Use of Unapproved drug Formulation in India poses a global threat to antibiotic resistance control
Antibiotic resistance is the resistance shown by the microorganism against the antibiotics used as a medicine. The beginning of resistant bacteria is occurring all over the world which is threatening the efficacy of antibiotics, which have transformed medicine and saved millions of lives. The antibiotic resistance crisis has been occurred due to overuse and misuse of these medications, as well as a lack of new drug development by the pharmaceutical industry due to reduced economic incentives and challenging regulatory requirements.
According to a new study published in the British Journal of Clinical Pharmacology, there are Millions of antibiotics being sold in India each year which are made from the unapproved formulation.
Parliamentary investigations have highlighted that antimicrobial resistance and antibiotic consumption is at its highest rates in India which shows the failures of the country’s drug regulatory system.
For their research, scientist examined the availability of antibiotics and their approval status in India and investigated the regulatory records of antibiotics as well as sales data from 2007 to 2012. They analyzed all the information of the pharmaceutical industry of India which included information on fixed-dose combination (FDC) antibiotics (formulations composed of two or more drugs in a single pill) and single drug formulation (SDF) antibiotics (composed of a single drug).
They analysed the 118 different formulations of FDCs which were sold from the year of 2007 to 2012 and then compared it with the 5 formulations approved in the United Kingdom and the United States and observed that out 118 different formulations of FDCs, only 36% are approved one while the other 64% were not approved by the national drugs regulator, the Central Drugs Standard Control Organisation with the fact that the sale of unapproved new drugs is illegal in India. In contrast to FDCs, 93% of 86 SDF antibiotics on the market in India had regulatory approval.
“Selling unapproved, unscrutinized antibiotics undermines measures in India to control antimicrobial resistance. Multinational companies should explain the sale of products in India that did not have the approval of their own national regulators and, in many cases, did not even have the approval of the Indian regulator,” said lead author Patricia McGettigan, MD, of the Queen Mary University of London.
About 3307 brand named products are made by these 118 different formulations and manufacturers includes a number of international companies.
According to the researchers, it is much needed to stop the use of unapproved formulation and to achieve the proper use of antibiotics set by the World Health Organization (WHO).
Author Allyson Pollock, MBChB, MSc, of the Institute of Health and Society at Newcastle University added that the main aim of WHO is to limit the antimicrobial resistance and Governments and regulators must help so that necessary steps could be taken to avoid the production of unapproved medicine and its illegal sale should also be prohibited and must inspect the actions of multinational companies.