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 light of recent debates surrounding the implementation of the Mid Day Meal Scheme (MDMS) in certain states, it is useful to understand the basic features of the scheme. The MDMS is the world’s largest school meal programme and reaches an estimated 12 crore children across 12 lakh schools in India. A brief introduction follows, outlining the key objectives and provisions of the scheme; modes of financing; monitoring and evaluation mechanisms and issues with implementation of the scheme. Examples of 'best practices' and major recommendations made by the Planning Commission to improve the implementation of the scheme are also mentioned. Provisions:  The MDMS emerged out of the National Programme of Nutritional Support to Primary Education (NP – NSPE), a centrally sponsored scheme formulated in 1995 to improve enrollment, attendance and retention by providing free food grains to government run primary schools. In 2002, the Supreme Court directed the government to provide cooked mid day meals (as opposed to providing dry rations) in all government and government aided primary schools.[1] Calorie norms for the meals have been regularly revised starting from 300 calories in 2004, when the scheme was relaunched as the Mid Day Meal Scheme. At present the MDMS provides children in government aided schools and education centres a cooked meal for a minimum of 200 days.[2] Table 1 outlines the prescribed nutritional content of the meals. Table 1: Prescribed nutritional content for mid day meals 

Item Primary (grade 1-5) Upper Primary(grade 6-8)
Calories 450 700
Protein (in grams) 12 20

Source: Annual Report, 2011 – 12, Ministry of Human Resource Development, Government of India; PRS. Objectives: The key objectives of the MDMS are to address the issues of hunger and education in schools by serving hot cooked meals; improve the nutritional status of children and improve enrollment, attendance and retention rates in schools and other education centres. Finances: The cost of the MDMS is shared between the central and state governments. The central government provides free food grains to the states. The cost of cooking, infrastructure development, transportation of food grains and payment of honorarium to cooks and helpers is shared by the centre with the state governments. The central government provides a greater share of funds. The contribution of state governments differs from state to state. Table 2 outlines the key areas of expenditure incurred by the central government under the MDMS for the year 2012 – 2013. Table 2: Key areas of expenditure in the MDMS (2012 - 2013)

Area of expenditure                                      Percentage of total cost allocated
Cooking cost 53
Cook / helper 20
Cost of food grain 14
Transportation assistance 2
Management monitoring and evaluation 2
Non recurring costs 10

Source: Ministry of Human Resource Development; Fourth NSCM Committee meeting, August 24, 2012; PRS. Monitoring and Evaluation: There are some inter state variations in the monitoring and evaluation mechanisms of the MDMS.  A National Steering cum Monitoring Committee and a Programme Approval Board have been established at the national level, to monitor the programme, conduct impact assessments, coordinate between state governments and provide policy advice to central and state governments. Review Missions consisting of representatives from central and state governments and non governmental agencies have been established. In addition, independent monitoring institutions such as state universities and research institutions monitor the implementation of the scheme. At the state level, a three tier monitoring mechanism exists in the form of state, district and block level steering cum monitoring committees. Gram panchayats and municipalities are responsible for day to day supervision and may assign the supervision of the programme at the school level to the Village Education Committee, School Management and Development Committee or Parent Teacher Association. Key issues with implementation: While there is significant inter-state variation in the implementation of the MDSM, there are some common concerns with the implementation of the scheme. Some of the concerns highlighted by the Ministry for Human Resource Development based on progress reports submitted by the states in 2012 are detailed in Table 3. Table 3: Key implementation issues in the MDMS

Issue State(s) where these problems have been reported
Irregularity in serving meals Karnataka, Madhya Pradesh, Orissa, Rajasthan, Maharashtra, Arunachal Pradesh
Irregularity in supply of food grains to schools Orissa, Maharashtra, Tripura, Karnataka, Arunachal Pradesh, Meghalaya, Delhi, Andhra Pradesh
Caste based discrimination in serving of food Orissa, Rajasthan, Madhya Pradesh
Poor quality of food Rajasthan, Tamil Nadu, Delhi, Chhattisgarh
Poor coverage under School Health Programme Orissa, Jharkhand, Madhya Pradesh, Rajasthan, Uttar Pradesh, Manipur, Arunachal Pradesh, Himachal Pradesh, Chhattisgarh
Poor infrastructure (kitchen sheds in particular) Andhra Pradesh, Tamil Nadu, Puducherry, Gujarat, Chandigarh, Himachal Pradesh, Jammu and Kashmir, Orissa
Poor hygiene Delhi, Rajasthan, Puducherry,
Poor community participation Most states – Delhi, Jharkhand, Manipur, Andhra Pradesh in particular

Source: Ministry of Human Resource Development; PRS. Best practices: Several state governments have evolved practices to improve the implementation of the MDMS in their states. These include involving mothers of students in implementation of the scheme in Uttarakhand and Jharkhand; creation of kitchen gardens, i.e., food is grown in the premises of the school, in Andhra Pradesh, Karnataka, Punjab and West Bengal; construction of dining halls in Tamil Nadu; and increased community participation in the implementation of the scheme Gujarat. More information is available here. Planning Commission evaluation of MDMS: In 2010, a Planning Commission evaluation of the MDMS made the following recommendations to improve implementation of the scheme: i. Steering cum monitoring committees at the district and block levels should be made more effective. ii. Food grains must be delivered directly to the school by the PDS dealer. iii. The key implementation authority must be made responsible for cooking, serving food and cleaning utensils, and school staff should have a supervisory role.  The authority should consist of local women’s self help groups or mothers of children studying in the schools. iv. Given the fluctuating cost of food grains, a review of the funds allocated to the key implementation authority must be done at least once in 6 months. v. Services might be delivered through private providers under a public private partnership model, as has been done in Andhra Pradesh.


[1] PUCL vs. Union of India, Writ Petition (Civil) 196 of 2001. [2] The following institutions are covered: Government and government aided schools, National Child Labour Project (NCLP) schools, Education Guarantee Scheme (EGS) and Alternative and Innovative Education (AIE) centres including Madrasas and Maqtabs supported under the SSA