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 issue of paid news has been debated for a long time, most recently during the 2012 Gujarat assembly elections, the Jindal Steel-Zee News dispute and disqualification of a sitting UP MLA by the Election Commission of India (ECI) in October 2011. The Standing Committee on Information Technology recently submitted its report on the “Issues Related to Paid News”. The report discusses the definition of paid news, reasons for its proliferation, existing mechanisms to address the problem and recommendations to control it. Need for comprehensive definition of paid news The Press Council of India (PCI) defines paid news as any news or analysis appearing in print or electronic media for consideration in cash or kind. The Committee acknowledged challenges in defining and establishing incidence of paid news, citing new manifestations like advertisements disguised as news, denial of coverage to select electoral candidates, private deals between media houses and corporates and the rise in paid content. Hence, it asked the Ministry of Information and Broadcasting (MoIB) to formulate a comprehensive legal definition of ‘paid news’ and suggest measures for usage of ‘circumstantial evidence’ in establishing incidence of paid news. Reasons for rise in incidence of paid news The Committee identified corporatisation of media, desegregation of ownership and editorial roles, decline in autonomy of editors/journalists and poor wage levels of journalists as key reasons for the rise in incidence of paid news. It urged the MoIB to ensure periodic review of the editor/journalist autonomy and wage conditions. It also recommended mandatory disclosure of ‘private treaties’ and details of advertising revenue by the media houses. Need for empowered regulators and stricter punitive provisions The Committee observed that statutory regulators like the PCI and Electronic Media Monitoring Centre (EMMC) lack adequate punitive powers while self-regulatory industry bodies like the News Broadcasting Standards Authority have even failed to take cognisance of the problem. The PCI and self-regulatory bodies are also plagued by conflict of interest since a majority of their members are media-owners. The Committee recommended the establishment of either a single regulatory body for both print and electronic media or setting-up a statutory body for the electronic media on the lines of the PCI. Such regulator(s) should have the power to take strong action against offenders and should not include media owners as members. It highlighted the need for stricter punitive provisions to control paid news and sought further empowerment of the ECI to deal with cases of paid news during elections. Committee critical of government’s inaction The Committee censured the MoIB for its failure to establish a strong mechanism to check the spread of paid news. It criticised the government for dithering on important policy initiatives, citing the lack of action on various recommendations of the PCI and ECI. Previously, the PCI had sought amendments to make its directions binding on the government authorities and to bring the electronic media under its purview. Similarly, the ECI recommended inclusion of indulgence by an electoral candidate in paid news as a corrupt practice and publication of such paid news as an electoral offence. The Committee also expressed concern that the MoIB and self-regulatory bodies have not conducted any study to evaluate the mechanism adopted by other countries to tackle the problem of paid news. For a PRS summary of the Standing Committee Report, see here.
