into two broad categories, viz. classical and proprietary. Classical products are generally common property and no single entity can own them. The government is generally reluctant to spend taxpayers’ money on any proprietary product. The private sector in ASU comprises small companies who are unable to invest in R&D. This also the main reason why ASU products could not be evaluated on modern scientific lines, to date, barring a few exceptions.”

“Overall it is a pleasure to see that the Government of India is open to recommending the use of ASU products for a serious condition like prevention and management of COVID-19 as long as there is adequate scientific backing,” he added.

Dr Hemant Koshia, Commissioner, FDCA shares the success story of some of the AYUSH medicines in the prevention/ management of COVID-19,  and said, “In our Government lab we tested four AYUSH products, namely San Shamani Vati, Yashtimadhu Vati, Ayush 64 capsules and Amruta Decongestion, for safety aspects and presence of heavy metals like lead, arsenic, cadmium and mercury. And all these products passed the safety test and addressed quality requirements. And now we are recommending these products as an immunity booster.”

He also informed that Gujarat FDA had given these products to 6000 people who were quarantined in the state. “When they were tested for COVID-19 after 14 days, only 11 people out of 6000 tested positive for COVID-19. Hence, we are distributing these medicines to people free of cost through the AYUSH centres in the state,” he informed.

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