On June 3, 2011, the National Advisory Council (NAC) posted the draft of the National Food Security Bill on its website and has asked for public feed back on the Bill by June 12, 2011. Key Features of the Draft National Food Security Bill, 2011 -          Every person shall have the right of access to sufficient and safe food either directly or by purchasing the food. -          The central and state government shall share the financial cost of procuring, storing and distributing food grains to the population entitled to it. -          There are special provisions for pregnant and lactating mothers, children in the 0-6 age group, destitute persons, homeless persons and disaster affected persons.  The appropriate government shall take immediate steps to provide relief to persons living in starvation. -          The state government shall provide all children upto class 8 freshly cooked meal in all schools run by local bodies and the government.  It shall also provide mid-day meals to children who are admitted under the 25% quota for children belonging to disadvantaged groups in unaided private schools -          Each household shall be categorised into priority and general in rural and urban areas. -          Each individual in the priority group households shall be entitled to at least 7kg of grain every month at a maximum price of Rs 3/kg for rice, Rs 2/kg for wheat and Rs 1/kg for millets. -          Each individual in the general group households shall be entitled to 4kg of grain per month at 50 per cent of the Minimum Support Price for paddy, wheat and millet. -          The state government can exclude certain persons who fulfil the exclusion criteria in rural and urban areas.  However, it has to cover at least 90% of the population in rural areas and 50% of the population in urban areas. -          The Bill lays down norms for procurement, storage and distribution of food grains under the Public Distribution System.  It also gives detailed norms for Fair Price Shops, ration cards, and monitoring the system. -          It seeks to set up a National Food Commission and State Food Commission in each state.  The Commission shall inquire into complaints on denial of entitlement, advise central and state governments and monitor the schemes.  Each district shall have a District Grievance Redressal Officer. -          The Bill includes penalties for dereliction of duty by public servants, which includes deduction of penalty from the salary of the public servant. -          Any person deprived of his entitlement to food shall be entitled to compensation from the appropriate government. -          The Gram Sabhas should conduct social audits of all schemes under this Act. The Back Story to the Bill The Right to Food Campaign In April 2001, the People’s Union for Civil Liberties (PUCL) Rajasthan had filed a writ petition in the Supreme Court against the Government of India, Food Corporation of India, and six state governments. The petition contended that the right to food was a fundamental right under “the right to life” provided by Article 21 of the Constitution of India. Although no final judgment has been given, the Supreme Court has issued several interim orders in the case.  Among the most significant of theses is the conversion of eight centrally sponsored schemes into legal entitlements, including the Public Distribution System (PDS), Antyodaya Anna Yojana (AAY), National Programme of Nutritional Support to Primary Education, also known as “Mid-Day Meals scheme”, and Integrated Child Development Services (ICDS), among others. Some orders by the Court in the area of food security include:

  • BPL families are entitled to 35kg of foodgrains at a subsidised price.
  • State governments are to implement the Mid-Day Meals scheme by providing every child in government schools and government assisted primary schools with a prepared mid-day-meal with a minimum content of 300 calories and 8-12 grams of protein each day of school for a minimum of 200 days.
  • Six priority groups have been identified who are entitled to the Antyodaya card.  The card entitles the people to 35 kg of grain per month, at Rs 2/kg for wheat and Rs 3/kg for rice.

On May 8, 2002, the Supreme Court appointed two Commissioners for the purpose of monitoring the implementation of the interim orders.  The Commissioners have submitted a number of reports highlighting the issues of concern on the implementation of the interim orders and making detailed recommendations. Government Initiatives One of the key commitments made by both UPA I and UPA II was on food security whereby it proposed to enact a legislation that would entitle every BPL family in both rural and urban areas to 25 kg of rice or wheat per month at Rs 3 per kg.  However, the Sonia Gandhi-led NAC has differences with the central government on the contours of the legislation.  The basic issues on which there are divergent views include (a) coverage under the Bill; (b) method to be adopted to ensure food security; (c) the amount of food grain required; and (d) the impact on the food subsidy burden. On October 23, 2010, the NAC made certain recommendations on the National Food Security Bill.  The Bill seeks to address nutritional deficiencies in the population. Some of its key recommendations are:

  • § Legal entitlements to subsidised food grains should be extended to at least 75% of the population – 90% in rural areas and 50% in urban areas.
  • § The priority households (46% in rural areas and 28% in urban areas) should have a monthly entitlement of 35kgs at Rs 1 per kg for millets, Rs 2 for wheat and Rs 3 for rice.  Rural coverage can be adjusted state-wise based on the Planning Commission’s 2004-05 poverty estimates.
  • § The general households (44% in rural areas and 22% in urban areas) should have a monthly entitlement of 20kgs at a price that does not exceed 50% of the current Minimum Support Price (the price at which the government buys food grains from the producer) for millets, wheat and rice.
  • § Government should specify criteria for categorisation of population into priority and general households.  Full coverage of food entitlements should be extended to all by March 31, 2014.
  • § Need for enabling provisions to revitalise agriculture, diversifying the commodities available under the Public Distribution System (PDS), ensuring universal access to safe water and proper sanitation, universalising primary health care, and extending nutritional and health support to adolescent girls.

In response, the Prime Minister set up an Expert Committee under Dr C. Rangarajan to examine the Bill and make recommendations.  The Rangarajan Committee submitted its report in January 2011.  It stated that it would not be possible to implement the NAC recommendations because of lack of availability of food grains and huge subsidy implications.  It was in favour of restricting entitlements of Rs 2/kg for wheat and Rs 3/kg for rice to households falling below the Tendulkar Committee poverty line plus 10 per cent of the BPL population.  This is equivalent to 48 per cent of the rural and 28 per cent of the urban population, which is about the same as the NAC categorisation for priority households. The NAC however criticised the Rangarajan Committee’s stand and proceeded with the task of drafting an appropriate legislation.  It finally posted the draft of the National Food Security Bill on its website and has asked for public feedback. Divergent Perspectives The draft has been critiqued by various experts.  A group of distinguished economists wrote an open letter to Mrs Sonia Gandhi opposing the NAC’s draft on the grounds that it legalises the PDS even though there is a large body of evidence of the inefficiency of the system (see Wadhwa Committee reports and Planning Commission report).  The economists contended that in addition to reforming the PDS, other alternate models of subsidy delivery should be examined such as direct cash transfers or food stamps.  The system of direct cash transfer through food coupons was also outlined in the Economic Survey of 2009-10.  It stated that the system would be less prone to corruption since it would cut down government’s involvement in procuring, storing and distributing food grains. However, there are divergent views on direct cash transfer too.  Some experts such as the economist and member of NAC, Prof Jean Dreze contend that food entitlement is better because it is inflation proof and it gets consumed more wisely than cash which can be easily misspent.  Others are of the view that cash transfer has the potential for providing economic and food security to the poor. The ball is now in the government’s court.  According to news reports, the government may finalise the Bill soon and introduce it in the forthcoming monsoon session of Parliament.

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.