Market Research Future, a Pune-based Market Reseach firm, recently expedited a study to better ascertain various aspects of the current pharmaceutical industry scenario in India. Titled ‘Withering USFDA Inspection: The Quality Challenge for Indian Drugmakers’, the report predicts that the Indian pharmaceuticals industry which was worth $45.5 billion in 2018, is expected to reach $73.5 billion by 2023.

India currently is home to the second highest number of USFDA-approved facilities globally and even boasts of labour costs 40 percent lower than in other countries. While by the end of 2017, USFDA issued 304 Abbreviated New Drug Application (ANDA) out of 846 ANDA approvals, and 61 tentative approvals for the 171 total tentative approvals to Indian companies, the number of ANDAs received by Indian companies in 2018 was 813. These USFDA approved plants in the country undergo regulatory inspections for product quality and good manufacturing practices, and hence the quality management of the companies should comply with USFDA 21 CFR Part 820 (Quality System Regulation).

The study also points out that while the number of warning letters USFDA issues to Indian pharmaceuticals increased between 2016 & 2017, the number of warning decreased from 17 last year to eight between 2017 & 2018; thanks to the surmounting emphasis on manufacturing quality by pharmaceuticals companies and a shift in their focus from quantity to quality.

The USFDA inspection and regulations caused a serious turmoil among the Indian pharma companies, pushing them to spend hefty monies to replace their outdated machines with modern tech equipment, training their staff, and putting in place a string scrutiny for the manufacturing process to ensure quality. Also, while the Indian pharma exports decreased from $16.9 billion in 2016 to $16.8 billion in 2017, there was an increase in exports by a margin of $0.5 billion from 2017 to 2018.

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