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.

In an Indian express editorial, Mandira Kala discusses the Bills, addressing corruption and good governance, pending in Parliament.  She discusses what their fate may be given that the Monsoon session is widely being viewed as a make or break session  for the government to get its legislative agenda through Parliament. The monsoon session of Parliament started on a stormy note last week. Question hour was disrupted on most days and only one government bill was passed. There are 11 days left in the session and more than 40 bills pending for parliamentary approval. With the 15th Lok Sabha drawing to an end, this session is being viewed as a "make or break" session for the government to get its legislative agenda through Parliament. Since 2010, there has been much debate in Parliament on corruption and an important part of the government's legislative agenda was the introduction of nine bills in the Lok Sabha to address corruption and improve governance through effective delivery of public services. Three of these bills have been passed by the Lok Sabha and are currently pending before the Rajya Sabha. These include legislation to address corruption in public office, enforce standards and accountability in the judiciary, and protect whistleblowers. The government has proposed amendments to each of these bills that the Rajya Sabha will have to consider and pass. If the Rajya Sabha passes these bills with amendments, they will be sent back to the Lok Sabha for approval. It is difficult to assess in what timeframe these bills will become law, given that both Houses need to agree on the amendments. The Lokpal and Lokayuktas Bill creates a process for receiving and investigating corruption complaints against public officials, including the Prime Minister, Ministers and Members of Parliament, and prosecuting these in a timebound manner. The government amendments include allowing states the flexibility to determine their respective Lokayuktas and giving the Lokpal power of superintendence over the CBI, if the case has been referred by him. A mechanism to protect whistleblowers and create a process for receiving and investigating complaints of corruption or wilful misuse of discretion against a public servant are proposed under the Whistleblowers' Protection Bill, 2010. The amendments proposed by the government prohibit whistleblowing if the disclosure of information affects the sovereignty of the country and its strategic, scientific and economic interest. The Judicial Standards and Accountability Bill requires judges to declare their assets, lays down judicial standards and establishes processes for the removal of judges of the Supreme Court and high courts. The bill is not listed in the government's legislative agenda for the monsoon session and media reports suggest that the government intends to make amendments to it. In the arena of strengthening governance and effective delivery of public services, there are three bills currently pending in Parliament. The Citizens' Charter Bill confers the right to timebound delivery of goods and services on every citizen and creates a mechanism for redressing complaints on such matters. The Electronic Delivery of Services Bill mandates that Central and state governments shall deliver public services electronically no later than eight years from the enactment of the law. The parliamentary standing committee had highlighted that the Citizens' Charter Bill and Electronic Delivery of Services Bill have an inherent overlap, which the government would have to resolve. While the former is listed for passing in this session, the government plans to withdraw the latter and replace it with a new bill. This new bill is not part of the list that is up for consideration and passing this session. To create a reliable method of identifying individuals to facilitate their access to benefits and services the National Identification Authority of India Bill was introduced in Parliament to provide unique identification numbers ("aadhaar") to residents of India. This bill has not been listed for parliamentary approval during this session. Two other pending bills do not find place in the government's legislative agenda for the session either. These include legislation that curbs the holding and transfer of benami property and regulates the procurement process in government departments to ensure transparency, accountability and probity. The Prevention of Bribery of Foreign Public Officials Bill, which imposes penalties on Indian companies and individuals who bribe officials of a foreign government or international agency, is listed for passing this session. Each of these nine bills were introduced in the Lok Sabha. If they are not passed by both Houses before the 15th Lok Sabha is dissolved in 2014, no matter where they are in the legislative process, the bills will lapse. This implies that the entire legislative process will have to start all over again, if and when there is political will to legislate on these issues in the 16th Lok Sabha. The challenges in getting legislation passed by Parliament are many, given that its overall productive time, especially time spent on legislation, is decreasing. Typically, Parliament spends about 25 per cent of its time debating legislation, but in the past few years this average has declined to 15 per cent. While the time lost by the House due to frequent adjournments is difficult to make up, parliamentarians will have to cautious about passing bills without the rigours of parliamentary debate. It is uncertain what the trajectory of the anti-corruption legislation in Parliament will be — enacted as law or resigned to a pool of lapsed legislation.