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.
Parliament

JPC vs PAC

admin_2 - December 2, 2010

By Chakshu Rai and Anirudh Burman What is the difference between a JPC and a PAC? A structured committee system was introduced in 1993 to provide for greater scrutiny of government functioning by Parliament. Most committees of Parliament include MPs from both the Lok Sabha and Rajya Sabha. A Joint Parliamentary Committee (JPC) is an ad-hoc body. It is set up for a specific object and duration. Joint committees are set up by a motion passed in one house of Parliament and agreed to by the other. The details regarding membership and subjects are also decided by Parliament. For example, the motion to constitute a JPC on the stock market scam (2001) and pesticide residues in soft drinks (2003) was moved by the government in the Lok Sabha. The motion on the stock market scam constituted a JPC of 30 members of which 20 were from the Lok Sabha and 10 were from the Rajya Sabha. The motion to constitute the JPC on pesticides included 10 members from the Lok Sabha and 5 from the Rajya Sabha. The terms of reference for the JPC on the stock market scam asked the committee to look into financial irregularities, to fix responsibility on persons and institutions for the scam, to identify regulatory loopholes and also to make suitable recommendations. The Public Accounts Committee (PAC), however, is constituted every year. Its main duty is to ascertain how the money granted (budget) by Parliament has been spent by the government. The PAC scrutinises the accounts of the government on the basis of CAG reports. The composition and functions of the committee are governed by parliamentary procedures. The PAC can consist of 15 to 22 members. Not more than 15 members can be from the Lok Sabha, and the representation from the Rajya Sabha cannot exceed 7 members. A minister cannot be a member of the PAC. What can a JPC do that a PAC cannot? The PAC examines cases involving losses and financial irregularities. Its examination is usually limited to the scrutiny of CAG reports and issues raised by the reports. The committee expresses no opinion on points of general policy, but it is within PAC’s jurisdiction to point out whether there has been waste in carrying out that policy. The mandate of a JPC depends on the motion constituting it. This need not be limited to the scrutiny of government finances. How many JPCs have we had so far? Although a number of joint committees have been formed since Independence, four major JPCs have been formed to investigate significant issues that have caused controversy. These are: (1) Joint Committee on Bofors Contracts; (2) Joint Committee to enquire into irregularities in securities and banking transactions; (3) Joint Committee on stock-market scam; and (4) Joint Committee on pesticide residues in and safety standards for soft drinks. How effective have JPCs been? Is the government bound by their recommendations? JPC recommendations have persuasive value but the committee cannot force the government to take any action on the basis of its report. The government may decide to launch fresh investigations on the basis of a JPC report. However, the discretion to do so rests entirely with the government. The government is required to report on the follow-up action taken on the basis of the recommendations of the JPC and other committees. The committees then submit ‘Action Taken Reports’ in Parliament on the basis of the government’s reply. These reports can be discussed in Parliament and the government can be questioned on the basis of the same. How effective is the PAC process? Between 2005 and 2010, the PAC has prepared 54 reports and examined ministries that have cumulatively received around 80% of the budgetary allocations in the last five financial years. Since it is not possible to examine every CAG audit finding in a formal manner, ministries have to submit Action Taken Notes to the PAC on all audit paragraphs. A 2009-10 report of the PAC, however, noted that there were 4,934 audit paragraphs still pending with various ministries. What can the JPC or the PAC find in the 2G case that is not already known, that the CAG and the Trai have not already said? The JPC or the PAC can only look at the documents and examine ministry officials who testify before the committee. The parliamentary committees can arrive at independent conclusions based on the documents placed before them. Members of the committee can also place dissent notes if they do not agree with the majority. Can Raja be tried and the telecom licences cancelled on basis of a JPC report or do we need a CBI report as well? Prosecution of individuals and cancellation of licences are executive functions and can only be initiated by the government. A JPC report can recommend the prosecution of a particular person or the cancellation of certain licences. However, the government can disagree with the JPC’s findings and refuse to take such action. How much of Parliament time have we lost already and how many critical Bills are stuck? The Lok Sabha and Rajya Sabha are supposed to work daily for six hours and five hours, respectively. The Lok Sabha has worked for five hours and forty five minutes and Rajya Sabha has worked for an hour and twenty five minutes in the past 12 days. Some important Bills that are listed for consideration and passing in Parliament are the Seeds Bill, 2004; the Commercial Division of High Courts Bill, 2009; and the Amendment to the Right to Education Act, 2010. Bills listed for introduction include the National Identification Authority Bill, 2010; the Protection of Women from Sexual Harassment in Workplace Bill, 2010; the Judicial Standards and Accountability Bill, 2010; Land Acquisition (Amendment) Bill; and the Rehabilitation and Resettlement Bill. This article appeared in Financial Express.