Home / News / India /  Lancet report on unapproved antibiotic use in India is 'misleading, inappropriate': Govt official

Days after Lancet Regional Health-Southeast Asia revealed that over 47% of antibiotic formulations used in India's private sector in 2019 were not approved by the central drug regulator, vice chairman of the Standing National Committee on Medicines (SNCM) Prof. Y K Gupta dismissed it calling the report as "misleading and inappropriate".

The senior pharmacologist Prof Gupta -- who prepared the National List of Essential Medicines (NLEM), said at a Health Ministry event on Tuesday 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," Prof Gupta said.

Following the media reports on the Lancet study last week, Union Health Minister Mansukh Mandaviya became concerned and called him up at 6 am wanting to be apprised about the issue following a detailed analysis, Prof Gupta said.

ALSO READ: Over 47% antibiotic used in India unapproved in 2019, azithromycin most consumed: Lancet study

While, referring to the media reports based on the Lancet study, Prof 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 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," Prof Gupta said.

In comparison to global situation, India's reported DID (defined daily doses per 1000 inhabitant per day) was 10.4, while higher rates have been reported from Europe, Brazil, Russia, Sri Lanka and Pakistan according to recent estimates.

The current study, in fact, reports improvements in 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, Prof 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.

"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," Prof Gupta said while citing some of the limitations of the study.

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, Prof Gupta added.

He also cited methodological limitations and said 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.

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

It is also important that whenever a new antibiotic is introduced in the country, its judicious use is ensured by all stakeholders, he said.

With PTI inputs.

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