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:
On Monday, December 4, the Chairman of Rajya Sabha disqualified two Members of Parliament (MPs) from the House under the Tenth Schedule of the Constitution (better known as the anti-defection law) for having defected from their party.[1] These members were elected on a Janata Dal (United) ticket. The Madras High Court is also hearing petitions filed by 18 MLAs who were disqualified by the Speaker of the Tamil Nadu Assembly in September 2017 under the anti-defection law. Allegations of legislators defecting in violation of the law have been made in several other states including Andhra Pradesh, Arunachal Pradesh, Goa, Manipur, Nagaland, Telangana and Uttarakhand in recent years.[2] In this context, we explain the anti-defection law.
What is the anti-defection law?
Aaya Ram Gaya Ram was a phrase that became popular in Indian politics after a Haryana MLA Gaya Lal changed his party thrice within the same day in 1967. The anti-defection law sought to prevent such political defections which may be due to reward of office or other similar considerations.[3]
The Tenth Schedule was inserted in the Constitution in 1985. It lays down the process by which legislators may be disqualified on grounds of defection by the Presiding Officer of a legislature based on a petition by any other member of the House. A legislator is deemed to have defected if he either voluntarily gives up the membership of his party or disobeys the directives of the party leadership on a vote. This implies that a legislator defying (abstaining or voting against) the party whip on any issue can lose his membership of the House. The law applies to both Parliament and state assemblies.
Are there any exceptions under the law?
Yes, legislators may change their party without the risk of disqualification in certain circumstances. The law allows a party to merge with or into another party provided that at least two-thirds of its legislators are in favour of the merger. In such a scenario, neither the members who decide to merge, nor the ones who stay with the original party will face disqualification.
Various expert committees have recommended that rather than the Presiding Officer, the decision to disqualify a member should be made by the President (in case of MPs) or the Governor (in case of MLAs) on the advice of the Election Commission.[4] This would be similar to the process followed for disqualification in case the person holds an office of profit (i.e. the person holds an office under the central or state government which carries a remuneration, and has not been excluded in a list made by the legislature).
How has the law been interpreted by the Courts while deciding on related matters?
The Supreme Court has interpreted different provisions of the law. We discuss some of these below.
The phrase ‘Voluntarily gives up his membership’ has a wider connotation than resignation
The law provides for a member to be disqualified if he ‘voluntarily gives up his membership’. However, the Supreme Court has interpreted that in the absence of a formal resignation by the member, the giving up of membership can be inferred by his conduct.[5] In other judgments, members who have publicly expressed opposition to their party or support for another party were deemed to have resigned.[6]
In the case of the two JD(U) MPs who were disqualified from Rajya Sabha on Monday, they were deemed to have ‘voluntarily given up their membership’ by engaging in anti-party activities which included criticizing the party on public forums on multiple occasions, and attending rallies organised by opposition parties in Bihar.[7]
Decision of the Presiding Officer is subject to judicial review
The law initially stated that the decision of the Presiding Officer is not subject to judicial review. This condition was struck down by the Supreme Court in 1992, thereby allowing appeals against the Presiding Officer’s decision in the High Court and Supreme Court.[8] However, it held that there may not be any judicial intervention until the Presiding Officer gives his order.
In 2015, the Hyderabad High Court, refused to intervene after hearing a petition which alleged that there had been delay by the Telangana Assembly Speaker in acting against a member under the anti-defection law.[9]
Is there a time limit within which the Presiding Officer has to decide?
The law does not specify a time-period for the Presiding Officer to decide on a disqualification plea. Given that courts can intervene only after the Presiding Officer has decided on the matter, the petitioner seeking disqualification has no option but to wait for this decision to be made.
There have been several cases where the Courts have expressed concern about the unnecessary delay in deciding such petitions.[10] In some cases this delay in decision making has resulted in members, who have defected from their parties, continuing to be members of the House. There have also been instances where opposition members have been appointed ministers in the government while still retaining the membership of their original parties in the legislature.[11]
In recent years, opposition MLAs in some states, such as Andhra Pradesh and Telangana, have broken away in small groups gradually to join the ruling party. In some of these cases, more than 2/3rd of the opposition has defected to the ruling party.
In these scenarios, the MLAs were subject to disqualification while defecting to the ruling party in smaller groups. However, it is not clear if they will still face disqualification if the Presiding Officer makes a decision after more than 2/3rd of the opposition has defected to the ruling party. The Telangana Speaker in March 2016 allowed the merger of the TDP Legislature Party in Telangana with the ruling TRS, citing that in total, 80% of the TDP MLAs (12 out of 15) had joined the TRS at the time of taking the decision.[12]
In Andhra Pradesh, legislators of the main opposition party recently boycotted the entire 12-day assembly session. This boycott was in protest against the delay of over 18 months in action being taken against legislators of their party who have allegedly defected to the ruling party.[13] The Vice President, in his recent order disqualifying two JD(U) members stated that all such petitions should be decided by the Presiding Officers within a period of around three months.
Does the anti-defection law affect the ability of legislators to make decisions?
The anti-defection law seeks to provide a stable government by ensuring the legislators do not switch sides. However, this law also restricts a legislator from voting in line with his conscience, judgement and interests of his electorate. Such a situation impedes the oversight function of the legislature over the government, by ensuring that members vote based on the decisions taken by the party leadership, and not what their constituents would like them to vote for.
Political parties issue a direction to MPs on how to vote on most issues, irrespective of the nature of the issue. Several experts have suggested that the law should be valid only for those votes that determine the stability of the government (passage of the annual budget or no-confidence motions).[14]
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[1] Parliamentary Bulletin-II, December 4, 2017, http://164.100.47.5/newsite/bulletin2/Bull_No.aspx?number=57066 and http://164.100.47.5/newsite/bulletin2/Bull_No.aspx?number=57067.
[2] MLA Defection Politics Not New, Firstpost, March 13, 2017, http://www.firstpost.com/politics/bjp-forms-govt-in-goa-manipur-mla-defection-politics-not-new-telangana-ap-perfected-it-3331872.html.
[3] The Constitution (52nd Amendment) Act, 1985, http://indiacode.nic.in/coiweb/amend/amend52.htm.
[4] Report of the Committee on Electoral Reforms, 1990, http://lawmin.nic.in/ld/erreports/Dinesh%20Goswami%20Report%20on%20Electoral%20Reforms.pdfand the National Commission to review the working of the Constitution (NCRWC), 2002, http://lawmin.nic.in/ncrwc/ncrwcreport.htm.
[5] Ravi Naik vs Union of India, 1994, https://indiankanoon.org/doc/554446/.
[6] G.Viswanathan Vs. The Hon’ble Speaker, Tamil Nadu Legislative Assembly, Madras& Another, 1996, https://indiankanoon.org/doc/1093980/ and Rajendra Singh Rana vs. Swami Prasad Maurya and Others, 2007, https://indiankanoon.org/doc/1620629/ and Parliamentary Bulletin-II, December 4, 2017, http://164.100.47.5/newsite/bulletin2/Bull_No.aspx?number=57066.
[7] Parliamentary Bulletin-II, December 4, 2017, http://164.100.47.5/newsite/bulletin2/Bull_No.aspx?number=57066.
[8] Kihoto Hollohon vs. Zachilhu and Others, 1992, https://indiankanoon.org/doc/1686885/.
[9] Sabotage of Anti-Defection Law in Telangana, 2015, https://www.epw.in/journal/2015/50/commentary/sabotage-anti-defection-law-telangana.html.
[10] Speaker, Haryana Vidhan Sabha Vs Kuldeep Bishnoi & Ors., 2012, https://indiankanoon.org/doc/45034065/ and Mayawati Vs Markandeya Chand & Ors., 1998, https://indiankanoon.org/doc/1801522/.
[11] Anti-Defecton Law Ignored, November 30, 2017, http://www.news18.com/news/politics/anti-defection-law-ignored-as-mlas-defect-to-tdp-trs-in-andhra-pradesh-and-telangana-1591319.htmland It’s official Minister Talasani is still a TDP Member, March 27, 2015, http://www.thehansindia.com/posts/index/Telangana/2015-03-27/Its-Official-Minister-Talasani-is-still-a-TDP-member/140135.
[12] Telangana Legislative Assembly Bulletin, March 10, 2016, http://www.telanganalegislature.org.in/documents/10656/19317/Assembly+Buletin.PDF/a0d4bb52-9acf-494f-80e7-3a16e3480460; 12 TDP MLAs merged with TRS, March 11, 2016, http://www.thehindu.com/news/national/telangana/12-tdp-mlas-merged-with-trs/article8341018.ece.
[13] The line TD leaders dare not cross, December 4, http://www.thehindu.com/todays-paper/tp-national/tp-andhrapradesh/the-line-td-leaders-dare-not-cross/article21257521.ece
[14] Report of the National Commission to review the working of the Constitution, 2002, http://lawmin.nic.in/ncrwc/ncrwcreport.htm, Report of the Committee on electoral reforms, 1990, http://lawmin.nic.in/ld/erreports/Dinesh%20Goswami%20Report%20on%20Electoral%20Reforms.pdf and Law Commission (170th report), 1999, http://www.lawcommissionofindia.nic.in/lc170.htm.
