The department of Ayush has certified 8 bhasmas to be safe for use and the details will be will be released in December. This validation of 8 bhasmas is the maiden project under the Golden Triangle project of the Central government. The project, set up with the support of the department of Ayush Indian Council of Medical Research (ICMR) and Council of Scientific and Industrial Research (CSIR), is expected to scientifically validate Ayurveda products.
The standardization, safety and toxicity studies of metallic bhasmas and mineral-based formulations including Kupipakwa Rasayanas have been a major issue for a while for the drug manufacturers, according to JSD Pani, president, Karnataka Indian Medicine Manufacturers Association. The issue of the presence of minerals and heavy metals has bogged down international marketing operations. Therefore the effort by the Ayush department will now help the industry, he added.
The Planning Commission had constituted a Working Group on Access to Health Systems in Ayush which in-turn formed five Sub-Group and one of them focused only on the standardization and Quality Control of Ayush drugs.
The Ayush department was keen to lay down pharmacopoeial standards for single and compound formulations besides carry out scientific validation of herbo-metallic compounds and address the standardization and quality control of herbal drugs. There is also a proposal to set up a Pharmacopoeial Commission for Indian Medicine under the 11th Plan which will be located in the newly constructed building of the Pharmacopoeial Laboratory of Indian Medicine, Ghaziabad. The key objective is to create an independent scientific body which will undertake laying down of pharmacopoeial standards and its revision.
The Department is likely to enforce mandatory testing of heavy metals not only for export of Ayurveda, Siddha and Unani medicines but also for sale in domestic market. Since over 80 per cent of the Ayush manufacturing units are in the small and medium scale sector, the department identified labs to test the drugs for these companies. This is because equipments like Atomic Absorption Spectrometer to test heavy metals and TLC/HPTLC/GLC to test crude drugs are expensive to be installed by many companies to test the raw materials and finished products.
Pani said that these metals have undergone extensive toxicity studies. There had been no reports of major adverse drug reaction. Standardization and quality control of Ayurveda, Siddha, Unani drugs is a problem area as botanicals do not lend themselves to as precise a quality control as synthetic molecules manufactured under controlled laboratory conditions. This requires state-of-the-art research for developing chemical/biological markers/chromatogram fingerprints/standardized operating procedures and phyto-chemical characterization of bhasmas.
Now with the department of Ayush being ready with the safety data of the 8 bhasmas, this would provide a major fillip for growth for the Traditional System of Medicine industry, stated Dr GG Gangadharan, joint director (Traditional System of Medicine), Foundation for Revitalization of Local Health Traditions (FRLHT).