'70% of antibiotic formulations in market in 2020 unapproved'

Bengaluru: An analysis of the Indian pharmaceutical market has found that 70.4 per cent of the fixed-dose antibiotic formulations present in the market in 2020 were either unapproved or banned. These drugs accounted for 15.9 per cent of the Fixed Dose Combination (FDC) antibiotic sales, reveals a research paper titled ‘Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics’ published in the Journal of Pharmaceutical Policy and Practice on November 10.

The researchers tried to analyse two major regulatory initiatives taken by the Central Drug Regulators in 2007 and 2013 to remove centrally unapproved systemic antibiotic FDCs from the market. Experts concluded that these drugs remain in circulation and are also being sold over the counter.

The paper said that the initiatives had limited impact. “Regulatory enforcement has been slow and weak, with many unapproved and even banned FDCs remaining in the market,” it said.

The report has raised concerns among the medical fraternity, especially since Antimicrobial Resistance (AMR) is increasing by the day. AMR occurs when pathogens change over time and stop responding to medicines, making infections harder to treat.

Incidentally, November 18 to 24 is observed as the World AMR Awareness Week.

“Several FDC formulations were banned considering the fact that they did not have a scientific backup. The use of such drugs results in AMR and other side effects. Though they were banned, enforcement has failed and there is a need to chalk out a common structure with coordinated effort from state and central agencies,” Dr Abdul Ghafour, Infectious Diseases Consultant, told DH.

Dr Vishal Rao, a member of Karnataka State Vision Group for Biotechnology, said it is important that hospitals come up with a stringent antibiotic policy and doctors need to champion the cause. “Times have changed and we are aware of the damage that such antibiotics could cause. Now, many of us are moving towards personalised medicines which are evidence-based,” he said.

Considering that AMR could be the next global threat, a National Action Plan regarding the same was prepared in 2017. Though states were supposed to chalk out plans, many have failed to do so. Even today, in many states, antibiotics are available over the counter and drug controllers have failed to control their use, Dr Ghafour said.

“There is a need for a strong policy. Many doctors tend to avoid detailed clinical analysis, and prescribe FDCs. Unless and until regulators control the manufacture and availability of these combinations, many doctors will continue to prescribe them,” he added.

Health and Family Welfare Minister Dinesh Gundu Rao recently directed officials to develop a plan that would focus on chalking out a strategic road map to combat AMR in Karnataka, which he said will be rolled out soon.