IPC releases amendment list for IP 2022, details here

The amendments are incorporated into the Indian Pharmacopoeia 2022, which was released on July 1, 2022, and will become effective on December 1, 2022.

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Last Updated on January 10, 2023 by The Health Master

The Indian Pharmacopoeia Commission (IPC) has finalized necessary amendments and corrections in respect of some of the monographs in the Indian Pharmacopoeia 2022, based on suggestions from different stakeholders.

The proposed amendments, as cited by different experts, have been intimated to the 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 the Indian Pharmacopoeia 2022, which was released on July 1, 2022, and will become effective on December 1, 2022.

The amendment was introduced to several monographs of Indian Pharmacopoeia based on stakeholders’ scientific inputs received by the Indian Pharmacopoeia.

Accordingly, the first amendment list to the 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 in compliance with the Indian Pharmacopoeia 2022, which aims 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 the identification, dissolution, disintegration, and 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 amendments 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,
  • Black quarter 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.

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