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Legislation

Bill to amend regulation of chemical weapons passed by Parliament

Jhalak - September 3, 2012

The Chemical Weapons Convention (Amendment) Bill, 2010 (the Bill) was recently passed by the Lok Sabha without any amendment.  The Chemical Weapons Convention Act, 2000 (the Act) was enacted to give effect to the United Nations Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction (the CWC).  The CWC aims to eliminate chemical weapons by prohibiting their development, acquisition, stockpiling, transfer or use by State Parties. The 188 State Parties of the CWC are required to take the steps necessary to prohibit these activities within their jurisdiction. India signed the Convention on January 14, 1993. The Bill was introduced in the Rajya Sabha on April 16, 2010 by the Minister of State in the Ministry of Chemicals and Fertilizers, Mr. Srikant Kumar Jena.  The Standing Committee submitted its report on August 3, 2010. This Bill was passed by the Rajya Sabha on May 3, 2012 with some amendments based on the recommendations of the Standing Committee.  The recommendations of the standing committee and the subsequent amendments made by the Rajya Sabha are as follows:

  • The Act disallows any person from transferring or receiving specified toxic chemicals from a citizen of a non-State Party.  The Bill changes this position by prohibiting transfer or receipt of the specified toxic chemicals from a non-State Party to the Convention.  The Committee recommended that the provision should clearly prohibit transfer or receipt from both non-State Parties and citizens of non-State Parties.  The Rajya Sabha has made the corresponding amendment to the Bill.
  • The Act mandates the registration of persons engaged in the production, transfer, or use of any toxic chemical.  The Bill makes registration mandatory, subject to certain threshold limits that are prescribed, for manufacturers of specified chemicals.  The Committee observed that this would make registration mandatory only for those manufacturers who cross the specified limit.  Thus, the Committee asked the government to consider a two-step process of compulsory registration of all manufacturers, followed by a declaration of those crossing the threshold limits.  This recommendation has not been accepted by the Rajya Sabha.  Hence, only those persons whose production of toxic chemicals exceeds the threshold would be required to register.
  •  The Act established a National Authority to implement the provisions of the Convention.  It empowers the central government to appoint officers of the National Authority as enforcement officers. The Bill broadens the central government’s power by allowing it to appoint any of its officers as enforcement officers.  The Committee recommended that eligibility criteria, such as technical qualifications and expertise, for these officers should be set under the rules.  The Committee also recommended that officers should be given suitable training before their appointment.  The Rajya Sabha has incorporated the suggestion of prescribing eligibility criteria under the Bill.

The Lok Sabha passed the Bill on August 30, 2012 without any amendments.  The standing committee report and its summary may be accessed here and here.

Legislation

Lapses in the process of drug approval in India

Sakshi - May 29, 2012

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.

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