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:
In April last year the government had notified the Information Technology (Intermediary Guidelines) Rules, 2011 (IT Rules) under the Information Technology Act, 2000. The IT Rules are listed for discussion in Rajya Sabha today in pursuance of a motion moved by Mr. P. Rajeeve [CPI(M)]. The motion seeks to annul these Rules and recommends that Lok Sabha also concur with the motion. The IT Rules require intermediaries (internet service providers, blogging sites like Blogger and Wordpress, and cyber cafés) to take certain action. Intermediaries are required to enter into agreements with their users prohibiting publication of certain content. Content that cannot be published includes anything that is ‘harmful to minors in any way’, ‘blasphemous’, ‘encouraging money laundering’ etc. This raises three issues. Some of the categories of content prohibited for publication are ambiguous and undefined. For instance, ‘grossly harmful’ and ‘blasphemous’ content are not defined. Publication of certain content prohibited under the IT Rules, is currently not an offences under other laws. Their publication is in fact allowed in other forms of media, such as newspapers. Newspapers are bound by Press Council Norms. These Norms do not prohibit publication of all the content specified under the IT Rules. For instance, while these Norms require newspapers to show respect to all religions and their gods, they do not prohibit publication of blasphemy. However, under the IT Rules blasphemy is prohibited. This might lead to a situation, where articles that may be published in newspapers legally, may not be reproduced on the internet for example in the e-paper or on the newspaper’s website. Prohibition of publication of certain content under the IT Rules may also violate the right to freedom of speech. Under Article 19(2) of the Constitution restrictions on the right to freedom of speech may be imposed in the interest of the State’s sovereignty, integrity, security and friendly relations with other States, public order, morality, decency, contempt of court, and for protection against defamation. The content prohibited under the IT Rules may not meet the requirement of Article 19(2). This may impinge on the right to freedom of speech and expression. Further, anyone can complain against such content to the intermediary. The intermediary is required to remove content if it falls within the description specified in the IT Rules. In the event the intermediary decides not to remove the content, it may be held liable. This could lead to a situation where, in order to minimise the risk of liability, the intermediary may block more content than it is required. This may imply adverse consequences for freedom of expression on the internet. PRS’s detailed analysis of the IT Rules may be accessed here.
