A Health Ministry official has dismissed as "misleading and inappropriate" a Lancet report claiming that more than 47 per cent of antibiotic formulations used in India's private sector in 2019 were unapproved.

Prof. Y K Gupta, a senior pharmacologist and vice chairman of the Standing National Committee on Medicines (SNCM) which prepared the National List of Essential Medicines (NLEM), said at a Health Ministry event on September 13 that these formulations were approved by state drug regulatory authorities.

"Even though the authors have used the term 'unapproved' for formulations not approved by CDSCO, it is pertinent to note that these formulations were approved by state drug regulatory authorities. Therefore, the term 'unapproved' seems to be inappropriate in this case," Gupta said. The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for pharmaceuticals.

He said after reading media reports on The Lancet study last week, Union Health Minister became concerned and called him up at 6 am wanting to be apprised about the issue following a detailed analysis.

Referring to the media reports based on The Lancet study, Gupta said it was not correct to say that the use of antibiotics in India was excessive and underlined that their use in the country is lower than in Brazil, Russia and Europe.

"Even though India is the biggest antibiotic consumer in terms of volume, the per-capita consumption rate of antibiotics in India is relatively low compared to many countries. This could be ascribed to our large population," Gupta said.

On perusing the paper, India's reported DID (defined daily doses per 1000 inhabitants per day) was 10.4. In global comparison, higher rates have been reported in Europe, Brazil, Russia, Sri Lanka and Pakistan according to recent estimates.

The current study, in fact, reports improvements in the per-capita consumption rate of systemic antibiotics of 10.4 DIDs which is lower compared to the rate reported in 2015 (13.6 DID) in another report, Gupta stated. According to the authors, this may be due to regulatory changes in the country aimed to restrict the sale of certain medicines although further investigation is required, he said.

"Notwithstanding, Azithromycin was the most consumed antibiotic molecule in 2019 but it was in NLEM and so I definitely agree that there is a need to create awareness and further promote antibiotic stewardship," he said.

Although only around 10 per cent of formulations in the market were listed in the NLEM, nearly 50 per cent of the DDDs (defined daily doses) came from these formulations indicating relatively higher consumption of NLEM-listed medicines.

Azithromycin 500 mg tablet was the most consumed formulation, followed by cefixime 200 mg tablet. Amoxicillin-clavulanic acid 500/125mg tablet was the most consumed FDC (fixed-dose combination), he stated. All three formulations are listed in NLEM 2015, he said.

Citing some of the limitations of the study, Gupta said, "The current study only looks at the pharmaceutical sales data in the private sector, whereas more detailed data is required to appreciate the patient care settings where these medicines are prescribed and used, prescription patterns existent across different groups of prescribers, and the indications for which these antibiotics are used, including laboratory data such as microbiological tests."

Although the metrics assessed to provide a broad assessment of antibiotic consumption, unless patient-level data is analysed, it is very difficult to conclusively assess the appropriateness of antimicrobial prescriptions since each clinical situation requires a nuanced approach best suited for the individual patient.

Highlighting methodological limitations, he said the PharmaTrac sample covers only 60 per cent of stockists in India. The data collected were extrapolated to represent the sales of medicines in the entire private retail sector.

The drugs dispensed through public health facilities were not accounted for which may have had a greater percentage of NLEM-listed formulations since most government procurement is usually based on either a national or state-level list of essential medicines.

Gupta stressed a more collaborative approach to promoting awareness about the appropriate use of antimicrobials and antibiotic stewardship so as to preserve the effectiveness of available antibiotics. It is also important that whenever a new antibiotic is introduced in the country, its judicious use is ensured by all stakeholders, he said.