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:
Parliament sessions are usually held thrice a year: once in February for the Budget Session, once around July or August for the Monsoon Session, and once in November for the Winter Session. This year, the government is yet to announce the dates for the Winter Session. While there has been uncertainty around whether Parliament will meet, ministers in the government have indicated that the Session will be held soon.[1]
The practice of allowing the government to convene Parliament differs from those followed in other countries. Some of these countries have a limited role for the government in summoning the legislature, because in a parliamentary democracy the executive is accountable to Parliament. Allowing the government to call the Parliament to meet could be in conflict with this principle. While we wait for the government to announce the dates for the Winter Session, this post looks at the relationship between Parliament and the government, recommendations made over the years on improving some parliamentary customs, and discusses certain practices followed by other countries.
What is the role of Parliament in a democracy?
The Constitution provides for the legislature to make laws, the government to implement laws, and the courts to interpret and enforce these laws. While the judiciary is independent from the other two branches, the government is formed with the support of a majority of members in the legislature. Therefore, the government is collectively responsible to Parliament for its actions. This implies that Parliament (i.e. Lok Sabha and Rajya Sabha) can hold the government accountable for its decisions, and scrutinise its functioning. This may be done using various methods including, during debates on Bills or issues on the floor of Parliament, by posing questions to ministers during Question Hour, and in parliamentary committees.
Who convenes Parliament?
Parliament must be convened by the President at least once in every six months. Since the President acts on the advice of the central government, the duration of the session is decided by the government.
Given the legislature’s role in keeping the executive accountable for its actions, one argument is that the government should not have the power to convene Parliament. Instead, Parliament should convene itself, if a certain number of MPs agree, so that it can effectively exercise its oversight functions and address issues without delay. Some countries such as the United Kingdom and Australia release an annual calendar with the sitting dates at the beginning of the year.
How regularly has Parliament been meeting over the years?
Over the years, there has been a decline in the sitting days of Parliament. While Lok Sabha met for an average of 130 days in a year during the 1950s, these sittings came down to 70 days in the 2000s. Lesser number of sittings indicates that Parliament was able to transact less business compared to previous years. To address this, the National Commission to Review the Working of the Constitution has recommended that Lok Sabha should have at least 120 sittings in a year, while Rajya Sabha should have 100 sittings.[2] 
The Constituent Assembly, while drafting the Constitution had debated the power that should be given to Parliament with regard to convening itself. Mr. K. T. Shah, a member of the Assembly, had suggested that in case the President or the Prime Minister are unable or unwilling to call for a Parliament session, the power to convene the Houses should be given to the presiding officers of those Houses (i.e., the Chairman of Rajya Sabha and the Speaker of Lok Sabha). In addition, he had also suggested that Parliament should itself regulate its procedure, sittings and timings.[3]
How does Parliament hold the government accountable?
One of the forums of holding the government accountable for its actions is the Question Hour. During Question Hour, MPs may pose questions to ministers related to the implementation of laws and policies by the government.
In the 16th Lok Sabha, question hour has functioned in Lok Sabha for 77% of the scheduled time, while in Rajya Sabha it has functioned for 47%. A lower rate of functioning reflects time lost due to disruptions which reduces the number of questions that may be answered orally. While Parliament may sit for extra hours to transact other business, time lost during Question Hour is not made up. Consequently, this time lost indicates a lost opportunity to hold the government accountable for its actions.
Further, there is no mechanism currently for answering questions which require inter-ministerial expertise or relate to broader government policy. Since the Prime Minister does not answer questions other than the ones pertaining to his ministries, such questions may either not get adequately addressed or remain unanswered. In countries such as the UK, the Prime Minister’s Question Time is conducted on a weekly basis. During the 30 minutes the Prime Minister answers questions posed by various MPs. These questions relate to broader government policies, engagements, and issues affecting the country.[4]
How is public opinion reflected in Parliament?
MPs may raise issues of public importance in Parliament, and examine the government’s response to problems being faced by citizens through: (i) a debate, which entails a reply by the concerned minister, or (ii) a motion which entails a vote. The time allocated for discussing some of these debates or Bills is determined by the Business Advisory Committee of the House, consisting of members from both the ruling and opposition parties.
Using these methods, MPs may discuss important matters, policies, and topical issues. The concerned minister while replying to the debate may make assurances to the House regarding steps that will be taken to address the situation. As of August 2017, 50% of the assurances made in the 16th Lok Sabha have been implemented.[5] 
Alternatively, MPs may move a motion for: (i) discussing important issues (such as inflation, drought, and corruption), (ii) adjournment of business in a House in order to express displeasure over a government policy, or (iii) expressing no confidence in the government leading to its resignation. The 16thLok Sabha has only discussed one adjournment motion so far.
To improve government accountability in Parliament, the opposition in some countries such as the UK, Canada, and Australia forms a shadow cabinet.[6],[7] Under such a system, opposition MPs track a certain portfolio, scrutinise its performance and suggest alternate programs. This allows for detailed tracking and scrutiny of ministries, and assists MPs in making constructive suggestions. Some of these countries also provide for days when the opposition parties decide the agenda for Parliament.
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[1] Sonia Gandhi accuses of Modi govt ‘sabotaging’ Parliament Winter session, Arun Jaitley rejects charge’, The Indian Express, November 20, 2017, http://indianexpress.com/article/india/jaitley-refutes-sonia-gandhis-charge-of-sabotaging-parliament-session-says-congress-too-had-delayed-sitting-4946482/; ‘Congress also rescheduled Parliament sessions: Arun Jaitley hits back at Sonia Gandhi’, The Times of India, November 20, 2017, https://timesofindia.indiatimes.com/india/congress-also-rescheduled-parliament-sessions-arun-jaitley-hits-back-at-sonia-gandhi/articleshow/61726787.cms.
[2] Parliament and State Legislatures, Chapter 5, National Commission to Review the Working of the Constitution, March 31, 2002, http://lawmin.nic.in/ncrwc/finalreport/v1ch5.htm.
[3] Constituent Assembly Debates, May 18, 1949.
[4] Prime Minister’s Question Time, Parliament of the United Kingdom, http://www.parliament.uk/about/how/business/questions/.
[5] Lok Sabha and Session Wise Report of Assurances in Lok Sabha, Ministry of Parliamentary Affairs, http://www.mpa.gov.in/mpa/print_summary_lses_ls.aspx.
[6] Her Majesty’s Official Opposition, Parliament of the United Kingdom, http://www.parliament.uk/mps-lords-and-offices/government-and-opposition1/opposition-holding/.
[7] Current Shadow Ministry List, Parliament of Australia, http://www.aph.gov.au/About_Parliament/Parliamentary_Departments/Parliamentary_Library/Parliam
