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:
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:
On October 2, 2021, Swachh Bharat Mission (SBM) celebrates its seventh anniversary. It was launched on October 2, 2014 to fulfil the vision of a cleaner India by October 2, 2019. The objective of the Mission was to eliminate open defecation, eradicate manual scavenging, and promote scientific solid waste management. In this blog post, we discuss the sanitation coverage leading up to the launch of the Swachh Bharat Mission and the progress made under this scheme.
Nation-wide sanitation programmes in past
According to the Census, the rural sanitation coverage in India was only 1% in 1981.
The first nationwide programme with a focus on sanitation was the Central Rural Sanitation Programme (CRSP), which was started in 1986 to provide sanitation facilities in rural areas. Later, in 1999, CRSP was restructured and launched as the Total Sanitation Campaign (TSC). While CRSP was a supply-driven infrastructure-oriented programme based on subsidy, TSC was a demand-driven, community-led, project-based programme organised around the district as the unit.
By 2001, only 22% of the rural families had access to toilets. It increased further to 32.7% by 2011. In 2012, TSC was revamped as Nirmal Bharat Abhiyan (NBA) to accelerate the sanitation coverage in rural areas through saturation approach and by enhancing incentives for Individual Household Latrines (IHHL).
In comparison to rural sanitation, fewer programmes were enacted to tackle deficiencies in urban sanitation. In the 1980s, the Integrated Low-Cost Sanitation Scheme provided subsidies for households to build low-cost toilets. Additionally, the National Slum Development Project and its replacement programme, the Valmiki Ambedkar Awas Yojana launched in 2001, were programmes that aimed to construct community toilets for slum populations. In 2008, the National Urban Sanitation Policy (NUSP) was announced to manage human excreta and associated public health and environmental impacts.
On October 2, 2014, the Swachh Bharat Mission was launched with two components: Swachh Bharat Mission (Gramin) and Swachh Bharat Mission (Urban), to focus on rural and urban sanitation, respectively. While the rural component of the Mission is implemented under the Department of Drinking Water and Sanitation, the urban one is implemented by the Ministry of Housing and Urban Affairs. In 2015, the Sub-Group of Chief Ministers on Swachh Bharat Abhiyaan under NITI Aayog had observed that the key difference between SBM and previous programmes was in the efforts to attract more partners to supplement public sector investment towards sanitation.
Swachh Bharat Mission – Gramin (SBM-Gramin)
The Sub-Group of Chief Ministers (2015) had noted that more than half of India’s 25 crore households do not have access to toilets close to places where they live. Notably, during the 2015-19 period, a major portion of expenditure under the Department of Drinking Water and Sanitation was towards SBM-Gramin (see Figure 1).
Figure 1: Expenditure on Swachh Bharat Mission-Gramin during 2014-22
Note: Values for 2020-21 are revised estimates and 2021-22 are budget estimates. Expenditure before 2019-20 were from the erstwhile Ministry of Drinking Water and Sanitation.
Sources: Union Budgets 2014-15 to 2021-22; PRS.
The expenditure towards Swachh Bharat – Gramin saw a steady increase from 2014-15 (Rs 2,841 crore) to 2017-18 (Rs 16,888 crore) and a decrease in the subsequent years. Moreover, during 2015-18, the expenditure of the scheme exceeded the budgeted amount by more than 10%. However, every year since 2018-19, there has been some under-utilisation of the allocated amount.
As per the Department of Drinking Water and Sanitation, 43.8% of the rural households had access to toilets in 2014-15, which increased to 100% in 2019-20 (see Figure 2). However, the 15th Finance Commission (2020) noted that the practice of open defecation is still prevalent, despite access to toilets and highlighted that there is a need to sustain the behavioural change of people for using toilets. The Standing Committee on Rural Development raised a similar concern in 2018, noting that “even a village with 100% household toilets cannot be declared open defecation-free (ODF) till all the inhabitants start using them”. The Standing Committee also raised questions over the construction quality of toilets and observed that the government is counting non-functional toilets, leading to inflated data.
Figure 2: Toilet coverage for rural households
Sources: Dashboard of SBM (Gramin), Ministry of Jal Shakti; PRS.
The 15th Finance Commission also noted that the scheme only provides financial incentives to construct latrines to households below the poverty line (BPL) and selected households above the poverty line. It highlighted that there are considerable exclusion errors in finding BPL households and recommended the universalisation of the scheme to achieve 100% ODF status.
In March 2020, the Department of Drinking Water and Sanitation launched Phase II of SBM-Gramin which will focus on ODF Plus, and will be implemented from 2020-21 to 2024-25 with an outlay of Rs 1.41 lakh crore. ODF Plus includes sustaining the ODF status, and solid and liquid waste management. Specifically, it will ensure that effective solid and liquid waste management is instituted in every Gram Panchayat of the country.
Swachh Bharat Mission – Urban (SBM-Urban)
SBM-Urban aims at making urban India free from open defecation and achieving 100% scientific management of municipal solid waste in 4,000+ towns in the country. One of its targets was the construction of 66 lakh individual household toilets (IHHLs) by October 2, 2019. However, this target was then lowered to 59 lakh IHHLS by 2019. This target was achieved by 2020 (see Table 1).
Table 1: Toilet construction under Swachh Bharat Mission-Urban (as of December 30, 2020)
|
Targets |
Original Target |
Revised Target |
Actual Constructed |
|
Individual Household Latrines |
66,42,000 |
58,99,637 |
62,60,606 |
|
Community and Public Toilets |
5,08,000 |
5,07,587 |
6,15,864 |
Sources: Swachh Bharat Mission Urban - Dashboard; PRS.
Figure 3: Expenditure on Swachh Bharat Mission-Urban during 2014-22 (in Rs crore)
Note: Values for 2020-21 are revised estimates and 2021-22 are budget estimates.
Sources: Union Budget 2014-15 to 2021-22; PRS.
The Standing Committee on Urban Development noted in early 2020 that toilets built under the scheme in areas including East Delhi are of very poor quality, and do not have adequate maintenance. Further, only 1,276 of the 4,320 cities declared to be open defecation free have toilets with water, maintenance, and hygiene. Additionally, it also highlighted in September 2020 that uneven release of funds for solid waste management across states/UTs needs to be corrected to ensure fair implementation of the programme.
The Standing Committee on Urban Development (2021) also expressed concern about the slow pace in achieving targets for source segregation and waste processing. The completion of their targets stood at 78% and 68% respectively of the goal set under SBM-Urban during 2020-21. In addition, other targets related to the door-to-door collection of waste also remained unfulfilled (see Table 2).
Table 2: Waste management under Swachh Bharat Mission-Urban (progress as of December 30, 2020)
|
Targets |
Target |
Progress |
Progress |
|
Door to Door Waste Collection (Wards) |
86,284 |
81,535 (96%) |
83,435 (97%) |
|
Source Segregation (Wards) |
86,284 |
64,730 (75%) |
67,367 (78%) |
|
Waste Processing (in %) |
100% |
65% |
68% |
Sources: Standing Committee on Urban Development (2021); PRS.
In February 2021, the Finance Minister announced in her budget speech that the Urban Swachh Bharat Mission 2.0 will be launched. Urban Swachh Bharat Mission 2.0 will focus on: (i) sludge management, (ii) waste-water treatment, (iii) source segregation of garbage, (iv) reduction in single-use plastics and (v) control of air pollution caused by construction, demolition, and bio-remediation of dumpsites. On October 1, 2021, the Prime Minister launched SBM-Urban 2.0 with the mission to make all our cities ‘Garbage Free’.
