With the final session of the Parliament concluding last week, some key policy initiatives keenly awaited by the pharmaceutical industry will remain indefinitely postponed. First among them is the finalization of the new pharmaceutical policy by the Group of Ministers headed by Sharad Pawar. The ministry of chemicals has been working on the new drug policy from 2000 onwards as there were major drawbacks in the drug policy of 1994. Apart from various other provisions, the number of drugs under the price control is limited to just 74 in the 1994 policy. After Drug Price Control Order was notified in 1995, several new drugs were approved for marketing for existing diseases and various new indications by the DCGI. Although many of them were essential drugs and priced quite high, there has been an unexplained hesitation on the part of the National Pharmaceutical Pricing Authority to include them under DPCO. The GoM was to care of this matter in the new Pharmaceutical Policy. A bill for formation of a Central Drug Authority for streamlining the drug control administration in the country was another major reform that did not come through. In the absence of a centralised drug control system, manufacturing licenses are being issued by various state drug authorities with no proper coordination with DCGI or other state drug bodies. Such a system has resulted in flooding of market with products containing same ingredients by a large number of companies. Many of these products are harmful with no therapeutic rationale. A centralised licensing system is expected to bring some order to this chaotic situation of today. Another statute that got stuck was the Spurious Drugs Bill seeking to curb the manufacturing and sale of fake and substandard drugs in the country. This has been a serious problem in the country for several years with no effective law to combat. Now, the draft Bill has excellent provisions to curb this illegal activity although some provisions are not properly defined. With the announcement of elections, enactment of this legislation will take several more months. Framing a law to govern clinical trials in the country was another critical piece of legislation. In the name of clinical research, thousands of poor patients and young men are being lured and subjected to unethical practices as there is no effective law to monitor the activities of CROs and pharma companies. Ethical Guidelines for Biomedical Research on Human Subjects drafted by ICMR has been lying with the health ministry since 2000. Clinical Establishment Bill and a set of rules for stem cell research are the other two key legislative initiatives the UPA government failed to bring about after years of preparation. It is shocking that the political leadership at the Centre could neglect these crucial bills involving issues of public health and welfare even with adequate bureaucratic support.