The Indian Pharmacopoeia Commission (IPC) and the US Pharmacopeia Convention (USP) have come together to conduct the 11th IPC-USP Science and Standards Symposium from February 22 to 23 in Mumbai.
The symposium is mainly aimed at highlighting India’s role as a global leader in pharmaceutical manufacturing with highest quality standards for biologics and healthcare products.
Industry leaders, and high profile delegates from manufacturing, regulatory bodies and quality standard organizations are expected to convene at the international symposium to initiate discussions not only on quality managements but also on some of the critical aspects of supply chain managements that are considered essential for the protection of public health.
The organisers of the symposium are expecting nearly 400 attendees who will explore ways in which science and quality standards can help ensure good quality medicines in India and throughout the world.
The symposium this year will focus mainly on two important areas. One is on global quality standards for biologic medicines and the second is on supply chain management. The forum is also expected to highlight efforts related to the Medicines Compendium (MC) from USP which comprising quality standards for medicines moving in international commerce.
In fact, the meeting is part of USP’s continuing efforts with the Government of India and the IPC in particular to promote access to good quality medicines not only for exports but also for the domestic consumption for the people in India.
Coinciding with the Symposium, USP and IPC are also planning additional meetings, including joint conclaves between the two pharmacopoeial bodies and meetings of the Council of Experts related to the USP Medicines Compendium.
The Association of Biotechnology Led Enterprises (ABLE), the Bulk Drug Manufacturers Association (BDMA), the Indian Drug Manufacturers Association (IDMA), the Indian Pharmaceutical Association (IPA), and the Organization of Pharmaceutical Producers of India (OPPI) are co-sponsoring the event.
“When it comes to medicines, good quality begins with good science,” said Dr Praveen Tyle, executive vice president and chief science officer at USP.
Dr V Srini Srinivasan, USP’s executive vice president for international sites and standards opined that increasingly sophisticated discoveries in science are leading to dramatic insights into health and disease, and the pharmaceutical community plays a key role in translating those advances into medical solutions that will help patients worldwide.
He further stressed that the pharmaceutical industry and regulatory circles in India and the world across must take increasingly robust measures to protect the quality of pharmaceutical products sourced and developed through a complex network of global partnerships and supply chains.
Prominent among the dignitaries at the event include Pankaj Patel of Zydus Cadila and K V Subramaniam of Reliance Life Sciences, who will deliver a keynote address and a lecture on biosimilar products, respectively.
Other speakers on the global biologics market include Dr Ivana Knezevic of the World Health Organization (WHO) on quality and safety of biologicals group and Dr Nora Dellepiane, who will address on the vaccine pre-qualification programme of WHO.
In addition to vaccines, other topics of the discussion will include therapeutic proteins, strategic perspectives on biotechnology products in developing countries, the role of bioassays in biosimilarity and the replacement of animal studies for potency testing of human vaccines.
Topics related to supply chains, cold chain management, pharmacopoeial advances in packaging standards, storage and shipping of pharmaceuticals and synergies between supply chain management and risk management will also be discussed.