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:
Media in India is mostly self-regulated. The existing bodies for regulation of media such as the Press Council of India which is a statutory body and the News Broadcasting Standards Authority, a self-regulatory organization, issue standards which are more in the nature of guidelines. Recently, the Chairman of the Press Council of India, former Justice of the Supreme Court, Mr. M. Katju, has argued that television and radio need to be brought within the scope of the Press Council of India or a similar regulatory body. We discuss the present model of regulation of different forms of media. This note was first published at Rediff. 1. What is the Press Council of India (PCI)? The PCI was established under the PCI Act of 1978 for the purpose of preserving the freedom of the press and of maintaining and improving the standards of newspapers and news agencies in India. 2. What is the composition of the PCI and who appoints the members? The PCI consists of a chairman and 28 other members. The Chairman is selected by the Speaker of the Lok Sabha, the Chairman of the Rajya Sabha and a member elected by the PCI. The members consist of members of the three Lok Sabha members, two members of the Rajya Sabha , six editors of newspapers, seven working journalists other than editors of newspapers, six persons in the business of managing newspapers, one person who is engaged in the business of managing news agencies, and three persons with special knowledge of public life. 3. What are its functions? The functions of the PCI include among others (i) helping newspapers maintain their independence; (ii) build a code of conduct for journalists and news agencies; (iii) help maintain “high standards of public taste” and foster responsibility among citizens; and (iv) review developments likely to restrict flow of news. 4. What are its powers? The PCI has the power to receive complaints of violation of the journalistic ethics, or professional misconduct by an editor or journalist. The PCI is responsible for enquiring in to complaints received. It may summon witnesses and take evidence under oath, demand copies of public records to be submitted, even issue warnings and admonish the newspaper, news agency, editor or journalist. It can even require any newspaper to publish details of the inquiry. Decisions of the PCI are final and cannot be appealed before a court of law. 5. What are the limitations on the powers of the PCI? The powers of the PCI are restricted in two ways. (1) The PCI has limited powers of enforcing the guidelines issued. It cannot penalize newspapers, news agencies, editors and journalists for violation of the guidelines. (2) The PCI only overviews the functioning of press media. That is, it can enforce standards upon newspapers, journals, magazines and other forms of print media. It does not have the power to review the functioning of the electronic media like radio, television and internet media. 6. Are there other bodies that review television or radio? For screening films including short films, documentaries, television shows and advertisements in theaters or broadcasting via television the Central Board of Film Certification (CBFC) sanction is required. The role of the CBFC is limited to controlling content of movies and television shows, etc. Unlike the PCI, it does not have the power to issue guidelines in relation to standards of news and journalistic conduct. Program and Advertisement Codes for regulating content broadcast on the television, are issued under the Cable Television Networks (Regulation) Act, 1995. The District magistrate can seize the equipment of the cable operator in case he broadcasts programs that violate these Codes. Certain standards have been prescribed for content accessible over the internet under the IT Rules 2011. However, a regulatory body such as the PCI or the CBFC does not exist. Complaints are addressed to the internet service provider or the host. Radio Channels have to follow the same Programme and Advertisement Code as followed by All India Radio. Private television and radio channels have to conform to conditions which are part of license agreements. These include standards for broadcast of content. Non-compliance may lead to suspension or revocation of license. 7. Is there a process of self regulation by television channels? Today news channels are governed by mechanisms of self-regulation. One such mechanism has been created by the News Broadcasters Association. The NBA has devised a Code of Ethics to regulate television content. The News Broadcasting Standards Authority (NBSA), of the NBA, is empowered to warn, admonish, censure, express disapproval and fine the broadcaster a sum upto Rs. 1 lakh for violation of the Code. Another such organization is the Broadcast Editors’ Association. The Advertising Standards Council of India has also drawn up guidelines on content of advertisements. These groups govern through agreements and do not have any statutory powers. 8. Is the government proposing to create a regulatory agency for television broadcasters? In 2006 the government had prepared a Draft Broadcasting Services Regulation Bill, 2006. The Bill made it mandatory to seek license for broadcasting any television or radio channel or program. It also provides standards for regulation of content. It is the duty of the body to ensure compliance with guidelines issued under the Bill.
