Quality Standards and Current Status of Ophthalmic Formulations in Indian Pharmacopoeia and National Formulary of India. (May 2014)

• Record Type: Journal Article
• Authors: Vivekanandan, Kalaiselvan; Prakash, Jai; Muthusamy, Kalaivani; Singh, Gyanendra Nath
• Is Part Of: Therapeutic innovation & regulatory science. Volume 48:Number 3(2014:May)
• Page Start: 386
• Page End: 392
• Publication Date: 2014-05
• Subjects: ophthalmic formulations -- Indian Pharmacopoeia -- National Formulary of India -- Central Drug Standards Control Organization -- Indian Pharmacopoeia Commission -- blindness; Drugs -- Periodicals; Pharmacology -- Periodicals; Drugs -- Research -- Periodicals; Drugs -- Testing -- Periodicals; 615.1
• DOI: 10.1177/2168479013513455
• Languages: English
• ISSNs: 2168-4790

Abstract

The global ophthalmic formulations (OFs) market is expanding dramatically with the approval of new drug formulations for a variety of ophthalmic indications by competent authorities in various countries. In India, the Central Drug Standards Control Organization (CDSCO) and Indian Pharmacopoeia Commission (IPC) are making efforts for approval and setting the standards for OFs, respectively. In fulfillment of the requirements of the Drugs and Cosmetics Act of 1940, the IPC is publishing an official book of standards for drugs known as the Indian Pharmacopoeia (IP). There are 44 ophthalmic active pharmaceutical ingredients (APIs) and combinations approved by CDSCO as of 2011; the IP 6th edition (2010) prescribes the quality standards monographs for 41 ophthalmic APIs and formulations. The IP monograph of OFs also includes description, identification, impurities, assay, and specific tests. In addition, the IPC is publishing the National Formulary of India (NFI), which covers 23 OFs for the diagnosis and treatment of various eye diseases. Both the IP and NFI play a significant role in monitoring and improving the safety and efficacy of medicines, with specific emphasis on OFs.