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.

Earlier this month, guidelines for the Swachh Bharat Mission (Gramin) were released by the Ministry of Drinking Water and Sanitation.  Key features of the Swachh Bharat Mission (Gramin), as outlined in the guidelines, are detailed below.  In addition, a brief overview of sanitation levels in the country is provided, along with major schemes of the central government to improve rural sanitation. The Swachh Bharat Mission, launched in October 2014, consists of two sub-missions – the Swachh Bharat Mission (Gramin) (SBM-G), which will be implemented in rural areas, and the Swachh Bharat Mission (Urban), which will be implemented in urban areas.  SBM-G seeks to eliminate open defecation in rural areas by 2019 through improving access to sanitation.  It also seeks to generate awareness to motivate communities to adopt sustainable sanitation practices, and encourage the use of appropriate technologies for sanitation. I. Context Data from the last three Census’, in Table 1, shows that while there has been some improvement in the number of households with toilets; this number remains low in the country, especially in rural areas. Table 1:  Percentage of households with toilets (national)

Year Rural Urban Total
1991 9% 64% 24%
2001 22% 74% 36%
2011 31% 81% 47%

In addition, there is significant variation across states in terms of availability of household toilets in rural areas, as shown in Table 2.  Table 2 also shows the change in percentage of rural households with toilets from 2001 to 2011.  It is evident that the pace of this change has varied across states over the decade. Table 2: Percentage of rural households with toilets

State

2001

2011

% Change

Andhra Pradesh

18

32

14

Arunachal Pradesh

47

53

5

Assam

60

60

0

Bihar

14

18

4

Chhattisgarh

5

15

9

Goa

48

71

23

Gujarat

22

33

11

Haryana

29

56

27

Himachal Pradesh

28

67

39

Jammu and Kashmir

42

39

-3

Jharkhand

7

8

1

Karnataka

17

28

11

Kerala

81

93

12

Madhya Pradesh

9

13

4

Maharashtra

18

38

20

Manipur

78

86

9

Meghalaya

40

54

14

Mizoram

80

85

5

Nagaland

65

69

5

Odisha

8

14

6

Punjab

41

70

30

Rajasthan

15

20

5

Sikkim

59

84

25

Tamil Nadu

14

23

9

Tripura

78

82

4

Uttar Pradesh

19

22

3

Uttarakhand

32

54

23

West Bengal

27

47

20

All India

22

31

9

II. Major schemes of the central government to improve rural sanitation The central government has been implementing schemes to improve access to sanitation in rural areas from the Ist Five Year Plan (1951-56) onwards.  Major schemes of the central government dealing with rural sanitation are outlined below.

Central Rural Sanitation Programme (1986): The Central Rural Sanitation Programme was one of the first schemes of the central government which focussed solely on rural sanitation.  The programme sought to construct household toilets, construct sanitary complexes for women, establish sanitary marts, and ensure solid and liquid waste management.
Total Sanitation Campaign (1999): The Total Sanitation Campaign was launched in 1999 with a greater focus on Information, Education and Communication (IEC) activities in order to make the creation of sanitation facilities demand driven rather than supply driven. Key components of the Total Sanitation Campaign included: (i) financial assistance to rural families below the poverty line for the construction of household toilets, (ii) construction of community sanitary complexes, (iii) construction of toilets in government schools and aganwadis, (iv) funds for IEC activities, (v) assistance to rural sanitary marts, and (vi) solid and liquid waste management.
Nirmal Bharat Abhiyan (2012): In 2012, the Total Sanitation Campaign was replaced by the Nirmal Bharat Abhiyan (NBA), which also focused on the previous elements.  According to the Ministry of Drinking Water and Sanitation, the key shifts in NBA were: (i) a greater focus on coverage for the whole community instead of a focus on individual houses, (ii) the inclusion of certain households which were above the poverty line, and (iii) more funds for IEC activities, with 15% of funds at the district level earmarked for IEC.
Swachh Bharat Mission (Gramin) (2014): Earlier this year, in October, NBA was replaced by Swachh Bharat Mission (Gramin) (SBM-G) which is a sub-mission under Swachh Bharat Mission.  SBM-G also includes the key components of the earlier sanitation schemes such as the funding for the construction of individual household toilets, construction of community sanitary complexes, waste management, and IEC. Key features of SBM-G, and major departures from earlier sanitation schemes, are outlined in the next section.

