Pharmacopoeia literally means “drug-making”. Pharmacopoeia is a book describing drugs, chemicals, and medicinal preparations; especially: one issued by an officially recognized authority and serving as a standard. Ayurvedic Pharmacopoeia of India (API) is a legal document of standards for the quality of Ayurvedic drugs and substances included therein (under the Drugs and Cosmetic Act, 1940.) The API is published by the Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), Ministry of Health and Family Welfare, Government of India.

National Formulary (NF) includes formulations and unofficial preparations for widely sold products. Addendum is an addition required to be made to a document by its author subsequent to its printing or publication. Herbal monographs normally include nomenclature, part used, constituents, range of application, contraindications, side effects, incompatibilities with other medications, dosage, use, and action of the herb.

Pharmacopoeia Commission for Indian System of Medicine
To lay down Pharmacopoeia Standards, Govt. of India has constituted three Pharmacopoeia Committees viz;
1.    Ayurvedic Pharmacopoeia Committee,
2.    Siddha Pharmacopoeia Committee &
3.    Unani Pharmacopoeia Committee

The purpose of above three is to lay down Pharmacopoeial Standards for Ayurvedic, Siddha & Unani drugs. Pharmacopoeial Laboratory for Indian Medicines, Ghaziabad in only laboratory to develop pharmacopoeial standards at present. Govt. of India has published standards on 540 single drugs and 101 compound formulations. Still, there are about 2000 single drugs and about an equal number of compounded formulations where standards are to be developed.

Ayurvedic Pharmacopoeia Committee
The 1st APC was constituted in 1962. Since then has been working continuously. The term of the Committee remains for a period of three years from the date of its first meeting and the members hold office for that period.

APC was functional at Dept. of AYUSH; however, it has been shifted to the Council in April 2006. Since then, Director General, CCRAS (erstwhile Director, CCRAS) has been designated as Member Secretary.

 
The existing Main Committee of APC (2009) with 23 (+13 co-opted) eminent members are chaired by Prof. S. S. Handa.

Advisor (Ay.), Dept. of AYUSH, Ministry of Health & Family Welfare is the Vice Chairman.

For finalization of Pharmacopoeial work, following subcommittees are functioning under APC:
1.    Formulary Subcommittee of APC (Ras Shastra/Bhaishjya kalpana-Ayurvedic Pharmacy),
2.    Ayurveda Single Drugs Subcommittee (Single Drugs of Plants, Minerals, Metals & Animal origin),
3.    Subcommittee of Pharmacogonosy,
4.    Subcommittee of Photochemistry & Chemistry.

The functions of APC are as follows:

• To prepare Ayurvedic Pharmacopoeia of India (API) of single drugs (Part I) and compound formulations (Part II)
• To prescribe the working standards for raw materials as well as compound formulations including tests for identity, purity, strength and quality so as to ensure uniformity of the finished formulations
• To develop and standardize method of preparations, dosage forms, toxicity profile etc. of formulations
• To identify methods and procedures for publication of the standards of all commonly used formulations of AFI in a phased manner.
• To provide all other information on Ayurvedic formulations regarding the distinguishing characteristics, methods of preparation, dosage, method of administration with various anupans (vehicles) and their toxicity
• To develop the Quality standards, safety, efficacy profile of different parts of the plants; as well as the inclusion of new plants as Ayurvedic drugs Any other matter relating to the quality standards, shelf life, identification, new formulations etc.
• To develop Quality standards, safety, efficacy profile of Intermediates like extracts of plant drugs used in Ayurveda.

Scope of Ayurvedic Pharmacopoeia of India
Ayurvedic Pharmacopoeia of India is an official document published by the authority for guiding the industry as far as standardisation and purity aspects of single drugs used in Ayurveda are concerned. This publication serves a milestone in establishing purity and potency of Ayurvedic formulations.

Data on bioassays and standardisation of single herbs mentioned in Ayurvedic Pharmacopoeia of India is a valuable tool in ensuring quality standards of finished formulations. These procedures are rarely adopted by manufacturers dealing with Ayurvedic formulations, despite being made compulsory as per provisions of the Drug and Cosmetic Act dealing with traditional drugs.

Ayurvedic drugs are better known as traditional drugs. As per the policy of the World Health Organisation (WHO) on traditional drugs, every country has to develop pharmacopoeia/essential drug list/formulary of drugs used in traditional medicines.

Recently, we have seen a revival of interest in Ayurvedic medicines and as per regulatory requirements; we need to amend the Ayurvedic Pharmacopoeia of India to increase scientific accountability of Ayurvedic medicines.

Several herbal drugs are not part and parcel of Ayurvedic Pharmacopoeia of India and are widely used as ingredients in finished formulations. These drugs have expanded medicinal uses and sometimes used as a substitute for principal drugs.

Limitations of Ayurvedic Pharmacopoeia of India
In an Allopathic system of medicine British Pharmacopoeia (BP), United States Pharmacopoeia (USP) and Indian Pharmacopoeia (IP) are widely accepted official publications for guiding the industry for regulatory requirements. Martindale Extra pharmacopoeia was created according to the need of the industry and is widely accepted with British Pharmacopoeia (BP), United States Pharmacopoeia (USP) and Indian Pharmacopoeia (IP). Similarly, British Pharmaceutical Codex is a valuable publication catering to the need of the synthetic drug industry in the UK.

Work on Ayurvedic drugs has been accelerated in recent past and during the last years, several volumes have been published. The need of the hour is to come up with Extrapharmacopoeia of Ayurveda, which should incorporate data on medicinal plants which are not mentioned in Ayurvedic Pharmacopoeia of India.

Ayurvedic Pharmacopoeia of India should be introduced in the syllabus of subjects like Dravyaguna and Rasa Shastra which have close proximity with pharmacognosy and latrochemistry. American Herbal Pharmacopoeia (AHP) and British Herbal Compendium (BHC) are commendable work on herbs of commerce and have described standard operative procedures (SOPs) and chromatogpahic conditions for the estimation of active constituents in finished products. Similarly, monographs on selected medicinal plants published by WHO are valuable for quality control and assurance purposes.

Why Extrapharmacopoeia for Ayurveda?
Compendiums and monographs on Indian herbs, cover only major plants. The herbs which we have described are not part and parcel of pharmacopoeia, Compendiums and monographs, hence a publication in form of Extrapharmacopoeia for Ayurveda justified. In an Allopathic system of medicine, BP, USP and IP are officially recognised documents for guiding the industry for regulatory requirements. Martindale Extrapharmacopoeia was published in 1883 as per requirement of the industry.

Work on Ayurvedic traditional drugs has been accelerated in recent times and the need of the hour is to come up with Extrapharmacopoeia of Ayurvedic drugs incorporating data on these drugs (which have not been defined in Ayurvedic Pharmacopoeia of India). Several pharmacopoeias are available online and catering to the need of researchers and academicians.

Other Pharmacopoeia related to herbal medicine
Ghana Herbal Pharmacopoeia has been published by Science and Technology Policy Research Institute, Council for Scientific and Industrial Research, Ghana 2007. Nigerian Herbal Pharmacopoeia was published in 2008. The traditional dermatological pharmacopoeia of Vulture-Alto Bradano has roots in folk remedies, including, based natural and spiritual illness and healing. These remedies find use in the treatment of 45 skin and soft tissue diseases in humans as well as animals. Mexican Herbal Pharmacopoeia is also known as The Aztec Herbal Pharmacopoeia. It covers Four Hundred Flowers. The Bedianus Codex is known as ‘The Little Book of Herbs’. It was composed in 1552 at a college of Santa Cruz by Aztec Physician Marin de la Cruz. Painting of the plants is the salient feature. It contains information of 251 plant species.