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Quality Standards for Antiretrovirals in Indian Pharmacopoeia

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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.

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Authors and Affiliations

  1. Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Sector 23, Rajnagar, Ghaziabad, UP, 201 002, India

    Kalaiselvan Vivekanandan MPharm, PhD, Hemant Sharma MPharm & Gyanendra Nath Singh MPharm, PhD

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  1. Kalaiselvan Vivekanandan MPharm, PhD
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  2. Hemant Sharma MPharm
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  3. Gyanendra Nath Singh MPharm, PhD
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Correspondence to Kalaiselvan Vivekanandan MPharm, PhD.

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Vivekanandan, K., Sharma, H. & Singh, G.N. Quality Standards for Antiretrovirals in Indian Pharmacopoeia . Ther Innov Regul Sci 46, 581–586 (2012). https://doi.org/10.1177/0092861512450568

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