Quality Assurance system for Ayurveda and Traditional medicines is of vital importance to countries like Sri Lanka, which are often compelled to import raw materials and medicines from a variety of sources due to economic reasons. The Quality Assurance Laboratory cum Standardization division of BMARI is providing the technical support needed to operate the quality system for Ayurveda and TM in Sri Lanka by monitoring the compliance of products with respect to quality standards at pre and post marketing levels and issuing recommendations based on the findings as per the pharmacopeal references. The primary function of the said concern is to conduct laboratory tests necessary for determining compliance with product safety and quality requirements and to ensure the quality, efficiency and safety before it reaches the consumer.
We have a Laboratory complex building and furnished it with modern equipment. And also subdivided it further viz Analytical chemistry, Pharmaceutical, Microbiology, Biotechnology, Cell culture and Histopathology divisions.
Other functions are of providing practical training to staff members and fellow research colleagues on a limited scale. Technical assistance too is provided services to parallel institutions and training facilities to the staff. In –house training for the staff members to update their knowledge, skills and to facilitate Quality Management Systems including 5’S has been already started.
Upon the request of senior medical officers “Advanced Training Program on Laboratory Techniques’’ had been successfully completed for the first time at the laboratory complex in 2021. This was a ten weeks extensive program and a number of five medical officers from BMARI and Ayurveda Teaching Hospital, Borella participated for the program. They received a first-hand training and exposure on GLP and techniques at each division covering from glassware to advance equipment, laboratory safety, isolation and separation techniques, standard QC methods etc completed. The training they received would definitely enhance their skills to conduct quality research independently by themselves in future.
Formulation development of three herbal natural Immune Boosters
This is a sort of service centred high-end pharmaceutical manufacturing concern with a broad economic value in return. Described medicinal formulae, had been used over generations and quoted in many textual references in Ayurveda and Indigenous Medical System (IMS). Their Ayurvedic and modern pharmacological therapeutic claims are already established and validated with many in vitro and vivo studies. These medicines have been used for generations up to date for their typical indications safely. Immunomodulatory effects of these medicines were recently discovered and several clinical phase 1 studies revelled promising results in boosting cell mediated and humeral immunity. The prime objective of the project was to pilot level manufacture of standardized and quality assured medicines for clinical use. Obviously, revalidation of its in vitro and vivo finding and clinical usage will be intended to further assessed. The products were formulated under stringent QA measures at a level of cGMP facility at the SPMC, Ratmalana with respect to pharmaceutical Product development parameters into a user friendly dosage forms. Dosage performance and Pharmaceutical analytical testing were carried out at the SPMC and BMARI laboratories.