Controlling spurious drugs is an international challenge today as these products have entered healthcare systems of several countries. Developed countries blame China and India for exporting this problem to the western world. Everyone knows that this is more of a biased and an exaggerated allegation with no reliable data to support. At the same time, the fact remains that both the countries do contribute, to a great extend, to this global problem. India has recognized this reality and has been working on to bring about an effective legislation to curb the menace in the country. The first serious attempt by the government was in 2003 with the framing of a bill amending the Drugs & Cosmetics Act incorporating death penalty for offenders. The bill was introduced in the Parliament in the same year but got lapsed with the dissolution of the Lok Sabha soon afterwards. In March 2005, a modified Bill with provisions for enhanced prison terms and speedy trials was cleared by the Union cabinet. Even this Bill did not get through the Parliament. Another attempt is being made by the health ministry in this regard with the move to introduce the Drugs & Cosmetics Amendment Bill 2007 now. The Bill contains more stringent provisions such as a maximum penalty of life imprisonment and a fine of not less than Rs 10 lakh for those engaged in manufacturing spurious and fake drugs. There are also punishments prescribed for the trade. The Bill has retained the provision of making the offences cognizable and non bailable. The Union health minister Dr Ambumani Ramadoss, made it clear a few days ago that the Bill would be tabled in the House during the session commenced from October 17 as the government is serious to wipe out spurious drugs from the market and redeem the image of the pharma sector. Now as the punishments prescribed under the Bill are quite stringent, units engaged in this illegal activity are going to have a tough time. The small scale drug units are a bit concerned as they fear some of their members would be unfairly booked once the Act gets implemented. A section of the SSIs feel that the definition of spurious drugs is not very clear and that can lead to harassment of genuine manufacturers for unintentional lapses by the regulatory officials. Their concern stem from the fact that there is no separate definition of substandard drugs in the Bill and it depends on the enforcement authorities what charges they frame for substandard drugs. Substandard drugs usually contain active pharmaceutical ingredients but not in right quantities and therefore they cannot be classified as spurious or fake drugs. It will be unfair to categorize manufacturers of substandard drugs with fake drug makers and punish. The health ministry needs to take note of this aspect and make suitable safeguards to protect genuine manufacturers while enforcing the new Act so that small time entrepreneurs are assured of justice.