The Bangalore-based Natural Remedies (NRPL) is planning to market its 100 primary phytochemical-reference standards (PRS) to herbal manufacturers in India. The referral standards for plant based drugs is of paramount importance now as the purity, safety and efficacy assessment of all herbal products produced in the country currently varies as no serious efforts went into the documentation of standards by the industry stakeholders so far. Though the herbal pharmacopoeia is in place today, it does not cover the complete referral standards pertaining to herbal/plant based drugs.
Currently, Natural Remedies is one of the few companies in the country to have a comprehensive PRS that helps to increase the quality standards of Indian herbal products and medicinal plants.
According to sources in the company, through rigorous research efforts and its expertise in phytochemistry, it has helped to identify and isolate primary phytochemical-reference standards from the selected herbal products by using special techniques.
"We have proved ourselves in generating reference standards confirming to international requirements for the phytopharmaceutical and nutraceutical industry. PRS is mandatory for all herbal drug production and without it no herbal manufacturer can produce consistent quality products," says RK Agarwal, chairman and managing director, Natural Remedies.
Herbal products consist of a complex mixture of phytochemicals each of which contributes to the efficacy of the product. The qualitative and quantitative evaluation protocols of phytochemicals present in the herbal products are followed worldwide. It is difficult to source PRS with certified purities, worldwide and particularly in the case of Indian medicinal plant products. "Multinational companies (MNCs) hesitate to team-up for marketing herbal products from India as they find the quality control standards maintained by Indian manufacturers below the internationally acceptable methods and techniques," he said.
Currently, only a handful of herbal companies in India adhere to stringent quality standards. The company's first business proposal to the herbal manufacturers is to help maintain consistent quality for their range of products by supplying its PRS. Secondly, it could also help herbal companies to isolate and identify the phytochemicals responsible for pharmacological activity from their products. "NRPL also has reference catalogues for its 100 PRS," he said.
Some of the PRS generated by NRPL have become benchmarks for the global herbal industry. The company was the first to highlight the composition of individual constituents of "Bacoside A", a major bioactive saponin mixture of the popular Ayurvedic drug Brahmi (Bacopa monnieri). Tribulosin was isolated from the extract of Gokru (Tribulus terrestris) by a unique process of bioactivity guided fractionation. These findings have been accepted for publication in international journals. The PRS list of NRPL includes three gingerols from Ginger (Zingiber officinale), eight boswellic acids from Sallaki (Boswellia serrata), and five types of andrographolides from Kalmegh (Andrographis paniculata).
NRPL's R&D centre is recognized by the Department of Science and Industrial Research (DSIR) and accredited by Department of Indian Systems of Medicine &Homeopathy. Plans are underway to offer the PRS along with biological standardizations so that it can provide comprehensive quality control standards to the herbal sector. It has set a target to generate over 500 PRS in the next five years.