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DTAB refuses to agree with proposed amendment of definition of phytopharmaceutical drugs in NDCTR, 2019
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Gireesh Babu, New Delhi
June 28 , 2023
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The Drugs Technical Advisory Board (DTAB), which advises the government on the technical matters related to drugs and pharmaceuticals and medical devices sectors, refused to agree with a proposed amendment to the existing definition of phytopharmaceutical drugs in the New Drugs and Clinical Trial Rules (NDCTR), 2019.
The Board received a representation requesting an amendment to the existing definition of phytopharmaceutical drugs, omitting the current requirement for the drug to have a minimum four bio-active or photochemical compounds of an extract of a medicinal plant.
The proposed amendment defined the phytopharmaceutical drug as, “Phytopharmaceutical drug includes purified and standard fraction of an extract of a medicinal plant or its part, assessed adequately by defined chemical marker(s) or biological methods of evaluation that demonstrate batch wise similarity, 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 as specified in Rule 2.”
At present, the Section 2 (1) (aa) of the NDCTR, 2019 defines, “phytopharmaceutical drug’ means a drug of purified and standardised fraction, assessed qualitatively and quantitatively with defined minimum four bio- active or phytochemical compounds of an extract of a medicinal plant or its part, for internal or external use on human beings or animals, for diagnosis, treatment, mitigation or prevention of any disease or disorder but does not include drug administered through parenteral route.”
The Board said that the details of the representation were placed before the Board for consideration in its latest meeting held in May, 2023. The DTAB deliberated the matter and opined that the existing definition of phytopharmaceutical drug including minimum four bio-active or phytochemical compounds of an extract of a medicinal plant or its part, assessed qualitatively and quantitatively are important for ensuring batch to batch consistency of such product.
Hence, the Board did not agree to the proposed amendment of the existing definition of phytopharmaceutical drug in NDCTR, 2019, it added.
According to the National Investment Promotion and Facilitation Agency Invest India, due to both its history of herbal remedies and incredible biodiversity, India offers a thriving market for phytopharmaceuticals.
In October, 2021, it said that the global market for herbal medicines is projected to reach $111 billion by 2023, in which, India is well-positioned to occupy a strong market share.
“The Indian herbal remedy market is currently valued at Rs. 5,000 crore and showcases an annual growth of about 14%, driven by both rising domestic and export demand, particularly since the onset of Covid-19, which has fuelled a steady increase in demand for traditional medicines in developed countries as well. Moreover, India is one of the only countries that has phytopharmaceutical drugs as a distinct category in its Drugs and Cosmetics Act, 1940 & Rules 1945 , which has helped to dispel ambiguities, spurring safer and higher quality products, which in turn further increases demand,” it said.
The sector is also supported by various government initiatives which provide a fillip to the sector, across both R&D and manufacturing.
The Council of Scientific & Industrial Research (CSIR), a government body dedicated to R&D, has launched a Phytopharmaceuticals Mission, running since 2018, aiming to improve the availability (through cultivation) of such medicinal plants which are in high demand by global and domestic industry. The mission aims to promote cultivation, conservation and discovery of medicinal plants through identifying the elite germplasm and conserving it by cultivation and in a gene bank, while supporting R&D through collaborating CSIR laboratories working in the area of medicinal plants with other public and private enterprises to advance technologies. The government has also announced the Phytopharmaceuticals Mission II, in order to take the efforts forward.
Besides, the Department of Pharmaceuticals has also launched a production linked incentive (PLI) scheme across a huge range of product categories including phytopharmaceuticals enabling fiscal incentives to investors interested in this sector.
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