‘Sun Pharma to Streamline Quality Control Processes’
Pharma major has been under USFDA scanner over manufacturing lapses
Mumbai: India’s largest drug maker Sun Pharma, bleeding lately for having been mauled by the USFDA over lax quality control at its plants, has reset its goals. India’s second-richest man and Sun Pharma MD, Dilip Shanghvi said he is trying to streamline quality control processes that were overtaken by the merger with Ranbaxy, making the company the world’s fifth-largest generic drug maker.
“All of a sudden we became twice the size of the company, we have 50,000 employees. That crystallised the need for working towards a system, working towards technology emphasis on improving IT backgrounds, focussing on issues that has affected us and also others in the world in regarding quality. How do we resolve problems faster? How do we design our products? … this has not happened and we have learnt this over an extended period of time,” said Shanghvi, addressing the Indian Pharmaceutical Alliance Quality Forum, an annual event for international regulators and Indian drug companies. Sun Pharma has been under the scanner of the US drug regulator for not following the good manufacturing practice. Shares of Sun pharma, which is one of the most watched stock on the BSE, have lost 24 % since 2015.
“We realised we require different organisation to manage the increasing complexity of managing our manufacturing sites”, Shanghvi explained. “The emphasis and focus was on common quality rather than country specific or geography specific quality. I think the objective is work towards enhancing our capabilities reaching towards global standard” he added. The merged entity has managed to standardise its quality metrics across plants on various issues which impact product quality. However, some concerns remain, Shanghvi said.
“We were on a journey to create a paperless laboratory process that is directly electronically captured on systems. In hindsight, we realised we underestimated the complexity and the enormity of what we were trying to do. So that project is almost 12-15 months behind schedule”, Shanghvi said.
DIVYA RAJAGOPAL Sun Pharma MD Dilip Shanghvi with Mathew Thomas, country director, USFDA India