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:
Explainer: The Central Educational Institutions (Reservation in Teachers’ Cadre) Bill, 2019
The Central Educational Institutions (Reservation in Teachers’ Cadre) Bill, 2019 was passed by Parliament today. It replaces an Ordinance that was promulgated in February 2019. The Bill brings about two major changes in reservation of teaching posts in central educational institutions. Firstly, it establishes that for the purpose of reservation, a university/college would be considered as one single unit. This means that posts of the same level across all departments (such as assistant professor) in a university would be grouped together when calculating the total number of reserved seats. Secondly, it extends reservations beyond Scheduled Castes (SC) and Scheduled Tribes (ST), to include socially and educationally backward classes (OBC) and economically weaker sections (EWS).
In this post, we look at how the Bill will impact the reservation of teaching posts in central educational institutions.
How has teachers’ reservation been implemented in the past?
In 2006, the University Grants Commission (UGC) issued guidelines for teacher reservations in central educational institutions.[1] These guidelines required central educational institutions to consider a university as one unit for the purpose of reservation. It stated that reservations would be calculated using a roster system specified by the Ministry of Personnel, Public Grievances, and Pension.[2]
However, the UGC Guidelines (2006) were challenged in the Allahabad High Court in 2017. The question before the Court was whether a university should be taken as a unit when applying the roster.[3] The Court found that individual departments should be taken as a unit for the purpose of reservation, instead of universities. It held that taking a university as a unit could result in some departments having only reserved candidates and others having only unreserved candidates. Following the judgment, departments were treated as a single unit for reservation at central educational institutions.
In March 2019, the Central Educational Institutions (Reservation in Teachers’ Cadre) Ordinance, 2019 was promulgated, and passed as a Bill in July 2019. The Bill overturns the Allahabad High Court judgment and reverts to the system where a university is regarded as one unit for the purpose of reservation.
Over the years, there has been deliberation on whether the university or department should be taken as a unit for reservation of teaching posts. This has to do with the manner in which the roster system [4]specified by the Ministry of Personnel, Public Grievances, and Pension is applied in both situations.
What was the roster system specified by the Ministry of Personnel, Public Grievances, and Pension?
The roster system calculates reservation based on cadre strength. A cadre includes all posts available to be filled within a unit, i.e. either department or university. For instance, all associate professor positions within a university or within a department would be considered a cadre.
At present, the roster system is applied in two ways, i.e., the 13-point system or the 200-point system. For initial recruitment in both systems, all posts in a cadre are numbered and allocated. This means that in a cadre with 18 posts, each post will be assigned a number from 1 to 18 and allocated to a particular category, i.e., either SC, ST, OBC, EWS or unreserved. Therefore, hiring of teachers for all posts takes place on the basis of this list.
However, there are two fundamental differences between the 200 point and 13 point systems.
When a university is taken as the unit for reservation, the 200-point system is used, as there tend to be more than 13 posts in a university. However, when a department is taken as a unit, the 13-point system or the 200-point system may be used, depending on the size of the department.
How are the number of reserved seats calculated in the roster system?
For both the systems, the number of seats reserved for SC, ST, OBC, and EWS is determined by multiplying the cadre strength with the percentage of reservation prescribed by the Constitution. The percentage of reserved seats for each category is as follows: (i) 7.5% for ST, (ii) 15% for SC, (iii) 27% for OBC, and (iv) 10% for EWS.
If the number of posts needed to be filled is 200, and the percentage of reservation for ST is 7.5%, we would use the following formula to calculate the number of reserved posts for that class:
Number of posts needed to be filled x percentage of reservation/100
= 200 x 7.5/100
= 15
Thus, the number of seats reserved for ST in a cadre with the strength of 200 posts is 15. Using the same formula, the number of seats reserved for SC is 30, OBC is 54, and EWS is 20.
How are these reserved seats distributed across posts?
To determine the position of each reserved seat in the roster systems, 100 is divided by the percentage of the reservation for each category. For instance, the OBC quota is 27%. Therefore, 100/27 = 3.7, that is, approximately every 4th post in the cadre list. Likewise, SC is approximately every 7th post, ST is approximately every 14th post, and EWS will be approximately every 10th post.
What is the difference in the application of the roster between the department and university systems?
To demonstrate the difference between the department and university systems, a hypothetical example of a university with 200 posts for associate professors, and nine departments with varying number of posts is provided below.
