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 Supreme Court passed its judgment in General Officer Commanding (Army) vs. CBI on May 01, 2012. The case addressed the issue of need for sanction to prosecute Army officers under the Armed Forces Special Powers Act (AFSPA). The case dealt with two instances of alleged fake encounters. Five people were killed by the Army in Assam in a counter insurgency operation in 1994. Another five people were killed in Jammu and Kashmir in March, 2000 in an encounter. In both cases, it was alleged that the Army officers had staged fake encounters. In both instances, the CBI was directed to investigate the matter. CBI claimed that the people who were killed were indeed victims of fake encounters. The CBI moved the court to initiate prosecution against the accused Army officers. The officers claimed that they could only be prosecuted with the prior sanction (permission) of the central government. The officers relied on provisions of the AFSPA,1958 and the Armed Forces J & K (Special Powers) Act, 1990 to support their claim. (See Notes for the relevant clauses) These provide that legal proceedings cannot be instituted against an officer unless sanction is granted by the central government. It must be noted that Army officers can be tried either before criminal courts or through court-martial (as prescribed under Sections 125 of the Army Act, 1950). The Army officers had appealed that both procedures require prior sanction of the government. The judgment touches upon various issues. Some of these have been discussed in more detail below:
Is prior sanction required to prosecute army officers for 'any' act committed in the line of duty? The judgment reiterated an earlier ruling. It held that sanction would not be required in 'all' cases to prosecute an official. The officer only enjoys immunity from prosecution in cases when he has ‘acted in exercise of powers conferred under the Act’. There should be 'reasonable nexus' between the action and the duties of the official. The Court cited the following example to highlight this point: If in a raid, an officer is attacked and he retaliates, his actions can be linked to a 'lawful discharge of duty'. Even if there were some miscalculations in the retaliation, his actions cannot be labeled to have some personal motive. The Court held that the AFSPA, or the Armed Forces (J&K) Special Powers Act, empowers the central government to ascertain if an action is 'reasonably connected with the discharge of official duty' and is not a misuse of authority. The courts have no jurisdiction in the matter. In making a decision, the government must make an objective assessment of the exigencies leading to the officer’s actions. At what stage is sanction required? The Court ruled that under the AFSPA, or the Armed Forces (J&K) Special Powers Act, sanction is mandatory. But, the need to seek sanction would only arise at the time of cognizance of the offence. Cognizance is the stage when the prosecution begins. Sanction is therefore not required during investigation. Is sanction required for court-martial? The Court ruled that there is no requirement of sanction under the Army Act, 1950. Hence, if the Army chooses, it can prosecute the accused through court-martial instead of going through the criminal court. The Court noted that the case had been delayed for over a decade and prescribed a time bound course of action. It asked the Army to decide on either of the two options - court martial or criminal court - within the next eight weeks. If the Army decides on proceedings before the criminal court, the government will have three months to determine to grant or withhold sanction. Notes Section 6 of the AFSPA, 1958: "6. Protection to persons acting under Act – No prosecution, suit or other legal proceeding shall be instituted, except with the previous sanction of the Central Government, against any person in respect of anything done or purported to be done in exercise of the powers conferred by this Act." Section 7 of the Armed Forces (J&K) Special Powers Act, 1990: "7. Protection of persons acting in good faith under this Act. No prosecution, suit or other legal proceeding shall be instituted, except with the previous sanction of the Central Government, against any person in respect of anything done or purported to be done in exercise of the powers conferred by this Act."
