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The President addressed the Parliament after the 2009 Lok Sabha Elections on 4th June 2009.  She also addressed Parliament on 22nd February 2010, as well as on 21st February 2011.  The tables below highlight some items from the agenda of the central government as outlined in these speeches, as well as the initiatives undertaken with respect to these agenda items. Table 1: Some Items from the President’s Address to Parliament on 4th June 2009

Agenda Items outlined in the President’s Speech Current Status
Establishment of National Counter-Terrorism Centre Proposed launch of NCTC in March 2011 on hold
Enactment of legislation for prevention of communal violence Communal Violence Bill 2005 pending in Parliament. New bill drafted by NAC but not introduced in Parliament
Unique Identity Card scheme to be implemented in three years Unique Identification Authority of India created under Planning Commission on 28 January 2009.  Bill to give statutory status pending in Parliament
Establishment of a regulator for the pension sector Bill introduced in Lok Sabha on 24 March 2011
Convergence of NREGA with other programs; expansion of works permitted; independent monitoring and grievance redressal  
Rashtriya Swasthya Bima Yojana to cover all families below the poverty line in five years  
Enactment of Right to Free and Compulsory Education Bill Bill passed in 2009 and brought into force on 1 April 2009
Madhyamik Shiksha Abhiyan to universalize access to secondary education Rashtriya Madhyamik Shiksha Abhiyan launched in March 2009
National Mission for Female Literacy to make every woman literate in five years National Literacy Mission recast in 2009 to focus on female literacy
Construction of 1.2 crore rural houses under Indira Awas Yojana in five years  
Introduction of Rajiv Awas Yojana for slum dwellers and urban poor Phase I approved by Cabinet on 2 June 2011
Enactment of National Food Security Act Introduced in Lok Sabha on 22 December 2011
Enactment of Amendment Bill to Land Acquisition Act and Rehabilitation and Resettlement Bill Land Acquisition, Rehabilitation and Resettlement Bill 2011 introduced in Lok Sabha on 7 September 2011
Enactment of Women’s Reservation Bill Passed by Rajya Sabha, pending in Lok Sabha
Constitutional Amendment for 50 percent reservation for women in panchayats and urban local bodies Two Bills introduced in Lok Sabha in November 2009; both pending in Parliament
Amendment of RTI to provide for disclosure by government in all non-strategic areas  
Model Public Services Law to be drawn up in consultation with states Right of Citizens for Time Bound Delivery of Goods and Services and Redressal of their Grievance Bill,     2011 introduced in Lok Sabha on 20 December 2011
Introduction of Goods and Services Tax Constitutional Amendment Bill introduced in Lok Sabha on 22 March 2011
National Council for Human Resources in Health Introduced in Rajya Sabha on 22 December 2011
National Council for Higher Education Bill introduced in Rajya Sabha on 28 December 2011

*Note: Blank cells indicate that PRS has not been able to find official information in the public domain. Table 2: Some Items from the President’s speech to Parliament on 22nd February 2010

Agenda Items outlined in the President’s Speech Current Status
Introduction of legislation to ensure food security Introduced in Lok Sabha on 22 December 2011
Rural teledensity of 40 percent by 2014 Rural teledensity of 33% as of February 2011
Introduction of Rajiv Awas Yojana for urban poor and slum dwellers Phase I approved by Cabinet on 2 June 2011
Disposal of remaining claims under the Scheduled Tribes  and Other Traditional Forest Dwellers Act  
Introduction of amendment to the Wakf Act Passed by Lok Sabha; pending in Rajya Sabha
Enactment of Communal Violence (Prevention, Control and Rehabilitation of Victims) Bill, 2005 Pending in Rajya Sabha since 2005
Enactment of Women’s Reservation Bill Passed by Rajya Sabha; pending in Lok Sabha
Constitutional amendments for 50 percent reservation for women in panchayats and urban local bodies Two Bills introduced in Lok Sabha in November 2009; both pending in Parliament
Establishment of National Council for Higher Education and Research Higher Education and Research Bill, 2011 introduced in Rajya Sabha on 28 December 2011
Legislation for facilitating participation of foreign academic institutions in the education sector Foreign Educational Institutions Bill, 2010 introduced in Lok Sabha on 3 May 2010
Voting rights for Indian citizens living abroad Bill passed.  NRIs can vote at the place of residence that is mentioned in their passport

Table 3: Some Items from the President’s speech to Parliament on 21st February 2011

Agenda Items outlined in the President’s Speech Current Status
Enactment of Food Security Law Introduced in Lok Sabha on 22 December 2011
Whistleblower Bill Bill passed by Lok Sabha; pending in Rajya Sabha
Enactment of Judicial Standards and Accountability Bill Introduced in Lok Sabha on 1 December 2010
Enactment of new Mines and Minerals Bill Introduced in Lok Sabha on 12 December 2011
Rural teledensity of 40 percent by 2014 Rural teledensity of 33% as of February 2011
Construction of 1.2 crore rural houses during 2009-14  
Enactment of Women’s Reservation Bill Passed by Rajya Sabha; pending in Lok Sabha
Introduction of Bill regarding protection of children from sexual offences Introduced in Rajya Sabha on 23 March 2011
Introduction of Biotechnology Regulatory Authority of India Bill Not introduced till date

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.