For India’s drug regulator and government, this is an alarm to step up vigilance. India must continue to be the ‘pharmacy to the world’ by ensuring that the quality of its products is not suspect. For this, GoI must take strong measures.
India is the third-largest pharma manufacturer, meeting 20% of global generic demand. Multiple assessments project the industry to grow further – $45-65 billion by 2025, and $120-130 billion by 2030. However, non-compliance with quality standards is the biggest challenge.
In 2019, Indian pharma companies received 19 warning letters. Nearly half were from the Office of Manufacturing Quality, US Food and Drug Administration (FDA). GoI has taken some measures since March 2021. Companies that manufacture and market pharmaceuticals are accountable for their products’ quality. That is not enough. A regulatory overhaul is needed.
The current fragmented system, where quality and standardisation become casualties, must be replaced by a modern, independent, statutory regulatory system. The Central Drugs Standard Control Organisation (CDCSO) is the non-statutory regulator under the health ministry. It has no jurisdiction over State Drug Regulatory Authorities that are part of state health departments. Each regulatory body acts independent of the other. This must change.
The pandemic has raised concerns about supply chains and inequity in access. Failure to address quality standards could derail the prospects of one of India’s brightest sectors.