Last Updated on December 26, 2023 by The Health Master
The Indian Pharmacopoeia Commission (IPC) is set to harmonize 31 general chapters and as many excipient monographs of the Indian Pharmacopoeia (IP) with the Pharmacopoeial Discussion Group (PDG) in three phases.
The first phase will start in December 2024 and the last phase in December 2028.
IPC has been selected by PDG for its year-long pilot for global expansion.
The year-long pilot will facilitate the harmonization of IP’s general chapters on Tablet Friability and Optical Microscope with European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP) and the United States Pharmacopoeia (USP) which are members of PDG.
The pilot project will start on December 1, 2022.
The decision to launch a pilot for the expansion of membership was taken at the PDG annual meeting last year.
This was a critical first step in the PDG’s commitment to expanding the recognition of harmonised pharmacopoeial standards with a view to achieving global convergence.
The commission will harmonize IP’s general chapters mapping with PDG in the first phase starting in December 2024 on:
- Particulate Contamination,
- Analytical Sieving,
- Laser Diffraction Measurement of Particle Size,
- X-Ray Powder Diffraction,
- Chromatography Peptide.
It will harmonize IP’s general chapters with international pharmacopoeias in second phase commencing from December 2026 on:
- Dissolution,
- Disintegration,
- Uniformity of Content/Mass,
- Color (Instrumental method),
- Residue on Ignition,
- Bulk Density and Tapped Density,
- Conductivity,
- Powder Fineness,
- Water-solid Interaction,
- Amino Acid determination,
- Capillary Electrophoresis.
IPC will further harmonize IP’s general chapters with PDG in the third phase starting from December 2028 on:
- Tests for Specified Microorganism,
- Microbial Enumeration,
- Limits for Non-sterile Products,
- Bacterial Endotoxins,
- Extractable Volume,
- Sterility Test,
- Gas Pycnometric Density of Solids,
- Powder Flow,
- Specific Surface Area,
- Thermal Analysis,
- Isoelectric Focusing,
- Polyacrylamide Gel Electrophoresis.
Besides this, the commission will also harmonize 31 excipient monographs of IP with PDG in three phases.
The first phase will begin in December 2024 wherein the following monographs of IP will be harmonised with PDG:
- Alcohol,
- Dehydrated Alcohol,
- Benzyl Alcohol,
- Croscarmellose Sodium,
- Lactose,
- Anhydrous,
- Ethyl Paraben,
- Propyl Paraben excipients.
The following monographs of excipients of IP will be harmonised with global pharmacopoeias in the second phase commencing from December 2026:
- Calcium Disodium Edetate,
- Calcium Phosphate Dibasic,
- Calcium Phosphate Dibasic Anhydrous,
- Carmellose Calcium,
- Cellulose,
- Microcrystalline,
- Crospovidone,
- Ethylcellulose,
- Hydroxyethylcellulose,
- Hydroxypropylcellulose Hydroxypropylcellulose,
- Low Substituted,
- Lactose,
- Monohydrate,
- Magnesium Stearate,
- Butyl Paraben.
The IPC will harmonise the following monographs of excipients of IP with PDG in third phase starting from December 2028:
- Cellulose Powdered,
- Cellulose Acetate Phthalate,
- Citric Acid,
- Anhydrous,
- Citric Acid,
- Monohydrate,
- Hypromellose,
- Hypromellose Phthalate,
- Methylcellulose,
- Methyl Paraben,
- Petrolatum,
- White Petrolatum,
- Polysorbate 80,
- Povidone.
The IPC has taken the decision to harmonize selected general chapters and excipient monographs of IP with PDG based on consultation with the pharmaceutical industry.
There are more than 200 general chapters and more than 40 excipient monographs in the 9th edition of Indian Pharmacopoeia, launched by the Union health and family welfare ministry on July 1, 2022.
Several monographs and general chapters have also been revised to update them as per current global requirements and to harmonize with other pharmacopoeias like USP, BP, EP, etc, said Dr Gaurav Singh, senior scientific officer, IPC.
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