Background:  India is a major producer of generic HIV antiretroviral drugs. These are widely used in developing countries since they are  cheaper than those produced elsewhere. However,  data describing the integrity of these drugs are not publicly available. We analyzed the content of 6 commonly used nucleoside and non-nucleoside reverse transcriptase inhibitors alone and in combination from 3 Indian sources and compared the values with proprietary medications that are manufactured in United States.

Methods:  Efavirenz (600 mg), nevirapine (200 mg), zidovudine (300 mg), stavudine (30 mg), lamivudine (150 mg), and a combination pill containing nevirapine, stavudine, and lamivudine in the same dosages--obtained from Aurobindo Pharma, Ranbaxy, and Cipla--were tested in this study. Zidovudine and lamivudine in syrup preparations were also tested. The concentration of all the antiretroviral formulations was determined by HPLC. Six tablets or capsules of each anti retroviral drug were processed and analysed in duplicate. The drugs were dissolved in methanol for analysis and appropriate dilutions were made in methanol.  After coding them, 12 chromatographic analyses were performed for each individual tablet. The concentration of the drugs were calculated from a set of calibration standards of known concentration.

Results:  The mean drug content of all the preparations compared well with the proprietary formulations and the variability ranged from 0.01 to 8.3%. All the formulations were within 5% range of the stated contents as compared to the proprietary drugs except for stavudine (single pill) and lamivudine (combination pill) which were slightly higher.

Conclusions:   Analyses of the above commonly used antiretroviral medications manufactured in India by Aurobindo Pharma, Ranbaxy, and Cipla indicate that the amount of active drug is very similar to those medications manufactured in United States. Although these data are reassuring given the widespread use of such products in the developing world, further studies are required to evaluate the bioequivalence, including bioavailability, of these medications over a larger sample size.

Keywords: Quality Assurance; Generic drugs; Anti retroviral drugs