United States Pharmacopoeial Convention (USP) and the National Institute of Biologicals (NIB) have tied up together to strengthen the collaboration in improving the regulatory standards in the areas of biosimilars and other biological products in India.
“We have infrastructure but we lack in manpower and expertise. As part of the collaboration with the USP, training will be given to the staff and capacity building measures will be initiated. Setting world-class standards in the biological sector will take time for India,” said NIB director Dr Surinder Singh, on the sidelines of recent Indian Pharmacopoeia Commission-USP scientific conference here.
“Our scientists will be sent to the US for training. India has an uphill task in the sector and we are trying to match up with the pace world around,” he added.
A senior USP official said the global agency has been collaborating with IPC since 2006 for capacity building and one of the key focus areas ahead will be biological. “Precisely, we will be looking to support the standardization mechanism for therapeutic proteins and vaccines. We have tied up with NIB in this regard,” he said.
The two-day science and standards symposium attended by different stakeholders and regulatory officials, from India and abroad, was held around the theme of 'Partnering globally for 21st century medicines'. The symposium had sessions on chemical medicines, excipients, biological medicines, besides covering the latest pharmacopoeial topics.
Addressing the conference, Biocon managing director Kiran Mazumdar Shaw felt that the industry had the task cut out to build confidence and credibility for Indian biosimilars. “There is phobia and myth about Indian biosimilars as once our generics faced. It is the duty of the industry to build credibility,” she said, while suggesting that data from the phase III trials should be used as case studies.
DCGI Dr G N Singh, US-FDA country director Bruce Ross, CEO of USP Dr Roger Williams, National Institute of Biological Standardization and Control director Dr Stephen Inglis, IPC chairman Dr B Suresh, USP chief scientific officer Dr V Srini Srinivasan, Gujarat FDCA commissioner Dr H G Koshia, senior scientists from leading companies and regulatory officials were among those who attended the conference.