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Legislation

Lapses in the process of drug approval in India

Sakshi - May 29, 2012

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.
Constitution

Explainer: Mechanisms to investigate charges against a Supreme Court judge

Roshni Sinha - April 25, 2019

This week, an in-house inquiry committee was constituted to consider a complaint against the current Chief Justice of India.  Over the years, three mechanisms have evolved to investigate cases of misconduct, including cases of sexual harassment, misbehaviour or incapacity against judges.  In this blog, we summarise the procedure for investigating such charges against judges of the Supreme Court.  

  • In-house procedure (1999): The Supreme Court has an in-house process to deal with allegations against a judge relating to the discharge of his judicial function, or with regard to his conduct or behaviour outside court.   
  • Sexual harassment guidelines: In 2013, Parliament passed the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013.  Subsequently, the Supreme Court framed regulations for protection of women against sexual harassment in the Supreme Court. Under the regulations, the CJI is required to constitute a Gender Sensitisation and Internal Complaints Committee (GSICC).  The GSICC will include 7-13 members including: (i) one or two judges of the Supreme Court, and (ii) up to two outside members (having experience in social justice, women empowerment, gender justice, among others) to be nominated by the CJI.  The Regulations require the majority of the members of GSICC to be women.  As of 2018, the GSICC has received 13 complaints, out of which 10 have been disposed of. 
  • Removal for proven misbehaviour or incapacity: Charges of misconduct may also be investigated in the context of proceedings for removal of a judge.  Article 124(4) of the Constitution of India provides that a judge can be removed only by Parliament on the basis of a motion in either the Lok Sabha or Rajya Sabha.  The procedure for removal of judges is elaborated in the Judges Inquiry Act, 1968.  Till date, no judge of the higher judiciary has been impeached under this process. 

Table 1: Process for investigation of charges against a Supreme Court judge

 

In-house Procedure of Supreme Court

2013 SC Sexual Harassment Regulation

Removal Proceedings

Who may file a complaint
  • Complaint of misconduct may be filed by any person.
  • Written complaint of sexual harassment by a woman.
  • Signed notice by at least 100 members of the Lok Sabha, or 50 members of the Rajya Sabha on charges of misbehaviour or incapacity by a judge. 

Persons to whom complaint must be filed
  • CJI or President of India
  • GSICC
  • Presiding Officer of the relevant House of Parliament

Preliminary Inquiry
  • The CJI is required to determine whether the complaint is either frivolous or serious. If the complaint is frivolous or relates to a pending case, no further action will be taken.
  • If the CJI finds that the complaint involves serious misconduct or impropriety, he will seek the response of the concerned Judge. 
  • Based on the response and supporting materials, if the CJI finds that the complaint needs a deeper probe, he will constitute an inquiry committee. 
  • If the GSICC is satisfied that the complaint is genuine, it will constitute a three-member Internal Sub-Committee to conduct an inquiry into the complaint. 
  • If the notice is in order, the Presiding Officer will constitute a three-member committee to investigate the complaint.

Composition of Inquiry Committee

  • The Committee will comprise three judges including a Judge of the Supreme Court and two Chief Justices of other High Courts.
  • The Committee will comprise members of the GSICC or persons nominated by the GSICC, with majority members being a woman and an outside member.
  • The committee will comprise a Supreme Court judge, Chief Justice of a High Court, and a distinguished jurist. 

Time limit for submission of inquiry report

  • No specific time limit provided.
  • To be completed within 90 days of the constitution of the Internal Sub-Committee, and forwarded to the GSICC within 10 days of completion. 
  • To be submitted to the presiding officer within 90 days.

Findings of the Committee
  • The Committee may report to the CJI that:

​1.  there is no substance in the allegation made, or,

2.  there is substance in the allegations but the misconduct is not of such serious nature as to warrant removal, or,

3.  the misconduct is serious enough to initiate removal proceedings against the judge. 
  • If the committee concludes that the allegation has been proved, it will submit its report to the GSICC to pass appropriate orders within 45 days.
  • If more than two thirds of the GSICC members differ from the conclusion of the Committee, it will, after hearing the complainant and the accused, record its reasons for differing and pass orders.
  • After concluding its investigation, the Committee will submit its report to the presiding officer, who will lay the report before the relevant House.

 

Action taken upon submission of report

  • If the finding is under category (2) above, the CJI may call and advise the Judge accordingly and direct that the report be placed on record.
  • If the finding is under category (3) above, the CJI may ask the judge to resign or seek voluntary retirement.  If the judge refuses to resign, the CJI may decide to not allocate any judicial work to the judge concerned. 
  •  Further, the CJI may inform the President of India and the Prime Minister of his reasons for the action taken and forward a copy of the inquiry report to them.
  • The GSICC has the power to: (i) to pass an order of admonition (reprimand), which may also be published in the court precinct, or (ii) pass an order to prohibit the accused from harassing or communicating with the complainant, or (iii) pass any other order to end the sexual harassment faced by the complainant.
  • GSICC may also recommend to the CJI to pass orders against the accused, including: (i) prohibiting entry of the accused into the Supreme Court for up to a year, or (ii) filing a criminal complaint before the concerned disciplinary authority governing the accused.
  • If the report records a finding of misbehaviour or incapacity, the motion for removal will be taken up for consideration and debated. 
  • The motion is required to be adopted by each House by a majority of the total membership of that House and a majority of at least two-thirds of the members of that House present and voting.
  • Once the motion is adopted in both Houses, it is sent to the President, who will issue an order for the removal of the judge.

Process for Appeals
  • No specific provision.
  • Any aggrieved person may make a representation to the CJI to set aside/modify the orders passed by the GSICC.  The CJI also has the power to issue any other orders in order to secure justice to the victim.
  • No specific provision.

Sources: Report of the Committee on In-House Procedure, December 1999, Supreme Court of India; Gender Sensitisation and Sexual Harassment of Women at the Supreme Court of India (Prevention, Prohibition and Redressal) Regulations, 2013; Article 124(4), Constitution of India; Judges Inquiry Act, 1968 read with the Judges Inquiry Rules, 1969; PRS.

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