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:
In India, police and law and order come under the purview of state governments.[1] Accordingly, each state has its own police force for maintaining law and order and investigating crimes. However, due to financial and other constraints, states have critical gaps in their policing infrastructure.2 Figure 1 shows the expenditure by states on police, as a percentage of their total budget. In 2015-16, Manipur spent the highest proportion of its state budget on police, followed by Punjab and Jammu and Kashmir.
Figure 1: Police Expenditure as a proportion of total state budget
The Ministry of Home Affairs has been supplementing resources of states under the Modernisation of Police Forces (MPF) scheme.[2] The Union Cabinet last week approved the implementation of an umbrella scheme of MPF and has allocated funding of Rs 25,060 crore for the 2017-18 to 2019-20 period.[3] In light of this decision, we present the key features of the scheme and examine other issues related to the police forces.
Modernisation of Police Forces scheme
The MPF scheme was initiated in 1969-70 and has undergone several revisions over the years.2 It was allocated Rs 11,946 crore for the period between 2012-13 to 2016-17, which has now been doubled after last week’s Cabinet approval.[4] Funds from the MPF scheme are typically used for improving police infrastructure through construction of police stations and provision of modern weaponry, surveillance and communication equipment. Upgradation of training infrastructure, police housing and computerisation are also important objectives funded through the scheme.
Following the recommendations of the Fourteenth Finance Commission, to increase the share of central taxes to states, it was decided that the MPF scheme would be delinked from central funding from 2015-16 onwards.[5] States were expected to finance the scheme using their own resources. However, of the recent allocation made by the Cabinet, Rs 18,636 crore will come from the central government and Rs 6,424 crore will come from the states.3 This implies that the centre will fund almost 75% of the scheme.
Underutilisation of Funds
Data from the Bureau of Police Research and Development (BPR&D) shows that funds have not been fully utilised under the MPF scheme. In the year 2015-16, out of a total grant of Rs 9,203 crore that was made available for modernisation, states utilised only Rs 1330 crore (14%).[6]
Figure 2 shows the trend in underutilisation of modernisation funds from 2009-10 to 2015-16. Over this period, there has been a consistent underutilisation of funds by states. On average, states spent 55% of the funds allocated to them, with the highest being 86% utilisation in 2013-14.
Figure 2: Utilisation of funds for modernisation by states (%)
Issues related to police forces
While the MPF scheme seeks to improve police infrastructure, there are a number of structural issues that have been raised by experts over the years related to police forces. We discuss a few of these below.
(i) Overburdened police force
Apart from the core function of maintaining law and order, police personnel carry out various other functions such as traffic management, disaster rescue and removal of encroachments. The Second Administrative Reforms Commission (2007) has noted that these extra obligations lead to overburdening of the police force. It recommended that these functions should be carried out by other government departments or private agencies.[7] Note that as of January 2016, 24 per cent of sanctioned police posts in India were vacant.6 This indicates that police personnel may be overburdened, which may have negative consequences on their efficiency and performance.
(ii) Poor quality of investigation
In 2015, the conviction rate for crimes recorded under the Indian Penal Code, 1860 was only 47%.[9] The Law Commission (2012) observed that one of the reasons for low conviction rates in India is poor quality of investigation by police.[8] The police lack training and expertise required to conduct professional investigations. They also have insufficient legal knowledge and inadequate forensic and cyber infrastructure. In light of these deficiencies, the Second Administrative Reforms Commission (2007) recommended that states should have specialised investigation units within the police force for better investigation of crimes.7
(iii) Police accountability
In India, control over the police force vests with the political executive.[10] The Second Administrative Reforms Commission (2007) noted that this has to led to abuse of police personnel and interference with their decision-making authority.7 To allow the police operational autonomy while maintaining accountability, the Supreme Court issued guidelines to the central government and state governments (and Union Territories) in the year 2006.[11]
The guidelines provided for the establishment of three institutions: (i) a State Security Commission, (ii) a Police Establishment Board, and (iii) a Police Complaints Authority.11 The Supreme Court also stated that the state Director General of Police (DGP) should be selected from three senior-most officers of the state empanelled by the Union Public Service Commission and must have a minimum two-year tenure.
In addition, the court recommended that officers in key positions in the field (Inspector General in charge of Range, Station House Officer) must be given a two-year tenure. Currently, DGPs and senior officers are selected by the political executive of the state and are not guaranteed security of tenure.[10] In order to improve the quality of investigation, the Court recommended that investigating police must be separated from law and order police.11
These guidelines and recommendations of other expert bodies were used to create the draft Model Police Bill, 2015 by BPR&D, which states have been encouraged to adopt. While states have partially implemented some of these guidelines, no state has adhered to them in full.[12] In most states, the three institutions which the Supreme Court has directed states to create have not been given the authority they need to ensure accountability and insulate the police force from political misuse.12
[1]Entry 1 and 2, List II, Schedule 7, Constitution of India, 1950.
[2] Modernisation of Police Force Scheme Book, Ministry of Home Affairs, 2010 http://mha.nic.in/sites/upload_files/mha/files/Scheme-MPF-11Nov.pdf.
[3] “Cabinet approves umbrella scheme of Modernisation of Police Forces”, Press Information Bureau, 27th September 2017.
[4] Annual Report, Ministry of Home Affairs, 2015-16, http://mha.nic.in/sites/upload_files/mha/files/AR(E)1516.pdf.
[5] “Major Programmes Under Central Assistance for State Plans”, Union Budget, 2015-16 http://indiabudget.nic.in/budget2015-2016/ub2015-16/bag/bag8.pdf.
[6] “Data on Police Organisations”, Bureau of Police Research and Development, 2016, http://bprd.nic.in/WriteReadData/userfiles/file/201701090303068737739DATABOOK2016FINALSMALL09-01-2017.pdf.
[7] “Public Order”, Second Administrative Reforms Commission, 2007, http://arc.gov.in/5th%20REPORT.pdf.
[8] “Report No. 239: Expeditious Investigation and Trial of Criminal Cases Against Influential Public Personalities”, Law Commission of India, March 2012, http://lawcommissionofindia.nic.in/reports/report239.pdf.
[9] “Crime in India”, National Crime Records Bureau, 2006-15 http://ncrb.nic.in/StatPublications/CII/CII2015/FILES/Compendium-15.11.16.pdf.
[10] Section 3, Police Act, 1861.
[11] Prakash Singh vs Union of India, Supreme Court, Writ Petition (Civil) No. 310 of 1996, November 8, 2010.
[12] “Building Smart Police in India: Background into the needed Police Force Reforms”, Niti Aayog, 2016, http://niti.gov.in/writereaddata/files/document_publication/Strengthening-Police-Force.pdf.
