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.

The doctrine of separation of powers implies that each pillar of democracy – the executive, legislature and the judiciary – perform separate functions and act as separate entities.  The executive is vested with the power to make policy decisions and implement laws.  The legislature is empowered to issue enactments.  The judiciary is responsible for adjudicating disputes.  The doctrine is a part of the basic structure of the Indian Constitution[1] even though it is not specifically mentioned in its text.  Thus, no law may be passed and no amendment may be made to the Constitution deviating from the doctrine.  Different agencies impose checks and balances upon each other but may not transgress upon each other’s functions.  Thus, the judiciary exercises judicial review over executive and legislative action, and the legislature reviews the functioning of the executive. There have been some cases where the courts have issued laws and policy related orders through their judgements.  These include the Vishakha case where guidelines on sexual harassment were issued by the Supreme Court, the order of the Court directing the Centre to distribute food grains (2010) and the appointment of the Special Investigation Team to replace the High Level Committee established by the Centre for investigating black money deposits in Swiss Banks. In 1983 when Justice Bhagwati introduced public interest litigation in India, Justice Pathak in the same judgement warned against the “temptation of crossing into territory which properly pertains to the Legislature or to the Executive Government”[2].  Justice Katju in 2007 noted that, “Courts cannot create rights where none exist nor can they go on making orders which are incapable of enforcement or violative of other laws or settled legal principles. With a view to see that judicial activism does not become judicial adventurism the courts must act with caution and proper restraint. It needs to be remembered that courts cannot run the government. The judiciary should act only as an alarm bell; it should ensure that the executive has become alive to perform its duties.” [3] While there has been some discussion on the issue of activism by the judiciary, it must be noted that there are also instances of the legislature using its law making powers to reverse the outcome of some  judgements.  (M.J. Antony has referred to a few in his article in the Business Standard here.)  We discuss below some recent instances of the legislature overturning judicial pronouncements by passing laws with retrospective effect. On September 7, 2011 the Parliament passed the Customs Amendment and Validation Bill, 2011 which retrospectively validates all duties imposed and actions taken by certain customs officials who were not authorized under the Customs Act to do the stated acts.  Some of the duties imposed were in fact challenged before the Supreme Court in Commissioner of Customs vs. Sayed Ali in 2011[4].  The Supreme Court struck down the levy of duties since these were imposed by unauthorised officials.  By passing the Customs Bill, 2011 the Parliament circumvented the judgement and amended the Act to authorize certain officials to levy duties retrospectively, even those that had been held to be illegal by the SC. Another instance of the legislature overriding the decision of the Supreme Court was seen in the Essential Commodities (Amendment) Ordinance, 2009 which was passed into an Act.  The Supreme Court had ruled that the price at which the Centre shall buy sugar from the mill shall include the statutory minimum price (SMP) and an additional amount of profits that the mills share with farmers.[5] The Amendment allowed the Centre to pay a fair and remunerative price (FRP) instead of the SMP.  It also did away with the requirement to pay the additional amount.  The amendment applied to all transactions for purchase of sugar by the Centre since 1974.  In effect, the amendment overruled the Court decision. The executive tried to sidestep the Apex Court decision through the Enemy Property (Amendment and Validation) Ordinance, 2010.  The Court had issued a writ to the Custodian of Enemy Property to return possession of certain properties to the legal heir of the owner.   Subsequently the Executive issued an Ordinance under which all properties that were divested from the Custodian in favour of legal heirs by a Court order were reverted to him.  The Ordinance lapsed and a Bill was introduced in the Parliament.  The Bill is currently being examined by the Parliamentary Standing Committee on Home Affairs. These examples highlight some instances where the legislature has acted to reverse judicial pronouncements.  The judiciary has also acted in several instances in the grey areas separating its role from that of the executive and the legislature.  The doctrine of separation of powers is not codified in the Indian constitution.  Indeed, it may be difficult to draw a strict line demarcating the separation.  However, it may be necessary for each pillar of the State to evolve a healthy convention that respects the domain of the others.  


[1] Keshavananda Bharti vs. State of Kerala  AIR 1973 SC 1461

[2] Bandhua Mukti Morcha  AIR 1984 SC 802

[3] Aravali Golf Club vs. Chander Hass  (2008) 1 SCC (L&S) 289

[4] Supreme Court in Commissioner of Customs vs. Sayed Ali (2011) 3 SCC 537

[5] Mahalakshmi Mills vs. Union of India (2009) 16 SCC 569