IPC releases Indian Pharmacopoeia 2022

Mumbai, May 9, 2022 :

In a bid to promote the highest standards of drugs for use in humans and animals, the Indian Pharmacopoeia Commission (IPC) has released Indian Pharmacopoeia 2022 containing 92 new monographs, 21 vitamins, minerals, amino acids, fatty acids and 27 active pharmaceutical ingredients (APIs).

The Indian Pharmacopoeia which is likely to be effective from December 1, 2022, also includes 3 new biotechnology derived therapeutic products, 2 herbs & herbal products, 2 blood & blood related products, 33 dosage forms (chemicals), 4 vaccines and immunosera for human use. Besides this, the IP also contains 12 new general chapters.

The chemicals which have been added to IP include 2-deoxy-D-glucose, 2-deoxy-D-glucose sachet, amifostine, amifostine for injection, amlodipine and valsartan tablets, apremilast, apremilast tablets, aprotinin injection, azithromycin eye drops, bosutinib, bosutinib tablets, brivaracetam, brivaracetam tablets, ceftriaxone and sulbactam for injection, desogestrel, desogestrel and ethinyl estradiol tablets, dextran 1, dextran 40, dextran 70, dextropropoxyphene hydrochloride and paracetamol tablets, diclofenac potassium, diclofenac potassium tablets, epalrestat, epalrestat tablets, estradiol hemihydrate, ethyl acetate, ethynodiol diacetate, ethynodiol diacetate and ethinyl estradiol tablets, fexofenadine hydrochloride and pseudoephedrine hydrochloride prolonged-release tablets, glipizide and metformin tablets.

A slew of chemicals which have also been integrated into IP are itraconazole, lenvatinib mesylate, lenvatinib capsules, mesna tablets, oxetacaine, polymyxin B sulphate, polymyxin b for injection, prasugrel and aspirin gastro-resistant capsules, repaglinide and voglibose tablets, ribavirin capsules, risperidone syrup, rocuronium bromide, rocuronium injection, sodium starch glycolate (type B), sofosbuvir, sofosbuvir and daclatasvir tablets, sofosbuvir tablets, sugar spheres, tofacitinib citrate, tofacitinib tablets, trazodone hydrochloride, trazodone tablets, teneligliptin and metformin hydrochloride prolonged-release tablets, triamterene and hydrochlorothiazide tablets, valacyclovir hydrochloride, valacyclovir tablets, valganciclovir hydrochloride, valganciclovir tablets, vildagliptin and metformin tablets, zanamivir.
 
In addition to this, newly added vitamins, minerals, amino acids, fatty acids to IP are Oil- soluble vitamins capsules, oil- soluble vitamins oral solution, oil- soluble vitamins tablets, water-soluble vitamins capsules, water-soluble vitamins tablets, alpha lipoic acid, biotin, calcium citrate malate, chromium picolinate, copper gluconate, glutamic acid, inositol, lutein, lysine hydrochloride, phenylalanine, selenomethionine, selenious acid, threonine, tryptophan, valine, zinc citrate.
 
Apart from this, Chitrak and Siri are newly added herbs and herbal products to IP 2022.
 
Diphtheria, tetanus, acellular pertussis, hepatitis B, Inactivated poliomyelitis and haemophilus influenzae type B conjugate vaccine adsorbed, meningococcal group A, C, W135 and Y conjugate vaccine, diphtheria, tetanus, pertussis (whole cell), hepatitis B, inactivated poliomyelitis and haemophilus influenzae type B conjugate vaccine adsorbed, bivalent poliomyelitis vaccine type 1 & 3, Live (oral) are newly added vaccines and immunosera for human use to the IP 2022.

Anti-D blend (IgM + IgG) monoclonal reagent and anti-D (IgG) monoclonal reagents have also been added to the IP under the category of blood and blood related products.

Besides this, 3 new biotechnology derived therapeutic products added to the IP are rituximab, rituximab injection, teriparatide concentrated solution.

In addition to this, 12 new general chapters incorporated into IP 2022 are microbiological examination of burkholderia cepacia complex in non-sterile products, approach to alternative microbiological methods, design and development of biological assay and its validation, subvisible particulate matter in therapeutic protein injections, assay of calcium pantothenate, raman spectrometry, uniformity of dosage units, test for absence of mycobacteria, protocol for determination of the PRP content of haemophilus type B conjugate vaccine by HPAECPAD, adjuvants for vaccines, elemental impurities, nitrosamine impurities.

To harmonised with prevailing international standards, IP also upgraded a slew of general chapters which comprise microbial contamination in non-sterile products, microbiological assay of antibiotics, general identification reactions of ions and functional groups, assay of oxygen, oxygen-flask method, assay of insulins, ultraviolet and visible absorption spectrophotometry, gas chromatography, liquid chromatography, paper chromatography, thin-layer chromatography, optical rotation and specific optical rotation, solubility, inductively coupled plasma spectrometry, dissolution, friability of uncoated tablets, content of packaged dosage units, composition of polysaccharide vaccines, cell substrates for the production of vaccines for human use, extraneous agents in viral vaccines, assay of human anti-D immunoglobulin, infra-red reference spectra, thin layer chromatograms of phytopharmaceuticals, herbs and herbal products, thin layer chromatograms of phytopharmaceuticals, thin layer chromatograms of herbs and herbal products, liquid/HPTLC/gas chromatograms of phytopharmaceuticals, herbs and herbal products, liquid/HPTLC/gas chromatograms of phytopharmaceuticals, liquid/HPTLC/gas chromatograms of herbs and herbal products, buffer solutions, general reagents, impurities, reference substance.
 
The IP 2022 contains 265 chemical monographs, 47 vaccine monographs, 17 vitamins, minerals, amino acids, fatty acids monographs, 7 phytopharmaceutical monographs, 43 monographs of herbs and herbal products, 14 monographs of blood and blood related products, 6 biotechnology derived therapeutic product monographs, 14 veterinary monographs.
 
The IP has omitted general chapters on assay of human anti-D immunoglobulin methods B and C. Monographs of lorcaserin hydrochloride hemihydrate and lorcaserin hydrochloride tablets have been omitted by IPC vide a notification on March 10, 2021.

In 2018 IPC had released the Eighth Edition of Indian Pharmacopoeia (IP-2018) which contains 220 new admissions, 366 revisions and 7 omissions. It is the mandate of IPC to publish a new edition and addenda of the Indian Pharmacopoeia. Pharmabiz