When the university is taken as a unit
|
If the university is taken as the unit for reservation, then the total number of posts for the reserved categories would be 119 (i.e., 30 for SC, 15 for ST, 54 for OBC, and 20 for EWS), whereas the number of unreserved (UR) seats would be 81. This is mentioned in Table 1. The method of calculation of these numbers is based on the roster system prescribed by the Ministry of Personnel, Public Grievances, and Pension. |
Table 1: No. of posts reserved when university is taken as a unit
|
When departments are taken as separate units
|
If different departments of a university are taken as separate units for reservation, then the total number of posts for the reserved categories would be 101 (i.e., 25 for SC, 9 for ST, 49 for OBC, and 18 for EWS), whereas the number of unreserved (UR) seats would be 99. This is mentioned in Table 2. The method of calculation of these numbers is based on the roster system prescribed by the Explainer: The Central Educational Institutions (Reservation in Teachers’ Cadre) Bill, 2019 The Central Educational Institutions (Reservation in Teachers’ Cadre) Bill, 2019 was passed by Parliament today. It replaces an Ordinance that was promulgated in February 2019. The Bill brings about two major changes in reservation of teaching posts in central educational institutions. Firstly, it establishes that for the purpose of reservation, a university/college would be considered as one single unit. This means that posts of the same level across all departments (such as assistant professor) in a university would be grouped together when calculating the total number of reserved seats. Secondly, it extends reservations beyond Scheduled Castes (SC) and Scheduled Tribes (ST), to include socially and educationally backward classes (OBC) and economically weaker sections (EWS). In this post, we look at how the Bill will impact the reservation of teaching posts in central educational institutions. How has teachers’ reservation been implemented in the past? In 2006, the University Grants Commission (UGC) issued guidelines for teacher reservations in central educational institutions.[1] These guidelines required central educational institutions to consider a university as one unit for the purpose of reservation. It stated that reservations would be calculated using a roster system specified by the Ministry of Personnel, Public Grievances, and Pension.[2] However, the UGC Guidelines (2006) were challenged in the Allahabad High Court in 2017. The question before the Court was whether a university should be taken as a unit when applying the roster.[3] The Court found that individual departments should be taken as a unit for the purpose of reservation, instead of universities. It held that taking a university as a unit could result in some departments having only reserved candidates and others having only unreserved candidates. Following the judgment, departments were treated as a single unit for reservation at central educational institutions. In March 2019, the Central Educational Institutions (Reservation in Teachers’ Cadre) Ordinance, 2019 was promulgated, and passed as a Bill in July 2019. The Bill overturns the Allahabad High Court judgment and reverts to the system where a university is regarded as one unit for the purpose of reservation. Over the years, there has been deliberation on whether the university or department should be taken as a unit for reservation of teaching posts. This has to do with the manner in which the roster system [4]specified by the Ministry of Personnel, Public Grievances, and Pension is applied in both situations. What was the roster system specified by the Ministry of Personnel, Public Grievances, and Pension? The roster system calculates reservation based on cadre strength. A cadre includes all posts available to be filled within a unit, i.e. either department or university. For instance, all associate professor positions within a university or within a department would be considered a cadre. At present, the roster system is applied in two ways, i.e., the 13-point system or the 200-point system. For initial recruitment in both systems, all posts in a cadre are numbered and allocated. This means that in a cadre with 18 posts, each post will be assigned a number from 1 to 18 and allocated to a particular category, i.e., either SC, ST, OBC, EWS or unreserved. Therefore, hiring of teachers for all posts takes place on the basis of this list. However, there are two fundamental differences between the 200 point and 13 point systems.
