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:
Yesterday, the BJP announced its candidate for the upcoming election of the President, which is scheduled to be held on July 17. In light of this, we take a look at the manner in which the election to the office of the President is conducted, given his role and relevance in the Constitutional framework.
In his report to the Constituent Assembly, Jawaharlal Nehru had explained, “we did not want to make the President a mere figurehead like the French President. We did not give him any real power but we have made his position one of great authority and dignity.” His comment sums up the role of the President as intended by our Constitution framers. The Constituent Assembly was clear to emphasise that real executive power would be exercised by the government elected directly by citizens. It is for this reason that, in performing his duties, the President functions on the aid and advise of the government.
However, it is also the President who is regarded as the Head of the State, and takes the oath to ‘protect and defend the Constitution and law’ (Article 60 of the Constitution). In order to elect a figure head who would embody the higher ideals and values of the Constitution, the Constituent Assembly decided upon an indirect method for the election of the President.
The President is elected by an Electoral College. While deciding on who would make up the electoral college, the Constituent Assembly had debated several ideas. Dr. B.R Ambedkar noted that the powers of the President extend both to the administration of the centre as well as to that of the states. Hence, in the election of the President, not only should Members of Parliament (MPs) play a part, but Members of the state legislative assemblies (MLAs) should also have a voice. Further, in relation to the centre, some members suggested that the college should comprise only members of the Lok Sabha since they are directly elected by the people. However, others argued that members of Rajya Sabha must be included as well since they are elected by members of directly elected state assemblies. Consequently, the Electoral College comprises all 776 MPs from both houses, and 4120 MLAs from all states. Note that MLCs of states with legislative councils are not part of the Electoral College.
Another aspect that was discussed by the Constituent Assembly was that of the balance of representation between the centre and the states in the Electoral College. The questions of how the votes of MPs and MLAs should be regarded, and if there should be a consideration of weightage of votes were raised. Eventually, it was decided that a ‘system of Proportional Representation’ would be adopted, and voting would be conducted according to the ‘single transferable vote system’.
Under the system of proportional representation, the total weightage of all MLA votes equals the total value of that of the MPs. However, the weightage of the votes of the MLAs varies on the basis of the population of their respective states. For example, the vote of an MLA from Uttar Pradesh would be given higher weightage than the vote of an MLA from a less populous state like Sikkim.
Under the single transferable vote system, every voter has one vote and can mark preferences against contesting candidates. To win the election, candidates need to secure a certain quota of votes. A detailed explanation of how this system plays out is captured in the infographic below.
Sources: Constitution of India; ECI Handbook; PRS.
Coming to the Presidential election to be held next month, the quota of votes required to be secured by the winning candidate is 5,49,452 votes. The distribution of the vote-share of various political parties as per their strength in Parliament and state assemblies looks like this:
Note that the last date for filing nominations is June 28th. In the next few days, political parties will be working across party lines to build consensus and secure the required votes for their projected candidates.
[The infographic on the process of elections was created by Jagriti Arora, currently an Intern at PRS.]
