The Union Ministry of Health and Family Welfare has issued guidelines on pre-clinical and clinical studies for the Ayurveda, Siddha and Unani (ASU) medicines through a notification of draft rules adding new rule in the Drugs and Cosmetics Act, 1945.
In a notification, the ministry has inserted new rules following the rule 169 of the Drugs and Cosmetics Act 1945 as guidelines for evaluation of Ayurveda, Siddha and Unani drugs and other traditional medicines of India. The guidelines suggest extensive safety evaluation procedures for approval of ASU medicines including sub-chronic toxicity tests, genotoxicity studies and clinical trials.
"The purpose of the guidelines are the developed methodologies for records and evaluation methods to facilitate the development of regulation and registration in ASU and other traditional medicines in a phased manner and also to facilitate to promote health understanding of these drugs," mentioned the draft notification. The guidelines are intended to serve as a reference source for research scientists, registered medical functionary, ASU drugs manufacturers and health authorities.
Currently, the patent proprietary ASU formulations are approved after a simple clinical trial even as there are no such studies required for classical formulations which are completely based on published classic literature, according to industry experts.
As per the guideline, the companies which are developing new combinations or formulations in ASU and other traditional medicines have to conduct sub-chronic toxicity tests including haematological examination, renal and hepatic function tests, ECG, visual and auditory tests in animals. The ministry suggests that pharmacological profile and clinical evaluation are required for ASU drug for a new indication with any of the ingredients of Schedule E (1) of Drugs and Cosmetics Act, 1940 even as clinical evaluation is suggested to any ASU drugs manufactured, as per Schedule Y on a case-to-case basis
The genotoxic studies consisting of pharmacological profile and clinical evaluation are also required for medicines based on extracts of medicinal plants of India, including acqueous and hydro-ethanol formulations. The safety data is required for the drugs used for new indications, proprietary medicines and aqueous extracts based formulation categories if the products are intended for human use for more than three months or if there are reports suggesting toxicity.
The notification suggests that the information on the formulation, experimental pharmacology data, safety data, investigator brochure, protocol, case report form, patient information sheet and informed consent form should be submitted by the ASU and other traditional medicines manufacturers prior to conducting clinical trials.
The draft rules, published for the information of all persons likely to be affected by the norms, will be taken into consideration after the expiry of a period of forty five days from the date of notification. The ministry also solicited objections and suggestions from the concerned persons within the time.