IPC set to harmonise 31 general chapters and as many excipient monographs of IP with PDG in three phases

Mumbai, November 12, 2022:

The Indian Pharmacopoeia Commission (IPC) is set to harmonize 31 general chapters and as many excipient monographs of Indian Pharmacopoeia (IP) with Pharmacopoeial Discussion Group (PDG) in three phases. The first phase will start from December 2024 and the last phase from December 2028.

IPC has been selected by PDG for its year-long pilot for global expansion. The year-long pilot will facilitate harmonization of IP’s general chapters on Tablet Friability and Optical Microscop with European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP) and the United States Pharmacopoeia (USP) which are members of PDG. The pilot will start from December 1, 2022.
 
The decision to launch a pilot for expansion of membership was taken at 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 on Particulate Contamination, Analytical Sieving, Laser Diffraction Measurement of Particle Size, X-Ray Powder Diffraction, Chromatography Peptide Mapping with PDG in first phase starting from December 2024.
 
It will harmonize IP’s general chapters 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 with international pharmacopoeias in second phase commencing from December 2026.
 
IPC will further harmonize IP’s general chapters 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 with PDG in third phase starting from December 2028.
 
Besides this, the commission will also harmonize 31 excipient monographs of IP with PDG in three phases.
 
The first phase will begin from December 2024 wherein monographs of Alcohol, Dehydrated Alcohol, Benzyl Alcohol, Croscarmellose Sodium, Lactose, Anhydrous, Ethyl Paraben, Propyl Paraben excipients of IP will be harmonised with PDG.
 
The monographs of excipients of IP--- Calcium Disodium Edetate, Calcium Phosphate Dibasic, Calcium Phosphate Dibasic Anhydrous, Carmellose Calcium, Cellulose, Microcrystalline, Crospovidone, Ethylcellulose, Hydroxyethylcellulose, HydroxypropylcelluloseHydroxypropylcellulose, Low Substituted, Lactose, Monohydrate, Magnesium Stearate, Butyl Parabe—will be harmonised with global pharmacopoeias in second phase commencing from December 2026.
 
The IPC will harmonise monographs of excipients of IP-- Cellulose Powdered, Cellulose Acetate Phthalate, Citric Acid, Anhydrous, Citric Acid, Monohydrate, Hypromellose, Hypromellose Phthalate, Methylcellulose, Methyl Paraben, Petrolatum, White Petrolatum, Polysorbate 80, Povidone with PDG in third phase starting from December 2028.
 
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.Pharmabiz