Criminal laws in India by way of “sanctions” allow for protective discrimination in favour of public officials.[1] Under various laws, sanctions are required to investigate and prosecute public officials. Over the past 15 years these provisions of law have been revisited by the judiciary and the legislature. Recently the Supreme Court in the Subramanian Swamy Case has suggested the concept of a deemed sanction. We look at the history of the requirement of sanction under criminal laws. Requirement of sanction to investigate certain public servants of the union government was introduced through a government notification[2]. The Criminal Procedure Code 1973 and the Prevention of Corruption Act 1988 provide that to prosecute a public servant, permission or sanction has to be secured from the government (central or state) for which the official works. Arguments that are often advanced in favour of such sanctions are that these ensure that (a) frivolous and vexatious cases are not filed, (b) public officials are not harassed, and (c) the efficacy of administrative machinery is not tampered with. Further, the requirement of sanction to investigate was also defended by the government before the Supreme Court in certain cases. In Vineet Narain vs. Union of India 1997[3], the government had argued that the CBI may not have the requisite expertise to determine whether the evidence was sufficient for filing a prima facie case. It was also argued that the Act instituting the CBI, Delhi Special Police Establishment Act 1946 (DSPE Act), granted the power of superintendence, and therefore direction, of the CBI to the central government. The Court in this case struck down the requirement of sanction to investigate. It held that “supervision” by the government could not extend to control over CBI’s investigations. As for prosecution, the Court affixed a time frame of three months to grant sanction. However, there was no clarity on what was to be done if sanction was not granted within such time. Following that judgment, the DSPE Act was amended in 2003, specifically requiring the CBI to secure a sanction before it investigated certain public servants. More recently, the Lokpal and Lokayukta Bill, 2011 that is pending before the Rajya Sabha, removed the requirement of sanction to investigate and prosecute public servants in relation to corruption. Recently, Mr. Subramanian Swamy approached the Supreme Court for directions on his request for sanction to prosecute Mr. A Raja in relation to the 2G Scam. As per the Supreme Court, judgment in Subramanian Swamy vs. Dr. Manmohan Singh & Anr, Mr. Swamy’s request was pending with the department for over 16 months. The Supreme Court held that denial of a timely decision on grant of sanction is a violation of due process of law (Right to equality before law read with Right to life and personal liberty). The Court reiterated the three month time frame for granting sanctions. It suggested that Parliament consider that in case the decision is not taken within three months, sanction would be deemed to be granted. The prosecution would then be responsible for filing the charge sheet within 15 days of the expiry of this period.
[1] Subramanian Swamy vs. Dr. Manmohan Singh & Anr. Civil Appeal No. 1193 of 2012 dated January 31, 2012
[2] Single Directive, No. 4.7.3
[3] AIR 1998 SC 889
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:
