Examples of India’s rather sorry drug quality control regime abound. But a recent analysis of the Indian antibiotics market by researchers at the Queen Mary University in London and the Newcastle University proves to be a particularly damning one. The study analyses regulatory records pertaining to fixed-dose combinations (FDCs) and single-drug formulations (SDF) antibiotics sold in India between 2007 and 2012. It finds that 64% of the 118 FDCs—available under 3,307 brand-names made by 476 companies, including MNCs—and 7% of 86 SDFs analysed did not have approval from the drug-quality regulator, the Central Drugs Standard Control Organisation. Selling of unapproved drugs is illegal, and yet, Indian companies and MNCs continued to be in flagrant violation the policy.
The problem of questionable drugs standards is compounded by the scale of drug/antibiotic abuse in India—it has one of the highest antibiotics consumption figure globally—which means resistance to antibiotics doubles down as a threat for the country. While resistance to antibiotics kills around 700,000 globally, by 2050, the figure could reach 10 million, of which 2 million will be Indians. In a study of 88,600 infants in Delhi’s three largest public hospitals, it was found that 14% of the babies admitted to the ICU within 72 hours of birth had infections that were hospital acquired, and therefore had highly drug-resistant strains of pathogen at the root of the sepsis.
In a scenario where drug quality is already suspect, unapproved drugs mean a worsening of resistance implications. Rampant self-medication can be treated by the steps such as matching of prescriptions to volumes of antibiotics sold, a step now the government is mulling for even over-the-counter drugs that include many commonly abused antibiotics. However, the problem is that antibiotics are also over-prescribed in India. That is a problem that needs tackling. In the light of unapproved antibiotics, cracking down on their sales could take them out of circulation and, hence, also out of prescriptions.