Officially, 5% drugs sold in India are substandard. Unofficially, the figure is much higher. Substandard drugs delay recovery; lead to resistance and even cause death. In India, about 60% of the medical expenses are out of consumer’s pocket. Of the expenses on medicines nearly 70% is on medicines, which may or may not work. That is really sad. You can blame this state of affairs on defective manufacturing, sale and distribution of drugs. Of course, all activities are regulated by the government. There are 36 regulators, and most of them have failed in their task. Successive governments have failed to check defects through centralization. The absence of a legal framework is compounded by manpower crunch. Paucity of human resources in numbers as well as quality is tying the regulators into knots. Even the manner in which the quality is assessed is a problem. Enforcement of quality takes place in the market place, when the regulator lifts samples for testing from the market- when they are already available for sale and consumption. This is not the global practice, where the intervention starts at the process level. In 2012, a parliamentary committee went on to say that the regulator, the Central Drug Standards Control Organization has given primacy to the drug manufacturing industries’ propagation instead of focusing on the biggest stake holder, the consumer. The public upheaval at home apart, this state of affairs has also had an adverse impact on India’s exports. India is the largest supplier of generic drugs. It accounts for 20% of the global market. Fixing the quality problem is not an impossible task. It requires a centralized and efficient regulatory mechanism. The real challenge is to find the political will.