Six generics compare well with US-made ARVs

A comparison between several generic antiretrovirals and the brand name formulations, carried out by researchers in Channai, India, and Boston, USA, shows that the drug content of the generics compared well.

All the formulations were within the 5% range of the stated contents compared with the proprietary drugs, except for two.

Researchers at the Tuberculosis Research Centre in Chennai and Tufts University School of Medicine in Boston, analysed six widely used nucleoside and non-nucleoside reverse transcriptase inhibitors alone and in combination, from three Indian manufacturers: Aurobindo Pharma, Ranbaxy and Cipla.

They looked at efavirenz (600mg), nevirapine (200mg), AZT (300mg), ddI (250mg) d4T (30mg), 3TC (150mg), and a combination pill containing nevirapine, d4T and 3TC in those dosages and compared them to drugs manufactured in the USA. The samples analysed were physicians’ samples provided for patient use during July and August 2003.

Six tablets or capsules of each drug were crushed to a fine powder and analysed in duplicate by high performance liquid chromatography. In total, 12 chromatographic analyses were performed for each medication.

The researchers report that all the formulations were within the 5% range of the stated contents compared with the American products, except for stavudine and lamivudine “which were slightly higher but within the 10% range”. The authors add that their analyses “indicate that the amount of active drug is very similar to those medications manufactured in the USA”.

Ramachandran G, Perloff E, von Moltke L et al. Analysis of generic antiretroviral formulations manufactured in India. AIDS 2004, Vol 18, No 10, 1482-3.