AYUSH Ministry suggests to bring Indian traditional medicines under Drug & Cosmetics Act 1940

A notification has been issued based on consultation with CDSCO informing that scientists, researchers, clinicians can conduct research on novel coronavirus through Ayurveda, Homeopathy, by following necessary guidelines.

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

The notification mentions mandatory steps which organisations must 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 CTR
(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

Till date, no specific regulatory provisions available in the Drugs and Cosmetics Rule 1945, for the conducting clinical trials Ayurveda, Homeopathy drugs, etc.

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.”

“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.” Puranik said.

Puranik 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.”

“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.”Amit Agarwal, Director, Natural Remedies said. 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 further added.

Dr Hemant Koshia, Commissioner, FDCA said that “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.”

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