Pharmacopoeia

What is a Pharmacopoeia?

A pharmacopoeia is a legal and scientific reference book that sets the standards for the identity, purity, strength, and quality of pharmaceutical substances and medicinal preparations. It contains a collection of monographs, which are detailed descriptions of individual drugs, and general chapters that outline the official tests and procedures for their analysis. These are essential for ensuring the quality of medicines and are published by a national authority, typically a government body. They are crucial for drug manufacturers, regulatory bodies, and healthcare professionals.

The term “pharmacopoeia” is derived from the Greek words pharmakon (drug) and poiein (to make).

Major Pharmacopoeias and Their History

1.Indian Pharmacopoeia (IP)

The Indian Pharmacopoeia (IP) is the official book of standards for drugs in India. It is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health & Family Welfare, Government of India. It fulfills the requirements of the Drugs and Cosmetics Act, 1940. The IP sets legally recognized standards for drugs imported, manufactured for sale, stocked, or distributed in India. It aims to ensure that medicines available in the country are of standard quality, safe, and effective.

• Origins: The history of Indian Pharmacopoeia traces back to 1833 when the East India Company’s Dispensary Committee recommended the publication of a pharmacopoeia for India.
• Early Attempts: The IP 1868 included drugs from the British Pharmacopoeia (BP) 1867 and indigenous Indian drugs. The BP became official in India from 1885 onwards.
• Post-independence: After India’s independence, the Indian Pharmacopoeia Committee was formed in 1948 by the Ministry of Health. The first official edition of the Indian Pharmacopoeia was published in 1955, incorporating both Western and traditional Indian medicines.
• Revisions: The IP has undergone regular revisions (1966, 1985, 1996, etc.), with recent editions focusing more on drugs used nationally and aligning with global standards. The Indian Pharmacopoeia Commission (IPC) was formally established in 2005 to oversee its publication and updates.

Salient Features of the Indian Pharmacopoeia (IP)

• Legally Enforceable Standards: The IP is recognized as the official book of standards for drugs in India under the Drugs and Cosmetics Act, 1940. This means that its standards are legally binding and must be followed by all pharmaceutical manufacturers.
• Comprehensive Coverage: The IP includes a wide range of drug substances, formulations, and excipients. It covers not only allopathic medicines but also some traditional preparations, biological products, and medical devices.
• Monographs: Each drug entry in the IP is a detailed monograph that provides specifications for its identity, purity, and strength. The monograph also includes specific test methods and acceptance criteria to ensure the quality of the substance.
• Focus on National Health Needs: The IP is regularly updated to include drugs that are relevant to the national health care programs and the National List of Essential Medicines in India.
• Harmonization with International Standards: The Indian Pharmacopoeia Commission continuously works to align its standards and testing methodologies with international pharmacopoeias like the USP and BP. This harmonization facilitates global trade and ensures the quality of Indian-made medicines on a global scale.
• Regular Updates: The IP is not a static document. New editions and addenum are published periodically to incorporate new drugs, update existing monographs, and adopt the latest scientific advancements in analytical methods and quality assurance. This ensures the standards remain current and effective.

2.British Pharmacopoeia (BP)

The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom. It is published annually and serves as a comprehensive collection of authoritative standards for pharmaceutical substances and medicinal products used in the UK. The BP is a vital reference for research, development, manufacturing, and quality control. It also includes all the monographs and texts from the European Pharmacopoeia (Ph. Eur.), which is mandatory for all member states of the European Union, and the BP (Veterinary) which is used for veterinary medicine.

• Earlier B.P:Standardization of medicines in the UK started with the publication of the London Pharmacopoeia in 1618. Edinburgh and Dublin also had their own pharmacopoeias.
• First BP:The first official British Pharmacopoeia was published in 1864, harmonizing the London, Edinburgh, and Dublin pharmacopoeias. Its purpose was to unify the standards for medicinal products in the United Kingdom.
• Development:The BP was updated regularly and served as a statutory standard under UK law. The British Pharmaceutical Codex, introduced in 1907, supplemented the BP for drugs not included.
• Global influence:The BP set standards not only for the UK, but also for many countries in the British Empire, and today supports harmonization of pharmaceutical standards globally.

3.United States Pharmacopeia (USP) and National Formulary (NF)

The United States Pharmacopeia (USP) and the National Formulary (NF) are two official compendia published together as the USP–NF. The USP sets standards for drug substances, dosage forms, and medical devices, while the NF provides standards for excipients (inactive ingredients). The USP–NF is published by the non-profit United States Pharmacopeial Convention and is recognized as an official standard by the US Food and Drug Administration (FDA) and other regulatory agencies worldwide. Its standards cover identity, strength, quality, purity, packaging, and labeling.

• Early U.S. Pharmacopoeias:The first U.S. pharmacopeia was the Lititz Pharmacopoeia (1778).
• USP Formation:In 1820, a national convention of physicians in Washington, D.C., founded the United States Pharmacopeial Convention and published the first USP, containing 221 monographs.
• Legal Status:The USP gained legal recognition with the Pure Food and Drug Act of 1906, making its standards enforceable for the first time.
• Evolution:The USP has been revised regularly (every ten years originally; now annually) to include new drugs and analytical methods, ensuring quality and safety in the U.S. and internationally. It is now produced by the nonprofit United States Pharmacopeial Convention.

4.Extra Pharmacopoeia (Martindale)

The Extra Pharmacopoeia, now widely known as Martindale: The Complete Drug Reference, is a unique and comprehensive international reference work. Unlike a national pharmacopoeia that sets official standards, Martindale provides unbiased and evidence-based information on drugs and medicines used globally. It includes details on drug interactions, side effects, clinical uses, and proprietary preparations from various countries. It’s a key resource for healthcare professionals worldwide, offering a broader and more descriptive perspective on medicinal products than a standard pharmacopoeia.

• Early U.S. Pharmacopoeias: The first U.S. pharmacopeia was the Lititz Pharmacopoeia (1778).
• USP Formation: In 1820, a national convention of physicians in Washington, D.C., founded the United States Pharmacopeial Convention and published the first USP, containing 221 monographs.
• Legal Status: The USP gained legal recognition with the Pure Food and Drug Act of 1906, making its standards enforceable for the first time.
• Evolution: The USP has been revised regularly (every ten years originally; now annually) to include new drugs and analytical methods, ensuring quality and safety in the U.S. and internationally. It is now produced by the nonprofit United States Pharmacopeial Convention.

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Dr.Dash Srimanta

Hi…! Currently, I am working as an  Professor at Department of Pharmaceutical Chemistry(H.O.D),The Pharmaceutical College, Barpali, Odisha. I have more than 19 years of teaching & research experience in the field of Chemistry & Pharmaceutical sciences.