The recent reports of chemical contamination of Viracept, an HIV drug, produced and marketed by Pfizer and Roche, have raised serious concerns about the quality standards and safety norms employed in manufacturing facilities of international pharmaceutical companies. In both cases, nelfinavir mesylate, the active ingredient in the drug, was contaminated by ethanol, a chemical used for cleaning the process machinery. The reaction of ethanol with the active ingredient during the manufacturing process caused formation of ethyl methanesulfonate (EMS) and that contaminated several batches of the drug already marketed by both the pharma giants in Europe and the US. Roche was asked to stop production and marketing of the drug by the European Medicines Agency in last June when the matter was brought to its notice and the company also lost its marketing authorization for the product in entire Europe. The EMS levels that triggered the product recall of Roche were caused by human error in cleaning processes which left large quantum of ethanol in the machinery causing reaction with the active ingredient during the manufacture. The company has been directed to compile registries of Viracept patients stretching back as far as 1998 and to carry out toxicology studies to record how harmful EMS could be on patients. EMEA has advised all patients who were on Viracept to switch over to alternative medications. According to Roche's figures, there are 20,000 to 25,000 patients who received batches of Viracept containing over 1,000ppm of the toxic contaminant. In Europe, most patients taking these dangerous batches of the drug were from countries like Italy, Spain and France. In sharp contrast to the European action against Roche, US FDA has been rather mild to Pfizer even after realizing its batches of Viracept also have the same contamination. A direction from US FDA only warned against the use of the drug by new pediatric or pregnant patients and advised pregnant women currently taking the medication to switch over to an alternative drug. Pfizer has taken the stand that the levels of EMS found in its version of Viracept were substantially lower than the recalled Roche's product across the EU. US FDA's decision to keep Viracept in the market is on the assumption that it would be better for patients to be exposed to a higher or interim levels of EMS for a short period of time rather than risking an abrupt switch of the drug. Now, the truth is patients all over the world should be victims to higher levels of EMS in Viracept as the product had hit the market 10 years ago. The concern regarding the presence of this type of contaminant in medicinal products has, however, convinced the US FDA to work on a set of guidelines dictating limits for such genotoxic compounds in pharmaceutical products. The move to frame the guidelines reflects the pressure on the agency to monitor the levels of these dangerous impurities present in pharmaceutical manufacturing even in sophisticated plants. However, the harsh truth is that toxic contaminants like EMS may be present in several thousands of other drug products that are in the market for many years. The Viracept issue raises the need to lay down stringent limits for impurities and other contaminants in pharmaceutical manufacturing across the world to ensure drug safety. And in India, drug safety has been a neglected area for several years considering the existence of several banned drugs and huge number of irrational combinations. The DCGI office has to wake up to this reality of contamination drugs in pharmaceutical plants and bring necessary regulations to constantly monitor the production processes of companies.