The Ayurveda Drug Manufacturers' Association (ADMA) has demanded the Department of Ayush to set up an autonomous Pharmacopoeia Commission for Indian Systems of Medicine (ISM), to set standards for formulations and to make the sector globally competitive.
The proposed Ayush Pharmacopoeia Commission (AUS-PC), in the lines of US Pharmacopoeia commission being recommended to set up standards for finished products in Ayurveda, Siddha and Unani (ASU) segments and to update the standards, is under consideration of the department, according to ADMA officials.
"As per the information we have received from the Department of Ayush, the proposal for the independent Pharmacopoeia Commission has been accepted by the officials in principle. The department sought more information from us for setting up the commission," Ranjith Puranik, general secretary, ADMA told Pharmabiz. The Association will submit more details for floating the commission soon, he added.
The recommendation suggests the department to allocate Rs 25 crore fund for the commission, Rs 5 crore each for five consecutive years. The suggestion is for the government to fund the commission for a fixed period until the autonomous body will start earning sufficient for its operations. The Association has also suggested some of the profit earning methods, for which the details will be furnished to the department soon.
In a broader outline of the AUS-PC, submitted as a recommendation, the Association instructs that eminent Pharmaceutical scientist should chair the commission with expertise in measurement technologies, eminent phytochemists, pharmacognosists with expertise in analytical chemistry. The Pharmacopoeia Laboratory for Indian Medicine (PLIM) and other central labs of ASU should be attached to the commission there should be a scientific body of experts from relevant disciplines to review the drafts of monographs, finalise and approve the works done for publication, added the recommendation.
If realised, the AUS-PC would mandate to review, update and publish the Pharmacopoeia and its supplements, to generate and certify reference herbs and standards, to conduct training for regulators and industry technical personnel, to develop safety and history of use database for Ayurveda, Unani, Siddha industry and formulary.
"The PC should not only a tool to set standards for the herbs and finished products, but also provide leadership go develop skills and competencies across the industries and machinery sector. The industry is tiered of hearing as non-standard systems of medicine and the current structure has not satisfied these requirements," said Ranjith.
According to the recommendation, the management structure of the commission should include a chairman who has worked in the area of quality, assurance and standardisation for many years and understands the requirements of Ayush industry, a Member Secretary who should be the chief executive officer appointed for proposes of implementation of the mandate given to this commission, the CEO with sufficient R&D exposure to the fundamentals of Ayush sciences, at least 5 members from the Ayush industry including representatives of ADMA.
The commission should also include officials from the relevant department including the Secretary with Department of Ayush, representatives from Central Council for Research in Ayurveda and Siddha (CCRAS), Department of Science and Technology (DST), Department of Biotechnology (DBT), CEO, National Medicinal Plants Board (NMPB) and three members from academia and related sciences with experience and exposure in such standards as are required by AYUSH Industry, he added.