Quality Standards for Antiretrovirals in Indian Pharmacopoeia
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Quality Standards for Antiretrovirals in Indian Pharmacopoeia
Drug Information Journal 46(5) 581-586 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512450568 http://dij.sagepub.com
Kalaiselvan Vivekanandan, MPharm, PhD1, Hemant Sharma, MPharm1, and Gyanendra Nath Singh, MPharm, PhD1
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
Introduction India has emerged as a world leader in the production of generic pharmaceuticals, contributing 20% of the global market for generic medicines, and more than 80% of all donor-funded antiretrovirals purchased since 2006 were supplied by Indian generic manufacturers.1 From 2002 to 2008, more than 4 million people were started on antiretroviral therapy in developing countries.2 The current market for antiretrovirals is dominating; however, the use of substandard drugs poses threats to society, not only with regard to side effects but also in terms of trade relations, economic implications, and effects on global pandemics.3–8 Furthermore, this is an issue that needs to be continually dealt with on the national and international policy levels. Various pharmacopoeial bodies are involved in this issue and try to set the standards for antiretroviral drugs. Pharmacopoeial standards and acceptance criteria are set with the intention that they be used only as compliance requirements and not as requirements to guarantee total quality assurance. Pharmacopoeial standards are the minimum with which a manufacturer must comply before release of a product for sale or distribution. To ensure the quality and standard of drugs in India, the Indian government’s Ministry of Health and Family Welfare publishes an official book of standards known as Indian Pharmacopoeia (IP) in fulfillment of the requirements of the Drugs
and Cosmetics Act of 1940. IP is periodically published by the Indian Pharmacopoeia Commission (IPC), which is an autonomous institution also under the Ministry of Health and Family Welfare. IP makes an important contribution to public health
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