india-map

FIND YOUR MP

Switch to Hindi (हिंदी)
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.
Constitution

Report of the Group of Interlocutors for Jammu and Kashmir

Pallavi - May 25, 2012

The central government appointed the J&K Interlocutors Group on October 13, 2010.  The Group submitted the Report to the Home Ministry earlier this year.  The Report was made public by the Home Ministry on May 24, 2012. It may be noted that under Article 370 of the Constitution special status has been granted to the State of Jammu and Kashmir.  The power of the Parliament to legislate is restricted to defence, external affairs, communication and central elections.  However, the President may with the concurrence of the state government extend other central laws to the state.  Furthermore, in 1952, an agreement known as the Delhi Agreement was entered into between the state of Jammu and Kashmir and the central government.  The Agreement too provided that the state government shall have sovereignty on all subjects except for matters specified above.  However, since then some central laws relating to other subjects such as environment have been made applicable to the state. This blog post divides the recommendation into two broad headings: political; and socio-economic.  It also looks at the roadmap proposed by the Group to achieve these recommendations. Political recommendations:

  • The Group recommended that a Constitutional Committee (CC) should be set up to review all the central Acts that have been extended to the state of Jammu and Kashmir since 1952.  The CC should come out with its findings within six months.  According to the Group, the CC should review whether, and to what extent, the application of central acts to the state has led to an erosion of the state's special status.
  • The word ‘Temporary’ in Article 370 should be replaced with ‘Special’ which has been used for certain states such as Assam, Nagaland, Andhra Pradesh[1].
  • Central laws shall only be made applicable to the state if they relate to the country's security or a vital economic interest, especially in the areas of energy and water resources.
  • Currently, the Governor is appointed by the President.  The Group recommended that the state government shall give three names for consideration for the position to the President.  However, the Governor shall finally be appointed by the President.
  • Separate Regional Councils for Jammu, Kashmir and Ladakh should be created and certain legislative, executive and financial powers should be devolved to them.  The subjects that could be transferred to the Regional Council include prison reforms, public health, roads and bridges and fisheries.

Cultural, Economic and Social Recommendations:

  • There are 16 centrally sponsored schemes which are mostly funded by the centre.  However, most of the funds for these schemes have not been utilised properly.  The Group recommended that an effective system to monitor these schemes should be put in place.
  • An expert committee to review the state’s financial needs should be constituted.
  • The central government should tap the hydro-electricity potential of the state.  Till date only 15 per cent of the potential has been harnessed.  Additional hydro-electricity projects should be established for which the central government should meet the entire equity capital.
  • Industrial establishments and other buildings occupied by the security officers should be vacated.
  • Financial package of incentives on the pattern given to the North Eastern States should be given to the state.
  • The hilly, remote areas should be declared as special development zones.
  • The restrictions on the internet and mobile phones should be reviewed.

In order to fulfil these recommendations, the Interlocutor’s Group proposed the following roadmap:

  • The ‘stone pelters’ and political prisoners against whom no serious charges have been framed should be released.
  • There should an amendment and review of the Armed Forces Special Powers Act, 1990 and the Jammu and Kashmir Public Safety Act, 1978.
  • The state policy should provide for the return of Kashmiri Pandits.
  • A judicial commission to supervise the identification of bodies buried in the unmarked graves should be established.

The full report may be accessed here. Sources:

[1] Article 371 provides certain ‘special provisions’ with respect to states of Maharashtra, Gujarat, Nagaland, Assam, Manipur, Andhra Pradesh and Sikkim

Recent Posts

  1. 1. A note of gratitude to Mr. N. Vaghul
  2. 2. What is Fuelling Power Sector Losses?
  3. 3. First no-confidence motion of the 17th Lok Sabha discussed today
  4. 4. Anti-cheating laws for competitive examinations
  5. 5. Uttarakhand Assembly concludes 2-day session; 13 Bills introduced and passed