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:
By Rohit & Anirudh A modified 'Modernization of State Police Forces' scheme was started by the central government in 2000-01. One of the objectives was to help police forces in meeting the emerging challenges to internal security in the form of terrorism, naxalism etc. The scheme aims to modernize police forces in terms of:
Under this scheme, States have been clubbed into different categories and Centre-State cost sharing is category specific. Since 2005-06, States have been categorized as category ‘A’ and ‘B’ with 100% and 75% Central funding respectively. All the North Eastern States, namely Arunachal Pradesh, Assam, Manipur, Meghalaya, Mizoram, Nagaland, Tripura and Sikkim have been placed in category ‘A’ and thus, are entitled to receive 100% Central assistance for implementation of their annual approved plans. Recently, CAG decided to evaluate the working of the scheme and commissioned ‘performance audit’ reviews covering select general category and special category States. Each review covers a contiguous five year period between 2000 and 2007, but varies across selected states. For the periods under review, each state had a plan outlay (the total amount proposed to be spent in modernizing the state's police forces). However, in most cases, the actual release of funds fell significantly short of this outlay - in some cases the Centre did not contribute its share, in others the States lagged behind. For instance, in the case of Bihar, the Centre released only 56% of its share; while in the case of Rajasthan and West Bengal, the States did not release any funds at all. The graph below shows the actual releases by the Centre and the States (as percentages of their share in the proposed outlays): 
Further, even the funds that were released were not fully utilized. Thus, the amount finally spent fell significantly short of the initial proposal. The graph below shows the actual expenditure by State: 
Following are some of the other main findings from the CAG report:
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Table 1: Summary of main findings in the CAG audit for different states for Modernisation of State Police Forces |
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Purpose for which money was sanctioned |
Summary of CAG Findings |
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Planning (Every state has to propose an Annual Action Plan every year. The plan is approved by the Ministry of Home Affairs and money is released as per the plan.) |
§ Submissions by the states to the MHA were delayed. § There were also delays in the clearance granted by the MHA. § In various states such as, a) Andhra Pradesh – the government spent money on works not covered by the Annual Action Plan. b) Bihar – Persistent delays in preparation of the Plan by the state police. c) West Bengal – the plans drawn up by the state did not include items covered under the scheme. |
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Mobility |
§ Overall shortage of vehicles was observed. Most of the new vehicles replaced the old ones. § The police response time was too long in some states. § To give examples from some states: a) Andhra Pradesh – 58 percent of vehicles procured were utilised for replacing old vehicles. b) Bihar – the shortage of vehicles was 43 percent. c) Uttar Pradesh – 2400 vehicles were procured against a shortage of nearly 10,000 vehicles. |
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Residential and non-residential buildings |
§ There were considerable delays in construction of buildings in most states. Consequently, police forces’ own security was in jeopardy. § In states such as: a) Andhra Pradesh – 53 percent of staff quarters and 43 percent of official buildings were not completed (2007). b) Bihar – The total requirement of housing was nearly 60,000. Only six percent of this were included in the Plan. c) Jharkhand – District Control rooms remained non-functional because of shortage of manpower. |
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Weapons |
§ Police force in states continue to depend on outdated weapons. § Shortages of weapons also happened as acquisition from ordnance factories was very slow. § The weapons that were procured were mostly kept in the district headquarters. § In some states such as, a) Bihar – AK-47s were kept at the disposal of bodyguards of VIPs. b) West Bengal – Adequate weapons were not supplied to extremist prone police stations. |
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Communication |
§ Police Telecommunication Networks were not set up successfully in some states. In others, network was functional only up to the district level. § Shortages of various communication equipments were also observed. § In some states such as, a) Bihar - The Police Telecommunication Network system (costing Rs. 4.96 crore) remained non-functional due to non-construction of tower. b) Maharashtra – Of the 850 purchased Remote Station Units, 452 were lying in stores. |
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Forensic Science Laboratory/ Finger Printing Bureau |
§ In most States the Forensic Science Laboratories lacked adequate infrastructure. § In the absence of automatic finger print identification systems, investigation was being done manually in some States. § In some states such as, a) Maharashtra - There were significant delays in receipt and installation. There was also shortage (284 vacant posts) of technical manpower. b) West Bengal - Performance of the Forensic Science Laboratory was poor and in some cases, the delay in issue of investigation reports was as high as 45 months. |
