Last Updated on December 31, 2023 by The Health Master
Phytopharmaceutical Drug Definition in NDCTR, 2019
The Drugs Technical Advisory Board (DTAB), an advisory body to the government on matters related to drugs, pharmaceuticals, and medical devices, has declined to accept a proposed amendment to the existing definition of phytopharmaceutical drugs in the New Drugs and Clinical Trial Rules (NDCTR), 2019.
The amendment sought to eliminate the requirement for these drugs to have a minimum of four bio-active or phytochemical compounds from a medicinal plant extract.
DTAB’s Decision:
The DTAB received a representation requesting a revision to the current definition of phytopharmaceutical drugs.
The proposal aimed to define these drugs as purified and standardized fractions of a medicinal plant extract or its part, adequately assessed using defined chemical markers or biological evaluation methods that demonstrate batch-wise similarity.
The proposed definition also excluded parenteral administration.
Consideration:
After careful consideration, the DTAB opined that the existing definition, which includes a minimum of four bio-active or phytochemical compounds from a medicinal plant extract, is crucial for ensuring batch-to-batch consistency of phytopharmaceutical products.
Consequently, the Board did not agree to the proposed amendment.
Importance of Phytopharmaceuticals in India:
India, renowned for its herbal remedies and rich biodiversity, presents a thriving market for phytopharmaceuticals.
According to the National Investment Promotion and Facilitation Agency Invest India, the global market for herbal medicines is projected to reach $111 billion by 2023, with India poised to capture a significant market share.
Herbal market
The Indian herbal remedy market is currently valued at Rs. 5,000 crore and experiences an annual growth rate of approximately 14%.
This growth is driven by rising domestic and export demand, particularly since the onset of the Covid-19 pandemic, which has fueled increased demand for traditional medicines in developed countries.
India’s inclusion of phytopharmaceutical drugs as a distinct category in its Drugs and Cosmetics Act, 1940 & Rules 1945 has contributed to dispelling ambiguities, resulting in safer and higher quality products and further driving demand.
Government Support and Initiatives:
he phytopharmaceutical sector in India benefits from various government initiatives that promote research and development (R&D) and manufacturing.
The Council of Scientific & Industrial Research (CSIR), a government body dedicated to R&D, launched the Phytopharmaceuticals Mission in 2018.
This mission aims to enhance the availability of medicinal plants in high demand by the global and domestic industry through cultivation.
It involves identifying elite germplasm, conserving it through cultivation and gene banks, and fostering collaboration between CSIR laboratories and other public and private enterprises to advance technologies.
To continue these efforts, the government has announced Phytopharmaceuticals Mission II.
Additionally, the Department of Pharmaceuticals has introduced a production-linked incentive (PLI) scheme that covers a wide range of product categories, including phytopharmaceuticals.
This scheme offers fiscal incentives to investors interested in the sector, further supporting its growth.
Conclusion:
The Drugs Technical Advisory Board’s (DTAB) decision to reject the proposed amendment to the definition of phytopharmaceutical drugs reaffirms the importance of maintaining the current criteria for batch-to-batch consistency.
India’s thriving market for phytopharmaceuticals, driven by its rich herbal heritage and increasing domestic and global demand, is further supported by government initiatives focusing on research, development, and manufacturing.
These efforts aim to strengthen the sector and position India as a significant player in the global phytopharmaceutical market.
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