III. Guidelines for Swachh Bharat Mission (Gramin) The guidelines for SBM-G, released earlier this month, outline the strategy to be adopted for its implementation, funding, and monitoring. Objectives: Key objectives of SBM-G include: (i) improving the quality of life in rural areas through promoting cleanliness and eliminating open defecation by 2019, (ii) motivating communities and panchayati raj institutions to adopt sustainable sanitation practices, (iii) encouraging appropriate technologies for sustainable sanitation, and (iv) developing community managed solid and liquid waste management systems. Institutional framework: While NBA had a four tier implementation mechanism at the state, district, village, and block level, an additional tier has been added for SBM-G, at the national level.  Thus, the implementation mechanisms at the five levels will consist of: (i) National Swachh Bharat Mission (Gramin), (ii) State Swachh Bharat Mission (Gramin), (iii) District Swachh Bharat Mission (Gramin), (iv) Block Programme Management Unit, and (v) Gram Panchayat/Village and Water Sanitation Committee.  At the Gram Panchayat level, Swachhta Doots may be hired to assist with activities such as identification of beneficiaries, IEC, and maintenance of records. Planning: As was done under NBA, each state must prepare an Annual State Implementation Plan.  Gram Panchayats must prepare implementation plans, which will be consolidated into Block Implementation Plans.  These Block Implementation Plans will further be consolidated into District Implementation Plans.  Finally, District Implementation Plans will be consolidated in a State Implementation Plan by the State Swachh Bharat Mission (Gramin). A Plan Approval Committee in Ministry of Drinking Water and Sanitation will review the State Implementation Plans.  The final State Implementation Plan will be prepared by states based on the allocation of funds, and then approved by National Scheme Sanctioning Committee of the Ministry. Funding: Funding for SBM-G will be through budgetary allocations of the central and state governments, the Swachh Bharat Kosh, and multilateral agencies.  The Swachh Bharat Kosh has been established to collect funds from non-governmental sources.  Table 3, below, details the fund sharing pattern for SBM-G between the central and state government, as provided for in the SBM-G guidelines. Table 3: Funding for SBM-G across components

Component Centre State Beneficiary Amount as a % of SBM-G outlay
IEC, start-up activities, etc 75% 25% - 8%
Revolving fund 80% 20% - Up to 5%
Construction of household toilets 75%(Rs 9000)90% for J&K, NE states, special category states 25%(Rs 3000)10% for J&K, NE states, special category states -- Amount required for full coverage
Community sanitary complexes 60% 30% 10% Amount required for full coverage
Solid/Liquid Waste Management 75% 25% - Amount required within limits permitted
Administrative charges 75% 25% - Up to 2% of the project cost

One of the changes from NBA, in terms of funding, is that funds for IEC will be up to 8% of the total outlay under SBM-G, as opposed to up to 15% (calculated at the district level) under NBA.  Secondly, the amount provided for the construction of household toilets has increased from Rs 10,000 to Rs 12,000.  Thirdly, while earlier funding for household toilets was partly through NBA and partly though the Mahatma Gandhi National Rural Employment Guarantee Scheme (MGNREGS), the provision for MGNREGS funding has been done away with under SBM-G.  This implies that the central government’s share will be met entirely through SBM-G. Implementation: The key components of the implementation of SBM-G will include: (i) start up activities including preparation of state plans, (ii) IEC activities, (iii) capacity building of functionaries, (iv) construction of household toilets, (v) construction of community sanitary complexes, (vi) a revolving fund at the district level to assist Self Help Groups and others in providing cheap finance to their members (vii) funds for rural sanitary marts, where materials for the construction of toilets, etc., may be purchased, and (viii) funds for solid and liquid waste management. Under SBM-G, construction of toilets in government schools and aganwadis will be done by the Ministry of Human Resource Development and Ministry of Women and Child Development, respectively.  Previously, the Ministry of Drinking Water and Sanitation was responsible for this. Monitoring: Swachh Bharat Missions (Gramin) at the national, state, and district levels will each have monitoring units.  Annual monitoring will be done at the national level by third party independent agencies.  In addition, concurrent monitoring will be done, ideally at the community level, through the use of Information and Communications Technology. More information on SBM-G is available in the SBM-G guidelines, here.