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Training |
§ It was observed that the percentage of police personnel trained was very low. § Training infrastructure was also inadequate. § In some states such as, a) Bihar - Only 10 per cent of total force was trained. b) West Bengal - Live training was not imparted for handling useful weapons and this severely affected the performance of police forces. |
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Sources: CAG Compendium of Performance Audit Reviews on Modernisation of Police Force; PRS. Note: The audit has been done broadly from 2000 to 2007. Consequently, the period of audit for different states may vary. |
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Table 1: Summary of main findings in the CAG audit for different states for Modernisation of State Police Forces |
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Purpose for which money was sanctioned |
Summary of CAG Findings |
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Planning (Every state has to propose an Annual Action Plan every year. The plan is approved by the Ministry of Home Affairs and money is released as per the plan.) |
§ Submissions by the states to the Ministry of Home Affairs (MHA) were delayed. § There were also delays in the clearance granted by the MHA. § In various states such as, a) Andhra Pradesh – the government spent Rs 32 crore on works not covered by the Annual Action Plan. b) Bihar – Persistent delays in preparation of the Plan by the state police. c) West Bengal – the plans drawn up by the state did not include items covered under the scheme. |
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Mobility |
§ Overall shortage of vehicles was observed. Most of the new vehicles replaced the old ones, and no additions were made. § The police response time was too long in some states. § To give examples from some states: a) Andhra Pradesh – 58 percent of vehicles procured were utilised for replacing old vehicles. b) Bihar – the shortage of vehicles was 43 percent. c) Uttar Pradesh – 2400 vehicles were procured against a shortage of nearly 10,000 vehicles. 203 ambassador cars were procured, though only 55 were approved by the MHA. |
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Residential and non-residential buildings |
§ There were considerable delays in construction of buildings in most states. Consequently, police forces’ own security was in jeopardy. Satisfaction levels with the housing provided were also very low. § In states such as: a) Andhra Pradesh – 53 percent of staff quarters and 43 percent of official buildings were not completed (2007). b) Bihar – The total requirement of housing was nearly 60,000. Only six percent of this were included in the Plan, and only 1045 units were completed by 2006. c) Jharkhand – District Control rooms remained non-functional even after spending Rs 2 crore because of shortage of manpower. |
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Weapons |
§ It was observed that the police force in states continue to depend on outdated weapons. § Shortages of weapons also happened as acquisition from ordnance factories was very slow. § The weapons that were procured were mostly kept in the district headquarters. § In some states such as, a) Bihar – AK-47s were kept at the disposal of bodyguards of VIPs. b) West Bengal – Adequate weapons were not supplied to extremist prone police stations. |
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Communication |
§ Police Telecommunication Networks were not set up successfully in some states. In others, network was functional only up to the district level. § Shortages of various communication equipments were also observed. § In some states such as, a) Bihar - The Police Telecommunication Network system (costing Rs. 4.96 crore) remained non-functional due to non-construction of tower. b) Maharashtra – Of the 850 purchased Remote Station Units, 452 were lying in stores. |
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Forensic Science Laboratory/ Finger Printing Bureau |
§ In most States the Forensic Science Laboratories lacked adequate infrastructure. § In the absence of automatic finger print identification systems, investigation was being done manually in some States. § In some states such as, a) Maharashtra - There were significant delays in receipt and installation. There was also shortage (284 vacant posts) of technical manpower. b) West Bengal - Performance of the Forensic Science Laboratory was poor and in some cases, the delay in issue of investigation reports was as high as 45 months. |
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Training |
§ It was observed that the percentage of police personnel trained was very low. § Training infrastructure was also inadequate. § In some states such as, a) Bihar - Only 10 per cent of total force was trained. b) West Bengal - Live training was not imparted for handling useful weapons and this severely affected the performance of police forces. |
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Sources: CAG Compendium of Performance Audit Reviews on Modernisation of Police Force; PRS. Note: The audit has been done broadly from 2000 to 2007. Consequently, the period of audit for different states may vary. |
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