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:
In 2010, the Legislative Assistants to Members of Parliament (LAMP) Fellowship was conceptualised by PRS Legislative Research, creating a unique platform for young Indians to engage with policy making at the national level. The Fellowship, a first of its kind in India, provides an opportunity for youth passionate about public policy to work with a Member of Parliament. Launched in collaboration with the Constitution Club of India, the Fellowship began with 12 Fellows and has now grown to include more than 40 young men and women from across India working with MPs from across political parties.
The Work
The bulk of the Fellow’s work focuses on Parliament. On average, Parliament passes 60 Bills a year. These Bills, covering a wide range of issues from food security to criminal laws, represent the government’s policy choices. Informed debates on legislation are therefore critical. Parliamentarians also use the floor of the House to discuss and debate urgent matters of public interest. The LAMP Fellowship provides young Indians with the opportunity to do legislative work through a 11-month professional engagement with an MP. Fellows are exposed to critical issues in public policy through which they will acquire knowledge about policy, parliament and governance structures, develop analytical abilities and hone leadership skills.
The Fellow typically supports an MP by providing research inputs for: policy and legislative debates, parliamentary Questions, standing committee meetings, and framing private members’ Bills. Beyond Parliament, MPs have to focus on their constituency; LAMP fellows may work on issues at the constituency level. Many Fellows in the current cohort have also had a chance to visit the parliamentary constituencies, often travelling with the MP to meet district officials and engage with constituents. Visits usually include a trip to the site of a centrally-sponsored scheme, engaging with public health officials, or attending panchayat meetings. Some Fellows also assist their MPs with media-related work like drafting press releases and preparing research for public appearances.
Policy Exposure
The LAMP Fellowship is enriched by various workshops, seminars and discussions providing greater exposure to public policy. The current cohort have already engaged with experts like former Director General, CAG Amitabh Mukhopadhyay; social activists Reetika Khera and Harsh Mander; policy practitioners Nitin Pai of The Takshashila Institution, Laveesh Bhandari of Indicus Analytics and former Chairman of TRAI Nripendra Misra; and leading JNU academic, Niraja Gopal Jayal.
"At LAMP, there is no 'typical' day at work. Each day comes with new tasks, new challenges. My work for my MP has forced me out of my comfort zone to explore and understand an array of subjects." - Kavya Iyengar, LAMP Fellow 2012-13
Fellows also get the opportunity to interact with organisations from various sectors like Google India, UNHCR and BCG. For instance, this year’s Fellows participated in the iPolicy workshop for young leaders, organised by the Centre for Civil Society. Last year, the Indian School of Business (ISB) Hyderabad hosted LAMP Fellows for a 3-day residential leadership development workshop, led by professors and guest speakers, including former RBI Governor, Dr. YV Reddy.
The LAMP Fellowship provides policy exposure but also guarantees a truly distinctive year: no two LAMP Fellows have the same experience. Every MP will have different research demands; LAMP Fellows have to be flexible, self-motivated and hungry to learn. Work can be challenging but also hugely rewarding. Previous Fellows have used the Fellowship as a launch pad, pursuing further studies at top Universities like Yale, John Hopkins, and Oxford and embarking on careers in political consulting, public relations and think tanks. Some Fellows have even continued to support the work of parliamentarians, pursuing their area of interest like media, policy and constituency development projects.
India’s vibrant democracy is constantly confronted by complex, urgent and important challenges. The Fellowship provides a once in a lifetime opportunity to understand these challenges and, perhaps, even help overcome them. Be a part of the solution, be a LAMP Fellow.
