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:
Recently, the Supreme Court collegium reiterated its recommendations for the appointment of 11 judges to certain High Courts. It had first recommended these names earlier this year and in August last year, but these appointments were not made. The Indian judiciary faces high vacancies across all levels (the Supreme Court, High Courts, and subordinate courts). Vacancy of judges in courts is one of the reasons for delays and a rising number of pending cases, as there are not enough judges to hear and decide cases. As of today, more than four crore cases are pending across all courts in India. In this blog post, we discuss vacancies across courts over the years, delays in appointment of judges, and methods to determine the adequate judge strength required to handle the caseload courts face.
High vacancy of judges across courts
Vacancies in courts keep on arising periodically due to retirement, resignation, demise, or elevation of judges. Over the years, the sanctioned strength of judges in both High Courts and subordinate courts has been increased gradually. However, vacancies persist due to insufficient appointments (see Figures 1 and 2). Between 2010 and 2020, vacancies increased from 18% to 21% across all levels of courts (from 6% to 12% in the Supreme Court, from 33% to 38% in High Courts, and from 18% to 20% in subordinate courts).
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Figure 1: Vacancy of judges in High Courts |
Figure 2: Vacancy of judges in subordinate courts |
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Sources: Court News 2010-2018; Vacancy Statement, and Rajya Sabha replies, Part I, Budget Session (2021), Department of Justice; PRS. |
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As on November 1, 2021, the Supreme Court had a vacancy of one judge (out of a sanctioned strength of 34). Vacancy in High Courts stood at 37% (406 posts vacant out of a sanctioned strength of 1,098). Since May, 2021, the Supreme Court collegium has recommended more than 130 names for appointment as High Court judges. In three High Courts (Telangana, Patna, and Calcutta), at least half of the posts are vacant (see Figure 3). The Standing Committee on Personnel, Public Grievances, Law and Justice (2020) noted that every year, 35-40% of posts of High Court judges remain unfilled.
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Figure 3: Vacancy of judges across High Courts (in %) (as on November 1, 2021)
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Source: Vacancy Statement, Department of Justice; PRS. |
Appointments of High Court judges are guided by a memorandum of procedure. As per this memorandum, the appointment process is to be initiated by the concerned High Court at least six months before a vacancy occurs. However, the Standing Committee (2021) noted that this timeline is rarely adhered to by High Courts. Further, in the final stage of the process, after receiving recommendations from the Supreme Court collegium, the executive appoints judges to the High Court. No timeline is prescribed for this stage of the appointment process. In 2018 and 2019, the average time taken to appoint High Court judges after receiving the collegium’s recommendations was five to seven months.
As of today, over 3.6 crore cases are pending before subordinate courts in India. As on February 20, 2020, 21% posts for judges were vacant (5,146 posts out of the sanctioned strength of 24,018) in subordinate courts. Subordinate courts in Bihar, Haryana, and Jharkhand (among the states with high population) had a high proportion of vacancies of judges (see Figure 4). Note that the Supreme Court is monitoring the procedure for appointment of judges to subordinate courts.
For an analysis of the data on pendency and vacancies in the Indian judiciary, see here.
Figure 4: Vacancy of judges across subordinate courts (in %) (as on February 20, 2020)
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Source: Report No. 101, Standing Committee on Personnel, Public Grievances, Law and Justice (2020); PRS. |
How many judges do we need?
The Law Commission of India (1987) had noted the importance of manpower planning for the judiciary. Lack of adequate number of judges means a greater workload per judge. Thus, it becomes essential to arrive at an optimal judge strength to deal with pending and new cases in courts. Over the years, different methods of calculating the required judge strength for subordinate courts (where the backlog of cases in the Indian judiciary is concentrated) have been recommended (see Table 1).
Table 1: Methods recommended for calculating the required number of judges for subordinate courts
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Method of calculation |
Recommendation and its status |
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Judge-to-population ratio: optimum number of judges per million population |
The Law Commission of India (1987) had recommended increasing this ratio to 50 judges per million people. This was reiterated by the Supreme Court (2001) and the Standing Committee on Home Affairs (2002). For 2020, the judge-to-population ratio was 21 judges per million population. Note that this figure is calculated based on the sanctioned strength of judges in the Supreme Court, High Courts and subordinate courts. |
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Rate of disposal: number of additional judges required (to clear the existing backlog of cases and ensure that new backlog is not created) based on the average number of cases disposed per judge |
The Law Commission of India (2014) proposed this method. It rejected the judge-to-population ratio method, observing that filing of cases per capita varies substantially across geographic units depending on socio-economic conditions. |
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Weighted case load method: calculating judge strength based on the disposal by judges, taking into account the nature and complexity of cases in local conditions |
The National Court Management Systems Committee (NCMS) (2016) critiqued the rate of disposal method. It proposed, as an interim measure, the weighted case load method, which addresses the existing backlog of cases as well as the new flow of cases every year in subordinate courts. In 2017, the Supreme Court accepted this model. |
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Time-based weighted case load method: calculating the required judge strength taking into account the actual time spent by judges in different types of cases at varying stages based on an empirical study |
Used widely in the United States, this was the long-term method recommended by the NCMS (2016) to assess the required judge strength for subordinate courts. It involves determining the total number of ‘judicial hours’ required for disposing of the case load of each court. The Delhi High Court used this approach in a pilot project (January 2017- December 2018) to calculate the ideal judge strength for disposing of pending cases in certain courts in Delhi. |
Sources: Reports No. 120 (1987) and 245 (2014), Law Commission of India; Report No. 85, Standing Committee on Home Affairs (2002); Note for Calculating Required Judge Strength for Subordinate Courts, National Court Management Systems Committee (NCMS) (2016); Imtiyaz Ahmad vs. State of Uttar Pradesh, Supreme Court (2017); PRS.
