The Lancet report claiming more than 47% of antibiotic formulations used in India’s private sector in 2019 were unapproved has been dismissed by a health ministry official as "misleading and inappropriate." Y K Gupta, Professor, a senior pharmacologist, and vice chairman of the Standing National Committee on Medicines (SNCM), which prepared the National List of Essential Medicines (NLEM), claimed that the formulations were approved by state drug regulatory authorities. He added that in the study, the authors used the term "unapproved" for formulations not approved by CDSCO, but it is pertinent to note that those formulations were approved by state drug regulatory authorities.

Referring to the Lancet study, Mr. Gupta stated that even though India is the biggest antibiotic consumer in terms of volume, the per-capita consumption rate could be ascribed to our large population. Therefore, it is not correct to conclude that there was excessive use of antibiotics in India, which is much lower than in other countries such as Brazil, Russia, and Europe. He added India’s reported DID (defined as daily doses per 1000 inhabitants per day) was 10.4. A lower value in global comparison, when higher rates have been reported from Europe, Brazil, Russia, Sri Lanka, and Pakistan.

However, according to another report, improvements in the per-capita consumption rate of systemic antibiotics were reported in the range of 10.4 DIDs, which is lower compared to the rate reported in 2015 (13.6 DID), noted Prof. Gupta. According to the study, azithromycin 500 mg tablets were the most consumed formulation, followed by cefixime 200 mg tablets. The Amoxicillin-clavulanic acid 500/125mg tablet was the most consumed FDC (fixed-dose combination), but all three formulations are listed in NLEM 2015.

He also cited the limitations of the study and 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." On the other hand, while highlighting the methodological limitations, he explained that the PharmaTrac sample covers only 60% of stockists in India.