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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

Allegations against Justice Soumitra Sen: Inquiry Committee Report

Sana - December 10, 2010

On December 1, 2010, the Judicial Standards and Accountability Bill was introduced in the Lok Sabha.  The Bill revamps the present system of inquiry into complaints against judges.  The case of Justice Sen was the one of the more recent instances where the integrity of judges has been called into question.

A motion was moved by 58 members of the Rajya Sabha for the removal of Justice Soumitra Sen, (a Judge of the Calcutta High Court) on grounds of misappropriation of funds. The Chairman, Rajya Sabha constituted an Inquiry Committee on March 20, 2009 to look into the matter. The Committee comprising Hon’ble Justice B. Sudershan Reddy (Chairman), Hon’ble Justice T.S.Thakur and Shri Fali S. Nariman submitted its report on September 10, 2010.

Charges framed in the Motion

The two charges which led to an investigation into alleged misconduct of Justice Soumitra Sen were:

  • Misappropriation of large sums of money, which he had received in his capacity as Receiver appointed by the High Court of Calcutta; and
  • Misrepresentation of facts with regard to the misappropriation of money before the High Court of Calcutta

 

General observations of the Committee on the case:

  • Justice Sen’s assertion that he had the right to remain silent during the investigations was fallacious.
  • He did not cooperate with the Court proceedings; was not present for hearings, did not furnish information requested by the Court and did not provide any evidence in his defence.

 

Facts and Findings of the investigation by the Committee:

a. During the period he was an Advocate:

  • Justice Soumitra Sen was appointed Receiver in a case by an order of the Calcutta High Court on April 30, 1984. A Receiver appointed by the High Court has the power to collect outstanding debts and claims due in respect of certain goods.
  • As required by the High Court, the Receiver should file and submit for passing,     his half yearly accounts in the Office of the Registrar of the High Court. However, Justice Sen did not comply with this rule both as an Advocate and a Judge.
  • The High Court requires the Receiver to open only one account and not move funds without prior permission. However, the Committee found that two separate accounts were opened by Justice Soumitra Sen as Receiver, with ANZ Grindlays Bank and Allahabad Bank.
  • A total sum of Rs 33,22,800 was transferred in these accounts from the sale of proceeds of the goods which was not accounted for either when Justice Sen was an Advocate or when he was made a High Court Judge.
  • Justice Sen claimed he could not account for this amount since it was invested in a company called Lynx India Ltd. to earn interest. The Committee found this claim to be false as well.
  • The Committee concluded that this was a case of misappropriation of funds as both of the Receiver’s bank accounts were closed with a nil balance without any investments being made on behalf of the High Court.

b. During the period he was a Judge:

  • Justice Soumitra Sen was appointed a High Court Judge on December 3, 2003. The committee noted that Justice Sen’s actions were, “an attempt to cover up the large-scale defalcations of Receiver’s funds”.
  • After he became a Judge he did not seek any permission from the Court for approval of the dealings, as required by the Court, nor did he account for the funds.

Conclusion

Based on the findings on the two charges the Inquiry Committee was of the opinion that Justice Soumitra Sen of the Calcutta High Court is guilty of “misbehaviour”.

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