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.

In the recently concluded Monsoon Session of Parliament , the Parliamentary Standing Committee on Rural Development released a report on the implementation of the Mahatma Gandhi National Rural Development Act, 2005 (MGNREGA).  This blog provides a brief introduction to the key provisions of MGNREGA , followed by an overview of the major findings and recommendations of the Standing Committee.

I. MGNREGA: A brief introduction

A. Objectives: MGNREGA, which is the largest work guarantee programme in the world, was enacted in 2005 with the primary objective of guaranteeing 100 days of wage employment per year to rural households.  Secondly, it aims at addressing causes of chronic poverty through the 'works' (projects) that are undertaken, and thus ensuring sustainable development.  Finally, there is an emphasis on strengthening the process of decentralisation through giving a significant role to Panchayati Raj Institutions (PRIs) in planning and implementing these works.

B. Key features:

  • Legal right to work: Unlike earlier employment guarantee schemes, the Act provides a legal right to employment for adult members of rural households.  At least one third beneficiaries have to be women.  Wages must be paid according to the wages specified for agricultural labourers in the state under the  Minimum Wages Act, 1948, unless the central government notifies a wage rate (this should not be less than Rs 60 per day).  At present, wage rates are determined by the central government but vary across states, ranging from Rs 135 per day to Rs 214 per day.
  • Time bound guarantee of work and unemployment allowance: Employment must be provided with 15 days of being demanded failing which an ‘unemployment allowance’ must be given.
  • Decentralised planning: Gram sabhas must recommend the works that are to be undertaken and at least 50% of the works must be executed by them.  PRIs are primarily responsible for planning, implementation and monitoring of the works that are undertaken.
  • Work site facilities: All work sites should have facilities such as crèches, drinking water and first aid.
  • Transparency and accountability: There are provisions for proactive disclosure through wall writings, citizen information boards, Management Information Systems and social audits.  Social audits are conducted by gram sabhas to enable the community to monitor the implementation of the scheme.
  • Funding:  Funding is shared between the centre and the states.  There are three major items of expenditure – wages (for unskilled, semi-skilled and skilled labour), material and administrative costs.  The central government bears 100% of the cost of unskilled labour, 75% of the cost of semi-skilled and skilled labour, 75% of the cost of materials and 6% of the administrative costs.

MGNREGA was implemented in phases, starting from February 2006, and at present it covers all districts of the country with the exception of those that have a 100% urban population.  The Act provides a list of works that can be undertaken to generate employment related to water conservation, drought proofing, land development, and flood control and protection works.  Table 1 provides information regarding employment generation and expenditure under MGNREGA.

Table 1: MGNREGA: Key indicators

Year

Number of households provided employment (in crore)

Average number of person days of work per household

Total Expenditure (in lakh)

2006-07

2.10

43

8823.35

2007-08

3.39

42

15856.88

2008-09

4.51

48

27250.10

2009-10

5.25

54

37905.23

2010-11

5.49

47

39377.27

2011-12*

4.99

43

 38034.69

2012-13**

4.25

36

 28073.51

Source: Standing Committee on Rural Development; PRS. Note: *Provisional ** As on 31.01.2013

II. Findings and Recommendations of the Standing Committee on Rural Development

A. Achievements: The Standing Committee highlighted several achievements of MGNREGA in the seven years of its implementation, especially:

  • Ensuring livelihood for people in rural areas.
  • Large scale participation of women, Scheduled Castes and Scheduled Tribes (SCs/STs) and other traditionally marginalised sections of society.  SCs/STs account for 51% of the total person-days generated and women account for 47% of the total person-days generated.
  • Increasing the wage rate in rural areas and strengthening the rural economy through the creation of infrastructure assets.
  • Facilitating sustainable development, and
  • Strengthening PRIs by involving them in the planning and monitoring of the scheme.

B. Challenges: However, the Committee found several issues with the implementation of the scheme. As Table 1 (above) shows, the average number of days of employment provided to households has been lower than the mandated 100 days, and has been decreasing since 2010-11. Key issues that the Committee raised include

  • Fabrication of job cards: While as many as 12.5 crore households have been issued job cards out of an estimated 13.8 crore rural households ( as per the 2001 census), there are several issues related to existence of fake job cards, inclusion of fictitious names, missing entries and delays in making entries in job cards.
  • Delay in payment of wages: Most states have failed to disburse wages within 15 days as mandated by MGNREGA.  In addition, workers are not compensated for a delay in payment of wages.
  • Non payment of unemployment allowances: Most states do not pay an unemployment allowance when work is not given on demand.  The non-issuance of dated receipts of demanded work prevents workers from claiming an unemployment allowance.
  • Large number of incomplete works: There has been a delay in the completion of works under MGNREGA and inspection of projects has been irregular.  Implementing agencies were able to complete only 98 lakh works out of 296 lakh works.  As Table 2 shows, a large percentage of works remain incomplete under MGNREGA and the work completion rate appears to be decreasing in recent years.

Table 2: Work completion rate

Year

Work completion rate (%)

2006-07

46.34

2007-08

45.99

2008-09

43.76

2009-10

48.94

2010-11

50.86

2011-12*

20.25

2012-13*

15.02

Total                  33.22

Source: Standing Committee on Rural Development. Note: * As on 30.01.2013

  • Other key challenges include poor quality of assets created, several instances of corruption in the implementation of MGNREGA, and insufficient involvement of PRIs.

C. Recommendations: The Committee made the following recommendations, based on its findings:

  • Regulation of job cards: Offences such as not recording employment related information in job cards and unlawful possession of job cards with elected PRI representatives and MGNREGA functionaries should be made punishable under the Act.
  • Participation of women: Since the income of female workers typically raises the standard of living of their households to a greater extent than their male counterparts, the participation of women must be increased through raising awareness about MGNREGA.
  • Participation of people with disabilities: Special works (projects) must be identified for people with disabilities; and  special job cards must be issued and personnel must be employed to ensure their participation.
  • Utilisation of funds:  The Committee found that a large amount of funds allocated for MGNREGA have remained unutilised.  For example, in 2010-11, 27.31% of the funds remained unutilised.  The Committee recommends that the Department of Rural Development should analyse reasons for poor utilisation of funds and take steps to improve the same.  In addition, it should initiate action against officers found guilty of misappropriating funds under MGNREGA.
  • Context specific projects and convergence: Since states are at various stages of socio-economic development, they have varied requirements for development.  Therefore, state governments should be allowed to undertake works that are pertinent to their context.  There should be more emphasis on skilled and semi-skilled work under MGNREGA.  In addition, the Committee recommends a greater emphasis on convergence with other schemes such as the National Rural Livelihoods Mission, National Rural Health Mission, etc.
  • Payment of unemployment allowance: Dated receipts for demanded work should be issued so that workers can claim unemployment allowance.  Funds for unemployment allowance should be met by the central government.
  • Regular monitoring: National Level Monitors (NLMs) are deployed by the Ministry of Rural Development for regular and special monitoring of MGNREGA and to enquire into complaints regarding mis-utilisation of funds, etc.  The Committee recommends that the frequency of monitoring by NLMs should increase and appropriate measures should be taken by states based on their recommendations.  Additionally, social audits must mandatorily be held every six months.  The Committee observes that the performance of MGNREGA is better in states with effective social audit mechanisms.
  • Training of functionaries: Training and capacity building of elected representatives and other functionaries of PRIs must be done regularly as it will facilitate their involvement in the implementation of MGNREGA.