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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

Money Bills vs. Other Bills

Prianka Rao - December 22, 2015

The Insolvency and Bankruptcy Code, 2015 was introduced in Lok Sabha yesterday, as a Money Bill [Clarification: This is as per news reports.*  The text of the Bill does not indicate that it is a Money Bill].  In this context, we briefly outline the various types of Bills in Parliament, and highlight the key differences between Money Bills and Financial Bills. What are the different types of Bills? There are four types of Bills, namely (i) Constitution Amendment Bills; (ii) Money Bills; (iii) Financial Bills; and (iv) Ordinary Bills. What are the features of each of these Bills?

  • Constitution Amendment Bills[i]: These are Bills which seek to amend the Constitution.
  • Money Bills[ii]: A Bill is said to be a Money Bill if it only contains provisions related to taxation, borrowing of money by the government, expenditure from or receipt to the Consolidated Fund of India. Bills that only contain provisions that are incidental to these matters would also be regarded as Money Bills.[iii]
  • Financial Bills[iv]: A Bill that contains some provisions related to taxation and expenditure, and additionally contains provisions related to any other matter is called a Financial Bill. Therefore, if a Bill merely involves expenditure by the government, and addresses other issues, it will be a financial bill.
  • Ordinary Bills[v]: All other Bills are called ordinary bills.

How are these bills passed?

  • Constitution Amendment Bills1: A Constitution Amendment Bill must be passed by both Houses of Parliament. It would require a simple majority of the total membership of that House, and a two thirds majority of all members present and voting.  Further, if the Bill relates to matters like the election of the President and Governor, executive and legislative powers of the centre and states, the judiciary, etc., it must be ratified by at least half of the state legislatures.
  • Money Bills[vi]: A Money Bill may only be introduced in Lok Sabha, on the recommendation of the President. It must be passed in Lok Sabha by a simple majority of all members present and voting.  Following this, it may be sent to the Rajya Sabha for its recommendations, which Lok Sabha may reject if it chooses to.  If such recommendations are not given within 14 days, it will deemed to be passed by Parliament.
  • Financial Bills4: A Financial Bill may only be introduced in Lok Sabha, on the recommendation of the President. The Bill must be passed by both Houses of Parliament, after the President has recommended that it be taken up for consideration in each House.
  • Ordinary Bills5: An Ordinary Bill may be introduced in either House of Parliament. It must be passed by both Houses by a simple majority of all members present and voting.

How is a Money Bill different from a financial bill? While all Money Bills are Financial Bills, all Financial Bills are not Money Bills.  For example, the Finance Bill which only contains provisions related to tax proposals would be a Money Bill.  However, a Bill that contains some provisions related to taxation or expenditure, but also covers other matters would be considered as a Financial Bill.  The Compensatory Afforestation Fund Bill, 2015, which establishes funds under the Public Account of India and states, was introduced as a Financial Bill.[vii] Secondly, as highlighted above, the procedure for the passage of the two bills varies significantly.  The Rajya Sabha has no power to reject or amend a Money Bill.  However, a Financial Bill must be passed by both Houses of Parliament. Who decides if a Bill is a Money Bill? The Speaker certifies a Bill as a Money Bill, and the Speaker’s decision is final.[viii]  Also, the Constitution states that parliamentary proceedings as well as officers responsible for the conduct of business (such as the Speaker) may not be questioned by any Court.[ix]

  [i]. Article 368, Constitution of India. [ii]. Article 110, Constitution of India. [iii]. Article 110 (1), Constitution of India. [iv]. Article 117, Constitution of India. [v]. Article 107, Constitution of India. [vi]. Article 109, Constitution of India. [vii]. The Compensatory Afforestation Fund Bill, 2015, introduced in Lok Sabha on May 8, 2015, http://www.prsindia.org/billtrack/the-compensatory-afforestations-fund-bill-2015-3782/. [viii]. Article 110 (3), Constitution of India. [ix]. Article 122, Constitution of India. [*Note: See Economic Times, Financial Express, The Hindu Business Line, NDTV ,etc.]

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