Handling and referring the Official References
- Introduction to Pharmacopoeia and Formulary
The term Pharmacopoeia is derived from Greek word “Pharmakon’ means a drug and ‘Poiea’ means to make. It is a legal and official book issued by recognized authorities usually appointed by Government of each country. It comprises list of pharmaceutical substances, and formulae along with their description and standards. The monographs consist of general titles such as definition, production, characters, identification, tests, assay, storage, labelling and impurities. The World Health Organization states that sixty-eight different Pharmacopoeias continue to be used effectively in fifty-six countries around the world.
• Importance of Pharmacopoeia
O To maintain the uniformity and control the standards of the drugs available in market.
O Avoid adulterated drugs. O Complete information on drugs and their dosage forms.
O Reference for laboratory, industry and academic institutions.
Formularies are the list of drugs or collections of formulas for the compounding of medicinal preparations. Formularies contains more comprehensive details on therapeutics Collectively these books are known as drug compendia. Pharmacopoeias + Formularies= Drug Compendia
• Examples of some Pharmacopoeias and Formularies: Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), British Pharmaceutical Codex (BPC), British National Formulary (BNF). International Pharmacopoeia, United States Pharmacopoeia (USP), European Pharmacopoeia, Chinese Pharmacopoeia, Russian Pharmacopoeia etc.
● Indian Pharmacopoeia
The Indian Pharmacopoeia 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 fulfilment 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
The pharmacopoeia comprises analysis and specification procedures (for the determination of the quality of pharmaceutical substances, excipients and dosage forms). The monographs comprise the articles about the definition, description, identification, packing, storage, specifications, impurities, assay and specific tests, analytical procedures for tests, acceptance criteria, other requirements etc. It includes General Chapters and Reference Data, General Notices, Dosage Forms (General Monographs), Drue Substances, Dosage Forms and Pharmaceutical Aids, Vaccines and Immunosera for Human Use, Herbs and Herbal Products, Blood and Blood-related Products, Biotechnology Products; Veterinary Products. Also, Indian Homeopathic Pharmacopoeia is used in India.
- Indian Pharmacopoeia 2007:Indian Pharmacopoeia 2007 is the 5th edition of Indian Pharmacopoeia. Indian Pharmacopoeia 2007 is published in the year 2007 in 3 volumes.
- Contents of Indian Pharmacopoeia 2007:
O Volume I contains Notices, Preface, Indian Pharmacopoeia Commission, Acknowledgements, Introduction and General Chapters.
O Volume II contains General Notices, General Monographs on Dosage Forms, Monographs on Drug substances, Dosage forms and Pharmaceutical aids Monographs A to M.
O Volume III contains General Notices, Monographs on Drug substances, Dosage forms and Pharmaceutical aids Monographs N to Z, Monographs on Vaccines and Immunosera for Human Use, Monographs on Herbs and Herbal Products, Monographs on Blood and Blood-related Products, Monographs on Biotechnology Products, Monographs on Veterinary Products and Index.
• Steps of handling and referring Pharmacopoeias, Formularies for retrieving formulas, procedures etc.
O Search Index for formulation / monograph in last volume of the pharmacopeia or formulary.
O Search name of formulation / monograph in index which is alphabetically in order and find the page number.
O Find out the formulation / monograph according to page number with different volumes of pharmacopoeia or formulary.
O Under the monograph find out the formula, procedure, storage, identification test etc.