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:
According to news reports (see here and here), the Cabinet approved four Bills for discussion in Parliament. The Bills cleared for consideration and passing are: the Copyright (Amendment) Bill, 2010; the National Accreditation Regulatory Authority for Higher Educational Institutions Bill, 2010 and the Protection of Women against Sexual Harassment at Work Place Bill, 2010. It cleared the Universities for Research and Innovation Bill, 2012 for introduction in Parliament. In this post, we discuss the key provisions of the Bills and the recommendations made by the Standing Committee on Human Resource Development (HRD). The Copyright (Amendment) Bill, 2010 The Bill was introduced on April 19, 2010 in the Rajya Sabha and referred to the Standing Committee on HRD, which tabled its report on November 23, 2010. The government had attempted to pass it in the Winter session twice. However, the Opposition raised the issue of conflict of interest. The Rules of the Ethics Committee state that a MP has to declare his personal or pecuniary interest in a matter, which is under discussion in the Rajya Sabha. The MPs contended that the HRD Minister, Kapil Sibal, could not pilot the Bill without declaring his interest. They argued that his son was the lawyer for a music company which is party to a legal dispute with TV broadcasters to which the amendment would apply (see here for debate on the issue in Parliament). The Copyright Act, 1957 defines the rights of authors of creative works such as books, plays, music, and films. Two key amendments proposed in the Bill are: - Copyright in a film currently rests with the producer for 60 years. The Bill vests copyright in a director as well. - The Bill makes special provisions for those whose work is used in films or sound recordings (e.g. lyricists or composers). Rights to royalties from such works, when used in media other than films or sound recordings, shall rest with the creator of the work. (See here for PRS analysis of the Bill) Key recommendations of the Standing Committee: (a) Drop the provision that makes the principal director the author of a film along with the producer; and (b) Keep the provisions for compulsory licensing in line with the terms of international agreements. (See here for PRS Standing Committee Report summary) The National Accreditation Regulatory Authority for Higher Educational Institutions Bill, 2010 The Bill was introduced on May 3, 2010 in the Lok Sabha and referred to the Standing Committee on HRD, which tabled its report on August 12, 2011. This Bill is part of the government’s attempt to reform the higher education sector. The key objective is to provide an effective means of quality assurance in higher education. Presently, accreditation is voluntary. Higher educational institutions are accredited by two autonomous bodies set up by the University Grants Commission and the All India Council of Technical Education. The Bill makes it mandatory for each institution and every programme to get accredited by an accreditation agency. The agencies have to be registered with the National Accreditation Regulatory Authority. Only non-profit, government controlled bodies are eligible to register as accreditation agencies. (See here for PRS analysis of the Bill) The Standing Committee made some recommendations: (a) assessment for accreditation should start after two batches of students have passed out of the institution; (b) there should be specific provisions for medical education; and (c) registration to accreditation agencies should initially be granted for five years (could be extended to 10 years). (See here for PRS Standing Committee Report summary) The Protection of Women against Sexual Harassment at Work Place Bill, 2010 The Bill was introduced on December 7, 2010 in the Lok Sabha and referred to the Standing Committee on HRD, which tabled
its report on December 8, 2011. The Indian Penal Code covers criminal acts that outrage or insult the 'modesty' of women. It does not cover situations which could create a hostile or difficult environment for women at the work place. The Supreme Court in 1997 (Vishaka judgment) laid down guidelines to protect women from sexual harassment. This Bill defines sexual harassment and provides a mechanism for redressing complaints. The protection against sexual harassment is applicable to all women at the workplace. However, the Bill does not cover domestic workers working at home. (See here for PRS analysis of the Bill) The Standing Committee recommendations addressed issues of gender neutrality, inclusion of domestic workers and the modified definition of sexual harassment. (See here for PRS Standing Committee Report summary) The Universities for Research and Innovation Bill, 2012 The Bill was cleared by the Cabinet and is likely to be introduced in Parliament this session. It seeks to provide for the establishment and incorporation of Universities for Research and Innovation. These universities shall be hubs of education, research and innovation. Although an official copy of the Bill is not yet available, newspaper reports suggest that this is an omnibus law under which innovation universities (focused on specific research areas such as environment, astrophysics and urban planning) shall be established. In India, a university can only be set up through an Act of Parliament or state legislature. The Planning Commission’s Working Group on Higher Education report stated that these universities could be funded by the private sector as well. The government aims to create 14 innovation universities, which would be world class.
