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The Pharmacopoeia
The word Pharmacopoeia is derived from two Greek words; the Pharmakon, which means “a drug or medicine” and Poieo, which means, “to make.”
Every country has legislation on pharmaceutical preparations that set standard and obligatory quality indices for medicaments, raw materials, and preparations employed in the manufacture of drugs.
As we all know that the drug trade now a days is advancing at a rapid pace and it becomes necessary to legalize standard to define the characters, establish the purity and regulate the strength of medicines; and in order to implement all these parameter many countries have recognized the use and roll of Pharmacopoeias, which is accepted as a book of standard.
A national pharmacopoeia contains a list of drugs and formulae for medicinal substances/preparations with description, test for these substances and the standard to which they must conform.
A pharmacopoeia is issued under the authority of the government of a country.
The Pharmacopoeia of India
Under the Drug & Cosmetics Act, the Indian pharmacopoeia is the authorized book of standard in India for drugs included therein and the standards as included in the Indian Pharmacopoeia would be official. Government of India, Ministry of Health and Family Welfare, publish the Indian Pharmacopoeia on the recommendation of Indian Pharmacopoeia committee. If considered necessary these standard can be amended and the Secretary of the Indian Pharmacopoeia Committee is authorized to issue such amendments. In order to keep the Pharmacopoeia accurate and up-to-date, the ministry has established a Central Indian Pharmacopoeia Laboratory at Ghaziabad and an Indian Pharmacopoeia Committee. The history of Indian Pharmacopoeia is as old as that of British Pharmacopoeia. The Bengal Dispensatory was published around 1841 and the Bengal Pharmacopoeia was published in 1844. As on record the first Pharmacopoeia of India was published in 1868, which was prepared under the authority of Her Majesty’s Secretary of State for India in Council. It was divided into sections on vegetable, anima, and inorganic substances, and the products of fermentation and distillation were put altogether in a different section. A supplement to the Pharmacopoeia of India was published in 1869. It was a catalogue of Indian synonyms of medicinal plants, products, inorganic and organic substances included in the Pharmacopoeia, with explanatory and descriptive remarks. By the turn of 19th century the Pharmacopoeia of India ceased to attract the attention. In 1902 Bose published the “Official Indigenous Dugs of India”, which was later published as enlarged edition in 1932 under the title “Pharmacopoeia Indica.” The Indian ‘Pharmacopoeial List’ was published in 1946 by the Government of India, which served as a supplement to the British Pharmacopoeia and consisted mainly of crude drugs along with preparation and few synthetics like Urea Stibamine. The Indian Pharmacopoeial Committee was appointed in 1948 to prepare a national Pharmacopoeia. The first edition of India Pharmacopoeia was published in 1955 and its supplement in 1960. The second edition of Indian Pharmacopoeia was published in 1966 and its supplement came in 1975. The third edition of Indian Pharmacopoeia was published in 1985 followed by the two addenda in 1989 and 1991. The fourth edition of I.P. was also published in 1996 and it is effective from the 1st December 1996. It contains 1149 monographs including 291 new monographs whereas 110 monographs have been deleted and the titles of 142 monographs have been changed. The qualitative test for determining the particulate matter was replaced by the quantitative test, applicable to large volume parenterals. New appendices on biological indicators, clarity and color of solutions, jelly strength, nonaqueous titrations, osmolality, particulate matter, contents of packaged dosage forms.
British Pharmacopoeia
The reason for the appearance of British Pharmacopoeia is ascribed to the Medical Act of 1858, Section 54 which stressed the need of publication of a book having a list of medicines and compounds, and the manner of preparing them, together with true weights and measures by which they are to be prepared and mixed. The first British Pharmacopoeia, 1864 was an outcome of the combination of three old and reputed Pharmacopoeias; Pharmacopoeia Londinensis (1618), Edinburgh Pharmacopoeia (1699) and Dublin Pharmacopoeia (1807). New editions and addendums followed in quick succession, the 2nd in the 1867, an addendum in 1874, a 3rd edition in 1885, a further addendum in 1890 and a 4th edition in 1898.
The British Pharmacopoeia 1864 included separate parts: Materia Medica and Preparations and Compounds. In the 1867 edition the contents had been arranged alphabetically as per the practice of several other pharmacopoeias.
A gap in revision delayed the next edition until 1914.
The British Pharmacopoeia from 1932 edition and onwards became the responsibility of Commission. It was then recommended that the B.P. must be revised every ten years.
The interim between 1932 and next 7th edition of 1948, was covered by seven addenda. In 7th edition of 1948 generic names were provided for the substances newly introduced into medicine. At this time, it was decided that the normal interval between new editions should be five instead of 10 years, due to the rapid pharmaceutical and pharmacological progress that had been made.
The next edition appeared in 1953 and titles of drugs and preparation were given in English instead of Latin. The 9th edition of 1958 was having 160 new monographs. Tranquilizing drugs and spectrophotometric analysis were added. The tenth edition appeared in 1963.
In Medicines Order 1970, the duties of British Pharmacopoeia Commission were defined. The thirteenth edition of British Pharmacopoeia (1980) was the first edition of Pharmacopoeia that was prepared strictly under the provisions of medicines Act.
Currently the British Pharmacopoeia starts publishing in two volumes due to an expansion of drug information.
Volume I deals with the medicinal and pharmaceutical substances. It also includes the infrared spectra needed for the identification of many of the materials. Volume II contains sections on formulated preparations, blood products, immunological products, radio-pharmaceutical preparations, and surgical materials.
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