New Delhi, July 24, 2021: In the complex environment where pharmaceuticals, nutraceuticals, AYUSH medicines, cosmeceuticals and herbal products and extracts, here is an excellent opportunity which differentiates and allows companies to look at this niche which is ‘phytopharmaceuticals’. This phytopharmaceuticals are different from other plant-based medicines as they are based on different parameters and regulatory considerations.
The standard definition of phytopharmaceuticals, as specified in Rule 2 (eb) of the Drugs & Cosmetics (D&C) Rules, 1945, is – “Phytopharmaceutical drug” includes purified and standard fraction with defined minimum four bio-active or phyto-chemical compound (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.
Although both Ayurveda, Siddha, Unani medicines (ASU medicines) and phytopharmaceuticals are plant-based medicines, ASU medicines are regulated under the purview of Department of AYUSH, on the other hand, phytopharmaceuticals are regulated by CDSCO (Central Drugs Standard Control Organisation). So, the regulatory and processing background differs significantly for both the categories which is emerging as one of the driving factors for phytopharmaceutical market in India.
Market dynamics for phytopharmaceuticals
On the global stage, traditional Chinese medicine has already established itself as a leader in the herbal market. India is at the second place, behind China in the herbal market. Currently, around 8000 plant-based remedies are available in India via AYUSH systems. The revenue from Ayurveda, Siddha and Unani alone is annually over half a billion dollars. The projected global market for herbal medicines by 2023 will be worth USD 111 Billion. India’s domestic market for AYUSH systems is currently worth Rs. 500 crores. The current valuation of the Indian herbal market is at Rs 5,000 crore showing an annual growth of about 14 %.
Although Phyto-pharma sector is still at formative stage in India and many developed countries, traditional and AYUSH medicines are positively influencing the medicinal markets all around the world which can offer an excellent opportunity for phytopharmaceuticals in the near future.
The key players in India like Himalaya Herbals, Dabur India Ltd, Hamdard Laboratories, PatanjaliAyurved Ltd, Emami Ltd and Zandu care. Schaper & Brummer, Biotech Corp., Bioforce AG and Max Zeller are already doing great in herbal and traditional medicine market, new research approaches can allow these companies to explore the phytopharmaceuticals region in more constructive manner.
Moreover, SundyotaNumandis Group of Ahmedabad has taken the licensing route to bring to India, clinically proven international phytopharmaceutical products. The group has also tied up with leading pharma players like Abbott India, ZydusCadila, Alkem, Cipla, USV Pharma, Eris Lifesciences etc. to unveil these products under their own brand names.
Possible growth drivers of phytopharmaceuticals
Unlike herbal products, phytopharmaceutical dosage forms are processed traditionally as well as pharmaceutically. In other words, it can be said that, phytopharmaceuticals are the processed materials which are the product of traditional and technology-based pharmaceutical formulation processes. This minimizes the risk of contamination and adulteration as instead of crude plant-based materials, standardized bioactives are incorporated in dosage form which enhance the psychological adaptivity toward phytopharmaceuticals.
Industry leaders in herbal products are putting several efforts at industry scale to convert Ayurvedic aqueous extract to a phytopharmaceutical with the help of technology-based approaches which will further generate great opportunities in this area.
It’s quite interesting to see that the regulatory framework for scientific data on quality control, efficacy and safety aspects and marketing of phytopharmaceuticals is on the same line as that ofsynthetic, chemical drugs which make such medicines more promising as we all are aware about the degree of accuracy, precise results and acceptability toward pharmaceutical evidences.
For AYUSH medicines, In-vitro bioequivalence data is necessary, on the other hand, for phytopharmaceuticals, in addition to non-clinical data, clinical evidences are also mandatory. High degree of characterisation is required and they have to undergo the clinical trials before launching. That’s why we call them evidence-based, like pharmaceuticals.
This evidence-based approach will promote research and interest of innovators, national laboratories, industries, etc in Phyto-pharma sector.
In the current times of the COVID-19 pandemic, there has been a great emphasis on the improvement of overall immunity of the body. Allopathic drugs act in a way to mitigate specific symptoms rather than stimulating the body to self-heal. This is where herbal medicines play a role. They are also perceived as being safer, hence in the last two decades there has been a significant increase in the use of herbal medicines.
65% of people in India use traditional medicine. There is a steady demand for traditional medicines in developed countries as well. And being evidence-based, people are becoming much adaptive toward phytopharmaceutical owing to the increasing awareness and educational initiatives to promote herbals.
4.Government and AYUSH initiative-
The governmenthas come up with many programs to boost the Phytopharmaceutical sector in India. The Council of Scientific and Industrial Research (CSIR) has conceptualized the Phytopharmaceutical Mission to bring transformative change in the medicinal plant sector. Another mission known as the Phytopharmaceutical mission for the Northeast region is aimed at cultivating and promoting the medicinal plants of that region.
Moreover, increasing educational approaches by AYUSH, to raise the standards of herbal and traditional medicines globally, are bringing several changes in AYUSH curriculum. NITI Ayog is also making strong recommendation in these regards.
To march toward the evidence-based approach for ayurvedic drugs, phytopharmaceuticals can offer a rigid platform through which specifications of plant materials can revalidated in much productive manner.
Clear growth trends backed by strong growth drivers are observed in the phytopharmaceutical industry of India. Consumers too are showing acceptance for Phytopharmaceuticals. A combination of all these factors provides lucrative opportunities for the Phytopharmaceutical business in India.
References
17.https://www.researchgate.net/publication/326635272_Phytopharmaceuticals_A_new_class_of_drug_in_India
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