In order to train workforce on standard setting of phytopharmaceuticals as per new regulations, Indian Pharmacopoeia Commission (IPC), Ghaziabad would be conducting five-day residential course between August 5 and August 9, 2019 on phytopharmaceuticals and herbal drugs monograph drafting, verification and validation.
This will also create skilled and competent workforce in the field of herbal drugs and phytopharmaceuticals monograph development.
Through this course, standard setting for phytopharmaceuticals would be done in a more practical manner as new phytopharmaceutical regulation have now come into being, according to a senior official associated with the development.
The new phytopharmaceutical regulation permits the development of drug using advanced techniques of solvent extraction, fractionation, potentiating steps, modern formulation development etc.
After approval from Central Drugs Standard Control Organisation (CDSCO), the marketing status of the new phytopharmaceutical drug would be like that of a new chemical entity-based drug. The new regulation for phytopharmaceutical is in line with regulations in USA, China and other countries involving scientific evaluation and data generation.
This new regulation is expected to promote innovations and development of new drugs from botanicals in a scientific way and would help in the acceptance of the use of herbal products by modern medical profession. It would encourage research in phytopharmaceutical drug development for academia, researchers, and industry.
Phytopharmaceutical drug is defined as purified and standardized fraction with defined minimum 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.
The training will help revisit herbal and phytopharmaceuticals monographs for upgradation of methods and strengthening of standards. It is also aimed to develop new herbal and phytopharmaceuticals monograph besides assisting in the process of BRS and PRS development and to promote pharmacopoeial education.
Renowned experts from herbal pharmaceutical industries, academic and research institutions, IPC and conglomerate institutes and regulatory authorities will be the faculties of the course.
The course is very much relevant as there is a need to integrate with academic and research institutions particularly the pharmacy institutions having master and doctoral degree engaged in research activities on herbal medicines for development of monograph, verification and validation.
The course content includes herbal and phytopharmaceutical monograph development, regulatory information in herbal drugs and phytopharmaceuticals, standardization of parameters of herbal drugs and phytopharmaceuticals, plenary lectures on identification and analytical tools and techniques for herbal drugs and phytopharmaceuticals, hands on training schedule on analytical techniques for herbal drugs and phytopharmaceuticals.
Maximum 30 participants will be enrolled for this training,
based on “first come first serve basis”. Scanned copy of duly filled and signed registration form, available at (www.ipc.gov.in), may be sent to firstname.lastname@example.org.