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, children in the age group of 6-14 years have the right to free and compulsory elementary education in a neighbourhood school under the Right of Children to Free and Compulsory Education (RTE) Act, 2009. This covers primary (classes 1-5) and upper primary (classes 6-8) levels, which collectively constitute elementary education.
Amongst several provisions focused on elementary education, the Act provides for the No Detention Policy. Under this, no child will be detained till the completion of elementary education in class 8. The RTE (Second Amendment) Bill, 2017, introduced recently, revisits the No Detention Policy. In light of this, we discuss the No Detention Policy and issues affecting the implementation of RTE.
What is the No Detention Policy?
The rationale for the No Detention Policy or automatic promotion to the next class is minimising dropouts, making learning joyful, and removing the fear of failure in exams.[1] The evaluation mechanism under the Policy is the Continuous and Comprehensive Evaluation (CCE) for holistic assessments (e.g., paper-pencil test, drawing and reading pictures, and expressing orally) as opposed to the traditional system of examinations. CCE does not mean no evaluation, but it means an evaluation of a different kind from the traditional system of examinations.
What does the RTE (Second Amendment) Bill, 2017 propose to do?
The Bill proposes a ‘regular examination’ which will be held in class 5 and class 8 at the end of every academic year.[2] In the event that a child fails these examinations, he will be given remedial instruction and the opportunity for a re-examination.
If he fails in the re-examination, the central or state governments may choose: (i) to not detain the child at all, or (ii) to detain the child in class 5, class 8, or in both classes. This is in contrast to the current Policy where a child cannot be detained until the completion of class 8.
Conversation around the No Detention Policy
Following the implementation of the No Detention Policy, experts have recommended rolling it back partially or fully. The reasons for this reconsideration include: (i) the lack of preparedness of the education system to support the Policy, (ii) automatic promotion disincentivising children from working hard, (iii) low accountability of teachers, (iv) low learning outcomes, and (iii) the lack of proper implementation of CCE and its integration with teacher training.1,[3],[4]
In 2015, all the states were asked to share their views on the No Detention Policy. Most of the states suggested modifications to the Policy in its current form.
What do the numbers say?
Consequent to the enactment of RTE, enrolment has been 100% at the primary level (see Figure 1). While enrolment has been universal (100%) at the primary level, low transition of students from one class to another at progressively higher levels has been noted. This has resulted in high dropouts at the secondary education level, with the highest dropout rate being 17% at the class 10 level (see Figure 2).
Figure 1: Enrolment in elementary education (2005-2014)
One of the reasons for low dropouts at the elementary level may be the obligation to automatically promote and not detain children under the No Detention Policy. However, there is no such obligation on the government to provide for the same post class 9 i.e., in secondary education. The reasons which explain the rise in dropouts at the secondary level include domestic activities for girls and economic activities for boys, reasons common to both include financial constraints and lack of interest in education.[5]
Figure 2: Dropout rates in school education (2014-15)
How does RTE ensure quality education?
Based on the high enrolment and low dropout rates in elementary education, it can be inferred that children are being retained in schools for longer. However, there have been some adverse observations regarding the learning outcomes of such children. For example, the Economic Survey 2015-16 pointed out that only about 42% of students in class 5 (in government schools) are able to read a class 2 text. This number has in fact declined from 57% in 2007.[6] The National Achievement Survey (2015) for class 5 has also revealed that performance of students, on an average, had gone down from the previous round of the survey conducted in 2014.[7]
Key reasons attributed to low learning levels are with regard to teacher training and high vacancies.7,[8],[9] Against a total of 19 lakh teacher positions sanctioned under Sarva Shiksha Abhiyan in 2011-12, only 12 lakh were filled. Further, approximately 4.5 lakh untrained teachers were operating in 19 states. Teacher training institutes such as District Institutes of Education and Training are also experiencing high vacancies with regard to trainers who train teachers.[10]
It has also been noted that the presence of contract/temporary teachers, instead of permanent teachers, contributes to the deterioration of quality of education. In fact, experts have recommended that to ensure quality secondary education, the reliance on contract/temporary teachers must be done away with. Instead, fully qualified teachers with salary and benefits must be hired.[11] It has also been recommended that teachers should not be burdened with ancillary tasks of supervising cooking and serving of mid-day meals.10
The RTE Act, 2009 sought to ensure that teachers acquire minimum qualifications for their appointment, within five years of its enactment (i.e. till March 31, 2015). Earlier this year, another Bill was introduced in Parliament to amend this provision under the Act. The Bill seeks to extend this deadline until 2019.
In sum, currently there are two Bills seeking to amend the RTE Act, which are pending in Parliament. It remains to be seen, how they impact the implementation of the Act going forward.
[1] “Report of CABE Sub Committee on Assessment on implementation of CCE and no detention provision”, 2015, Ministry of Human Resource Development, http://mhrd.gov.in/sites/upload_files/mhrd/files/document-reports/AssmntCCE.pdf
[2] The RTE (Second Amendment) Bill, 2017.
[3] Change in No-Detention Policy, Ministry of Human Resource Development, March 9, 2017, Press Information Bureau.
[4] Unstarred question no. 1789, Ministry of Human Resource Development, Rajya Sabha, December 1, 2016.
[5] “Key Indicators of Social Consumption in India: Education”, NSS 71st Round, 2014, http://mail.mospi.gov.in/index.php/catalog/160/related_materials
[6] Economic Survey 2015-16, Ministry of Finance, http://indiabudget.nic.in/budget2016-2017/es2014-15/echapter-vol2.pdf
[7] National Achievement Survey, Class V (Cycle 3) Subject Wise Reports, 2014, http://www.ncert.nic.in/departments/nie/esd/pdf/NationalReport_subjectwise.pdf
[8] “253rd Report: Demands for Grants 2013-14, Demand No. 57”, Department of School Education and Literacy, Standing Committee on Human Resource Development, April 26, 2013, http://164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20HRD/253.pdf
[9] “285th Report: Action Taken Report on 250th Report on Demands for Grants 2016-17”, Department of School Education and Literacy, Standing Committee on Human Resource Development, December 16, 2016, http://164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20HRD/285.pdf
[10] “283rd Report: The Implementation of Sarva Shiksha Abhiyan and Mid-Day-Meal Scheme’, Department of School Education and Literacy, Standing Committee on Human Resource Development, December 15, 2016, http://164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20HRD/283.pdf
[11] “Report of the CABE Committee on Girls’ education and common school system”, Ministry of Human Resource Development, 2005, http://mhrd.gov.in/sites/upload_files/mhrd/files/document-reports/Girls%20Education.pdf
