AYUSH ministry clarification on Scroll.in article on claims about Ayurvedic drugs

This is with regard to the article dated April 15 published on Scroll.in entitled “Under the Microscope: AYUSH Ministry’s dubious claims about Ayurvedic drugs for Diabetes, Malaria” (Editor’s note: The headline was subsequently changed to “Under the microscope: Questionable claims about Ayurvedic drugs for diabetes, malaria”).

The above mentioned article, which is stated to be an excerpt from the book India Misinformed: The True Story, has come to the notice of the Ministry of AYUSH and it is to convey that the publication is objectionable and unfounded with malintention for defaming the Ministry of AYUSH, Government of India.

In this regard it is to clarify that as per the provisions of the Drugs & Cosmetics Act, 1940 and Rules thereunder, the licenses and approval of the Ayurvedic product formulations are not granted by the Ministry of AYUSH rather by the licensing authorities appointed by the state governments. The Ayurvedic medicinal products alleged in the article are based on the formulations developed by CCRAS [Central Council for Research in Ayurvedic Sciences] and CSIR [Council of Scientific and Industrial Research] institutions and their manufacturing technology transferred to the drug manufactures through National Research and Development Corporation and approval granted to them by the respective State Licensing Authorities under the provisions of Drugs and Cosmetic Rules, 1945 pertaining to licensed manufacturing.

AYUSH- 64 and AYUSH-82, respectively the anti-malarial and anti-diabetic Ayurvedic drugs, are poly-herbal formulations developed by CCRAS on the basis of scientific studies for standardisation, pharmacological, toxicological, safety and efficacy aspects conducted since 1980s. Ayurveda Research Council has reported 89% response of treatment with AYUSH-64 comparable with known anti-malarial drugs Choloroquin and Primaquine. Double blind studies conducted on 178 patients revealed that the formulation was effective in 95.4% of the patients under study. Similarly, clinical study of AYUSH-82 was carried out on 886 patients and the results indicated statistically significant reduction in the fasting and post prandial blood sugar levels along with clinical improvement. Studies on both the coded Ayurvedic drugs are published in the volumes of Journal of Research in Ayurveda and Siddha.

It is known that advertisements on the alleged Ayurvedic products are being done by the manufacturers and the complaints thereto received in the Ministry are forwarded to the respective State Licensing Authorities/Drug Controller for taking necessary actions in accordance with the relevant provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Drugs & Cosmetics Act, 1940 and Rules thereunder. – Dr Muzamil Rehman, Assistant Adviser and Central Drug Inspector.