Authored by Anil Nair and CV Madhukar PRS just concluded a workshop for MLAs from 50+ from more than a dozen states. What an AMAZING experience this was, even though this is the sixth such workshop we have held in this past year! This three day workshop on 'Mastering the Budget' was designed to help MLAs understand how to work with budget documents and numbers, find trends, understand the most critical macro numbers to track, etc. The second day of the workshop was tailored to reflect on the big thematic issues that have an impact on state finances. The Fiscal Responsibility and Budget Management Act, the Goods and Services Tax, the pattern of quantum of funds flow from the Centre to the state and local governments, the 13th Finance Commission, etc. The final day was devoted to doing an inter-state comparison of states on important budget parameters, and gleaning lessons from them. The idea for this budget workshop germinated at a previous workshop held at IIM Bangalore. The participating MLAs requested PRS to organise a special session on 'Mastering the Budget'. So this workshop was being organised as a result of their feedback. The choice of location was easy -- this was held at the National Institute for Public Finance and Policy in Delhi, which is amongst India's foremost institutions working on state budgets and public finance issues. Invitations were sent out to MLAs in several states. Responses started coming in within a few days, with about 70 confirmations. But there is always an uncertainty on the participation until the very last minute because elected politicians have immense demands on their time, at least some of which are unpredictable. So it was heartening to see that more than 50 MLAs came to the workshop representing 15 states -- Bihar, Rajasthan, Odisha, Uttar Pradesh, Assam, Kerala, West Bengal, Andhra Pradesh, Meghalaya, Tamil Nadu, Madhya Pradesh, Himachal Pradesh, Gujarat, Haryana, Manipur. The participants ranged from first time MLAs (about 50%), to a sitting Minister, a sitting Speaker, former Ministers, and senior leaders of political parties from some states. But the best part about the interaction in this workshop was that even on seemingly complex issues being discussed in the classroom, the MLAs were not mere recipients of 'gyan' that was being dished out. They had important questions to raise, and well articulated points of disagreement with the faculty, and brought in practical perspectives that might not have otherwise come up in the discussions. They went beyond the scope of the workshop to engage the economists on discussions on subjects like FDI in retail, state of India’s economy… Based on our experience of several workshops with MLAs, we want to share some observations about the participating MLAs: - There are MLAs in every state who want to understand substantive policy issues, and are willing to invest time and energy to do so. - When the MLAs participate in these workshops, they choose to do so on their own, and are not compelled by anyone to do so. - The sessions almost always begin and end on time, even in the freezing cold mornings in the Delhi winter. - The MLAs are very engaged in the discussions, ask questions, and bring in their experiences into the classroom discussions. - They keep partylines completely out of the substantive classroom discussions, and in the rare event that some new participant mentions anything partisan, other participants quickly ask him to avoid making any such mentions. In 2011, we have engaged with over 250 MLAs through these workshops and more. These workshops are just a starting point of what we hope will develop into a sustained, longer term engagement with MLAs on policy issues coming up in their states. In an important partnership with the Indian School of Business, Hyderabad, PRS has already conducted two workshops at the world class facilities at the ISB campus, and is planning to hold more in 2012. Just as PRS engages with about 300 MPs in Parliament, the hope is that more MLAs will be able to derive value from the work of PRS in the years to come, thereby making their decisions better informed. Some feedback from MLAs from our earlier workshops can be seen here: http://www.youtube.com/watch?v=9XlgKCp2bvs or http://www.youtube.com/watch?v=01kLLTVtJOU&feature=related or http://www.youtube.com/watch?v=WA4NZqCj2xk&feature=related
The Parliamentary Standing Committee on Health and Family Welfare tabled a Report in Parliament on May 8, 2012, on the functioning of the Central Drugs Standard Control Organization (CDSCO). CDSCO is the agency mandated with the regulation of drugs and cosmetics in India. The Report covers various aspects of drug regulation including organizational structure and strength of CDSCO, approval of new drugs, and banning of drugs, among others. Following the Report, the Minister of Health and Family Welfare has constituted a Committee to look into the procedure for drug regulation. The Committee is expected to make its submissions within a period of two months. This post focuses on irregularities in the approval of new drugs by CDSCO. It discusses the regulations relating to drug approval and the Standing Committee's observations on the working of CDSCO. Approval of new drugs Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945 [Rules]. The CDSCO, under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import. State Drug Authorities are the licensing authorities for marketing drugs. New Drugs are defined as:
The Rules require an applicant for a new drug to conduct clinical trials in India to determine the drug’s safety and efficacy. These trials are necessary for both domestically manufactured and imported drugs. However, the authority can exempt a drug from the requirement of local and clinical trials in the public interest based on data available in other countries. Observations and recommendations of the Committee The Committee found that a total of 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients. The Report mentioned that drug manufacturers, CDSCO officials and medical experts colluded to approve drugs in violation of laws. Following are some of the Report’s findings:
