Lok Sabha

First session of 17th Lok Sabha: What to expect

The results of General Election 2019 were declared last week concluding the process for electing the 17th Lok Sabha.  Immediately after the results, the previous Lok Sabha was dissolved.  The next couple of days will witness several key events such as swearing-in ceremony of the Prime Minister and Cabinet, and the first session of the 17th Lok Sabha.  In the first session, the newly elected MPs will take their oaths, the Speaker of the 17th Lok Sabha will be elected, and the President will address a joint sitting of Parliament.   In this blog, we explain the process and significance of the events that will follow in the days to come.

Key Events in the First Session of the 17th Lok Sabha

The Bharatiya Janta Party has emerged as the single largest party and the leader of the party will be sworn-in as the Prime Minister.  As per Article 75(1) of the Constitution, the other ministers are appointed by the President on the advice of the Prime Minister.  The 91st Amendment to the Constitution limits the total size of the Council of Ministers to 15% of the total strength of the House (i.e., 81 Ministers).  As per media reports, swearing-in of the Council of Ministers is scheduled for May 30, 2019.

How is the schedule for first session decided?

The 17th Lok Sabha will commence its first session in the first week of June.  The exact date of commencement of the first session and the schedule of key events in the session, including the date of President’s address, is decided by the Cabinet Committee on Parliamentary Affairs.  This Committee will be set up after the swearing in of the Council of Ministers.  The previous Lok Sabha had commenced on June 4, 2014 and its first session had six sitting days (June 4, 2014 to June 11, 2014). 

Who presides over the first session?

Every proceeding of the House is presided by a Speaker.  The Office of the Speaker becomes vacant immediately before the first meeting of a new Lok Sabha.  Therefore, a temporary speaker, known as the pro-tem Speaker, is chosen from among the newly elected MPs.  The pro-tem Speaker administers oath/affirmation to the newly elected members, and also presides over the sitting in which the new Speaker is elected.  The office of the pro-tem Speaker ceases to exist when the new Speaker is elected.  

How is the pro-tem speaker chosen?

Once the new government is elected, a list containing the names of the senior-most members of the House is prepared.  The seniority is decided by total tenure as a member of either Lok Sabha or Rajya Sabha.  The Prime Minister then identifies a Member from the list who acts as the Speaker pro-tem.  Three other members are also identified before whom other members may take oath/affirmation.

How is the new Speaker chosen?

Any member may give notice of a motion that another Member be chosen as the Speaker of the House.  The motions are then moved and voted upon.  After the results are announced, the Speaker-elect is felicitated by leaders of all political parties, including the Prime Minister and Leader of the Opposition.  From then, the new Speaker takes over the proceedings of the House.

An understanding of the Constitution, the Rules of Procedure, and conventions of Parliament is considered a major asset for the Speaker.  While this might indicate that a Speaker be one of the senior-most members of the House, this has not always been the norm.  There have been occasions in the past where the Speaker of the House was a first-time MP.  For instance, Mr. K.S. Hegde, the Speaker of the sixth Lok Sabha and Mr. Bal Ram Jakhar, the Speaker of the seventh Lok Sabha were both first time MPs

What is the role of the Speaker in the House?

The Speaker is central to the functioning of the legislature.  The proceedings of the House are guided by the Rules of Procedure and the final authority for the interpretation and implementation of these rules rests with the Speaker.  The Speaker is responsible for regulating the discussion in the House and maintaining order in the House.  For instance, it is the Speaker’s discretion on whether to allow a member to raise a matter of public importance in the House.  The Speaker can suspend a sitting member for obstructing the business of the House, or adjourn the House in case of major disorder.

The Speaker is also the chair of the Business Advisory Committee, which is responsible for deciding the business of the House and allocating time for the same.  The Speaker also chairs the General Purposes Committee and the Rules Committee of the Lok Sabha and appoints the chairpersons of other committees amongst the members.  In the past, Speakers have also been instrumental in strengthening the Committee system.  Mr. Shivraj Patil, the Speaker of the 10th Lok Sabha, played a key role in the initiation of 17 Departmental Standing Committees, therefore strengthening Parliament’s control over the functioning of different ministries of the government.

Since the Speaker represents the entire House, the office of the Speaker is vested with impartiality and independence.  The Constitution and the Rules of Procedure have prescribed guidelines for the Speaker’s office to ensure such impartiality and independence.  Dr. N. Sanjiva Reddy, the Speaker of the fourth Lok Sabha, formally resigned from his political party as he was of the opinion that the Speaker belongs to the whole House and should therefore remain impartial.  As per Article 100 of the Constitution, the Speaker does not exercise vote on any matter being voted upon, in the first instance.  However, in case there’s a tie during the voting, the Speaker exercises her vote. 

What does the President’s Address entail?

The election of the Speaker is followed by the President’s Address.  Article 87 of the Constitution requires the President to address both Houses at the beginning of the first session after each general election.  The President also addresses both the Houses at the beginning of the first session of each year.  The President’s address highlights the initiatives of the government from the previous year, and mentions the policy priorities for the upcoming year.  After the address, the ruling party moves a Motion of Thanks to the President’s address in both Houses of Parliament.  In the Motion of Thanks, MPs may move amendments to the motion, which are then put to vote. 

The President of India, Mr. Ram Nath Kovind will address Parliament in this first session of the 17th Lok Sabha.  During the 16th Lok Sabha, the first President’s address was held on June 9, 2014 and the last time he addressed Parliament was on January 31, 2019 (highlights of this address can be read here).

 

Sources: The Constitution of India; Rules and Procedure and Conduct of Business in Lok Sabha; Handbook on the Working of Ministry of Parliamentary Affairs; The website of Parliament of India, Lok Sabha; The website of Office of the Speaker, Lok Sabha.

Winter Session 2018: What's happened so far

So far, both Houses of Parliament have been witnessing disruptions.  At the beginning of the session, 23 Bills were listed for passage, and 20 were listed for introduction.  Two weeks in, one Bill has been passed by both Houses, and three others by Lok Sabha.  These include Bills dealing with the re-haul of consumer protection laws, regulation of surrogacy, and recognition of transgender persons.  Six Bills have been introduced.  These include three Bills which replace the Ordinances currently in force, and a Bill to regulate dam safety.  In this blog, we discuss the key features of some of these Bills. 

Enhancing rights of consumers

The Consumer Protection Bill, 2018 replaces the Consumer Protection Act, 1986.  It was introduced in view of the significant changes in the consumer market landscape since the 1986 Act.  It introduces several new provisions such as enabling consumers to make product liability claims for an injury or harm caused to them, nullifying unfair contracts which impact consumer interests (such as contracts which charge excessive security deposits), and imposing penalties for false and misleading advertisements on manufacturers, as well as on the endorsers of such advertisements. 

The Bill also sets up Consumer Dispute Redressal Commissions (or courts) at the district, state, and national level, to hear complaints on matters related to deficiencies in services or defects in goods.  While these Commissions are also present under the 1986 Act, the Bill increases their pecuniary jurisdiction: District Commissions will hear complaints with a value of up to one crore rupees; State Commissions between one and ten crore rupees; and National Commission above 10 crore rupees.  The Bill also sets up a regulatory body known as the Central Consumer Protection Authority.  This Authority can take certain actions to protect the rights of consumers as a class such as passing orders to recall defective goods from the market, and imposing penalties for false and misleading advertisements. 

Recognising transgender persons and their rights

Last week, Lok Sabha also passed the Transgender Bill, 2018.  This Bill seeks to recognise transgender persons, confers certain rights and entitlements on them related to education, employment, and health, and carves out welfare measures for their benefit.  The Bill defines a transgender person as one whose gender does not match the gender assigned at birth.  It includes trans-men and trans-women, persons with intersex variations, gender-queers, and includes persons having such socio-cultural identities as kinnar, hijra, aravani, and jogta.  The Bill requires every establishment to designate one person as a complaint officer to act on complaints received under the Bill. 

The Bill provides that a transgender person will have the right to self-perceived gender identity.  Further, it also provides for a screening process to obtain a Certificate of Identity, certifying the person as ‘transgender’.  This implies that a transgender person may be allowed to self-identify as transgender individual, but at the same time they must also undergo the screening process to get certified as a transgender.  Therefore, it is unclear how these two provisions of self-identification and an external screening process will reconcile with each other. 

Regulating surrogacy and overhauling the Medical Council of India

The Surrogacy Bill, 2017 which regulates altruistic surrogacy and prohibits commercial surrogacy was also passed in Lok Sabha.  Surrogacy is a process where an intending couple commissions an eligible woman to carry their child.  In an altruistic surrogacy, the surrogate mother is not given any monetary benefit or reward, and the arrangement only covers her medical expenses and health insurance.  The Bill sets out certain conditions for both the intending couple and the surrogate mother to be eligible for surrogacy.  The intending couple must be Indian citizens, be married for at least five years, and at least one of them must be infertile.  The surrogate mother must be a close relative of the couple, must be married and must have had a child of her own.  Further, a surrogate mother cannot provide her own gametes for surrogacy.

The surrogate mother has been given certain rights with regard to the procedure of surrogacy.  These include requiring her written consent to abort the surrogate child, and allowing her to withdraw from the surrogacy at any time before the embryo is implanted in her womb. 

Another key Bill which was listed for passage in Lok Sabha this session but could not be taken up is the National Medical Commission Bill, 2017 (NMC Bill).  Several amendments to this Bill were introduced in Lok Sabha last week.  The NMC Bill seeks to replace the Medical Council of India, with a National Medical Commission.  It introduces a common final year undergraduate medical examination called the National Exit Test which will also grant the license to practice medicine.  Only medical students graduating from a medical institute which is an institute of national importance will be exempted from qualifying this National Exit Test.  The Bill also gives the NMC the power to frame guidelines to decide the fees of up to 50% of seats in private medical colleges and deemed universities.  The NMC may also grant limited license to certain mid-level practitioners connected with the medical profession to practice medicine.  The qualifying criteria for such mid-level practitioners will be determined through regulations, and they may prescribe specified medicines in primary and preventive healthcare. 

Regulating dam safety

The Dam Safety Bill, 2018 was introduced in Lok Sabha and applies to all specified dams across the country.  These are dams with: (i) height more than 15 metres, or (ii) height between 10 metres to 15 metres and subject to certain additional design and structural conditions.  It seeks to provide for the surveillance, inspection, operation and maintenance of specified dams for prevention of dam failure related disasters.  It creates authorities at the national and state level to formulate policies and regulations on dam safety and implement them.  It also puts certain obligations on dam owners by requiring them to provide a dam safety unit in each dam, among other things. 

When the Bill was being introduced, few opposition members raised objections on the grounds of Parliament’s legislative competence to make a law on dam safety which applies to all states.  They gave the example of the previous Dam Safety Bill, 2010, which applied only to the states of Andhra Pradesh and West Bengal who had adopted resolutions requiring Parliament to pass a law on dam safety.

So far the winter session has seen poor productivity with Lok Sabha working for 14% of its scheduled time, and Rajya Sabha for 5%.  This is one of the least productive sessions of the 16th Lok Sabha.  This is also the last major session before the dissolution of the 16th Lok Sabha.  Both Houses will meet tomorrow after the Christmas break.  With a packed legislative agenda, it is essential for Parliament to function in order to discuss and deliberate the Bills listed.  However, with a limited number of sitting days available in the ongoing session and continued disruptions, it remains to be seen if Parliament will be able to achieve its legislative agenda.

- This post is a modified version of an article published by The Wire on December 26, 2018.

Rajya Sabha extends sitting hours, changes timing of Question Hour

Recently the Chairman of Rajya Sabha issued a direction to extend the sitting hours and change the timing of Question Hour in the Upper House. Beginning with the Winter Session, which starts on November 24, Rajya Sabha will meet from 11 am to 6 pm, an hour more than its typical sitting hours. Question Hour will be scheduled from 12 pm to 1 pm, which was earlier held in the first hour of meeting. Members of Parliament (MPs), in addition to their legislative capacity, play an important role to keep the government accountable. One mechanism for them to hold the government responsible for its policies and actions is Question Hour in Parliament. During Question Hour, MPs raise questions to Ministers on various policy matters and decisions. Currently, all MPs can submit up to ten questions for every day that Parliament is in Session. Of these, 250 Questions are picked up by a random ballot to be answered each day that Parliament meets. While 230 Questions are answered in writing by Ministries, 20 Questions are scheduled to be answered orally by Ministers on the floor of the House. When a Question is answered orally by a Minister, MPs are also able to ask him/her two Supplementary Questions as a follow up to the response given. Therefore the proper functioning of Question Hour allows Parliament to be effective in its accountability function. Over the years Question Hour has become a major casualty to disruptions in Parliament. The last decade has seen a decline in the number of questions answered orally on the floor of the House. Rajya Sabha had tried to address this problem in 2011, when Question Hour was shifted to be held from 2 pm to 3 pm, but this was discontinued within a few days. Percentage of Questions Answered Orally The 2014 Budget Session saw both Houses of Parliament work for over hundred percent of their scheduled sitting time. However, while Question Hour functioned for 87% of its scheduled time in Lok Sabha, it functioned for only 40% of its scheduled time in Rajya Sabha. In 13 of the 27 sittings of the 2014 Budget Session, Question Hour in Rajya Sabha was adjourned within a few minutes due to disruptions. It was as a result of these increasing disruptions in the Upper House that the change in timing of the Question Hour and extension of its hours of sitting were proposed. While the Rules of Procedures of Rajya Sabha designate the first hour of sitting for Question Hour, they also allow the Chairman of the House to direct otherwise. It is using this Rule that the Chairman of Rajya Sabha, Mr. Hamid Ansari, issued directions for the Question Hour to be shifted to noon. It now remains to be seen whether this change in timing of Question Hour in the Upper House will be sufficient to allow for its smoother functioning. Sources: M.N. Kaul and S.L. Shakdher, Practice and Procedure of Parliament, Lok Sabha Secretariat, 6th Edition, 2009 Rajya Sabha Rules of Procedure, Rajya Sabha Secretariat, 2010  

Status of Legislation in the 15th Lok Sabha

The ongoing Monsoon Session of Parliament is being widely viewed as the 'make or break' session for passing legislation before the end of the 15th Lok Sabha in 2014. Hanging in balance are numerous important Bills, which will lapse if not passed before the upcoming 2014 national elections.

Data indicates that the current Lok Sabha has passed the least number of Bills in comparison to other comparable Lok Sabhas. The allocated time to be spent on legislation in the Monsoon Session is also below the time recommended for discussion and passing of Bills by the Business Advisory Committee of the Lok Sabha. Eight out of a total of 16 sittings of the Monsoon Session have finished with only 15 percent of the total time spent productively.

Success rate of the 15th Lok Sabha in passing legislation

India’s first Lok Sabha (1952-1957)  passed a total of 333 Bills in its five year tenure. Since then, every Lok Sabha which has completed over three years of its full term has passed an average of 317 Bills. Where a Lok Sabha has lasted for less than 3 years, it has passed an average of 77 Bills. This includes the 6th, 9th, 11th and 12th Lok Sabhas. The ongoing 15th Lok Sabha, which is in the fifth year of its tenure, has passed only 151 Bills (This includes the two Bills passed in the Monsoon Session as of August 18, 2013).

In terms of parliamentary sessions, Lok Sabhas that have lasted over three years have had an average of fifteen sessions. The 15th Lok Sabha has finished thirteen parliamentary sessions with the fourteenth (Monsoon Session) currently underway.

Bills Passed by Lok Sabhas

Legislative business accomplished in the 15th Lok Sabha

For the 15th Lok Sabha, a comparison of the government's legislative agenda at the beginning of a parliamentary session with the actual number of Bills introduced and passed at the end of the session shows that: (i) on average, government has a success rate of getting 39 percent of Bills passed; and (ii) on average, 60 percent success rate in getting Bills introduced.

final2.2

final2.3

The Monsoon Session of Parliament was scheduled to have a total of 16 sitting days between August 5-30, 2013. Of the 43 Bills listed for consideration and passage, 32 are Bills pending from previous sessions. As of August 18, 2013, the Rajya Sabha had passed a total of five Bills while the Lok Sabha had passed none. Of the 25 Bills listed for introduction, ten have been introduced so far.

The Budget Session of Parliament earlier this year saw the passage of only two Bills, apart from the appropriation Bills,  of the 38 listed for passing. These were the Protection of Women Against Sexual Harassment at Workplace Bill and the Criminal Law (Amendment) Bill.

Time allocated for legislation in the Monsoon Session

The Lok Sabha is scheduled to meet for six hours and the Rajya Sabha for five hours every day.  Both houses have a question hour and a zero hour at the beginning of the day, which leaves four hours for legislative business in the Lok Sabha and three hours in the Rajya Sabha. However, both Houses can decide to meet for a longer duration. For example, Rajya Sabha has decided to meet till 6:00 PM every day in the Monsoon Session as against the normal working hours of the House until 5:00 PM.

The Business Advisory Committee (BAC) of both Houses recommends the time that should be allocated for discussion on each Bill. This session's legislative agenda includes a total of 43 Bills to be passed by Parliament.  So far, 30 of the Bills have been allocated time by the BAC, adding up to a total of 78 hours of discussion before passing.

If the Lok Sabha was to discuss and debate the 30 Bills for roughly the same time as was recommended by the BAC, it would need a minimum of 20 working days.  In addition, extra working days would need to be allocated to discuss and debate the remaining 13 Bills.

With eight sitting days left and not a single Bill being passed by the Lok Sabha, it is unclear how the Lok Sabha will be able to make up the time to pass Bills with thorough debate.

 

House of Lost Opportunities

The last few days have seen repeated disruptions in Parliament. In an Opinion Editorial published in the Indian Express, Chakshu Roy of PRS Legislative Research discusses the impact of the current disruptions on Parliament. His analysis points to how disruptions are an opportunity lost  to hold the government accountable and to deliberate on significant legislative and policy issues. The second half of the budget session commenced last week with hardly any business transacted due to disruptions on different issues. This is not new. The 15th Lok Sabha has seen entire parliamentary sessions lost without any work being done. As it nears the end of its term, Parliament's productive time stands at 70 per cent, which is significantly lower than that of previous Lok Sabhas. As disruptions in Parliament have become routine, public reaction to such disruptions has also become predictable. Figures depicting the quantum of taxpayers' money lost every hour that Parliament does not function start doing the rounds, and the cry for docking the salary of disrupting members of Parliament becomes louder. What does not get adequate attention is the opportunity lost for holding the government accountable and deliberating on important legislative and policy issues. MPs are required to keep the government in check and oversee its functioning. One of the ways in which they do so is by asking ministers questions about the work done by their ministries. Ministers respond to such questions during the first hour of Parliament, which is known as question hour. During this hour, 20 questions are slotted for oral responses by ministers. Based on the response, MPs can cross-question and corner the minister by asking supplementary questions. On certain occasions, they are also able to extract assurances from the minister to take action on certain issues. When question hour is disrupted, not only are these opportunities lost, it also leads to ineffective scrutiny of the work done by the various ministries of the government. Last week, some of the questions that could not be orally answered related to four-laning of highways, performance of public sector steel companies, supply of food grains for welfare schemes, and generic versions of cancer drugs. In 2012, out of the 146 hours allocated for question hour in both Houses of Parliament, roughly only 57 hours were utilised. Since the beginning of the 15th Lok Sabha in 2009, approximately 43 per cent of the allocated time has been spent on question hour. When Parliament is disrupted regularly, its capacity to make laws is affected. Excluding routine financial legislation, since 2009, the government had planned to introduce 390 bills. So far, it has been able to introduce only 187 of them. It had also planned to have 365 bills scrutinised and passed by Parliament. So far, 96 of them have received parliamentary approval. Disruptions in Parliament also eat into the time available for discussing a bill in the house. In Lok Sabha, roughly 35 per cent of bills were passed with an hour or less of debate, a case being the sexual harassment bill, which was passed by Lok Sabha in September of last year in 16 minutes. Some would argue that since parliamentary committees scrutinise most bills in detail, there is no harm done if the bills are not debated in the House. However scrutiny of a bill behind closed doors is hardly a substitute for spirited debates on the merits and demerits of a bill on the floor of the House. Currently there are 115 bills awaiting parliamentary scrutiny and approval. Important social and economic legislation is currently pending before Parliament. The food security bill, the land acquisition bill, the companies and the goods and services tax bill are just a few of them. Out of the laundry list of pending bills, some are political and may be stuck in Parliament till consensus around them can be built. But there are a number of bills that are administrative in nature, and have no political undercurrents and are possibly not coming up for discussion because of the limited time that is available for legislative debate on account of frequent disruptions. In September 1997, to celebrate the golden jubilee of the country's Independence, a special session of Parliament was convened. At this special session, MPs had resolved to preserve and enhance the dignity of Parliament by adhering to the rules of procedure of Parliament relating to the orderly conduct of parliamentary proceedings. Last year, Parliament completed 60 years since its first sitting. To mark the occasion, another special session of both Houses was convened, where MPs had resolved to uphold the dignity, sanctity and supremacy of Parliament. Ensuring that the proceedings of both Houses run smoothly so that Parliament can discharge its responsibility effectively is the best way of ensuring its supremacy. The question that needs to be asked is whether our members of Parliament are ready to stand by the resolutions that they voluntarily adopted.

Lokpal Bill: Cabinet accepts key suggestions of the Select Committee

In the run up to the Budget session of Parliament, the Cabinet has decided to accept some of the key recommendations of the Select Committee on the Lokpal and Lokayuktas Bill, 2011.  The Bill, passed by the Lok Sabha in December 2011, was referred to a Select Committee by the Rajya Sabha.  The Select Committee gave its recommendations on the Bill a year later in November 2012.  At the Cabinet meeting held on January 31, 2013, the government has accepted some of these recommendations (see here for PRS comparison of the Bill, Select Committee recommendations and the approved amendments). Key approved amendments Lokayuktas: One of the most contentious issues in the Lokpal debate has been the establishment of Lokayuktas at the state level.  The Bill that was passed by the Lok Sabha gave a detailed structure of the Lokayuktas.  However, the Committee was of the opinion that while each state has to set up a Lokayukta within a year of the Act coming into force, the nature and type of the Lokayuktas should be decided by the states.  The Cabinet has agreed with the suggestion of the Committee. Inclusion of NGOs: Currently, “public servant” is defined in the Indian Penal Code to include government officials, judges, employees of universities, Members of Parliament, Ministers etc. The Bill expanded this definition by bringing societies and trusts which receive donations from the public (over a specified annual income) and, organizations which receive foreign donations (over Rs 10 lakh a year) within the purview of the Lokpal.  The Committee had however objected to the inclusion of organisations that receive donations from the public on the ground that bodies such as a rotary club or a resident’s welfare association may also be covered under the Lokpal. Bringing such entities within the Lokpal’s purview would make it unmanageable.  The Cabinet decided not to accept this recommendation stating that this view had been accepted by the Standing Committee while examining the version of the Bill introduced in the Lok Sabha.  However, the government has exempted trusts or societies for religious or charitable purposes registered under the Societies Registration Act. Procedure of inquiry and investigation:  A key recommendation of the Committee was to allow the Lokpal to directly order an investigation if a prima facie case existed (based on the complaint received).  The Cabinet has accepted this suggestion but suggested that the Lokpal should, before deciding that a prima facie case exists, call the public servant for a hearing.  An investigation should be ordered only after hearing the public servant.  Also, the Cabinet has not accepted the recommendation of the Committee that a public servant should be allowed a hearing only at the end of the investigation before filing the charge-sheet and not at any of the previous stages of the inquiry.  Power to grant sanction:  One of the key reasons cited for delays in prosecuting corrupt public officials is the requirement of a sanction from the government before a public servant can be prosecuted.  The Bill shifts the power to grant sanction from the government to the Lokpal.  It states that the investigation report shall be considered by a 3-member Lokpal bench before filing a charge-sheet or initiating disciplinary proceedings against the public servant.  The Committee recommended that at this point both the competent authority (to whom the public servant is responsible) and the concerned public servant should be given a hearing.  This has been accepted by the Cabinet. Reforms of CBI:  There are divergent views over the role and independence of the CBI.  The Committee made several recommendations for strengthening the CBI.  They include:  (a) the appointment of the Director of CBI will be through a collegium comprising of the PM, Leader of the Opposition of the Lok Sabha and Chief Justice of India; (b) the power of superintendence over CBI in relation to Lok Pal referred cases shall vest in the Lokpal; (c) CBI officers investigating cases referred by the Lokpal will be transferred with the approval of the Lokpal; and (d) for cases referred by the Lokpal, the CBI may appoint a panel of advocates (other than government advocates) with the consent of the Lok pal.  All the recommendations regarding the CBI has been accepted by the Cabinet except one that requires the approval of the Lokpal to transfer officers of CBI investigating cases referred by the Lokpal. Eligibility of Lokpal member:  According to the Bill, any person connected with a political party cannot be a member of the Lokpal.  The Committee’s recommendation was to change the term connected to affiliated to remove any ambiguity about the meaning.  This suggestion was accepted by the government. Now the interesting question is what happens if the Rajya Sabha passes the Bill with these amendments.  The Bill will have to go back to the Lok Sabha for its approval since new amendments were added by the Rajya Sabha.  If the Lok Sabha passes these amendments, the office of the Lokpal may finally see the light of day.  (See here for PRS analysis of the Lokpal and Lokayukta Bill, 2011).

Lapses in the process of drug approval in India

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:

  • drugs that have not been used in the country before,
  • drugs that have been approved by a Licensing Authority but are now being marketed for different purposes, and
  • fixed dose combinations of two or more drugs that have been individually approved before but are proposed to be combined in a fixed ratio that has not been approved.

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:

  • Under the Rules, the Drugs Controller General (India) (DCGI), the head of CDSCO, can clear sites of clinical trials after ensuring that major ethnic groups are enrolled in these trials to have a truly representative sample.  This rule was violated by the DCGI when sites for clinical trials were approved without ensuring diversity.  The Committee recommended that the DCGI approve sites for trials only if they cover patients from major ethnic backgrounds.
  •  The Report found that certain actions by experts were in violation of the Code of Ethics of the Medical Council of India.  A review of expert opinions revealed that several medical expert recommendations had been given as personal opinions rather than on the basis of scientific data.  Additionally, many expert opinions were written by what the Report calls ‘the invisible hands’ of drug manufacturers.  The Committee recommended that CDSCO formulate a clear set of written guidelines on the selection process of experts with emphasis on expertise in the area of drugs.
  •  The Rules ban the import and marketing of any drug whose use is prohibited in the country of origin.  CDSCO violated this rule by approving certain Fixed Dose Combination drugs for clinical trials without considering the drugs’ regulatory status in their respective country of origin.  Drugs such as Deanxit and Buclizine, which have been prohibited for sale and use in their countries of origin, Denmark and Belgium, respectively, were approved for clinical trials.  The Committee recommended an inquiry into the unlawful approval of these drugs.
  • The Rules require animal studies to be conducted for approval of a drug for use by women of reproductive age.  CDSCO violated this rule in approving Letrozole for treating female infertility.  Globally the drug has only been used as an anti-cancer drug for use among post-menopausal women.  The drug has not been permitted for use among women of reproductive age because of side effects.  The Committee recommended that responsibility be fixed for unlawfully approving Letrozole.
  •  Rules require Post-marketing Safety Update Reports (PSURs) on drugs to be submitted to CDSCO.  PSURs are used to collect information on adverse effects of drugs on Indian patients as a result of ethnic differences.  When asked by the Committee to furnish PSURs on 42 randomly selected new drugs, the Ministry was able to submit PSURs for only 8 drugs.  The Report contended that this action reflected a poor follow-up of side effects on Indian patients.  The Committee recommended that manufacturers of new drugs be warned about suspension of marketing approval unless they comply with mandatory rules on PSURs.

