(2002; 166 pages)
Access to quality pharmaceuticals: the Indian experience
Dr Nitya Anand, India
The key issues for developing countries in relation to drug accessibility are availability, acceptable quality, and affordability. The Indian Government has implemented policies to address these issues, including giving special incentives to the pharmaceutical industry and the research and development bodies, imposing drug price controls, and introducing policies on drug procurement and process patents. Manufacturers in India produce practically all classes of formulations and over 85% of active pharmaceutical ingredients (APIs) at internationally competitive prices. Sizeable amounts of both APIs and formulations are exported to developed and developing countries.
The Drugs and Cosmetics Act 1940 regulates the import, manufacture, sale and distribution of drugs and cosmetics. The Central Drug Standards Control Organization (CDSCO) is responsible for the approval and introduction of new drugs and for the Indian Pharmacopoeia. The State Drug Control Organization looks after the quality of the manufacturing and distribution system. The main objective of quality assurance enforcement is to ensure that all products meet specifications and are manufactured under GMP.
The Indian Pharmacopoeia is managed by the Indian Pharmacopoeia Committee, which updates and publishes the Pharmacopoeia and related publications, procures or prepares and supplies reference substances, takes up laboratory work for the development and validation of test procedures for pharmacopoeial standards, and interacts with international counterparts and with the WHO section on Quality Assurance and Safety: Medicine. The current version of the Indian Pharmacopoeia was published in 1996 but two lists of new drugs were published as addenda in 2000.
In order to achieve effective quality assurance, national pharmacopoeias should incorporate monographs on drugs against diseases of national concern, irrespective of the patent status. More work is needed in collaboration with international agencies to evaluate the biopharmaceutical properties of fixed-dose combinations of drugs. Educational emphasis must be on the storage, trans-shipment, and the other conditions related to the quality of the products taking into account the environment and conditions in the country.
In view of the trend towards global free trade, there is a need for close interaction between countries and harmonization of pharmacopoeial standards. The ambit of the existing pharmacopoeial discussion groups to search for harmonized, but not necessarily identical, standards that can be adopted worldwide should be expanded.