Newly developed ayurvedic medications would reach pharmacy shelves at a quicker pace as the Ayush ministry has finalised a new policy to streamline and expedite their commercialisation process. The guidelines prepared by the Central Council of Research in Ayurvedic Sciences (CCRAS) focus on transferring technology to industry, calculating royalty and resolving intellectual property rights issues.
The new provisions for commercialising products, technologies and processes have been approved by Union minister of state for Ayush Shripad Naik.
The CCRAS, an autonomous body under the ministry, has been developing and validating drugs and technologies at its in-house facilities and in tie-up with various research organisations. The technologies developed by the council are being commercialised through National Research Development Corporation (NRDC). The licensing of technologies to drug manufacturing companies is a source of revenue for both CCRAS and NRDC in terms of lumpsum fee and royalty. The new policy is expected to expedite the transfer by setting clear-cut guidelines.
As per the policy document reviewed by Pharmabiz, technologies are grouped into three categories – independently developed, collaborative efforts and value-added tech. While the royalty is set at 4% of ex-factory sales, lumpsum premium would be calculated on a case-to-case basis depending on commercial viability and translational value. The CCRAS’ efforts to develop scientific assessment tools and parameters for ayurvedic products assumes significance, as according to official figures, India, with 15 agro-climatic zones, is home to around 7,000 medicinal plants. The market for herbal products is pegged at Rs. 50,000 crore, growing at a fast rate of 15 per cent annually. The sector is being driven by the release of good manufacturing practices for dietary supplements by the FDA, an ageing global population and escalating cost of modern medicinal system.
In the last two years, the council has successfully commercialised products such as Ayush-82 for type –II diabetes and Ayush SG for rheumatoid arthritis. These formulations are already available in the market and are cost effective compared to other forms of therapy. The CCRAS has also developed new drugs for different ailments. Formulations such as Ayush Manas for cognitive deficit, Ayush QOL for cancer patients and Ayush K1 for chronic kidney problems are at different phases of development.