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In the run up to the Budget session of Parliament, the Cabinet has decided to accept some of the key recommendations of the Select Committee on the Lokpal and Lokayuktas Bill, 2011.  The Bill, passed by the Lok Sabha in December 2011, was referred to a Select Committee by the Rajya Sabha.  The Select Committee gave its recommendations on the Bill a year later in November 2012.  At the Cabinet meeting held on January 31, 2013, the government has accepted some of these recommendations (see here for PRS comparison of the Bill, Select Committee recommendations and the approved amendments). Key approved amendments Lokayuktas: One of the most contentious issues in the Lokpal debate has been the establishment of Lokayuktas at the state level.  The Bill that was passed by the Lok Sabha gave a detailed structure of the Lokayuktas.  However, the Committee was of the opinion that while each state has to set up a Lokayukta within a year of the Act coming into force, the nature and type of the Lokayuktas should be decided by the states.  The Cabinet has agreed with the suggestion of the Committee. Inclusion of NGOs: Currently, “public servant” is defined in the Indian Penal Code to include government officials, judges, employees of universities, Members of Parliament, Ministers etc. The Bill expanded this definition by bringing societies and trusts which receive donations from the public (over a specified annual income) and, organizations which receive foreign donations (over Rs 10 lakh a year) within the purview of the Lokpal.  The Committee had however objected to the inclusion of organisations that receive donations from the public on the ground that bodies such as a rotary club or a resident’s welfare association may also be covered under the Lokpal. Bringing such entities within the Lokpal’s purview would make it unmanageable.  The Cabinet decided not to accept this recommendation stating that this view had been accepted by the Standing Committee while examining the version of the Bill introduced in the Lok Sabha.  However, the government has exempted trusts or societies for religious or charitable purposes registered under the Societies Registration Act. Procedure of inquiry and investigation:  A key recommendation of the Committee was to allow the Lokpal to directly order an investigation if a prima facie case existed (based on the complaint received).  The Cabinet has accepted this suggestion but suggested that the Lokpal should, before deciding that a prima facie case exists, call the public servant for a hearing.  An investigation should be ordered only after hearing the public servant.  Also, the Cabinet has not accepted the recommendation of the Committee that a public servant should be allowed a hearing only at the end of the investigation before filing the charge-sheet and not at any of the previous stages of the inquiry.  Power to grant sanction:  One of the key reasons cited for delays in prosecuting corrupt public officials is the requirement of a sanction from the government before a public servant can be prosecuted.  The Bill shifts the power to grant sanction from the government to the Lokpal.  It states that the investigation report shall be considered by a 3-member Lokpal bench before filing a charge-sheet or initiating disciplinary proceedings against the public servant.  The Committee recommended that at this point both the competent authority (to whom the public servant is responsible) and the concerned public servant should be given a hearing.  This has been accepted by the Cabinet. Reforms of CBI:  There are divergent views over the role and independence of the CBI.  The Committee made several recommendations for strengthening the CBI.  They include:  (a) the appointment of the Director of CBI will be through a collegium comprising of the PM, Leader of the Opposition of the Lok Sabha and Chief Justice of India; (b) the power of superintendence over CBI in relation to Lok Pal referred cases shall vest in the Lokpal; (c) CBI officers investigating cases referred by the Lokpal will be transferred with the approval of the Lokpal; and (d) for cases referred by the Lokpal, the CBI may appoint a panel of advocates (other than government advocates) with the consent of the Lok pal.  All the recommendations regarding the CBI has been accepted by the Cabinet except one that requires the approval of the Lokpal to transfer officers of CBI investigating cases referred by the Lokpal. Eligibility of Lokpal member:  According to the Bill, any person connected with a political party cannot be a member of the Lokpal.  The Committee’s recommendation was to change the term connected to affiliated to remove any ambiguity about the meaning.  This suggestion was accepted by the government. Now the interesting question is what happens if the Rajya Sabha passes the Bill with these amendments.  The Bill will have to go back to the Lok Sabha for its approval since new amendments were added by the Rajya Sabha.  If the Lok Sabha passes these amendments, the office of the Lokpal may finally see the light of day.  (See here for PRS analysis of the Lokpal and Lokayukta Bill, 2011).

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.