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, there have been multiple Naxal attacks on CRPF personnel in Chhattisgarh. Parliamentary Committees have previously examined the working of the Central Armed Police Forces (CAPFs). In this context, we examine issues related to functioning of these Forces and recommendations made to address them.
What is the role of the Central Armed Police Forces (CAPFs)?
Under the Constitution, police and public order are state subjects. However, the Ministry of Home Affairs (MHA) assists state governments by providing them support of the Central Armed Police Forces. The Ministry maintains seven CAPFs: (i) the Central Reserve Police Force, which assists in internal security and counterinsurgency, (ii) the Central Industrial Security Force, which protects vital installations (like airports) and public sector undertakings, (iii) the National Security Guards, which is a special counterterrorism force, and (iv) four border guarding forces, which are the Border Security Force, Indo-Tibetan Border Police, Sashastra Seema Bal, and Assam Rifles.
What is the sanctioned strength of CAPFs personnel compared to the actual strength?
As of January 2017, the sanctioned strength of the seven CAPFs was 10,78,514 personnel. However, 15% of these posts (1,58,591 posts) were lying vacant. Data from the Bureau of Police Research and Development shows that vacancies in the CAPFs have remained over the years. Table 1 shows the level of vacancies in the seven CAPFs between 2012 and 2017. 
The level of vacancies is different for various police forces. For example, in 2017, the Sashastra Seema Bal had the highest level of vacancies at 57%. On the other hand, the Border Security Force had 2% vacancies. The Central Reserve Police Force, which account for 30% of the sanctioned strength of the seven CAPFs, had a vacancy of 8%.
How often are CAPFs deployed?
According to the Estimates Committee of Parliament, the number of deployment of CAPFs battalions has increased from 91 in 2012-13 to 119 in 2016-17. The Committee has noted that there has been heavy dependence by states on central police forces even for day-to-day law and order issues. This is likely to affect anti-insurgency and border-guarding operations of the Forces, as well as curtail their time for training. The continuous deployment also leaves less time for rest and recuperation.
The Estimates Committee recommended that states must develop their own systems, and augment their police forces by providing adequate training and equipment. It further recommended that the central government should supplement the efforts of state governments by providing financial assistance and other help for capacity building of their forces.
What is the financial allocation to CAPFs?
Under the Union Budget 2018-19, an allocation of Rs 62,741 crore was made to the seven CAPFs. Of this, 32% (Rs 20,268 crore) has been allocated to the Central Reserve Police Forces. The Estimates Committee has pointed out that most of the expenditure of the CAPFs was on salaries. According to the Committee, the financial performance in case of outlays allocated for capacity augmentation has been very poor. For example, under the Modernization Plan-II, Rs 11,009 crore was approved for the period 2012-17. However, the allocation during the period 2013-16 was Rs 251 crore and the reported expenditure was Rs 198 crore.
What are the working conditions for CAPFs personnel?
The Standing Committee on Home Affairs in the year 2017 had expressed concern over the working conditions of personnel of the border guarding forces (Border Security Force, Assam Rifles, Indo-Tibetan Border Police, and Sashastra Seema Bal). The Committee observed that they had to work 16-18 hours a day, with little time for rest or sleep. The personnel were also not satisfied with medical facilities that had been provided at border locations.
In addition, the Standing Committee observed that personnel of the CAPFs have not been treated at par with the Armed Forces, in terms of pay and allowances. The demand for Paramilitary Service Pay, similar to Military Service Pay, had not been agreed to by the Seventh Central Pay Commission. Further, the Committee observed that the hard-area allowance for personnel of the border guarding forces was much lower as compared to members of the Armed Forces, despite being posted in areas with difficult terrain and harsh weather.
What is the status of training facilities and infrastructure available to CAPFs?
The Estimates Committee has noted that all CAPFs have set up training institutions to meet their training requirements and impart professional skills on specialised topics. However, the Committee noted that there is an urgent need to upgrade the curriculum and infrastructure in these training institutes. It recommended that while purchasing the latest equipment, training needs should also be taken care of, and if required, should be included in the purchase agreement itself. Further, it recommended that the contents of training should be a mix of conventional matters as well as latest technologies such as IT, and cyber security.
According to the Estimates Committee, the MHA has been making efforts to provide modern arms, ammunition, and vehicles to the CAPFs. In this regard, the Modernization Plan-II, for the period 2012-17, was approved by the Cabinet Committee on Security. The Plan aims to provide financial support to CAPFs for modernisation in areas of arms, clothing, and equipment.
However, the Committee observed that the procurement process under the Plan was cumbersome and time consuming. It recommended that the bottlenecks in procurement should be identified and corrective action should be taken. It further suggested that the MHA and CAPFs should hold negotiations with ordnance factories and manufacturers in the public or private sector, to ensure an uninterrupted supply of equipment and other infrastructure.
