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, Delhi witnessed large scale protests by various groups demanding stricter punishment and speedier trial in cases of sexual assault against women. In light of the protests, the central government has constituted a Commission (headed by Justice Verma) to suggest possible amendments in the criminal law to ensure speedier disposal of cases relating to sexual assault. Though the Supreme Court, in 1986, had recognised speedy trial to be a fundamental right, India continues to have a high number of pending cases. In 2012, the net pendency in High Courts and subordinate courts decreased by over 6 lakh cases. However, there is still a substantial backlog of cases across various courts in the country. As per the latest information given by the Ministry of Law and Justice, there are 43.2 lakh cases pending in the High Courts and 2.69 crore cases pending in the district courts.[1]
After the recent gang-rape of a 23 year old girl, the Delhi High Court directed the state government to establish five Fast Track Courts (FTCs) for the expeditious adjudication of cases relating to sexual assault. According to a news report, other states such as Maharashtra and Tamil Nadu have also begun the process of establishing FTCs for rape cases. In this blog, we look at the status of pending cases in various courts in the country, the number of vacancies of judges and the status of FTCs in the country. Vacancies in the High Courts and the Subordinate Courts One of the reasons for the long delay in the disposal of cases is the high number of vacancies in position for judges in the High Courts and the District Courts of the country. As of December 1, 2012, the working strength of the High Court judges was 613 as against the sanctioned strength of 895 judges. This reflects a 32% vacancy of judges across various High Courts in the country. The highest number of vacancies is in the Allahabad High Court with a working strength of 86 judges against the sanctioned strength of 160 judges (i.e. vacancy of 74 judges). The situation is not much better at the subordinate level. As on September 30, 2011, the sanctioned strength of judges at the subordinate level was 18,123 judges as against a working strength of 14,287 judges (i.e. 21% vacancy). The highest vacancy is in Gujarat with 794 vacancies of judges, followed by Bihar with 690 vacancies. Fast Track Courts The 11th Finance Commission had recommended a scheme for the establishment of 1734 FTCs for the expeditious disposal of cases pending in the lower courts. In this regard, the Commission had allocated Rs 500 crore. FTCs were to be established by the state governments in consultation with the respective High Courts. An average of five FTCs were to be established in each district of the country. The judges for these FTCs were appointed on an adhoc basis. The judges were selected by the High Courts of the respective states. There are primarily three sources of recruitment. First, by promoting members from amongst the eligible judicial officers; second, by appointing retired High Court judges and third, from amongst members of the Bar of the respective state. FTCs were initially established for a period of five years (2000-2005). However, in 2005, the Supreme Court[2] directed the central government to continue with the FTC scheme, which was extended until 2010-2011. The government discontinued the FTC scheme in March 2011. Though the central government stopped giving financial assistance to the states for establishing FTCs, the state governments could establish FTCs from their own funds. The decision of the central government not to finance the FTCs beyond 2011 was challenged in the Supreme Court. In 2012, the Court upheld the decision of the central government.[3] It held that the state governments have the liberty to decide whether they want to continue with the scheme or not. However, if they decide to continue then the FTCs have to be made a permanent feature. As of September 3, 2012, some states such as Arunachal Pradesh, Assam, Maharashtra, Tamil Nadu and Kerala decided to continue with the FTC scheme. However, some states such as Haryana and Chhattisgarh decided to discontinue it. Other states such as Delhi and Karnataka have decided to continue the FTC scheme only till 2013.[4]
Table 1: Number of Fast Track Courts and the pending cases in FTCs (As on March 31, 2011)
| State | No of FTC | No of cases transferred until March 31, 2011 | Pending cases |
| Arunachal Pradesh | 3 | 4,162 | 2,502 |
| Bihar` | 179 | 2,39,278 | 80,173 |
| Assam | 20 | 72,191 | 16,380 |
| West Bengal | 109 | 1,46,083 | 32,180 |
| Goa | 5 | 5,096 | 1,079 |
| Punjab | 15 | 58,570 | 12,223 |
| Jharkhand | 38 | 1,10,027 | 22,238 |
| Gujarat | 61 | 5,37.636 | 1,03,340 |
| Chattisgarh | 25 | 9,4670 | 18,095 |
| Meghalaya | 3 | 1,031 | 188 |
| Rajasthan | 83 | 1,49,447 | 26,423 |
| Himachal Pradesh | 9 | 40,126 | 6,699 |
| Karnataka | 87 | 2,18,402 | 34,335 |
| Andhra Pradesh | 108 | 2,36,928 | 36,975 |
| Nagaland | 2 | 845 | 129 |
| Kerala | 38 | 1,09,160 | 13,793 |
| Mizoram | 3 | 18,68 | 233 |
| Haryana | 6 | 38,359 | 4,769 |
| Madhya Pradesh | 84 | 3,60,602 | 43,239 |
| UP | 153 | 4,64,775 | 53,117 |
| Maharashtra | 51 | 4,23,518 | 41,899 |
| Tamil Nadu | 49 | 4,11,957 | 40,621 |
| Uttarakhand | 20 | 98,797 | 9006 |
| Orissa | 35 | 66,199 | 5,758 |
| Manipur | 2 | 3,059 | 198 |
| Tripura | 3 | 5,812 | 221 |
| Total | 1192 | 3898598 | 6,05,813 |
Sources: Lok Sabha Unstarred Question No.498, March 3, 2012; PRS
[1]. Rajya Sabha Starred Question no 231 dated December 10, 2012.
[2]. Brij Mohan Lal v Union of India (2005) 3 SCR 103.
[3]. Brij Mohan Lal v Union of India (2012) 6 SCC 502. [4]. Rajya Sabha Unstarred Question no 2388 dated September 3, 2012.
