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In order to take the Ayurveda Research and Development (R&D) on a global scale, the Union Ministry of Ayush should help private sector in Ayurveda research by bringing in clarity on the patentability of medicines in the system as a short-term goal, to be implemented within the year 2029.
The report titled 'Strategic Roadmap for Making Ayurveda Global' from the Health Division of NITI Aayog details a comprehensive assessment of Ayurveda's global footprint and a phased roadmap for making Ayurveda global.
The study, while deliberating on the scope of India in developing international R&D in Ayurveda, said that the private sector research being conducted by Ayurveda drug manufacturers is limited and is mostly focused on process optimisation and building quality parameters within the manufacturing processes to achieve internationally accepted standards of good agriculture, collection and manufacturing practices.
"It has been observed that a reason for the lack of private sector participation in Ayurveda research is the lack of patent access for them, citing India’s no patent policy for traditional knowledge. Communicating a simple policy line to the private sector that 'Traditional knowledge per se is not patentable, but substantial improvements may be', which is consistent with India’s patent position as well, would be very helpful in this regard," said the study.
Ministry of Ayush can publish and socialize “green lane” examples of patentable innovations like novel extraction or standardisation processes, novel delivery systems, validated biomarkers/diagnostics, formulation optimisation with demonstrated technical effect, and new manufacturing controls—while ensuring claims don’t merely repackage known formulations.
Generating robust, regulator-grade evidence on the safety and efficacy of Ayurveda products, particularly where the intent is to support “drug” positioning in overseas markets, is expected to be anchored by India’s publicly funded R&D ecosystem, including apex research bodies such as the CCRAS, CSIR and institutions such as the All India Institute of Ayurveda (AIIA), working in partnership with industry and regulators.
In terms of funding, in FY 2024-25, CCRAS was allocated Rs 457 crore, and the allocation for AIIA in the same period was Rs. 251.2 crore. This is sharply in contrast with the substantial capital requirements often exceeding $20 million (around Rs. 180 crore) mandated for high-end clinical trials for a single drug and its global regulatory entry.
"This resource gap highlights a significant opportunity for enhanced public-private partnerships and international collaborative funding to bridge the path between traditional knowledge and global pharmaceutical standards," said the report.
It also elaborates on the global best practices, such as China investing $1.76 billion in 2021 in Traditional Chinese Medicine, lading to development of more than 8,800 new products, with TCM research integrated into the country's five-year plans with a focus on AI-based diagnosis, system pharmacology, and drug discovery.
"Budget for the financial year 2025-26 increased the Ministry of Ayush outlay to Rs. 3,992.90 crore, including Rs. 457.2 crore for CCRAS and Rs. 251.2 crore for AIIA. But in comparison to the financial resources available with the premium TCM research institution like CACMS, which is approximately around Rs.15,000 crore, Ayurveda still has a long way to go," says the report.
"For research abroad, Ayurveda should look to establish international research centres which can act as hubs for international research and multi-country clinical trials," it added.
Ayurveda needs to adopt modern research tools (AI, pharmacogenomics, big data) and create global clinical trial registries for Ayurveda, similar to TCM’s evidence-based approach. Also, Ayurveda can look to promote research, evidence generation for prioritised therapies and treatment areas where acceptability and interest are high to ensure comprehensive regulatory compliance for products, services, and insurance as well.
In short term, up to the year 2029, India should focus its research on flagship conditions such as chronic low back pain, knee osteoarthritis, functional GI disorders, insomnia or stress, metabolic syndrome, and women’s health for developing international acceptability for Ayurveda therapies and drugs associated with these conditions.
"... generating more evidence regarding the efficacy and safety of single herbs like Psyllium can open doors for lots of new substances to be classified as a drug in the US markets," it added.
The government should work on setting up an Ayurveda Research Development Committee for increased coordination between industry and academia; developing real-world data (RWD) on outcomes, safety, utilisation, and cost offsets, feeding payer dossiers overseas, by leveraging Insurance Regulatory and Development Authority of India (IRDAI) mandated Ayurveda coverage in India; and promoting Ayurgenomics as an important research vertical in the international research being planned with WHO Collaboration centres.
In medium term up to the year 2035 and long term up to the year 2047, it should establish International Ayurveda Centres of Excellence and WHO Collaboration Centre networked trials in various countries on safety, efficacy, and pharmacovigilance; establish five more WHO Collaboration Centres with three of them dedicated to Ayurveda and one each for Siddha and Unani Systems of Medicine; build an international Ayurveda research alliance under the WHO-Global Traditional Medicine Centre (GTMC); and bring newer technologies like network pharmacology and AI-based quality control, it added.
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