Monograph of phytopharmaceutical ingredients: IPC set to develop

The PPI monographs will also facilitate appropriate maintenance of the standards by the stakeholders

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Last Updated on July 10, 2023 by The Health Master

The Indian Pharmacopoeia Commission (IPC) will soon come out with phytopharmaceutical ingredient (PPI) monograph to provide the scientific information on the quality standards and characterization of minimum four biomarkers /analytical markers of a PPI to help the industry develop botanical drugs.

The PPI monographs will also facilitate appropriate maintenance of the standards by the stakeholders. The IPC in a notice on August 17, 2020 sought suggestions from stakeholders on PPI monograph.

Dr V Kalaiselvan, principal scientific officer at the IPC said, “To include a PPI monograph in Indian Pharmacopoeia (IP), an herbal drug/extract/purified fraction needs to be characterized minimum of its four bio/analytical marker compounds.

Of them, one analytical marker will have biological/therapeutic value. As a standard setting authority, the IPC must ensure four analytical markers present in a phytopharmaceutical ingredient which is used for development for a botanical drug.”

He clarified that PPI monographs may or may not strictly meet the requirements of definition of phytopharmaceutical drugs which are essentially herbal medicine extracted from plants. They are a cocktail of different compounds, but have a biological origin from a plant. He said inclusion criteria of phytopharmaceutical drug monographs in IP differ from herbal drug monographs.

“The monograph of a phytopharmaceutical drug is developed after it gets approved from CDSCO. However, IPC does require CDSCO’s approval to develop monographs of herbal drugs which are used in Indian systems of medicine and these medicines are available in India,” Dr Kalaiselvan said.

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In 2015 Drugs and Cosmetics Act and Rules 1945 was amended to create a new category of drugs called phytopharmaceuticals. As per the gazette notification G.S.R.918 (E), published by government of India on November 30, 2015, the regulatory provisions for phytopharmaceuticals and regulatory submission requirements for scientific data on quality, safety, and efficacy to evaluate and permit marketing approval for phytopharmaceuticals drug on similar lines to synthetic, chemical moieties have been made under the Drugs & Cosmetics Act 1940 and Rules 1945 thereunder.

As per the notification, phytopharmaceuticals 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 requirements for phytopharmaceuticals differ from Ayurvedic, Siddha or Unani drugs. Phytopharmaceutical drugs are a fraction of crude extract and are distinctly differentiated by being purified and standardized.

There is a separate category of PPI monograph in IP where an herbal drug/extract/purified fraction has been characterized with a minimum of four marker compounds. The inclusion criteria herbal drugs monograph will also apply for PPI category monograph besides ensuring minimum four analytical markers.

For example, the existing monograph in IP, namely Andrographis paniculata modified to provide for testing qualitatively/quantitatively for four bio/ analytical markers such as, Andrographolide, Andrograpanin, Neo-andrographolide and 14-deoxy -11,12 didehydro andrographolide. Such monographs are categorized with the suffix PPI next to the name of the monograph to denote that such ingredients demonstrate potentially meeting the defined criteria for a phytopharmaceutical in IP.

However, the phytopharmaceutical drugs dosage form monograph shall be included in IP only after the approval of CDSCO.  It is to be recognized that mere inclusion of a monograph for an herb or extract or PPI in IP does not give it a status of drug and relevant regulations need to be complied with, and approval as a drug is to be obtained from the office of Drugs Controller General (India) after submission of relevant applications.

The CDSCO approves a phytopharmaceutical drug including a monograph in IP. For this the applicant will need to provide adequate information including specifications and test methods for raw botanical, in the formulation. The samples of new drugs should go through a step of checking the specification and test method in one of the Central drug testing laboratories.

The applicants need to submit conventional pre-clinical study and safety documents to CDSCO along with an application for a phytopharmaceutical drug.

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