India has the second-highest number of USFDA-approved facilities and labor costs in the country are lower than other manufacturing hubs by up to 40%.
Market Research Future (MRFR) in its latest analysis titled, “Withering USFDA inspections: The Quality Challenge for Indian Drug makers” the India pharmaceuticals market is growing at a significant rate and was worth approximately USD 45.5 billion in 2018 and is expected to reach USD 73.5 billion by 2023.
India has the second-highest number of USFDA-approved facilities and labor costs in the country are lower than other manufacturing hubs by up to 40%. The USFDA is responsible for protecting public health by ensuring the efficacy, safety, and security of biological products, human and veterinary drugs and medical devices.
All the USFDA-approved plants in India undergo regulatory inspections for product quality and good manufacturing practices. The quality management system of pharmaceuticals company should comply with US FDA 21 CFR Part 820 (Quality System Regulation); the FDA conducts random QSR audits on short notice.
According to the US FDA, for the full year ended December 2017, Indian companies received final approval for 304 ANDAs out of 846 ANDA approvals and 61 tentative approvals for the 171 total tentative approvals. In 2018, Indian pharmaceuticals companies received 290 ANDA approvals from the USFDA. The organisation approved a total of 813 ANDAs in 2018, slightly less than the previous year.
As per the study Indian drugmakers are braving the quality challenge as the number of US FDA warning letters increased from 2016 to 2017. However, from 2017 to 2018, the number decreased from 17 to 8. This substantial decrease in the number of warning letters can be attributed to increasing emphasis on manufacturing quality by pharmaceuticals companies and a shift in focus of manufacturers from quantity to quality.
The research additionally points out that USFDA inspections and regulations has impacted the pharmaceutical market in the country in a positive manner. These inspections did impact the stock market causing a turmoil as the BSE healthcare index plunged by 4% however these inspections have resulted in drug companies to spend millions on the purchase of new machinery, training and scrutinising he manufacturing processes thereby resulting in improving the quality of pharmaceutical products manufactured in the country. The number of Indian pharmaceuticals exports had decreased from USD 16.9 billion in 2016 to USD 16.8 billion in 2017. However, there was an increase in exports of 0.5 billion from 2017 to 2018.
The analysis attributes this shift to standardisation of manufacturing processes by Indian pharmaceuticals companies, strategic initiatives by major market players, and increasing R&D expenditure.