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 is expected to take up a motion for impeaching Justice Soumitra Sen of the Calcutta High Court.  We wrote an FAQ on the process of impeachment and the facts of this case for Rediff. See: http://www.rediff.com/news/report/faq-on-impeachment-of-judges/20110816.htm The full text is reproduced below. What is the importance of Parliament's discussion on the Justice Sen issue? The Rajya Sabha is scheduled to discuss a motion for the removal of Justice Soumitra Sen of the Calcutta High Court.  Till date, no judge of the higher judiciary (Supreme Court and High Courts) has been successfully impeached. What is the legal framework regarding impeachment of judges? The Constitution has measures to ensure the independence of the judiciary from executive action.  This helps judges give judicial decisions in a free and fair manner without any inducements. The Constitution also provides checks against misbehaviour by judges.  It states that a judge may be removed only through a motion in Parliament with a two thirds support in each House.  The process is laid down in the Judges (Inquiry) Act, 1968. How is the motion initiated?  What is the process after that? A motion has to be moved by either 100 Lok Sabha members of Parliament or 50 Rajya Sabha MPs.  If the motion is admitted, the Speaker of Lok Sabha or Chairman of Rajya Sabha constitutes an inquiry committee. The committee has three members: a Supreme Court judge, a High Court Chief Justice, and an eminent jurist.  The Committee frames charges and asks the judge to give a written response. The judge also has the right to examine witnesses.  After the inquiry, the committee determines whether the charges are valid or not.  It then submits its report. What happens then? If the inquiry committee finds that the judge is not guilty, then there is no further action.  If they find him guilty, then the House of Parliament which initiated the motion may consider continuing with the motion. The motion is debated.  The judge (or his representative) has the right to represent his case.  After that, the motion is voted upon.  If there is two-thirds support of those voting, and majority support of the total strength of the House, it is considered to have passed.  The process is then repeated in the other House. After that, the Houses send an address to the President asking that the judge be removed from office. Has this process taken place earlier? Yes, there has been one such case.  Justice Ramaswamy of the Supreme Court faced such a motion.  The inquiry committee found that the charges against him were valid.  However, the motion to impeach him did not gather the required support in Lok Sabha. What are the charges against the Justice Sen? There are two charges.  He is accused of misappropriating large sums of money which he received as a receiver appointed by the Calcutta High Court.  He is also accused of misrepresenting facts in this regard to the High Court. What is the charge of misappropriation?  What did the inquiry committee conclude? Justice Soumitra Sen was appointed Receiver in a case by an order of the Calcutta High Court on April 30, 1984. As a Receiver, Justice Sen had the power to collect outstanding debts and claims due in respect of certain goods. The Receiver is required to 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.  As a Receiver, Justice Sen was required to open only one account and not move funds without prior permission. However, the Inquiry 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 over Rs 33 lakh was transferred in these accounts from the sale of the goods which was unaccounted for. 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 Inquiry Committee found this claim to be false as well. It was found that the amount transferred to Lynx India Ltd. had been made out of an account opened by Justice Sen in his own name.  The Committee concluded that (a) there was a large-scale diversion of fund, and (b) such diversion was in violation of the orders of the High Court. The purpose for such diversion remains unexplained. This action was done by him as an advocate? Are there any charges against him after he was appointed as a judge? Justice Soumitra Sen was appointed a High Court Judge on December 3, 2003. The Inquiry 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. Is there any other case?  What is the status? Another such motion has been initiated against Chief Justice Dinakaran of Sikkim High Court.  An Inquiry Committee is looking investigating the issue.  However, Mr Dinakaran has reportedly sent in his resignation to the President.  If the resignation is accepted, then the motion to remove him will become ineffective.