Last Updated on October 10, 2024 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.
Latest Circulars: (IPC) Indian Pharmacopoeia Commission
Latest Notifications regarding Pharmaceuticals
Latest on National Formulary of India (NFI)
Covid: Govt warns against self-medication, steroid use
Molnupiravir has serious safety concerns: ICMR
USFDA gives nod to Alembic for generic drug to treat Parkinson’s…
No Paracetamol, Painkillers recommended after Covaxin jab
Govt is expected to amend New Drugs and Clinical Trial Rules 2019
Chemists told to stock up on key medicines
Govt to allow parallel submission of these applications for New Drugs
DCGI directs all State Drugs Controllers to implement ONDLS portal
DTAB recommends Bar code on top 300 brands of drug products
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: