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:
Earlier today, the Supreme Court struck down the two Acts that created an independent body for the appointment of judges to the higher judiciary. One of the Acts amended the Constitution to replace the method of appointment of judges by a collegium system with that of an independent commission, called the National Judicial Appointments Commission (NJAC). The composition of the NJAC would include: (i) the Chief Justice of India (Chairperson) (ii) two other senior most judges of the Supreme Court, (iii) the Union Law Minister, and (iv) two eminent persons to be nominated by the Prime Minister, the CJI and the Leader of Opposition of the Lok Sabha. The other Act laid down the processes in relation to such appointments. Both Acts were passed by Parliament in August 2014, and received Presidential assent in December 2014. Following this, a batch of petitions that had been filed in Supreme Court challenging the two Bills on grounds of unconstitutionality, was referred to a five judge bench. It was contended that the presence of executive members in the NJAC violated the independence of the judiciary. In its judgement today, the Court held that the executive involvement in appointment of judges impinges upon the independence of the judiciary. This violates the principle of separation of powers between the executive and judiciary, which is a basic feature of the Constitution. In this context, we examine the proposals around the appointment of judges to the higher judiciary. Appointment of judges before the introduction of the NJAC The method of appointment of the Chief Justice of India, SC and HC judges was laid down in the Constitution.[i] The Constitution stated that the President shall make these appointments after consulting with the Chief Justice of India and other SC and HC judges as he considers necessary. Between the years 1982-1999, the issue of method of appointment of judges was examined and reinterpreted by the Supreme Court. Since then, a collegium, consisting of the Chief Justice of India and 4 other senior most SC judges, made recommendations for persons to be appointed as SC and HC judges, to the President.[ii] Recommendations of various bodies for setting up an independent appointments commission Over the decades, several high level Commissions have examined this method of appointment of judges to the higher judiciary. They have suggested that an independent body be set up to make recommendations for such appointments. However, they differed in the representation of the judiciary, legislature and executive in making such appointments. These are summarised below. Table 1: Comparison of various recommendations on the composition of a proposed appointments body
| Recommendatory Body | Suggested composition |
| 2nd Administrative Reforms Commission (2007) | Judiciary : CJI; [For HC judges: Chief Justice of the relevant High Court of that state] Executive : Vice-President (Chairperson), PM, Law Minister, [For HC judges: Includes CM of the state] Legislature: Speaker of Lok Sabha, Leaders of Opposition from both Houses of Parliament. Other: No representative. |
| National Advisory Council (2005) | Judiciary: CJI; [For HC judges: Chief Justice of the relevant High Court of that state] Executive: Vice-President (Chairman), PM (or nominee), Law Minister, [For HC judges: Includes CM of the state] Legislature: Speaker of Lok Sabha, Leader of Opposition from both Houses of Parliament. Other: No representative. |
| NCRWC (2002) | Judiciary :CJI (Chairman), two senior most SC judges Executive: Union Law Minister Legislature: No representative Other: one eminent person |
| Law Commission (1987) | Judiciary : CJI (Chairman), three senior most SC judges, immediate predecessor of the CJI, three senior most CJs of HCs, [For HC judges: Chief Justice of the relevant High Court of that state] Executive: Law Minister, Attorney General of India, [For HC judges: Includes CM of the state] Legislature: No representative Other: One Law academic |
Sources: 121st Report of the Law Commission, 1987; Report of the National Commission to Review the Working of the Constitution (NCRWC), 2002; A Consultation Paper on Superior Judiciary, NCRWC, 2001; A National Judicial Commission-Report for discussion in the National Advisory Council, 2005; Fourth Report of the 2nd Administrative Reforms Commission (ARC), ‘Ethics in Governance’, 2007; PRS. It may be noted that the Law Commission, in its 2008 and 2009 reports, suggested that Government should seek a reconsideration of the judgments in the Three Judges cases. In the alternative, Parliament should pass a law restoring the primacy of the CJI, while ensuring that the executive played a role in making judicial appointments. Appointments process in different countries Internationally, there are varied methods for making appointments of judges to the higher judiciary. The method of appointment of judges to the highest court, in some jurisdictions, is outlined in Table 2. Table 2: Appointment of judges to the highest court in different jurisdictions
| Country | Method of Appointment to the highest court | Who is involved in making the appointments |
| UK | SC judges are appointed by a five-person selection commission. | It consists of the SC President, his deputy, and one member each appointed by the JACs of England, Scotland and Northern Ireland.[iii] (The JACs comprise lay persons, members of the judiciary and the Bar and make appointments of judges of lower courts.) |
| Canada | Appointments are made by the Governor in Council.[iv] | A selection panel comprising five MPs (from the government and the opposition) reviews list of nominees and submits 3 names to the Prime Minister.[v] |
| USA | Appointments are made by the President. | Supreme Court Justices are nominated by the President and confirmed by the United States Senate.[vi] |
| Germany | Appointments are made by election. | Half the members of the Federal Constitutional Court are elected by the executive and half by the legislature.[vii] |
| France | Appointments are made by the President. | President receives proposals for appointments from Conseil Superieur de la Magistrature.[viii] |
Sources: Constitutional Reform Act, 2005; Canada Supreme Court Act, 1985; Constitution of the United States of America; Basic Law for the Federal Republic of Germany; Constitution of France; PRS. In delivering its judgment that strikes down the setting up of an NJAC, the Court has stated that it would schedule hearings from November 3, 2015 regarding ways in which the collegium system can be strengthened.
[i] Article 124, Constitution of India (Prior to 2015 Amendments)
[ii] S.P. Gupta vs. Union of India, AIR 1982, SC 149; S.C. Advocates on Record Association vs. Union of India, AIR 1994 SC 268; In re: Special Reference, AIR 1999 SC 1.
[iii]. Schedule 8, Constitutional Reform Act, 2005.
[iv]. Section 4(2), Supreme Court Act (RSC, 1985).
[v]. Statement by the Prime Minister of Canada on the retirement of Justice Morris Fish, http://www.pm.gc.ca/eng/news/2013/04/23/statement-prime-minister-canada-retirement-justice-morris-fish.
[vi]. Article II, Section 2, The Constitution of the United States of America.
[vii]. Article 94 (1), Basic Law for the Federal Republic of Germany.
[viii] Article 65, Constitution of France, http://www.conseil-constitutionnel.fr/conseil-constitutionnel/root/bank_mm/anglais/constiution_anglais_oct2009.pdf.
