|
In a significant move towards safe and efficacious medicines, the newly released Indian Pharmacopoeia 2026 (IP-2026) has introduced a total of 3,340 quality standards for medicines with new blood, blood components and excipient quality standards to ensure safe and efficacious medicines for patient safety in India. IP-2026 was released in both physical hard bound as well as online subscription format.
Published by Indian Pharmacopoeia Commission (IPC), these quality standards have comprehensively covered key therapeutic categories, including anti-tuberculosis, anti-diabetic and anti-cancer medicines and iron supplements among others for use in national health programmes.
IP-2026 which is the 10th edition of India’s official book of drug standards was officially released by Union health minister J P Nadda on January 02, 2026 in New Delhi in the presence of Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), Harsh Mangla, joint secretary, ministry of health and family welfare and Dr. V. Kalaiselvan, secretary-cum-scientific director, IPC.
The earlier 9th edition of the IP-2022 had introduced a total number of 3152 monographs, which included 92 new monographs of APIs, dosage forms and vitamins, 12 new general chapters, and categories for biotechnology-derived products, vaccines, and herbal products.
IP-2026 contains a total of 121 new monographs including 88 drug substances, dosage forms, and pharmaceutical aids, 05 vitamins, minerals, amino acids, fatty acids etc, 02 biotechnology derived therapeutic products, 03 human vaccines, 02 blood related products, 20 blood and blood component monographs, and 01 veterinary vaccines monographs.
In addition, 05 new general chapters have also been introduced. Further, 18 general chapters and 22 excipient monographs are harmonized with the Pharmacopoeial Discussion Group (PDG) pharmacopoeias (i.e. European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), and United States Pharmacopoeia (USP). The harmonization of standards with global standards is expected to help IP getting recognized and accepted in foreign countries.
Total 22 monographs or quality standards in blood and blood components has been introduced which includes 02 revised monographs and 20 new monographs. It also includes general requirements for blood and blood components from human source and general requirements for irradiation of blood and blood components.
Monographs for whole blood include whole blood, whole blood: irradiated. Monographs for red cell components include packed red blood cells, red blood cells in additive solution, leucodepleted red blood cells, red blood cells: Buffy coat removed in additive solution, red blood cells: cryopreserved, red blood cells: Washed.
Monographs for plasma components include fresh frozen plasma (FFP): whole blood, fresh frozen plasma (FFP): Apheresis method, cryoprecipitate, cryo-poor plasma (CPP).
Monographs for platelets components include platelet rich plasma (PRP), pooled random donor platelets, pooled platelet concentrate: Buffy coat method, random donor platelet concentrate: PRP method, random donor platelet concentrate: Buffy coat method, single donor platelets (SDP): Apheresis method, single donor platelets in additive solution (SDP-PAS), double single donor platelets: apheresis method and monographs for granulocyte components include granulocytes: Apheresis method and pooled granulocytes: Buffy coat method.
IP-2022 contained a total of 92 new monographs including 60 chemical, 21 vitamins, minerals, amino acids, fatty acids etc., 3 biotechnology-derived therapeutic products, 4 human vaccines, 2 blood and blood related products, 2 herbs and herbal related products, and 7 phytopharmaceutical ingredient category monographs. Several monographs and general chapters had also been revised to update them as per current global requirements and to harmonize with other pharmacopoeias like USP, JP, EP and BP.
|