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Legislation

Lapses in the process of drug approval in India

Sakshi - May 29, 2012

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.
Policy

National Telecom Policy 2012

admin_2 - July 2, 2012

The National Telecom Policy was adopted by the cabinet on May 31, 2012.  It was released in public domain later in June.  Among other things, the policy aims to provide a single licence framework, un-bundle spectrum from licences, and liberalise spectrum. Previously, the central government had decided to unbundle spectrum and licenses for all future licences on January 29, 2011.  TRAI too in its recommendation dated May 11, 2010 and April 23, 2012 sought to de-link spectrum from licences.  The Supreme Court in the 2G judgment had held that spectrum should not be allocated on a first-cum-first-serve basis and should instead be auctioned.  In the April 23 recommendations, TRAI has detailed the mechanism for auctioning spectrum. TRAI has also recommended moving to a unified licence framework under which a single licence would be required to provide any telecom service.  It has also recommended that spectrum should be liberalised so that any technology could be used to exploit it. The new policy is in line with the government decisions and TRAI recommendations discussed above.  The policy also aims to achieve higher connectivity and quality of telecommunication services.  Its key features are detailed below.

  • Licensing:  Presently, as per the 2003 Amendment to the 1999 Telecom Policy, there are two forms of licences – Unified Service Licence (to provide any telegraph service in various geographical areas) and Unified Access Service Licence (to provide basic and cellular services in defined service areas).  The new policy targets simplification of licensing framework by establishing a unified license for all telecom services and conversion to a single-license system for the entire country.  It also seeks to remove roaming charges.
  • Spectrum:  As of now spectrum bands are reserved on the basis of technology that may be used to exploit them.  For instance, the 900 and 1800 bands are reserved for GSM technology and 800 for use of CDMA technology.  The new policy seeks to liberalise spectrum.  Further, spectrum would be de-linked from all future licenses.  Spectrum would be refarmed so that it is available to be used for new technology.  The policy aims to move to a system where spectrum can be pooled, shared and traded.  Periodic audits of spectrum usage would be conducted to ensure efficient utilization of spectrum.  The policy aims at making 300 MHz of additional spectrum available for mobile telecom services by the year 2017 and another 200 MHz by 2020.
  • Connectivity: The policy aims to increase rural tele-density from the current level of approximately 39% to 70% by 2017, and 100% by 2020.  It seeks to provide 175 million broadband connections by the year 2017 and 600 million by 2020 at a minimum 2 Mbps download speed.  Higher download speeds of 100 Mbps would be made available on demand.  Broadband access to all village panchayats would be made available by 2014 and to all villages by 2020.  The policy aims to recognise telecom, including broadband connectivity, as a basic necessity like education and health, and work towards the ‘Right to Broadband’.
  • Promotion of domestic industry: The policy seeks to incentivise and give preference to domestic telecom products in procurements that (i) have security implications for India; or (ii) are for the government’s own use.  It also seeks to establish a Telecom Finance Corporation to mobilise and channelise finances for telecom projects.
  • Legislations: The policy seeks to review the TRAI Act to remove impediments to effective functioning of TRAI.  It also seeks to review the Indian Telegraph Act, 1885.  The need to review the Indian Telegraph Act, 1885 was also recognised in the 1999 Telecom Policy.

The policy as adopted can be accessed here.

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