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.

Yesterday the Rajya Sabha and Lok Sabha engaged in a debate on the President's speech, known as the Motion of Thanks. The President's speech is a statement of the legislative and policy achievements of the government during the preceding year and gives a broad indication of the agenda for the year ahead. Close to the end of the UPA government’s term, it would be useful to evaluate the status of the commitments made in the President’s addresses. (To know more about the significance of the President’s speech refer to this Indian Express article. To understand the broad policy and legislative agenda outlined in this year's address see this PRS Blog.) The President's speeches since the beginning of the 15th Lok Sabha in 2009, have addressed reforms to the financial and social sectors, improving accountability of public officials, and making the delivery of public services more efficient.  We analyse the status of each of these commitments. Accountability in governance processes In an effort to increase accountability and transparency in governance processes, the government introduced a number of Bills.

  • The the Lokpal and Lokayukta Bill and the Judicial Standards and Accountability Bill enable individuals to file complaints against judges and other government officials for corruption and misbehaviour.
  • The Whistleblowers Bill has been introduced to protect persons who are making disclosures on corruption, on the misuse of power and on criminal offences by public servants.

These bills have been passed by the Lok Sabha and are pending in the Rajya Sabha.  The government has recently approved amendments to the Lokpal Bill, which may be considered by the Rajya Sabha in the Budget session. Public service delivery In order to make public service delivery more efficient, the government introduced the Electronic Services Delivery Bill and the Citizen’s Charter Bill.

  • The Electronic Services Delivery Bill aims to deliver all government services electronically .
  • The Citizens Charter Bill creates a grievance redressal process for complaints against the functioning of any public authority.
  • Both Bills are pending in the Lok Sabha since introduction in December 2011.
  • Related initiatives include linking the delivery of public services to Aadhaar and moving towards the cash transfer of subsidies. On January 1, 2013, the government piloted cash transfers to deliver subsidies for scholarships and pensions.

Social sector reforms: land, food security and education Broad sectoral reforms have been undertaken in land acquisition, food security and education to aid development and economic growth.

  • Land:  In 2011, the government introduced the Land Acquisition, Rehabilitation and Resettlement Bill. The Standing Committee Report on the Bill was released in May last year, based on which the government circulated a list of amendments to the Bill in December 2012.
  • Education: Elementary and middle school education saw reform in 2009 with the passage of the Right to Education Act (RTE Act). This legislation provides every child between the age of six to fourteen years with the right to free and compulsory education. As per the law, by March 2013 all schools are to conform to the minimum standards prescribed. States have expressed concerns over their preparedness in meeting this requirement and it remains to be seen how the government addresses this issue.
  • Food security: The National Food Security Bill is pending in Parliament since 2011. The Bill seeks to make food security a legal entitlement, reform the existing Public Distribution System and explore innovative mechanisms such as cash transfer and food coupons for the efficient delivery of food grains. The Standing Committee gave its recommendations on the Bill in January this year.

Financial sector reforms In order to aid growth and encourage investments, the President had mapped out necessary financial sector reforms.

  • Taxation: The Direct Taxes Code has been introduced in Parliament to enhance tax realisation. However, even though the Standing Committee has presented its report, there has been little progress on the Bill. Efforts are underway to build political consensus on the Goods and Services Tax to rationalise indirect taxes.
  • Regulation of specific sectors: A bill to regulate the pension sector has been introduced in Parliament. Other financial sector reforms include a new Companies Bill, amendments to the Banking laws and a bill regulating the insurance sector.  Amendments to the banking laws have been approved by Parliament, while those to the Companies Bill have only been passed by the Lok Sabha.

In the backdrop of these legislations, it will be interesting to see the direction the recommendations of the Financial Sector Legislative Reforms Commission, responsible for redrafting all financial sector regulation, takes. Internal security The government is taking measures to deal with internal security concerns such as terrorism and naxalism. In 2009, the President mentioned that the government has proposed the setting up of a National Counter Terrorism Centre. However, this has been on hold since March 2011. At the beginning of the 15th Lok Sabha in June 2009, the President presented the 100 day agenda of the UPA II government, in his address. Of the eight bills listed for passing within 100 days, none have been passed. In addition, the President’s address in 2009 mentioned five other Bills, from which, only the RTE Act has been passed.  In the final year of its tenure, it needs to be seen what are the different legislative items and economic measures, on which the government would be able to build consensus across the political spectrum.