In light of the decision of the union cabinet to promulgate an Ordinance to uphold provisions of the Representation of People Act, 1951, this blog examines the Ordinance making power of the Executive in India.  The Ordinance allows legislators (Members of Parliament and Members of Legislative Assemblies) to retain membership of the legislature even after conviction, if (a)     an appeal against the conviction is filed before a court within 90 days and (b)     the appeal is stayed by the court. However, the Ordinance will only be promulgated after it receives the assent of the President. I. Separation of powers between the Legislature, Executive and Judiciary In India, the central and state legislatures are responsible for law making, the central and state governments are responsible for the implementation of laws and the judiciary (Supreme Court, High Courts and lower courts) interprets these laws. However, there are several overlaps in the functions and powers of the three institutions.  For example, the President has certain legislative and judicial functions and the legislature can delegate some of its functions to the executive in the form of subordinate legislation. II. Ordinance making powers of the President Article 123 of the Constitution grants the President certain law making powers to promulgate Ordinances when either of the two Houses of Parliament is not in session and hence it is not possible to enact laws in the Parliament.[i] An Ordinance may relate to any subject that the Parliament has the power to legislate on. Conversely, it has the same limitations as the Parliament to legislate, given the distribution of powers between the Union, State and Concurrent Lists. Thus, the following limitations exist with regard to the Ordinance making power of the executive: i.   Legislature is not in session: The President can only promulgate an Ordinance when either of the two Houses of Parliament is not in session. ii.   Immediate action is required: The President cannot promulgate an Ordinance unless he is satisfied that there are circumstances that require taking ‘immediate action’[ii]. iii.   Parliamentary approval during session: Ordinances must be approved by Parliament within six weeks of reassembling or they shall cease to operate.  They will also cease to operate in case resolutions disapproving the Ordinance are passed by both the Houses.   Figure 1 shows the number of Ordinances that have been promulgated in India since 1990.  The largest number of Ordinances was promulgated in 1993, and there has been a decline in the number of Ordinance promulgated since then.  However, the past year has seen a rise in the number of Ordinances promulgated.            Figure 1: Number of national Ordinances promulgated in India since 1990 Ordinances PromulgatedSource: Ministry of Law and Justice; Agnihotri, VK (2009) ‘The Ordinance: Legislation by the Executive in India when the Parliament is not in Session’; PRS Legislative Research III. Ordinance making powers of the Governor Just as the President of India is constitutionally mandated to issue Ordinances under Article 123, the Governor of a state can issue Ordinances under Article 213, when the state legislative assembly (or either of the two Houses in states with bicameral legislatures) is not in session.  The powers of the President and the Governor are broadly comparable with respect to Ordinance making.  However, the Governor cannot issue an Ordinance without instructions from the President in three cases where the assent of the President would have been required to pass a similar Bill.[iii] IV. Key debates relating to the Ordinance making powers of the Executive There has been significant debate surrounding the Ordinance making power of the President (and Governor).  Constitutionally, important issues that have been raised include judicial review of the Ordinance making powers of the executive; the necessity for ‘immediate action’ while promulgating an Ordinance; and the granting of Ordinance making powers to the executive, given the principle of separation of powers. Table 1 provides a brief historical overview of the manner in which the debate on the Ordinance making powers of the executive has evolved in India post independence. Table 1: Key debates on the President's Ordinance making power

Year

Legislative development

Key arguments

1970 RC Cooper vs. Union of India In RC Cooper vs. Union of India (1970) the Supreme Court, while examining the constitutionality of the Banking Companies (Acquisition of Undertakings) Ordinance, 1969 which sought to nationalise 14 of India’s largest commercial banks, held that the President’s decision could be challenged on the grounds that ‘immediate action’ was not required; and the Ordinance had been passed primarily to by-pass debate and discussion in the legislature.
1975 38th Constitutional Amendment Act Inserted a new clause (4) in Article 123 stating that the President’s satisfaction while promulgating an Ordinance was final and could not be questioned in any court on any ground.
1978 44th Constitutional Amendment Act Deleted clause (4) inserted by the 38th CAA and therefore reopened the possibility for the judicial review of the President’s decision to promulgate an Ordinance.
1980 AK Roy vs. Union of India In AK Roy vs. Union of India (1982) while examining the constitutionality of the National Security Ordinance, 1980, which sought to provide for preventive detention in certain cases, the Court argued that the President’s Ordinance making power is not beyond the scope of judicial review. However, it did not explore the issue further as there was insufficient evidence before it and the Ordinance was replaced by an Act. It also pointed out the need to exercise judicial review over the President’s decision only when there were substantial grounds to challenge the decision, and not at “every casual and passing challenge”.
1985 T Venkata Reddy vs. State of Andhra Pradesh In T Venkata Reddy vs. State of Andhra Pradesh (1985), while deliberating on the promulgation of the Andhra Pradesh Abolition of Posts of Part-time Village Officers Ordinance, 1984 which abolished certain village level posts, the Court reiterated that the Ordinance making power of the President and the Governor was a legislative power, comparable to the legislative power of the Parliament and state legislatures respectively. This implies that the motives behind the exercise of this power cannot be questioned, just as is the case with legislation by the Parliament and state legislatures.
1987 DC Wadhwa vs. State of Bihar It was argued in DC Wadhwa vs. State of Bihar (1987) the legislative power of the executive to promulgate Ordinances is to be used in exceptional circumstances and not as a substitute for the law making power of the legislature.  Here, the court was examining a case where a state government (under the authority of the Governor) continued to re-promulgate ordinances, that is, it repeatedly issued new Ordinances to replace the old ones, instead of laying them before the state legislature.  A total of 259 Ordinances were re-promulgated, some of them for as long as 14 years.  The Supreme Court argued that if Ordinance making was made a usual practice, creating an ‘Ordinance raj’ the courts could strike down re-promulgated Ordinances.

Source: Basu, DD (2010) Introduction to the Constitution of India; Singh, Mahendra P. (2008) VN Shukla's Constitution of India; PRS Legislative Research

  This year, the following 9 Ordinances have been promulgated:

  1. The Securities Laws (Amendment) Ordinance, 2013
  2. The Readjustment of Representation of Scheduled Castes and Scheduled Tribes in Parliamentary and Assembly Constituencies Second Ordinance, 2013
  3. The Securities and Exchange Board of India (Amendment) Second Ordinance, 2013
  4. The National Food Security Ordinance, 2013
  5. The Indian Medical Council (Amendment) Ordinance, 2013
  6. The Securities and Exchange Board of India (Amendment) Ordinance, 2013
  7. The Readjustment of Representation of Scheduled Castes and Scheduled Tribes in Parliamentary and Assembly Constituencies Ordinance, 2013
  8. The Criminal Law (Amendment) Ordinance, 2013
  9. The Securities Laws (Amendment) Second Ordinance, 2013

Three of these Ordinances have been re-promulgated, i.e., a second Ordinance has been promulgated to replace an existing one.  This seems to be in violation of the Supreme Court’s decision in DC Wadhwa vs. State of Bihar.  


Notes: [i] With regard to issuing Ordinances as with other matters, the President acts on the advice of the Council of Ministers. While the Ordinance is promulgated in the name of the President and constitutionally to his satisfaction, in fact, it is promulgated on the advice of the Council of Ministers.

[ii] Article 123, Clause (1)

[iii]  (a) if a Bill containing the same provisions would have required the previous sanction of the President for introduction into the legislature; (b) if the Governor would have deemed it necessary to reserve a Bill containing the same provisions for the consideration of the President; and (c) if an Act of the legislature containing the same provisions would have been invalid unless it received the assent of the President.

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.