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:
The Governor of Rajasthan promulgated two Ordinances amending the Code of Criminal Procedure, 1973 and Indian Penal Code, 1860 applicable in Rajasthan on September 7. The Ordinances restrain any investigation to be conducted against a judge, magistrate or public servant without prior sanction of the government. The decision to grant sanction will have to be taken within six months, failing which such sanction will be deemed to have been granted. The Ordinances also restrain any person from reporting on the individual in question until sanction for investigation is granted. Two Bills replacing these Ordinances were introduced in the Rajasthan Assembly by the state Home Minister last week, on October 23.[i] After introduction, the Bills were referred to a 15-member select committee comprising of legislators from the state Assembly, and headed by the Home Minister of Rajasthan. This blog examines the role of committees and some of the practices observed in state legislatures.
Purpose of committees in legislatures
In India, state legislatures sit for 31 days a year on an average.* Several Bills are passed within a few days of their introduction. One of the primary responsibilities of the legislature is to hold the executive accountable, and examine potential laws. Due to paucity of time, it is difficult for the members go through all the bills and discuss them in detail. To address this issue, various committees are set up in Parliament and state assemblies where smaller group of members examine Bills in detail, and allow for an informed debate in the legislature. Apart from scrutinising legislation, committees also examine budgetary allocations for various departments and other policies of the government. These mini-legislatures provide a forum for law makers to develop expertise, engage with citizens and seek inputs from stakeholders. Since these committees consist of members from different parties, they provide a platform for building consensus on various issues.
Figure 1: Average sitting days in a year (2012-16)
Sources: Website of various state assemblies as on October 30, 2017.
Types of committees
There are broadly three types of committees: (i) Financial committees: These scrutinise the expenditure of the government and recommend efficient ways of spending funds (example: Public Accounts Committee and Estimates Committee), (ii) Department-Related Standing Committees (DRSC): These scrutinise performance of departments under a ministry, (iii) Other committees: These deal with day-to-day functioning of the legislature (example: Business Advisory Committee, Papers Laid, Rules, etc.) While there are 3 financial committees and 24 department related committees in Parliament, the number of committees in state legislatures varies. For example, Kerala has 14 subject committees examining all departments, while Delhi has seven standing committees scrutinising performance of various departments. [ii],[iii] However, not all states have a provision for specific DRSCs or subject committees.
Similar to Parliament, state legislatures also have a provision to form a select committee to examine a particular legislation or a subject. Such a committee is disbanded after it presents a report with its findings or recommendations. Several Bills in states are referred to select committees. However, the practice in some state legislatures with respect to select committees deviate from those in the Parliament.
Independence of select committee from the executive
The rules in several states provide for the minister in-charge piloting the bill to be an ex-officio member of the select committee. These states include Rajasthan, Assam, Andhra Pradesh, Chhattisgarh, Telangana. Moreover, in Manipur, the rules provide for the minister to be chairman of the select committee. Note that the minister is part of the executive. His inclusion in the committee may be in conflict with the committee’s role of scrutinising the functioning of the executive.
The practice of including ministers in committees is in contrast with the protocol followed in Parliament where a minister is not part of any DRSC or select committee. As committees of the legislature hold the executive accountable, having a minister on the select committee undermines the role of legislature as an oversight mechanism. A minister, as a representative of the executive being part of such committees may impede the ability of committees to effectively hold the executive accountable.
The two Bills introduced in the Rajasthan Assembly last week were referred to a select committee headed by the Home Minister of the state. There have been several instances in other state legislatures where the minister introducing a bill was chairman of the select committee examining it. In Goa, a bill empowering the government to acquire land for development of public services is headed by the Revenue Minister of the state.[iv] Similarly, in Arunachal Pradesh, the select committee examining a bill for establishment of a university was headed by the Education Minister.[v] In Maharashtra as well, the Education Minister was chairman of the select committee scrutinising a bill granting greater autonomy to state universities.[vi] For rigorous scrutiny of legislation, it is essential that the committees are independent of the executive.
Strengthening state legislature committees [vii]
The functioning of committees in states can be strengthened in various ways. Some of these include:
(i) Examination of Bills by assembly committees: In the absence of DRSCs, most bills are passed without detailed scrutiny while some bills are occasionally referred to select committees. In Parliament, bills pertaining to a certain ministry are referred to the respective DRSCs for scrutiny. To strengthen legislatures, DRSCs must examine all bills introduced in the assembly.
(ii) Scrutiny of budgets: Several states do not have DRSCs to examine budgetary proposals. Some states like Goa, Mizoram and Arunachal Pradesh have a budget committee to examine budget proposals. Post the 14th Finance commission, there is a higher devolution of funds to state governments from the centre. With states increasingly spending more, it is necessary for them to have DRSCs that scrutinise the allocations and expenditures to various departments before they are approved by state assemblies.
*Based on the average sitting days for 18 state assemblies from 2012-2016.
[i] The Code of Criminal Procedure (Rajasthan Amendment) Bill, 2017 http://www.rajassembly.nic.in/BillsPdf/Bill39-2017.pdf;The Criminal Laws (Rajasthan Amendment) Bill, 2017 http://www.rajassembly.nic.in/BillsPdf/Bill38-2017.pdf.
[ii] List of subject committees http://niyamasabha.org/codes/comm.htm.
[iii] Delhi Legislative Assembly National Capital Territory Of Delhi Composition Of House Committees
2017 – 2018, http://delhiassembly.nic.in/Committee/Committee_2017_2018.htm.
[iv] The Goa Requisition and Acquisition of Property Bill, 2017 http://www.goavidhansabha.gov.in/uploads/bills/468_draft_BN18OF2017-AI-REQUI.pdf.
[v] The Kameng Professional and Technical University Arunachal Pradesh Bill 2017 http://www.assamtribune.com/scripts/detailsnew.asp?id=oct1717/oth057.
[vi] Maharashtra Public Universities Bill, 2016 http://mls.org.in/pdf/university_bill_english.pdf.
[vii] Strengthening State Legislatures http://www.prsindia.org/uploads/media/Conference%202016/Strengthening%20State%20Legislatur
