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Report on Khap Panchayats The Law Commission has drafted a consultation paper on caste panchayats.    A draft legislation titled “The Prohibition of Unlawful Assembly (Interference with the Freedom of Matrimonial Alliances) Bill, 2011” has been attached to the consultation paper. The Bill prohibits people from congregating together to condemn a legal marriage on the ground that the said marriage has brought dishonour to the caste or community.     Every member of such a group shall be punished with imprisonment of a minimum term of 6 months and a maximum term of 1 year.   The member may also be liable to a fine of up to Rs 10,000. Under our criminal justice system, the presumption is that the accused person is innocent until proven guilty.   This Bill reverses this presumption.   It provides that if an accused person participated in an unlawful assembly, then it will be presumed that the accused intended to commit an offence under the Bill. The Commission has invited public comments on the consultation paper within 4 weeks.   The comments can be sent by post or email to lci-dla@nic.in.    A copy of the consultation paper is available at http://lawcommissionofindia.nic.in/reports/cp-Honour%20Killing.pdf. Report on compounding of offences including Sec 498A of IPC (harassment for dowry) The Law Commission has also submitted its report on ‘Compounding of (IPC) Offences.    Compoundable offences are offences which allow the parties to enter into a private compromise.   The Supreme Court in some recent cases had asked the Law Commission to identify more offences which could be treated as compoundable.   Section 320 of the Code of Criminal Procedure lists the offences which are compoundable.  Currently under the section there are 56 compoundable offences.   Certain offences can be compounded only with the prior permission of the court. The Commission has recommended that Section 498A of the IPC (cruelty against a married woman by her husband or relatives) should be made compoundable with the permission of the Court.   It has recommended that the magistrate should give a hearing to the woman and then permit or refuse the compounding of the offence.  This has been recommended to ensure that woman is not coerced into compounding the offence. The other IPC offences that the Commission has recommended should be made compoundable include (a) Section 324 (simple hurt); (b) Section 147 (rioting); (c) Section 380 (theft in dwelling house); (d) Section 384 (extortion) and  (e) Section 385 (extortion by threat  to person). A copy of the report is available at http://lawcommissionofindia.nic.in/reports/report237.pdf  

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.