In an effort to ensure access to high quality drugs in the market, the World Health Organization (WHO) has issued draft guidelines outlining steps to consider when preparing and conducting a survey of medicines quality.

The draft guidelines provide recommendations and examples of various methodological approaches with the advantages and disadvantages. WHO expects the comments on the same before September 30,2015. After this it would make a presentation at the 50th meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations held between October 12-16,2015.

The key objective of guidelines is to evaluate quality of selected medicines available in the market in selected countries at various levels of distribution chain. There is also a need to comprehend the exposure of patients to poor-quality medicines and propose appropriate actions. Further, there is a need to compare quality of drugs manufactured within each country over the imported ones.

The quality of medicines is essential for efficient disease management, said WHO. To ensure that good quality medicines are available to patients in their countries, national medicines regulatory authorities (NMRA) can apply various regulatory instruments. These cover registration for marketing with the assessment of products, documentation, inspection of manufacturers’ compliance with the principles of good manufacturing practices (GMP) and approval of products’ information.

There is need for post-marketing surveillance activities including maintenance of products.

Quality surveys serve as an important source of information which can be made available to patients. These surveys can be organized by NMRAs, international organizations, procurers, non-governmental organizations or academic and research groups, said WHO.

Not all countries have a stringent system of medicines regulation in place. Information from quality surveys is specifically important for countries with weak systems, observed WHO.

Data on the quality of medicines, if properly collected, interpreted and used, are vital for the planning of effective interventions to improve the quality of medicines. Surveys give snapshots of the medicine quality situation, accuracy, reliability and interpretation of the data obtained depend on the survey design, organization of sample collection, and available resources.

Medicine quality surveys are expensive and available resources may restrict the number of collected samples, tested parameters, techniques to be used for analysis, or number of staff available to conduct the survey and analysis. Therefore it is important to  optimize use of resources by focusing on medicines and parameters that pose higher risk to patients and apply risk analysis during planning of the survey. Also co-operation with  partners, joint organization of surveys in several countries, and sharing testing capacities, experience and information can enhance the effectiveness of quality surveys, stated WHO.

Objectives for a quality survey should reflect the reasons why the survey is conducted. It should be formulated to identify medicines to be surveyed, sites of sample collection, surveyed countries and tests to be conducted. Clearly defined purposes are essential to create conditions for sampling and testing which should be described in detail in the survey protocol, noted WHO.

In India, a maiden effort is made nationally where the Central Drugs Standard Control Organisation (CDSCO) along with National Institute of Biologicals (NIB) have embarked to test drug samples to ascertain the quantum of not of standard quality drugs.