Quality Standards for Antiretrovirals in Indian Pharmacopoeia

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


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.


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


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Waning B, Diedrichsen E, Moon S. A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries. J Int AIDS Soc. 2010;13:13–35.CrossRefGoogle Scholar
  2. 2.
    World Health Organization. Towards Universal Access: Scaling Up Priority HIV/AIDS Interventions in the Health Sector. Geneva: World Health Organization; 2009.Google Scholar
  3. 3.
    Nsimba SE. Problems associated with substandard and counterfeit drugs in developing countries: a review article on global implications of counterfeit drugs in the era of antiretroviral (ARVs) drugs in a free market economy. East Afr J Public Health. 2008;5:205–210.PubMedGoogle Scholar
  4. 4.
    Caudron JM, Ford N, Henkens M, Mace C, Kiddle-Monroe R, Pinel J. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health. 2008;13:1062–1072.CrossRefGoogle Scholar
  5. 5.
    Gautam CS, Utreja A, Singal GL. Spurious and counterfeit drugs: a growing industry in the developing world. Postgrad Med J. 2009;85:251–256.CrossRefGoogle Scholar
  6. 6.
    Aldhous P. Counterfeit pharmaceuticals: murder by medicine. Nature. 2005;434:132–136.CrossRefGoogle Scholar
  7. 7.
    Newton PN, Green MD, Fernandez FM. Impact of poor-quality medicines in the developing world. Trends Pharmacol Sci. 2010;3:99–101.CrossRefGoogle Scholar
  8. 8.
    Videau JY. Quality of medicines in least developed countries. Med Trop (Maras). 2006;66:533–537.Google Scholar
  9. 9.
    Ministry of Health and Family Welfare, Government of India. Indian Pharmacopoeia. Ghaziabad: Indian Pharmacopoeia Commission; 2010.Google Scholar
  10. 10.
    Ministry of Health and Family Welfare, Government of India. Indian Pharmacopoeia. Ghaziabad: Indian Pharmacopoeia Commission; 2007.Google Scholar
  11. 11.
    Mendez A, Steppe M, Schapoval E. Stability and degradation kinetics of meropenem in powder for injection and reconstituted sample. J Pharm Biomed Anal. 2006;4:1363–1366.CrossRefGoogle Scholar
  12. 12.
    Gorog S. Chemical and analytical characterization of related organic impurities in drugs. Anal Bioanal Chem. 2003;377:852–862.CrossRefGoogle Scholar
  13. 13.
    Qiu F, Norwood DL. Identification of pharmaceutical impurities. J Liq Chromatogr Relat Technol. 2007;30:877–935.CrossRefGoogle Scholar
  14. 14.
    Rao RN, Nagaraju V. An overview of the recent trends in development of HPLC methods for determination of impurities in drugs. J Pharm Biomed Anal. 2003;33:335–377.CrossRefGoogle Scholar
  15. 15.
    Rousseau G. International Conference on Harmonisation impurity guidelines: the industry perspective. Drug Information Journal. 2000;34:903–907.CrossRefGoogle Scholar
  16. 16.
    International Conference on Harmonisation. Q3A(R): Draft Revised Guidance on Impurities in New Drug Substances. Fed Regist. 2000;65(140):45085.Google Scholar
  17. 17.
    International Conference on Harmonisation. Q3B(R): Draft Revised Guidance on Impurities in New Drug Products. Fed Regist. 2000;65(139):44791.Google Scholar
  18. 18.
    Mallipeddi R, Rohan LC. Progress in antiretroviral drug delivery using nanotechnology. Int J Nanomed. 2010;5:533–547.CrossRefGoogle Scholar
  19. 19.
    Flora SJS, Mittal M, Mehta A. Heavy metal induced oxidative stress and its possible reversal by chelation therapy. Indian J Med Res. 2008;128:501–523.PubMedGoogle Scholar
  20. 20.
    Graeme KA, Pollack CV Jr.. Heavy metal toxicity, part I: arsenic and mercury. J Emerg Med. 1998;16:45–56.CrossRefGoogle Scholar
  21. 21.
    Sanjay BB, Bharati RK, Yogini SJ, Atul AS. Impurity profile: significance in active pharmaceutical ingredient. Eurasian J Anal Chem. 2007;2:32–53.CrossRefGoogle Scholar

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

Personalised recommendations