Over the last couple of weeks, MNREGA is back in the spotlight. The Union Minister for Rural Development wrote to certain states regarding potential misuse of funds, and it was announced that rural development schemes are open to CAG audit.  In large schemes like MNREGA, officials at all levels of government - central, state, district, block, panchayat - have roles to play. This can make it difficult to locate the responsible authority in case implementation issues arise. We list the responsibilities of different government agencies involved in implementation of MNREGA in the Table below.

Stakeholder Responsibilities
Gram Sabha (a) recommending works; (b) conducting social audits on implementation every six months; and (c) functioning as a forum for sharing information.
Gram Panchayat (a) planning works; (b) receiving applications for registration; (c) verifying applications; (d) registering households; (e) issuing job cards, (f) receiving applications for employment; (g) issuing detailed receipts; (h) allotting employment within 15 days of application; (i) executing works; (j) maintaining records; (k) convening Gram Sabha for social audit; and (l) monitoring implementation at the village level.
Intermediate Panchayat (a) consolidating Gram Panchayat plans into a Block plan and (b) monitoring and supervision at the block level.
Programme Officer (PO) (a) ensuring work to applicants within 15 days; (b) scrutinising Gram Panchayat annual development plans; (c) consolidating proposals into a Block plan and submitting to intermediate panchayat; (d) matching employment opportunities with demand for work at the Block level; (e) monitoring and supervising implementation; (f) disposing of complaints; (g) ensuring that Gram Sabha conducts social audits; and (h) payment of unemployment allowance.
District Panchayat (a) finalizing district plans and labour budget; and (b) monitoring and supervising at district level.
District Programme Coordinator (DPC) (a) ensuring that the scheme is implemented according to the Act at the district level; (b) information dissemination; (c) training; (d) consolidating block plans into a district plan; (e) ensuring that administrative and technical approval for projects are obtained on time; (f) release and utilisation of funds; (g) ensuring monitoring of works; (h) muster roll verifications; and (i) submitting monthly progress reports.
State Employment Guarantee Council (SEGC) (a) advising the state government on implementation; (b) evaluate and monitor implementation; (c) determining the "preferred works" to be taken up; (d) recommending the proposal of works to be submitted to the state government; and (e) prepare an annual report to the state legislature.
State Government (a) wide communication of the scheme; (b) setting up the SEGC; (c) setting up a State Employment Guarantee Fund; (d) ensuring that dedicated personnel are in place for implementation, including Gram Rozgar Sahayak, Programme Officer, and technical staff; (e) ensuring state share of the scheme budget is released on time; (f) delegation of financial and administrative powers to the DPC and Programme Officer if necessary; (g) training; (h) establishing a network of professional agencies for technical support and quality control; (i) regular review, monitoring, and evaluation of processes and outcomes; and (j) ensuring accountability and transparency.
Central Employment Guarantee Council (a) advising the central government on MNREGA matters; (b) monitoring and evaluating implementation of the Act; and (c) preparing annual reports on implementation and submitting them to Parliament.
Ministry of Rural Development (a) ensuring resource support to states and the CEGC; (b) regular review, monitoring, and evaluation of processes and outcomes;  (c) maintaining and operating the MIS to capture and track data on critical aspects of implementation; (d) assessing the utilization of resources through a set of performance indicators; (e) supporting innovations that help in improving processes towards the achievement of the objectives of the Act; (f) support the use of Information Technology (IT) to increase the efficiency and transparency of the processes as well as improve interface with the public;  and (g) ensuring that the implementation of NREGA at all levels is sought to be made transparent and accountable to the public..
Source: Operational Guidelines, National Rural Employment Guarantee Scheme, Ministry of Rural Development.

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.