India is patting itself on the back for being the ‘pharmacy of the world’. But a glaring transgression has been found at the level of regulation. An analysis in the Journal of Pharmaceutical Policy and Practice revealed that about 70% of the fixed-dose combinations of antibiotics sold in 2020 were either banned by the government or are pending regulatory approval. While the total number of FDCs — cocktails of two or more active pharmaceutical ingredients that are marketed by drug companies to circumvent the government’s price control orders — fell from 574 to 395, their sale increased from 32.9% in 2008 to 37.3% in 2020. This, of course, points to the “weak, convoluted... and inefficient” regulatory structure that the report alluded to; which, in turn, has an additional complication. There has been an explosion in the use of FDCs in India owing to their utility in the treatment of maladies such as HIV, tuberculosis and malaria. However, this quick-fix solution, medical researchers suggest, is exacting a steep toll on public health. The easy availability of such over-the-counter drugs is resulting in antimicrobial resistance. India has the second-highest burden of multi-drug-resistant tuberculosis in the world, with as many as 99,000 new cases recorded annually.

The government has not been sitting idle: it has introduced measures to curb the irrational use of FDCs. The Central Drugs Standard Control Organisation cautioned about the overuse and misuse of antibiotic cocktails in a 2012 circular. Several FDCs were proscribed in 2018 and 2019. Yet, the abuse of FDCs continues. This may be because regulatory authorities have, more often than not, been content with issuing show-cause notices instead of adopting an iron-handed approach to weed out such malpractices. There is another issue that merits attention: drug manufacturers have to secure licences from states and not the CDSCO in the case of FDCs: in its 59th report, a parliamentary standing committee of the ministry of health and family welfare observed that some of the state licensing authorities had issued manufacturing licences for a large number of FDCs without prior clearance from CDSCO. This calls for a greater coordination between state and central vigilance authorities without getting into turf wars. Tighter regulations must be put in place along with public awareness programmes sensitising consumers about the health hazards of antibiotic abuse to ward off this threat.