Mumbai : The Indian Pharmacopoeia Commission (IPC) has finalised necessary amendments and corrections in respect of some of the monographs in the Indian Pharmacopoeia 2022, based on the suggestions from different stakeholders.
The proposed amendments, as cited by different experts, have been intimated to drugs controller general of India (DCGI), CDSCO zonal offices, all the state drug controllers, drug laboratories and other stakeholders like IDMA, OPPI, BDMA, FOPE, FSSAI and small-scale industry associations, sources said.
The amendments are incorporated into Indian Pharmacopoeia 2022 which has been released on July 1, 2022 and will become effective from December 1, 2022.
The amendment was introduced to several monographs of Indian Pharmacopoeia based on stakeholders’ scientific inputs received by Indian Pharmacopoeia. Accordingly, first amendment list to ninth edition of Indian Pharmacopoeia was issued on November 28 containing such amendments and this will become effective from December 1, 2022. Pharmaceutical manufacturers need to be compliance with Indian Pharmacopoeia 2022 which aimed at improving the health of the common man in the country by ensuring the quality, safety and efficacy of medicines, said Dr Rajeev Singh Raghuvanshi, secretary-cum-scientific director, Indian Pharmacopoeia Commission.
The list includes amendments to identification, dissolution, disintegration, reference solutions of several monographs viz. glacial acetic acid, amiloride and hydrochlorothiazide, aminophylline, aminophylline injection, apremilast tablets, azelastine hydrochloride, bacitracin zinc, bisoprolol fumarate, carbomers, clemastine tablets, codeine phosphate, croscarmellose sodium, clindamycin palmitate hydrochloride, cyclobenzaprine hydrochloride, docusate sodium, eberconazole nitrate, clotrimazole cream, finasteride tablets, histamine phosphate, imatinib mesylate, itraconazole, lenvatinib capsule, Lenvatinib mesylate, levamisole tablets, levetiracetam, levocetirizine tablets, lindane, mefloquine tablets, perphenazine tablets, phenylephrine eye drops, nitrofurantoin tablets, piperazine phosphate, paracetamol infusion, propylparaben, white soft paraffin, quinapril hydrochloride, rabeprazole injection, tacrolimus capsules, racecadotril, triamcinolone, salicylic acid ointment, silver sulfadiazine, sitagliptin phosphate, sofosbuvir, activated charcoal, folic acid and methylcobalamin.
Besides this, the amendment list also consists of changes in monographs of blood and blood-related products, viz. anti-A blood grouping serum, anti-human globulin serum, dried human antihemophilic fraction, fibrin sealant kit, human coagulation factor VIII (rDNA), human normal immunoglobulin for intravenous use.
Furthermore, the list also contains amendment to monographs of biotechnology derived therapeutic products viz, erythropoietin concentrated solution, insulin aspart, insulin glargine injection as well as monographs of veterinary products—buserelin injection, calcium borogluconate injection, isoflupredone acetate injectable suspension, nandrolone laurate, blackquarter vaccine.
The Indian Pharmacopoeia 2022 was received well by the stakeholders. Special efforts were also being taken to curb the piracy of the document.
The ninth edition of the pharmacopoeia has many unique new features and is prepared in a user-friendly format. Published in four volumes, it has over 3152 monographs.