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 Union government’s Cabinet Committee on Security recently gave clearance to the Home Ministry’s NATGRID project.  The project aims to allow investigation and law enforcement agencies to access real-time information from data stored with agencies such as the Income Tax Department, banks, insurance companies, Indian Railways, credit card transactions, and more.  NATGRID, like a number of other government initiatives (UIDAI), is being established through governmental notifications rather than legislation passed in Parliament.  The examination of this issue requires an assessment of the benefits of legislation vis-a-vis government notifications. Government notifications can be issued either under a specific law, or independent of a parent law, provided that the department issuing such notification has the power to do so.  Rules, regulations which are notified have the advantage of flexibility since they can be changed without seeking Parliamentary approval. This advantage of initiating projects or establishing institutions through government notifications is also potentially of detriment to the system of checks and balances that a democracy rests on.  For, while legislation takes a longer time to be enacted (it is discussed, modified and debated in Parliament before being put to vote), this also enables elected representatives to oversee various dimensions of such projects.  In the case of NATGRID, the process would provide Parliamentarians the opportunity to debate the conditions under which private individual information can be accessed, what information may be accessed, and for what purpose.  This time consuming process is in fact of valuable import to projects such as NATGRID which have a potential impact on fundamental rights. Finally, because changing a law is itself a rigorous process, the conditions imposed on the access to personal information attain a degree of finality and cannot be ignored or deviated from.  Government rules and regulations on the other hand, can be changed by the concerned department as and when it deems necessary.  Though even governmental action can be challenged if it infringes fundamental rights, well-defined limits within laws passed by Parliament can help provide a comprehensive set of rules which would prevent their infringement in the first place. The Parliamentary deliberative process in framing a law is thus even more important than the law itself.  This is especially so in cases of government initiatives affecting justiciable rights.  This deliberative process, or the potential scrutiny of government drafted legislation on the floor of Parliament ensures that limitations on government discretion are clearly laid down, and remedies to unauthorised acts are set in stone.  This also ensures that the authority seeking to implement the project is The other issue pertains to the legal validity of the project itself.  Presently, certain departmental agencies maintain databases of personal information which helps them provide essential services, or maintain law and order.  The authority to maintain such databases flows from the laws which define their functions and obligations.  So the power of maintaining legal databases is implicit because of the nature of functions these agencies perform.  However, there is no implicit or explicit authorization to the convergence of these independent databases. One may argue that the government is not legally prevented from interlinking databases.  However, the absence of a legal challenge to the creation of NATGRID does not take away from the importance of establishing such a body through constitutionally established deliberative processes.  Therefore, the question to be asked is not whether NATGRID is legally or constitutionally valid, but whether it is important for Parliament to oversee the establishment of NATGRID. In October 2010, the Ministry of Personnel circulated an “Approach paper for a legislation on privacy”.  The paper states: “Data protection can only be ensured under a formal legal system that prescribes the rights of the individuals and the remedies available against the organization that breaches these rights. It is imperative, if the aim is to create a regime where data is protected in this country, that a clear legislation is drafted that spells out the nature of the rights available to individuals and the consequences that an organization will suffer if it breaches these rights.” As the lines above exemplify, it is important for a robust democracy to codify rights and remedies when such rights may be potentially affected.  The European Union and the USA, along with a host of other countries have comprehensive privacy laws, which also lay down conditions for access to databases, and the limitations of such use.  The UIDAI was established as an executive authority, and still functions without statutory mandate.  However, a Bill seeking to establish the body statutorily has been introduced, and its contents are being debated in the Parliamentary Standing Committee on Finance and the Bill has also been deliberated on by civil society at large. A similar approach is imperative in the case of NATGRID to uphold the sovereign electorate’s right to oversee institutions that may affect it in the future.