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:
The protests against the nuclear power plant at Kudankulam have intensified over the recent weeks. The Kudankulam plant is expected to provide 2 GW of electricity annually. However, activists concerned about the risks of nuclear energy are demanding that the plant be shut down. The safety of nuclear power plants is a technical matter. In this blog post we discuss the present mechanism to regulate nuclear energy and the legislative proposals to amend this mechanism. Atomic materials and atomic energy are governed by the Atomic Energy Act, 1962. The Act empowers the central government to produce, develop and use atomic energy. At present, nuclear safety is regulated by the Atomic Energy Regulatory Board (AERB). Some of the drawbacks of the present mechanism are discussed below. Key issues under the present nuclear safety regulatory mechanism The AERB is not empowered to operate as an independent operator. The AERB was established by the government through a notification and not through an Act of Parliament. Its powers and functions are therefore amendable by the Department of Atomic Energy through executive orders. The parliamentary oversight exercised upon such executive action is lower than the parliamentary oversight over statutes. [1. The executive action or the Rules are in force from the date of their notification. They are to be tabled before Parliament mandatorily. However, an executive action is discussed and put to vote in Parliament only if an objection is raised by a Member of Parliament. The executive orders may be reviewed by the committee on sub-ordinate legislation. However, this committee has to oversee a large volume of rules and regulations. For instance, there were 1264 statutory notifications that were tabled before the Rajya Sabha in 2011-12.] Furthermore, the Atomic Energy Commission that sets out the atomic energy policy, and oversees the functioning of the AERB, is headed by the Secretary, Department of Atomic Energy. This raises a conflict of interest, as the Department exercises administrative control over NPCIL that operates nuclear power plants. It is pertinent to note that various committee reports, including a CAG Report in 2011, had highlighted the drawbacks in the present regulatory mechanisms and recommended the establishment of a statutory regulator. A summary of the Report may be accessed here. Proposed mechanism Following the Fukushima nuclear incident in 2011, the Nuclear Safety Regulatory Authority Bill, 2011 was introduced in Parliament to replace the AERB. The Bill establishes the Nuclear Safety Regulatory Authority (NSRA) to regulate nuclear safety, and a Nuclear Safety Council to oversee nuclear safety policies that the NSRA issues. Under the Bill, all activities related to nuclear power and nuclear materials may only be carried out under a licence issued by the NSRA. Extent of powers and independence of the NSRA The Bill establishes the NSRA as a statutory authority that is empowered to issue nuclear safety policies and regulations. The Nuclear Safety Council established under the Bill to oversee these policies includes the Secretary, Department of Atomic Energy. The conflict of interest that exists under the present mechanism may thus continue under the proposed regulatory system. The Bill provides that members of the NSRA can be removed by an order of the central government without a judicial inquiry. This may affect the independence of the members of the NSRA. This process is at variance with enactments that establish other regulatory authorities such as TRAI and the Competition Commission of India. These enactments require a judicial inquiry prior to the removal of a member if it is alleged that he has acquired interest that is prejudicial to the functions of the authority. The proposed legislation also empowers the government to exclude strategic facilities from the ambit of the NSRA. The government can decide whether these facilities should be brought under the jurisdiction of another regulatory authority. These and other issues arising from the Bill are discussed here.
