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 last few days have seen repeated disruptions in Parliament. In an Opinion Editorial published in the Indian Express, Chakshu Roy of PRS Legislative Research discusses the impact of the current disruptions on Parliament. His analysis points to how disruptions are an opportunity lost  to hold the government accountable and to deliberate on significant legislative and policy issues. The second half of the budget session commenced last week with hardly any business transacted due to disruptions on different issues. This is not new. The 15th Lok Sabha has seen entire parliamentary sessions lost without any work being done. As it nears the end of its term, Parliament's productive time stands at 70 per cent, which is significantly lower than that of previous Lok Sabhas. As disruptions in Parliament have become routine, public reaction to such disruptions has also become predictable. Figures depicting the quantum of taxpayers' money lost every hour that Parliament does not function start doing the rounds, and the cry for docking the salary of disrupting members of Parliament becomes louder. What does not get adequate attention is the opportunity lost for holding the government accountable and deliberating on important legislative and policy issues. MPs are required to keep the government in check and oversee its functioning. One of the ways in which they do so is by asking ministers questions about the work done by their ministries. Ministers respond to such questions during the first hour of Parliament, which is known as question hour. During this hour, 20 questions are slotted for oral responses by ministers. Based on the response, MPs can cross-question and corner the minister by asking supplementary questions. On certain occasions, they are also able to extract assurances from the minister to take action on certain issues. When question hour is disrupted, not only are these opportunities lost, it also leads to ineffective scrutiny of the work done by the various ministries of the government. Last week, some of the questions that could not be orally answered related to four-laning of highways, performance of public sector steel companies, supply of food grains for welfare schemes, and generic versions of cancer drugs. In 2012, out of the 146 hours allocated for question hour in both Houses of Parliament, roughly only 57 hours were utilised. Since the beginning of the 15th Lok Sabha in 2009, approximately 43 per cent of the allocated time has been spent on question hour. When Parliament is disrupted regularly, its capacity to make laws is affected. Excluding routine financial legislation, since 2009, the government had planned to introduce 390 bills. So far, it has been able to introduce only 187 of them. It had also planned to have 365 bills scrutinised and passed by Parliament. So far, 96 of them have received parliamentary approval. Disruptions in Parliament also eat into the time available for discussing a bill in the house. In Lok Sabha, roughly 35 per cent of bills were passed with an hour or less of debate, a case being the sexual harassment bill, which was passed by Lok Sabha in September of last year in 16 minutes. Some would argue that since parliamentary committees scrutinise most bills in detail, there is no harm done if the bills are not debated in the House. However scrutiny of a bill behind closed doors is hardly a substitute for spirited debates on the merits and demerits of a bill on the floor of the House. Currently there are 115 bills awaiting parliamentary scrutiny and approval. Important social and economic legislation is currently pending before Parliament. The food security bill, the land acquisition bill, the companies and the goods and services tax bill are just a few of them. Out of the laundry list of pending bills, some are political and may be stuck in Parliament till consensus around them can be built. But there are a number of bills that are administrative in nature, and have no political undercurrents and are possibly not coming up for discussion because of the limited time that is available for legislative debate on account of frequent disruptions. In September 1997, to celebrate the golden jubilee of the country's Independence, a special session of Parliament was convened. At this special session, MPs had resolved to preserve and enhance the dignity of Parliament by adhering to the rules of procedure of Parliament relating to the orderly conduct of parliamentary proceedings. Last year, Parliament completed 60 years since its first sitting. To mark the occasion, another special session of both Houses was convened, where MPs had resolved to uphold the dignity, sanctity and supremacy of Parliament. Ensuring that the proceedings of both Houses run smoothly so that Parliament can discharge its responsibility effectively is the best way of ensuring its supremacy. The question that needs to be asked is whether our members of Parliament are ready to stand by the resolutions that they voluntarily adopted.