The World Bank (WB) has approved a US$ 54 million credit to the Government of India to help improve the quality and safety of food and drugs in India, according to a WB news release dated June 5, 2003.

The Ministry of Health and Family Welfare will implement the project through its existing directorates for foods and drugs quality control. The credit from the International Development Association (IDA), the World Bank's concessionary lending arm, carries no interest and has a 35-year maturity.

This follows Health Ministry's proposal to the Bank for a a Capacity Building Project which was expected to become operational in the year 2002-03.

The Health Ministry is responsible for ensuring quality food to the consumers. Keeping this in view, a legislation called "Prevention of Food Adulteration Act, 1954" (PFA) was enacted which came into force on 1st June 1955.

The subject of the PFA is in the concurrent list of the Constitution. However, in general, the enforcement of the Act is done by the state / union territory governments. The central government primarily plays an advisory role in its implementation besides carrying out various statutory functions and duties assigned to it under the various provisions of the Act.

As of now India has four Central Food Laboratories (CFL) have been established under the Act, which work as appellate laboratories for the purpose of analysis of appeal samples of food lifted by the Food Inspectors of the states and union territories and local bodies. There are 82 food laboratories under the administrative control of various states and union territories and local bodies.

The main function of CFL laboratory is to test the samples of imported drugs, new drugs and to act as the appellate laboratory under Drugs and Cosmetics Act. It also assists States/Union Territories for testing of any samples. During the period April 2000 to March 2001, of the 236 samples of imported drugs tested, 12 samples were found not of standard quality.

Since the signing of the Agreement on the Application of Sanitary and Sanitary and Phytosanitary Measures (SPS) and Agreement on Technical Barriers to Trade (TBT) under the World Trade Organisation (WTO), the issue of International Trade in Food has become very important.

The SPS Agreement recognizes that governments have the right to adopt sanitary and phytosanitary measures but stipulates they should be applied only to the extent necessary to achieve the necessary level of protection; that governments should not arbitrarily or without scientific justification discriminate between members where identical or similar conditions prevail; and emphasizes the use of science in making decisions as well as utilizing the principles of risk analysis in setting appropriate levels of protection. Several very important words, with even more important meanings and impact, are contained in the SPS Agreement. These include discrimination, equivalence, risk assessment and transparency.

The TBT Agreement on the other hand is related to the quality aspects of food, such as labelling of products and those issues not covered by food safety aspects, which are not specifically covered under the SPS Agreement.

The Codex Alimentarious Commission with its 165 Member Nations sets food Standards at the International level. In order to strengthen the Indian Codex infrastructure, FAO has also sanctioned a project, which is currently on-going.

The objective of this project is to strengthen the Codex contact point in the Ministry of Health. This includes strengthening coordination and networking between Departments, Organisations and Industry to effectively present the Indian view point in the Codex process as well as to take action according to decisions made.

It is meant to develop training materials for concepts in food safety like Hazard Analysis Critical Control Point (HACCP) system, Good Hygiene Practices (GHP) etc and prepare a panel of trainees in different sectors. This is being undertaken as an attempt to harmonise to the extent possible the standards in the PFA Act and Codex.

The World Bank’s Food and Drugs Capacity Building Project will be the first stage of a long-run program supporting the Government of India's vision of ensuring safe and high quality food and drugs for the Indian public. The project claims to be of benefit to society in general and the poor in particular, who will gain from lower morbidity and premature mortality as a result of increased safety and quality of foods and drugs available.

India has made considerable progress in improving the health status of its population in the last 50 years, but disparities between regions and between the poor and non-poor continue to widen. Food and drugs oversight is an essential public health function, but inadequate institutional arrangements and limited financial resources prevent the Government of India from fulfilling its role.

In addition, India has a large and rapidly expanding food and drugs industry, and pharmaceuticals are a large and growing component of health care expenditure. Consumption of street foods as well as processed foods is also on the rise, as is the concern for consumer protection, particularly for the poor.

"The poor would especially benefit from the Food and Drugs Capacity Building Project because they are more likely to be victims of poor quality foods and access to medication," says G N V Ramana, a senior public health specialist for the World Bank and task leader for the project. "For example, recent household surveys in India indicate that the incidence of diarrhea in children under five is 20 percent higher for the poorest quintile of the population as compared to the highest quintile. The true difference is probably greater, since poor households tend to under-report illnesses."

The Bank’s project has three components:

Policy Development, Program Coordination and Monitoring, consisting of strengthening of the central government's food and drug directorates and improved program coordination and monitoring. Improvement of central physical facilities for food and drugs oversight, and related staffing are also included, as is monitoring activities, such as the implementation of household surveys to assess public perceptions and knowledge about quality and safety of foods and drugs, and the organization of independent audits of public and private laboratories.

Food Safety, consisting of activities to strengthen the government's oversight and regulatory capacity for food safety at the central and State levels and to educate consumers on matters related to food safety. This component will also finance civil works, equipment, furniture, laboratory supplies, training, technical assistance, consultants, contracting of
non-governmental organizations and media agencies, and incremental operating and maintenance costs.

Drugs Quality and Safety, consisting of activities to strengthen the government's oversight and regulatory capacity for ensuring drugs quality at the central and state levels, to educate consumers on matters related to drugs quality and safety, and to upgrade related skills in public and private sectors. Information and education activities to improve consumer and prescribes awareness and behavior regarding quality and rational use of drugs, will also be carried out with the support of professional media agencies and NGOs.

The Central Drugs Standard Control Organization (CDSCO) along with Drug Control Organization in the States are responsible for safety, efficacy and quality of drugs, their import, manufacture, distribution, sale and standards. This is regulated under the Drugs & Cosmetics Act, 1940 and the Rules, 1945 made there under.

The main functions of the CDSCO include control of the quality of drugs imported into the country, coordination of the activities of the States and Union Territory’s Drug Control Authorities, approval of new drugs proposed to be imported or manufactured in the country, laying down standards and regulatory measures and acting as the Central License Approving Authority (CLAA) in respect of whole human blood and its products, Large Volume Parenterals (IV Fluids), Sera and Vaccines.

There is Central Drug Testing Laboratory, Mumbai and Chennai, which acts as government analyst and assists CDSCO in the analysis of drug formulations and drug substances. During April 2000 to March 2001, 1165 drug samples were analyzed of which 109 were found not of standard quality. Quality of cosmetics manufactured and marketed in the country is also regulated under the D&C Act. The I.P. Committee under the CDSCO brings out the Indian harmacopoeia, which lays down the National Standards for drugs and formulations.

The Bank’s project is supposed to support some key policy and institutional developments, such as increased government regulatory efficiency, and partnership between the public and private sectors. In the private sector, medium and small-scale manufacturers will benefit from opportunities for training and assistance in improving manufacturing processes and product quality.