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  • Saturday, 25 May, 2019
  • 12:42:01 AM

SIGNIFICANCE OF I.P OVER U.S.P & B.P

                     The Indian Pharmacopoeia (IP) is published in fulfilment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder. It prescribes the standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines. The standards of this pharmacopoeia are authoritative and legally enforceable. It intends to help in the licensing of manufacturing, inspection and distribution of medicines.

                     The actual process of publishing the first Pharmacopoeia started in the year 1944 under the chairmanship of Col. R. N. Chopra under the British Regime. The I. P. list was first published in the year 1946 and was put forth for approval. First edition of I.P published in the year 1955 followed by the 8th edition in 2018. Indian Pharmacopoeia Commission (IPC) is an autonomous institution of the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India. The set of standards are published under the title Indian Pharmacopoeia (IP) which has been modelled over and historically follows from the British Pharmacopoeia because I.P is conceptualised by British Government.

                      The IP 2014 which is 7th edition, incorporates 2567 monographs of drugs out of which 577 are new monographs consisting of APIs, excipients, dosage forms, herbal products, biotechnology products and radiopharmaceuticals etc. 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.

                                            Significance of I.P over USP & B.P

Keeping in view the essential requirement for harmonization of analytical methods with those accepted internationally, steps have been taken for monitoring drug standards.

  • Most of the existing Assays and Related Substances Test methods have been upgraded by liquid chromatography to harmonize with other International Pharmacopoeias.
  • I.P covers 90%  assay and impurity test methods similar to U.S.P
  • 53 New Fixed Dose Combination (FDCs) monographs have been included, out of which 25 FDC monographs are not available in any Pharmacopoeia.
  • 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.
  • Pyrogen test has been replaced by Bacterial Endotoxin test (BET) in parenteral preparations and other monographs.

                  India is manufacturing medicine for approximately 200 countries and saving valuable life of human being and other living organisms. Manufacturers have to take many administrative documents in case of U.S.P & B.P formulations to manufacturer sample for dossier documentation and registration. It requires more than 6-8 months. Procurement of raw materials, reference standard and impurities in U.S.P & B.P are again time taking and challenging.

                   It is hoped that acceptance of I.P across the world would play a significant role in improving timely demand and supply of medicines which in turn promote public health and accelerate the growth and development of Pharma Sector. 

 

 

 

 

Conceptualize and documented by Mohammad Shahbaz Alam

 



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