JOIN USA World Health Organisation (WHO) report which says that one in 10 drugs sold in low and middle-income countries is fake or substandard raises serious questions about the management and supervision of drug quality and the efficacy of regulatory processes in these countries. The report is based on a study that extended for many years involving 48,000 samples and it showed that over 10% of the drugs were fake or substandard. Many of the fake drugs were for treatment of pneumonia and malaria, which posed serious health risks in poor countries, and quite a few were antibiotics, anti-cancer drugs and contraceptive pills. Children's cough syrups contained opioids and antimalarial drugs were made of potato and cornstarch. Tens of thousands of people die the world over from the use of fake and substandard drugs, including about 1,50,000 from pneumonia and malaria. They also exacerbate the problem of antibacterial resistance, result in more prolonged treatment and cause unnecessary expenditure. It is estimated that the fake drug business is worth $ 30 billion.
According to the WHO, the problem is most serious in Africa, followed by Europe and Asia. But it says that the reporting of more fake drugs in one region might only mean that they were easier to find there, and other regions might be equally bad. The problem arises mostly from the presence of wrong ingredients or no ingredients, incorrect doses and improper storage. Internet sale of drugs is cited as one reason for the circulation of bad drugs. The responsibility to ensure that all drugs are safe and of the right quality rests with the health authorities of individual countries. Many countries do not have the right system, means and expertise to test drugs and to monitor their sales and supply chain. Mismanagement, inefficiency and corruption are also serious handicaps.
India is not among the countries worst hit, but poor drug quality is a serious issue in the country. Two years ago, the Central Drug Standard Control Organization (CDSC) reported that 5.1 % of the drugs in the country failed quality parameters. Even this is a high figure because that might mean a human toll running into many thousands. There is a view that the CDSCO samples were too few and that the standards against which the drugs are tested in the country are not very high. Indian drugs often fail tests in other countries. India is a major manufacturer and consumer of drugs and so it is important to maintain the best standards of quality. There is the need to improve practices, effectively enforce rules and fine-tune regulations wherever necessary.