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A note of gratitude to Mr. N. Vaghul

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.
Parliament

Parliamentary oversight of intelligence agencies

Anirudh - July 8, 2010

"Parliamentary approval of the creation, mandate and powers of security agencies is a necessary but not sufficient condition for upholding the rule of law. A legal foundation increases the legitimacy both of the existence of these agencies and the (often exceptional) powers that they possess." Though mechanisms for ensuring accountability of the executive to the Parliament are in place for most aspects of government in India, such mechanisms are completely absent for the oversight of intelligence agencies. In India, various intelligence agencies such as the Research and Analysis Wing, and the Intelligence Bureau are creations of administrative orders, and are not subject to scrutiny by Parliament. This is in direct contrast to the practise of the Legislature's oversight of intelligence agencies in most countries.  Though different countries have different models of exercising such oversight, the common principle - that activities of intelligence agencies should be subject to Parliamentary scrutiny, remains uniform. In the US for example, both the House and the Senate have a Committee which exercises such scrutiny.  These are House Permanent Select Committee on Intelligence, established in 1977, and the Senate Select Committee on Intelligence, created in 1976.  Both committees have broad powers over the intelligence community.  They oversee budgetary appropriations as well as legislation on this subject.  In addition, the House Committee can do something which the Senate can not:  “tactical intelligence and intelligence-related activities.”  This gives the Committee the power to look into actual tactical intelligence, and not just broader policy issues.  Intelligence agencies are also governed by a variety of laws which clearly lay out a charter of responsibilities, as well as specific exemptions allowing such agencies to do some things other government agencies ordinarily cannot. (For source, click here) In UK, the Intelligence Services Act of 1994 set up a similar framework for intelligence organisations in the UK, and also set up a mechanism for legislative oversight.  The Act set up a Committee which should consists mostly of Members of Parliament.  The members are appointed by the Prime Minister in consultation with the leader of opposition, and the Committee reports to the Prime Minister.  The Prime Minister is required to present the report of the Committee before Parliament. (For the Act, click here) Recently, the Committee has expressed concerns in its 2009-10 report over the fact that it is financially dependent on the Prime Minister's office, and that there could be a conflict of interest considering it is practically a part of   the government over which it is supposed to express oversight. (For the report, click here) A study titled "Making Intelligence Accountable: Legal Standards and Best Practice" captures the best components of Parliamentary oversight of intelligence bodies.  Some of these are:

  1. The entire intelligence community, including all ancillary departments and officials, should be covered by the mandate of one or more parliamentary oversight bodies.
  2. The mandate of a parliamentary oversight body might include some or all of the following (a) legality, (b) efficacy, (c) efficiency, (d) budgeting and accounting; (e) conformity with relevant human rights Conventions (f) policy/administrative aspects of the intelligence services.
  3. The recommendations and reports of the parliamentary oversight body should be (a) published; (b) debated in parliament; (c) monitored with regard to its implementation by the government and intelligence community.
  4. The resources and legal powers at the disposal of the parliamentary oversight body should match the scope of its mandate.
  5. Parliament should be responsible for appointing and, where necessary, removing members of a body exercising the oversight function in its name.
  6. Representation on parliamentary oversight bodies should be cross-party, preferably in accordance with the strengths of the political parties in parliament.
  7. Government ministers should be debarred from membership (and parliamentarians should be required to step down if they are appointed as ministers) or the independence of the committee will be compromised. The same applies to former members of agencies overseen.
  8. The oversight body should have the legal power to initiate investigations; Members of oversight bodies should have unrestricted access to all information which is necessary for executing their oversight tasks.
  9. The oversight body should have power to subpoena witnesses and to receive testimony under oath.
  10. The oversight body should take appropriate measures and steps in order to protect information from unauthorised disclosure.
  11. The committee should report to parliament at least yearly or as often as it deems necessary.
  12. The oversight body should have access to all relevant budget documents, provided that safeguards are in place to avoid leaking of classified information.

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