Indian Pharmacopoeia 2018

The IP is an authoritative and legally enforceable book of standards of drugs manufactured/marketed in India. It is published by the Indian Pharmacopoeia Commission(IPC) on behalf of the Ministry of Health & Family Welfare, Government of India, in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940 and the Rules thereunder. It intends to help in the licensing of manufacturing, inspection, and distribution of medicines.

Regular publication of IP is an important mandate of IPC aimed at improving health by ensuring the quality, safety and efficacy of medicines. The Commission has been receiving significant advice and directions from regulatory bodies and valuable inputs from industrial houses, academic institutions, national laboratories, individual scientists and others.

IP-2018 has been brought out in 4 Volumes incorporating

220 new monographs (Chemical Monographs (170),
Herbal Monographs (15),
Blood and Blood-related products (10),
Vaccines and Immunosera for Human use monographs (02),
Radiopharmaceutical monographs (03),
Biotechnology Derived Therapeutic Products (06),
Veterinary monographs (14)),
366 revised monographs and 7 omissions.

Salient Features of IP-2018 are:

Keeping in view the essential requirement for harmonization of analytical methods with those accepted internationally, steps have been taken for monitoring drug standards.
General Chemical tests & Thin Layer Chromatography (TLC) for the identification of an article have been almost eliminated; and more specific infrared, ultraviolet spectrophotometer and HPLC tests have been emphasized. The concept of relying on published infrared spectra as a basis for identification has been continued.
The use of chromatographic methods has been extended to cope with the need for more specificity in assays and in particular, in assessing the nature and extent of impurities in ingredients and products.
Most of the existing Assays and Related Substances Test methods have been upgraded by liquid chromatography to harmonize with other International Pharmacopoeias.
The pyrogen test has been replaced by the Bacterial Endotoxin test (BET) in parenteral preparations and other monographs.
For ease of access to make Pharmacopoeia more user-friendly, an Index has been incorporated in Volume-I along with the already existing one in Volume-IV of IP.
53 New Fixed-Dose Combination (FDCs) monographs have been included, out of which 25 FDC monographs are not available in any Pharmacopoeia.

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General Chapters on Volumetric Glassware, Conductivity, Dissolution test, Disintegration test, Dimensions of Hard Gelatin Capsule Shells, etc. have been revised.
For Controlling the Microbial quality of the entire medicinal range, a general chapter on the maintenance, Identification, Preservation, and Disposal of microorganisms has been revised.