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Legislation

An Analysis of the Deferred Educational Tribunals Bill, 2010

Kaushiki - September 7, 2010

Given India’s anti-defection laws, the Educational Tribunals Bill, 2010 should have sailed through smoothly in the Rajya Sabha.  The Bill was passed in the Lok Sabha on August 26 in spite of opposition from many MPs who raised a number of pertinent issues. However, in a surprising turn of events the Bill faced opposition from Congress Rajya Sabha MP K. Keshava Rao (along with other Opposition members).  It forced the Minister of Human Resource Development Shri Kapil Sibal to defer the consideration and passing of the Bill to the Winter session of Parliament. Such an incidence raises the larger issue of whether an MP should follow the party line or be allowed to express his opinion which may be contrary to the party.  Last year, Vice President Hamid Ansari had expressed the view that there was a need to expand the scope for individual MPs to express their opinion on policy matters.  One of the ways this could be done, he felt, was by limiting the issuance of whips “to only those bills that could threaten the survival of a government, such as Money Bills or No-Confidence Motions.”  There are others who feel that MPs should not oppose the party line in the House since they represent the party in the Parliament. (See PRS note on The Anti-Defection Law: Intent and Impact). The Educational Tribunals Bill, introduced in the Lok Sabha on May 3, 2010, seeks to set up tribunals at the state and national level to adjudicate disputes related to higher education.  The disputes may be related to service matters of teachers; unfair practices of the higher educational institutions; affiliation of colleges; and statutory regulatory authorities.  The tribunals shall include judicial, academic and administrative members.  The Bill bars the jurisdiction of civil courts over any matters that the tribunals are empowered to hear.  It also seeks to penalise any person who does not comply with the orders of the tribunals. (See the analysis of PRS on the Educational Tribunals Bill). The Bill was referred to the Standing Committee on Human Resource Development, which submitted its report on August 20, 2010.  Although the report expressed dissatisfaction with the lack of inputs from states and universities and made a number of recommendations on various provisions, the HRD Ministry rejected those suggestions. Some of the key issues raised by the Standing Committee are as follows:

  • The Committee observed that no specific assessment about quantum of litigation has been carried out. It recommended that before setting up tribunals, the magnitude of cases and costs incurred in litigation should be assessed. A minimum court fee should be fixed to ensure viability of the tribunals.
  • The Committee pointed out that the status of existing tribunals is unclear. Also, since the number of educational institutions vary from state to state, the Committee felt that one educational tribunal per state cannot be made uniformly applicable.
  • The Committee stated that there is no clear rationale for fixing a minimum age limit of 55 years for members of the tribunals. It recommended that competent people with adequate knowledge and experience, irrespective of age, should be considered.
  • In case there is a vacancy in the chairperson’s post, other two members shall hear cases in the state educational tribunals. However, this leaves the possibility of cases being heard without a judicial member (since chairperson is the only judicial member). The Committee pointed out that a recent Supreme Court judgment states that every two-member bench of the tribunal should always have a judicial member. Also, whenever any larger or special benches are constituted, the number of technical members should not exceed the judicial member. The Committee were of the view that certain provisions of the Bill violate the Supreme Court judgment and should be re-thought.
  • The Committee recommends that the term “unfair practice” should be defined in the Bill so that it is not open to interpretation by the courts.
  • The Selection Committee to recommend panel for national tribunal includes the Chief Justice of India and Secretaries, Higher Education, Law and Justice, Medical Education and Personnel and Training as members. The Committee recommended that there should be adequate representation of the academia in the Selection Committee.
  • The Committee proposed that the government needs to identify the lacunae of the existing tribunal systems and ensure that orders of the tribunals have some force.
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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