In a recent judgement (Judgement on Feb 23 - Baldev Singh and Ors. V. State of Punjab), the Supreme Court reduced the sentence of three persons convicted of rape from 10 years to 3 and a half years, and also asked the three convicts to pay a fine of Rs 50,000 each to the victim.   In reducing the sentence, the court drew from the provision in S. 376 (punishment for rape) of the Indian Penal Code which allows the court to reduce the sentence for "adequate and special reasons". There have been a number of past cases where the Supreme Court has reversed High Court decisions reducing sentences under this provision for not giving suitable reasons.  In 2007, the Supreme Court struck down a decision of the Karnataka High Court which had reduced the sentence of a convicted rapist to 3 and a half years.  The High Court had stated that the sentence should be reduced since the accused was "a young boy of 18 years belonging to Vaddara Community and Illiterate".  The Supreme Court stated that there is a legislative mandate to impose a sentence for not less than 10 years.  Only in exceptional cases, for "adequate and special reasons" can a sentence less than 10 years be imposed.  It overturned the Karnataka High Court decision saying that there was an "absence of any reason which could have been treated as "special and adequate reason"". In Baldev Singh's case, the Supreme Court said: 1.  The fact that the incident is an old one (the incident took place in 1997) is a circumstance which fits into "adequate and special reasons" for reducing a sentence. 2. The parties have entered into a compromise among themselves. The issue is whether this judgement has gone beyond the legislative mandate, and whether it has adhered to the principles laid down by earlier decisions of the Supreme Court.  In 2007, the Supreme Court itself stated that for a crime like rape, strong reasons have to be given to reduce the sentence envisaged by the legislature.  Moreover, the provision does not envisage the settlement of a crime by payment of compensation to the victim of a crime.  A criminal act is seen in law as a crime against the whole of society (which is why the state's prosecution agency, and not the victim, goes to court against alleged criminals).  Therefore, criminal actions such as rape (or murder, robbery, kidnapping etc.) cannot be "settled" by the payment of compensation under the Indian Penal Code.  In this light, it should be interesting to see whether the State files an appeal against this judgement.

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.