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Quality Standards for Antiretrovirals in Indian Pharmacopoeia

  • Kalaiselvan VivekanandanEmail author
  • Hemant Sharma
  • Gyanendra Nath Singh
Drug Information

Abstract

The global antiretroviral market is expanding dramatically with the approval of competent authorities in individual countries. In India, the Central Drugs Standard Control Organization (CDSCO) and Indian Pharmacopoeia Commission (IPC) are making efforts to approve and set the standards for antiretroviral drugs, respectively. The IPC publishes an official book of standards known as Indian Pharmacopoeia (IP) in fulfillment of the requirements of the Drugs and Cosmetics Act of 1940. There are 41 antiretroviral active pharmaceutical ingredients (APIs) and combinations approved by the CDSCO; the sixth edition of IP contains 52 monographs of different APIs and formulations. The monographs of antiretrovirals include descriptions, identifications, impurities, assays, and specific tests. IP plays a significant role in improving the quality of antiretroviral drugs, which in turn promote public health.

Keywords

antiretrovirals Indian Pharmacopoeia Commission Indian Pharmacopoeia monograph Central Drugs Standard Control Organization 

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Copyright information

© Drug Information Association, Inc 2012

Authors and Affiliations

  • Kalaiselvan Vivekanandan
    • 1
    Email author
  • Hemant Sharma
    • 1
  • Gyanendra Nath Singh
    • 1
  1. 1.Indian Pharmacopoeia Commission, Ministry of Health and Family WelfareGovernment of IndiaGhaziabad, UPIndia

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