When a university is taken as the unit for reservation, the 200-point system is used, as there tend to be more than 13 posts in a university. However, when a department is taken as a unit, the 13-point system or the 200-point system may be used, depending on the size of the department. How are the number of reserved seats calculated in the roster system? For both the systems, the number of seats reserved for SC, ST, OBC, and EWS is determined by multiplying the cadre strength with the percentage of reservation prescribed by the Constitution. The percentage of reserved seats for each category is as follows: (i) 7.5% for ST, (ii) 15% for SC, (iii) 27% for OBC, and (iv) 10% for EWS. If the number of posts needed to be filled is 200, and the percentage of reservation for ST is 7.5%, we would use the following formula to calculate the number of reserved posts for that class: Number of posts needed to be filled x percentage of reservation/100 = 200 x 7.5/100 = 15 Thus, the number of seats reserved for ST in a cadre with the strength of 200 posts is 15. Using the same formula, the number of seats reserved for SC is 30, OBC is 54, and EWS is 20. How are these reserved seats distributed across posts? To determine the position of each reserved seat in the roster systems, 100 is divided by the percentage of the reservation for each category. For instance, the OBC quota is 27%. Therefore, 100/27 = 3.7, that is, approximately every 4th post in the cadre list. Likewise, SC is approximately every 7th post, ST is approximately every 14th post, and EWS will be approximately every 10th post. What is the difference in the application of the roster between the department and university systems? To demonstrate the difference between the department and university systems, a hypothetical example of a university with 200 posts for associate professors, and nine departments with varying number of posts is provided below. When the university is taken as a unit
When departments are taken as separate units
As can be seen in the above example, if departments are taken as separate units, there is a decrease in the number of reserved posts. The number of reserved posts decreased by five for SC, six for ST, five for OBC, and two for EWS. This example is corroborated by the special leave petition filed by the Ministry of Human Resource Development in the Supreme Court against the 2017 order of Allahabad High Court. It demonstrates that the number of reserved seats in Banaras Hindu University (BHU) decreased when departments were taken as separate units. The number of reserved posts decreased by 170 for SC, 114 for ST, and 90 for OBC.[5] EWS was not included in the reservation system when the BHU numbers were calculated. Thus, the trade off between the two systems is as follows. On the one hand, when the university is taken as a unit there is a possibility that some departments would only have reserved candidates and others would have only unreserved candidates. However, when a department is taken as a unit, there is a decrease in the total number of reserved posts within the university.
[1] Circular No. F. 1-5/2006(SCT), University Grants Commission, 2006. [2] O.M. No. 36012/2/96-Esst. (Res), ‘Reservation Roster- Post based- Implementation of the Supreme Court Judgement in the case of R.K. Sabharwal Vs. State of Punjab, Department of Personnel and Training, Ministry of Personnel, Public Grievances, and Pension, July 1997, http://documents.doptcirculars.nic.in/D2/D02adm/36012_2_96_Estt(Res).pdf. [3] Vivekanand Tiwari v. Union of India, Writ petition no. 43260, Allahabad High Court, April 2017. [4] O.M. No.36039/1/2019-Estt (Res), ‘Reservation for Economically Weaker Sections (EWSs) in direct recruitment in civil posts and services in the Government of India’, Department of Personnel and Training, Ministry of Personnel, Public Grievances, and Pension, https://dopt.gov.in/sites/default/files/ewsf28fT.PDF. [5] Special Leave Petition filed in Supreme Court by Ministry of Human Resource Development, January 2019, as reported in Indian Express, https://indianexpress.com/article/explained/simply-put-the-unit-in-teachers-quota-5554261/. Ministry of Personnel, Public Grievances, and Pension. |
Table 2: No. of posts reserved when department is taken as the unit
Note: Number of posts in each department are hypothetical. |
As can be seen in the above example, if departments are taken as separate units, there is a decrease in the number of reserved posts. The number of reserved posts decreased by five for SC, six for ST, five for OBC, and two for EWS. This example is corroborated by the special leave petition filed by the Ministry of Human Resource Development in the Supreme Court against the 2017 order of Allahabad High Court. It demonstrates that the number of reserved seats in Banaras Hindu University (BHU) decreased when departments were taken as separate units. The number of reserved posts decreased by 170 for SC, 114 for ST, and 90 for OBC.[5] EWS was not included in the reservation system when the BHU numbers were calculated.
Thus, the trade off between the two systems is as follows. On the one hand, when the university is taken as a unit there is a possibility that some departments would only have reserved candidates and others would have only unreserved candidates. However, when a department is taken as a unit, there is a decrease in the total number of reserved posts within the university.
[1] Circular No. F. 1-5/2006(SCT), University Grants Commission, 2006.
[2] O.M. No. 36012/2/96-Esst. (Res), ‘Reservation Roster- Post based- Implementation of the Supreme Court Judgement in the case of R.K. Sabharwal Vs. State of Punjab, Department of Personnel and Training, Ministry of Personnel, Public Grievances, and Pension, July 1997, http://documents.doptcirculars.nic.in/D2/D02adm/36012_2_96_Estt(Res).pdf.
[3] Vivekanand Tiwari v. Union of India, Writ petition no. 43260, Allahabad High Court, April 2017.
[4] O.M. No.36039/1/2019-Estt (Res), ‘Reservation for Economically Weaker Sections (EWSs) in direct recruitment in civil posts and services in the Government of India’, Department of Personnel and Training, Ministry of Personnel, Public Grievances, and Pension, https://dopt.gov.in/sites/default/files/ewsf28fT.PDF.
[5] Special Leave Petition filed in Supreme Court by Ministry of Human Resource Development, January 2019, as reported in Indian Express, https://indianexpress.com/article/explained/simply-put-the-unit-in-teachers-quota-5554261/.
