In the aftermath of the nuclear leaks in Japan, there have been concerns regarding the safety of nuclear power plants around the world. There are some proposals to change the regulatory framework in India to ensure the safety of these plants. We examine some of the issues in the current structure. Which body looks at safety issues regarding nuclear power plants in the country? The apex institution tasked to look at issues regarding nuclear safety is the Atomic Energy Regulatory Board. The AERB was set up in 1983 to carry out regulatory and safety functions regarding nuclear and radiation facilities. The agency has to give clearances for establishing nuclear power plants and facilities. It issues clearances for nuclear power projects in stages after safety reviews. The safety of setting up a nuclear plant in any given area is also assessed by the AERB. For example, it would have looked into the safety of setting up a nuclear power project in Jaitapur in Maharashtra. AERB also reviews the safety mechanisms within existing nuclear plants and facilities. To do this, it requires nuclear facilities to report their compliance with safety regulations, and also makes periodic inspections. Under the recently passed Civil Liability for Nuclear Damage Act, 2010 the AERB is also the authority responsible for notifying when a nuclear incident takes place. Mechanisms for assessing and claiming compensation by victims will be initiated only after the nuclear incident is notified. Why is the Atomic Energy Regulatory Board in the news? Prime Minister Manmohan Singh announced on March 29, 2011, "We will strengthen the Atomic Energy Regulatory Board and make it a truly autonomous and independent regulatory authority." This announcement came in the backdrop of the continuing crisis and high radiation levels at the Fukusima nuclear plant in Japan. News reports opined that the lack of proper autonomy of Japan's nuclear regulator curbed its effectiveness. Japan's ministry of economy, trade and industry regulates the nuclear power industry, and also promotes nuclear technology. These two aims work at cross-purposes. India's regulatory structure is similar to Japan in some respects. What measures has the AERB taken post the Fukushima nuclear incident in Japan? Following the nuclear incident in Japan, a high-level committee under the chairmanship of a former AERB chairman has been set up to review the safety of Indian nuclear power plants. The committee shall assess the capability of Indian nuclear power plants to withstand earthquakes, tsunamis, cyclones, floods, etc. The committee will review the adequacy of provisions for ensuring safety in case of such events. Is there any issue in the current regulatory structure? The AERB is a regulatory body, which derives administrative and financial support from the Department of Atomic Energy. It reports to the secreatry, DAE. The DAE is also involved in the promotion of nuclear energy, and is also responsible for the functioning of the Nuclear Power Corporation of India Limited, which operates most nuclear power plants in the country. The DAE is thus responsible both for nuclear safety (through the AERB), as well as the operation of nuclear power plants (through NPCIL). This could be seen as a conflict of interest. How does the system of independent regulators differ from this? The telecom sector provides an example of an independent regulator. The Telecom Regulatory Authority of India does not report to the Department of Telecommunications. The DoT is responsible for policy matters related to telecommunications, promoting private investment in telecom, and also has a stake in BSNL. Had TRAI reported to the DoT, there would have been a conflict of interest within the DoT. What will the proposed legislation change? Recent news reports have stated that a bill to create an independent regulatory body will be introduced in Parliament soon. Though there is no draft bill available publicly, news reports state that an independent Nuclear Regulatory Authority of India will be created by the bill, and the authority will subsume the AERB within it. This post first appeared as an article on rediff.com and can be accessed here.
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:
