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The simple answer is yes. Under the Copyright Act, 1957, the government, and the government alone, can print its laws and issue copies of them. If, for instance, a person, takes a copy of an Act, and puts it up on their website for others to download, it's technically a violation of copyright. The only way any person can do so, without infringing copyright, is to 'value-add' to the text of the Act, by say, adding their own commentary or notes. But simply reproducing the entire text of the Act, without comment, is an infringement of the copyright. Section 52 (1)(q) of the copyright Act, which covers 'fair use' of a copyrighted work says the following: 52 (1) The following acts shall not constitute an infringement of copyright, namely: (q) the reproduction or publication of- (i) any matter which has been published in any Official Gazette except an Act of a Legislature; (ii) any Act of a Legislature subject to the condition that such Act is reproduced or published together with any commentary thereon or any other original matter; (iii) the report of any committee, commission, council, board or other like body appointed by the Government if such report has been laid on the Table of the Legislature, unless the reproduction or publication of such report is prohibited by the Government; (iv) any judgement or order of a court, tribunal or other judicial authority, unless the reproduction or publication of such judgment or order is prohibited by the court, the tribunal or other judicial authority, as the case may be; So the text of an Act is copyrighted, but the rules produced under it, and published in the Gazette are not. This is odd, to put it politely. Why should the text of a law, one of the basic building blocks of a modern state, not be freely available to anyone, without cost? (Even if you can make an argument that laws should be covered by copyright, shouldnt that copyright rest with Parliament, which 'creates' laws, rather than the government?) The Parliament Standing Committee on Human Resource Development is currently studying the Copyright (Amendment) Bill, 2010, which has already achieved a certain amount of fame, for the changes it makes to the rights of lyricists and music composers. But perhaps the Committee should also consider recommending an amendment to 52(1) of the Copyright Act, allowing not just laws, but all works funded by the government, and by extension the taxpayer, to be freely available to all.
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:
