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Phytopharmaceuticals to propel new avenues in research, leading to novel treatments: Dr Vidhu Aeri
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Nandita Vijayasimha, Bengaluru
September 03 , 2024
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The growing attention to phytopharmaceuticals in the Indian lifesciences landscape is an opportunity to develop potent botanical extracts, said Dr. Vidhu Aeri, Professor of Pharmacognosy & Phytochemistry and former Dean, School of Pharmaceutical Education & Research, Jamia Hamdard, New Delhi.
Development of science-based drugs from botanicals especially from Ayurveda has a long history of safety and use documented in the authoritative books. The new guidelines issued by the Union government published as a draft amendment to Drugs and Cosmetics Act, and Rules on October 24, 2013, created regulatory provisions of de?ning phytopharmaceuticals, botanical-based drugs. This was an endeavor for separate and appropriate regulatory provision for botanicals as drugs, she added.
It called to evaluate scienti?c data on quality, safety, and ef?cacy and marketing authorization for a plant-based leads as a drug on similar lines to synthetic and chemical moieties. The draft regulations are under Chapter IV of D&C Act and Rules, related to synthetic drug-based products. Ayurveda, Siddha, and Unani (ASU) drugs are regulated under Chapter IV A of D&C Act and Rules. But this draft regulation does not have any impact on the way ASU product is currently regulated. One may continue to manufacture and sell ASU drugs under the current ASU licensing system as per classical texts or proprietary formulations, pointed out Dr Aeri.
The stimuli to develop phytopharmaceuticals is to provide impetus to herbal based products, an alternative to NCE (new chemical entities) which is increasing the cost of new drug discovery. Of course, in an effort to meet the possibility of medical unmet needs, multi-component drugs may be ideal for multi-target diseases, providing window of IPR unlike Ayurveda dugs and prohibiting cross prescription, Dr Aeri told Pharmabiz in an email.
The permits for development of a botanical as a drug adopting the technologies, stress on high degree of characterization of the plant-based ingredient. Phytopharmaceutical proposal can be from a botanical which is a medicinal plant from any part of the globe and this is in line with regulations of US, China, and other countries involving scienti?c evaluation and data generation.
The correlation of botanical plant integrity is based on good collection practices (GCP), Botanical Reference Material (BRM) with Chemistry, manufacturing, Control (CMC) of the enriched fraction (GMP) with at least 4 marker compounds. However, it is critical to evaluate for safety and ef?cacy through well-conducted human clinical trials on lines similar to synthetic compound-based drugs, said Dr Aeri.
No doubt, development of phytopharmaceuticals would give boost to research for drug development in India. Also phytopharmaceuticals approved by Drug Controller General of India would have the same status for marketing as that given for a synthetic compound-based drug. The recommended products licensed may be allowed to be prescribed by both MBBS and Bachelor of Ayurveda Medicine and Surgery (BAMS) quali?ed physicians. Moreover, phytopharmaceutical regulations provide an easy approach to as overseas registration process.
At present, there is a muted interest amongst lifesciences firms. Only national laboratories are developing phyto leads. The need of the hour is to bring herbal drugs under the umbrella of phytopharmaceuticals, said Dr Aeri.
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