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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

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:

  • drugs that have not been used in the country before,
  • drugs that have been approved by a Licensing Authority but are now being marketed for different purposes, and
  • fixed dose combinations of two or more drugs that have been individually approved before but are proposed to be combined in a fixed ratio that has not been approved.

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:

  • Under the Rules, the Drugs Controller General (India) (DCGI), the head of CDSCO, can clear sites of clinical trials after ensuring that major ethnic groups are enrolled in these trials to have a truly representative sample.  This rule was violated by the DCGI when sites for clinical trials were approved without ensuring diversity.  The Committee recommended that the DCGI approve sites for trials only if they cover patients from major ethnic backgrounds.
  •  The Report found that certain actions by experts were in violation of the Code of Ethics of the Medical Council of India.  A review of expert opinions revealed that several medical expert recommendations had been given as personal opinions rather than on the basis of scientific data.  Additionally, many expert opinions were written by what the Report calls ‘the invisible hands’ of drug manufacturers.  The Committee recommended that CDSCO formulate a clear set of written guidelines on the selection process of experts with emphasis on expertise in the area of drugs.
  •  The Rules ban the import and marketing of any drug whose use is prohibited in the country of origin.  CDSCO violated this rule by approving certain Fixed Dose Combination drugs for clinical trials without considering the drugs’ regulatory status in their respective country of origin.  Drugs such as Deanxit and Buclizine, which have been prohibited for sale and use in their countries of origin, Denmark and Belgium, respectively, were approved for clinical trials.  The Committee recommended an inquiry into the unlawful approval of these drugs.
  • The Rules require animal studies to be conducted for approval of a drug for use by women of reproductive age.  CDSCO violated this rule in approving Letrozole for treating female infertility.  Globally the drug has only been used as an anti-cancer drug for use among post-menopausal women.  The drug has not been permitted for use among women of reproductive age because of side effects.  The Committee recommended that responsibility be fixed for unlawfully approving Letrozole.
  •  Rules require Post-marketing Safety Update Reports (PSURs) on drugs to be submitted to CDSCO.  PSURs are used to collect information on adverse effects of drugs on Indian patients as a result of ethnic differences.  When asked by the Committee to furnish PSURs on 42 randomly selected new drugs, the Ministry was able to submit PSURs for only 8 drugs.  The Report contended that this action reflected a poor follow-up of side effects on Indian patients.  The Committee recommended that manufacturers of new drugs be warned about suspension of marketing approval unless they comply with mandatory rules on PSURs.