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 Arms Act, 1959 governs matters related to acquisition, possession, manufacture, sale, transportation, import and export of arms and ammunition. It defines a specific class of ‘prohibited’ arms and ammunitions, restricts their use and prescribes penalties for contravention of its provisions. Section 7 of the Act forbids the manufacture, sale, and use of prohibited arms and ammunition unless it has been specially authorised by the central government.1 Section 27(3) prescribes that any contravention of Section 7 that results in the death of any person 'shall be punishable with death'.2 Section 27(3) of the Act was challenged in the Supreme Court in 2006 in State of Punjab vs. Dalbir Singh. The final verdict in the case was pronounced last week. The judgment not only affects the Act in question but may have important implications for criminal law in the country. Legislative history of Section 27 When the law was first enacted, Section 27 provided that possession of any arms or ammunition with intent to use the same for any unlawful purpose shall be punishable with imprisonment up to seven years and/ or a fine. This section was amended in 1988 to provide for enhanced punishments in the context of escalating terrorist and anti-national activities. In particular, section 27(3) was inserted to provide for mandatory death penalty. The Judgment The Supreme Court judgment says that Section 27(3) is very 'widely worded'. Any act (including use, acquisition, possession, manufacture or sale) done in contravention of Section 7 that results in death of a person will attract mandatory death penalty. Thus, even if an accidental or unintentional use results in death, a mandatory death penalty must be imposed. The bench quotes relevant sections of an earlier judgment delivered in 1983, in Mithu vs. State of Punjab. In this case, the court had looked into the constitutional validity of mandatory death sentence. The final verdict had ruled that a provision of law which deprives the Court of its discretion, and disregards the circumstances in which the offence was committed, can only be regarded as 'harsh, unjust and unfair'. The judgment goes on to say that the concept of a 'just, fair and reasonable' law has been read into the guarantees under Article 14 (Equality before law) and Article 21 (Protection of life and personal liberty) of the Constitution. A law that imposes an irreversible penalty such as death is 'repugnant to the concept of right and reason'. Therefore, Section 27 (3) of the Arms Act, 1959 is unconstitutional. Section 27(3) is also unconstitutional in that it deprives the judiciary from discharging its duty of judicial review by barring it from using the power of discretion in the sentencing procedure. What happens now? Under Article 13 of the Constitution, laws inconsistent with the Constitution shall be null and void. Therefore, Section 27(3) of the Arms Act, 1959 shall now stand amended. Courts shall have the discretion to impose a lesser sentence. It is noteworthy that the Home Minister had also introduced a Bill in the Lok Sabha on the 12th of December, 2011 to amend the Arms Act, 1959. The Bill seeks to remove the words ‘shall be punishable with death’ and replace these with ‘shall be punishable with death or imprisonment for life and shall also be liable to fine’. This Bill is currently being scrutinized by the Standing Committee. Notes: 1) Section 7 of the Arms Act, 1959: “7. Prohibition of acquisition or possession, or of manufacture or sale, of prohibited arms or prohibited ammunition. No person shall -- (a) acquire, have in his possession or carry; or (b) use, manufacture, sell, transfer, convert, repair, test or prove; or (c) expose or offer for sale or transfer or have in his possession for sale, transfer, conversion, repair, test or proof; any prohibited arms or prohibited ammunition unless he has been specially authorised by the Central Government in this behalf.” 2) Section 27(3) of the Arms Act, 1959: “27(3) Whoever uses any prohibited arms or prohibited ammunition or does any act in contravention of section 7 and such use or act results in the death of any other person, shall be punishable with death.” Sources: Arms Act, 1959; Supreme Court judgment
