Unapproved drugs cause for worry

Private sector pharmacies contribute to over 85% of the total consumption of antibiotics

It is a matter of concern that antibiotic formulations that do not have the approval of the central drug regulator are in wide use in the country. A study published in The Lancet has revealed that over 47 per cent of the antibiotic drugs sold in private sector pharmacies in 2019 were not approved by the Central Drugs Standard Control Organisation (CDSCO). Private sector pharmacies contribute to over 85 per cent of the total consumption of antibiotics. The study was based on data collected from 9,000 stockists across the country. Drugs dispensed from public facilities were not included. The high level of use of unapproved drugs has serious implications for public health.

The study shows that formulations included in the national list of essential medicines (NLEM) contributed 49 per cent and unapproved formulations were to the tune of 47.1 per cent. Cephalosporins, macrolides, and penicillins were the top three antibiotic classes among the unapproved formulations. Combinations discouraged by the World Health Organisation (WHO) constituted 48.7 per cent of fixed dose drug combinations (FDCs), which are combinations of two or more active drugs. The unapproved drugs include broad-spectrum antibiotics. The data for the study was collected in 2019 but there is reason to believe that the situation is no better now. Antibiotics are an important part of modern medicine, but their use and handling have created serious problems, too.

There are different ways in which unapproved drugs come to be used. Some doctors prescribe them, though it is wrong and unprofessional to do so. An unholy nexus between drug manufacturers, sellers and doctors leads to such conduct. There are a large number of quacks and unqualified doctors in the country. They also prescribe such drugs. Many people do not go to a doctor but buy medicines over the counter without prescription. The study has noted that wrong and inappropriate use of antibiotics is a significant driver of antibiotic resistance in India. Such resistance will create a situation where antibiotics will no longer be useful in the treatment of diseases. The supervisory mechanism for monitoring and checking the production and distribution of fake and unapproved drugs should be strengthened. India’s drug manufacturing industry has made great progress and has acquired a global reputation. But there have been cases of many drug units failing quality tests. Recently, a unit in Himachal Pradesh was sealed after it was found to be illegally manufacturing drugs for which it had no licence. Strict action should be taken in such cases. There should be awareness campaigns also to spread information about the need to reduce the use of antibiotics and avoid the use of unapproved medicines.