Experts who recently spoke at the ‘Global Bio India 2021’ e-conference organized by the Department of Biotechnology (DBT) and the Biotechnology Research Assistance Council (BIRAC) are confident about the huge potential of phytopharmaceuticals, the medicinal plant-based pharma products that have origins in Chinese medicine, Kampo medicine, Bhutanese medicine, Unani, Ayurveda, tribal and other sources.

“COVID-19 has presented an opportunity to re-evaluate and repositioning many drugs against the virus. DBT, ICMR, CSIR, and several ministries have joined hands and even BIRAC has funded many projects,” says Dr Madhu Dixit, Research Director, CSIR-Central Drug Research Institute (CDRI) Lucknow while stressing the role of traditional Indian medicines as potential therapeutic options for SARS-CoV2. She adds, “Public acceptability is an important criterion for drugs and traditional medicine enjoys a plenty of that. More than 60% of drugs in modern medicine have originated from natural products. Few of the drugs such as Artemisinin used for cerebral malaria; Paclitaxel used for cancer; and Avermectin which is an anti-parasitic drug has been well received and few even received a noble prize. These drugs have made a real difference in the medicinal world.”

Dixit shares the example of Ashwagandha (Withania somnifera) which she calls a potential phytopharma. “THSTI Faridabad has a model to evaluate the efficacy of Withania. We evaluated the cytokine levels and there was good protection against free radical generation.”

“Phytopharma industry is the one with appetite and the opportunity that is even bigger than Artificial Intelligence,” says Dr JLN Sastry, Chief Executive Officer, National Medicinal Plant Board, Ministry of Ayush who points out the fact that global herbal market size would exceed USD 411 billion by 2026. “There are a lot of opportunities such as the establishment of GI varieties will provide space to Indian companies globally. There is room for germplasm DNA studies, QPM protocol development, biotic and abiotic stress studies, and post-harvesting practices that can help in value-added products. Among the challenges are DNA markers and data required, specific varieties need to be reported and storage conditions need to be studied.”

Sastry believes that biotechnology has a role to play in phytopharma development. “The plant molecular biologists will play their part besides material researchers, and physicians. The toxicologists will help in technical evaluation and chemist in developing the standards,” he adds.

COVID-19, there is a huge thrust on the traditional medicine, immunity booster, immuno-modulators, says Dr. Pulok Mukherjee, Director, Institute of Bioresources and Sustainable Development (IBSD) Imphal. “We have been working on the drug discovery programs on aromatic plants especially the North-East. There are specific documentation and identifying programs for building repositories of knowledge. Based on indigenous knowledge, a sustainable bioeconomy model can be developed using both codified as well as non-codified sources. However, to explore these drugs, we need knowledge-sharing platforms. We need to validate our knowledge and the integration of  phytochemical profiling, high throughput screening, pharmacovigilance, and other modern medicine development processes will certainly help.”

Sharing his candid views, Prof Anand Chaudhary, Banaras Hindu University laments that while phytopharma being touted as modern medicine, the Ayurvedic from where it derives its doctrine is hardly given any credit.  “The phytopharma concept is welcome and might sound good when called a modern medicine but it should have a taste of Ayurveda. While it is a separate area, it could grow side by side with others. The manufacturing process, pharmacovigilance, and even prescription are completely different from other segments. At this moment, there is not a single drug is present in the market in the name of phytopharma and therefore, we need to follow stringent regulations to gain global acceptance.”

Sharing the policymakers’ perspective, Dr. Mohd. Aslam, Former Advisor, DBT, and former MD, BIRAC, says, “Phytopharma can be a big contributor for bioeconomy as there is enormous potential. All funding bodies such as DBT, Council for Scientific and Industrial Research (CSIR), Indian Council for Medical Research (ICMR), and Department of Science and Technology (DST), will have to work together to shape this emerging industry. DBT has signed an MoU with CSIR and ICMR to develop a pipeline of drugs. Simultaneously, the DBT has a Mission Program for North East and is driving the Himalayan Bioresource Program in which a vertical is dedicated to phytopharma and traditional knowledge.”

Better clarity emerges on the regulatory front

Since 2015, regulatory requirements for phytopharmaceuticals are under the purview of the Central Drugs Standards Control Organization (CDSCO). The regulatory submission requirements for scientific data on quality, safety, and efficacy to evaluate and permit marketing for an herbal drug are now on similar lines to synthetic, chemical moieties.

According to Dr CK Katiyar, CEO (Healthcare), Emami Ltd, the phytopharmaceuticals are the silver line for enhancing the productivity of Pharmaceutical R&D. “Earlier it was difficult to make a distinction between the Ayurveda and phytopharma but that has been clearly made now. Phyopharma will require a much rigorous scientific intervention before it is prescribed by the doctors. A phytopharma drug is defined as a purified and standardized fraction with a defined minimum of four bio-active or phytochemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation, or prevention of any disease or disorder but does not include administration by parenteral route.”

“Regulatory requirements for phytopharma are tough as it is like any modern drug and not just like Ayurveda and homeopathy,” says Dr. Ravindra Singh, Assistant Director, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush who also points out that while former is a timely process and may take as long as 15 years to develop with a huge cost to it. “Modern drug discovery is time-consuming and has a lot of side effects whereas in the case of phytopharma that would be minimal to nil. There is a growing onus on plant-based medicine. A few of the examples of potential candidates for drug development are Morphine, Quinine, taxol, digitoxin, and vinblastin. I am sure the phytopharma might be included in various pharma courses in the future.”

Meanwhile, the CSIR, DBT and ICMR have collaborated on many projects to conduct rigorous modern scientific testing and development of standard products to maintain global competitiveness. Unlike the traditional forms of medicines, proper toxicology studies and human clinical trials might not be far away in the case of phytopharma, raising the hope that it is surely an industry in making.