IPC releases 9th amendment list of 40 monographs to IP 2018

Download the 9th amendment: list of 40 monograph amendments

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Last Updated on January 9, 2022 by The Health Master

Download the list: In a bid to strengthen the quality of drugs in the country, the Indian Pharmacopeia Commission (IPC) has come up with the 9th amendment list to the Indian Pharmacopeia (IP) 2018. The list comprises 40 monograph amendments.

The eighth edition of IP became effective on January 1, 2018. Based on scientific inputs, some IP monographs needed upgrading, and accordingly, amendment list 9 to IP 2018 is issued containing such amendments.

The same has become effective from December 31, 2021. Pharmaceutical manufacturers need to be compliance with IP-2018 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, IPC in a notification on December 30, 2021.

The list includes amendments to the monographs of the following:

  • Dapoxetine hydrochloride,
  • Enoxaparin sodium,
  • Imatinib mesylate,
  • Neotame,
  • Parental preparations (powders for injection) such as amphotericin B injection
  • Ammonium chloride,
  • Aspartame,
  • Artemether and lumefantrine tablet,
  • Aspirin gastro-resistant and atorvastatin capsules,
  • Aspirin gastro-resistant and rosuvastatin capsules,
  • Atomoxetine hydrochloride,
  • Benzoic acid,
  • Buprenorphine and naloxone sublingual tablets,
  • Dolutegravir,
  • Lamivudine and tenofovir disoproxil fumarate tablets,
  • Calcium folinate injection,
  • Cyclosporine eye drops,
  • Ferrous ascorbate,
  • Glycerin,
  • Imipenem and cilastatin injections,
  • Isopropyl alcohol,
  • Isopropyl rubbing alcohol,
  • Lamivudine and zidovudine tablets,
  • Luliconazole,
  • Luliconazole lotion,
  • Menotropin,
  • Menotropin for injection,
  • Mitomycin injection,
  • Quiniodochlor,
  • Rabeprazole
  • Gastro-resistant and itopride prolonged-release capsules,
  • Remdesivir injection,
  • Streptokinase injection,
  • Tenofovir alafenamide fumarate,
  • Thiamin mononitrate,
  • Tigecycline,
  • Tigecycline injection,
  • Human albumin as well as biotechnology derived therapeutic products,
  • Follicle stimulating hormone,
  • Follicle stimulating hormone concentrated solution,
  • Follicle stimulating hormone injection,
  • Recombinant streptokinase bulk solution.

IPC had earlier added 15 new impurity reference substances and 11 new Indian Pharmacopeia reference substances.

On December 17, 2021, the commission released the second edition of the guidance manual for “Monograph Development of Herbs and Herbal Products, including Phytopharmaceutical Drugs”.

In order to focus on contemporary challenges, the second edition has added new chapters such as phytopharmaceutical drugs, dissolution of herbal products, contaminants, etc.

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