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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.
Parliament

Pre-legislative scrutiny: How can citizens be more actively involved?

Tonusree - December 18, 2010

In recent public discourse over lobbying, two issues that have underscored the debate are:

  1. Greater transparency in the policymaking process, and
  2. Equality of access for all stakeholders in engaging with the process.

There is a need to build linkages between citizens and the policy making process, especially by strengthening scrutiny before a Bill is introduced in Parliament. Currently, there is no process established to ensure pre-legislative scrutiny by the citizenry. Other democracies incorporate several measures to enhance public engagement in the pre-legislative process. These include:

  • Making all Bills available in the public domain for a stipulated period before introducing them in the legislature. This includes, publishing these Bills in forms (language, medium etc) that are accessible to the general public.
  • Making a report or Green paper on the legislative priorities addressed by the Bill available for citizens.
  • Forming adhoc committees to scrutinise the Bill before it is piloted in the House.
  • Having Standing Committees examine the Bill before introducing it in the House.
  • Providing a financial memorandum for each Bill, which specifies the budgetary allocation for the process/bodies created by the Bill.
  • Creating online fora for discussion. For the sections of the stakeholders who have limited access to the internet, efforts are made to proactively consult them through other media.
  • Expanding the purview of citizens’ right to petition their representatives with legislative proposals.

There are several instances, in the last few years itself, wherein civil society groups have played an active role in the development of pre-legislative scrutiny in India.

  • Public consultation with cross-section of stakeholders when drafting a Bill: The Right to Information Act is seen as a landmark legislation when highlighting the role of civil society actors in the drafting of a Bill.  It also serves as a prime example for how it the movement mobilised widespread public opinion for the Bill, bringing together different sections of the citizenry.
  • Public feedback on draft Bills: In several cases, after a Bill has been drafted the concerned ministry or public body publishes the Bill, inviting public comments. The Right to Education Bill, the National Identification Authority Bill and the Draft Direct Taxes Code Bill 2009 are recent cases in point. These announcements are made through advertisements published in newspapers and other media. For instance, the government has recently proposed to amend the rules of the RTI and has invited public feedback on the rules by December 27.
  • Engaging with legislators: It is important to expand engagement with lawmakers after the Bill has been introduced in Parliament, as they will determine what the law will finally contain.  This is done by approaching individual legislators or members of the committee which is likely to examine the legislation. Standing Committees invite feedback on the Bill through newspaper advertisements.  For instance, the Standing Committee examining the Civil Nuclear Liability Bill heard testimonies from journalists, civil society groups, thinktanks, public bodies and government departments.

The role of the media and channelising the potential of the internet are other key approaches that need to be explored. Other examples and channels of engagement with the legislative process are illustrated in the PRS Primer on Engaging with Policymakers

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