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:
Speaker Meira Kumar has urged political parties to arrive at a consensus on the women’s reservation bill. The 2008 Bill has the following main features. 1. It reserves one-third of all seats in Lok Sabha and Legislative Assemblies within each state for women. 2. There is quota-within-quota for SCs, STs and Anglo-Indians. 3. The reserved seats will be rotated after each general elections – thus after a cycle of three elections, all constituencies would have been reserved once. This reservation will be operational for 15 years. This Bill has had a chequered history. A similar Bill was introduced in 1996, 1998 and 1999 – all of which lapsed after the dissolution of the respective Lok Sabhas. A Joint Parliamentary Committee chaired by Geeta Mukherjee examined the 1996 Bill and made seven recommendations. Five of these have been included in the latest 2008 Bill. These are (i) reservation for a period of 15 years; (ii) including sub-reservation for Anglo Indians; (iii) including reservation in cases where the state has less than three seats in Lok Sabha (or less than three seats for SCs/STs); (iv) including reservation for the Delhi assembly; and (v) changing “not less than one-third” to “as nearly as may be, one-third”. Two of the recommendations are not incorporated in the 2008 Bill. The first is for reserving seats in Rajya Sabha and Legislative Councils. The second is for sub-reservation for OBC women after the Constitution extends reservation to OBCs. The 2008 Bill was referred to the Standing Committee on Law and Justice. This Committee failed to reach a consensus in its final report. The Committee has recommendedthat the Bill “be passed in Parliament and put in action without further delay. Two members of the Committee, Virender Bhatia and Shailendra Kumar (both belonging to the Samajwadi Party) dissented stating that they were not against providing reservation to women but disagreed with the way this Bill was drafted. They had three recommendations: (i) every political party must distribute 20% of its tickets to women; (ii) even in the current form, reservation should not exceed 20% of seats; and (iii) there should be a quota for women belonging to OBCs and minorities. The Standing committee considered two other methods of increasing representation. One suggestion (part of election commission recommendations) was to requite political parties to nominate women for a minimum percentage of seats. The committee felt that parties could bypass the spirit of the law by nominating women to losing seats. The second recommendation was to create dual member constituencies, with women filling one of the two seats from those constituencies. The Committee believed that this move could “result in women being reduced to a subservient status, which will defeat the very purpose of the Bill”. It is interesting to note that the Committee did not reject the two recommendations of the Geeta Mukherjee Committee that are not reflected in the Bill. The Committee concluded that the issue of reservations to Rajya Sabha and Legislative Councils needs to be examined thoroughly as the upper Houses play an equally important role under the Constitution. Incidentally, it is not possible to reserve seats in Rajya Sabha given the current system of elections to that house (see Appendix below). On the issue of reservations to OBC women, the Committee said that “all other issues may be considered at an appropriate time by Government without any further delay at the present time in the passage of the Bill”. Though the Bill does not have a consensus – it has been opposed by SP, RJD and JD(U) – most parties have publicly expressed their support for it. The government will likely not find it difficult to muster two-third support in each House of Parliament were the Bill be taken up for consideration and passing. It would be interesting to see whether the Bill is brought before Parliament in the upcoming Budget Session. Appendix: Impossibility of Reservation in Rajya Sabha Article 80of the Constitution specifies that members of state assemblies will elect Rajya Sabha MPs through single transferable vote. This implies that the votes are first allocated to the most preferred candidate, and then to the next preferred candidate, and so on. This system cannot accommodate the principle of reserving a certain number of seats for a particular group. Currently, Rajya Sabha does not have reservation for SCs and STs. Therefore, any system that provides reservation in Rajya Sabha implies that the Constitution must be amended to jettison the Single Transferable Vote system.
