Building A Culture Of Compliance

Lingering cGMP issues underline the importance of hiring right, rigorous training and continuous oversight to consistently comply with safety norms

- Viveka Roychowdhury

The globalisation of the pharmaceutical chain poses both opportunities and challenges. Making affordable, safe medicines more accessible benefits patients as well as the companies who makes these medicines. But the flip side is that the growing complexity of these supply chains adds to the risks at every level. And regulations and regulators are unfortunately left playing catch up.

Let's consider the world's largest pharma market. In the period 2011-2018, the number of US FDA registered drug facilities in the US has decreased by 10 per cent in the US but increased 63 per cent in India, followed by 51 per cent in China, according to a presentation by Dr Letitia Robinson, Country Director, India Office Office of International Programs, US FDA at the 4th Indian Pharmaceutical Forum 2019 (IPF 2019) held this February in Mumbai.

As the number of registered overseas facilities increased, there was a corresponding increase in inspections of these sites. According to a statement from FDA Commissioner Dr Scott Gottlieb dated last September 25, as of fiscal year 2017, about 5,063 pharma sites worldwide had routine surveillance inspections, of which 3,025 were overseas. For that year, the FDA conducted 1,453 drug surveillance inspections, including 762 overseas inspections.