 

Are measures to minimize conflict of interest of MPs adequate?

In India, one of the common threads that run through many of the corruption scandals is the issue of conflict of interest i.e. public officials taking policy decisions based on their personal interest.  For example, Shashi Tharoor in the IPL controversy or Ashok Chavan in the Adarsh Housing Society scam. Many countries take measures to minimize conflict of interest of its MPs by regulating membership of parliamentarians in Committees, making it mandatory for them to declare pecuniary interest, and restricting employment both during and after completion of tenure.  For example, the US Senate has a detailed Code of Official Conduct that provides guidelines on conflict of interest. India also has some measures in place to minimize conflict of interest.  These are codified in the Code of Conduct for Ministers, Code of Conduct for Members of the Rajya Sabha, Rules of Procedure and Conduct of Business in the Lok Sabha and Rajya Sabha and Handbook for Members of Lok Sabha and Rajya Sabha.  Every Rajya Sabha MP has to declare his or her interest (along with assets and liabilities).  He has to declare five pecuniary interests:  remunerative directorship, remunerated activity, majority shareholding, paid consultancy and professional engagement.  Lok Sabha MPs can object to another MP joining a parliamentary committee on grounds that he has personal, pecuniary or direct interest.  (For more details, see PRS note on Conflict of Interest Issues in Parliament). On December 1, 2010, PRS held its annual Conference on Effective Legislatures.  One of the topics discussed was MPs and Conflict of Interest: Issues and Resolution.  Panelists included D Raja, Prakash Javdekar and Supriya Sule.  Issues such as requirement for transparency, expertise of legislators, election of honest legislators, and ethical media were discussed.  The issues that were raised during the discussion are summarised in the PRS Summary of Proceedings from the Conference.

From the states: Data on functioning of state legislatures

Apropos Madhukar’s post on available information on the functioning of state legislatures, data on the number of days State Assemblies shows a mixed trend over the 2000 to 2010 period. However, most states uniformly under perform when it comes to number of days of sitting. (Spreadsheet with relevant data here) As with Parliament, state assemblies are convened at the will of the executive. In comparison to the Lok Sabha, the state assemblies perform miserably. In any given year, most state assemblies do not sit for even half the number of the days clocked by the Lok Sabha.

Can Ministers be summoned by Public Accounts Committee?

The Public Accounts Committee  examines how the Government spends public money. It examines the amount granted by the Parliament and the amount actually spent. A Speaker in the past, has passed a direction which specifies clearly that a Minister cannot be summoned by the Financial Committees.  This has been incorporated in a document titled "Directions by the Speaker" available here. The actual text of the direction reads - "99. (1) The Committee on Estimates or the Committee on Public Accounts or the Committee on Public Undertakings may call officials to give evidence in connection with the examination of the estimates and accounts, respectively, relating to a particular Ministry or Undertaking. But a Minister shall not be called before the Committee either to give evidence or for consultation in connection with the examination of estimates or accounts by the Committee." -Co-authored by Chakshu