Indian Pharmacopoeia Commission (IPC) and the US Pharmacopoeial Convention (USP) stressed on strengthening its collaboration in the field of biologics to develop biological standards and references substance that will enable the companies to manufacture quality medicines for people across the world. There was a general consensus among the organisers, regulators and the industry representatives to take strategic decisions in this matter so that it will help India to churn out its own reference substances for biologics.

In the two-day symposium on 'science and standards', which is being held in Mumbai from February 22 to 23, they are focusing on the need to maintain global quality standards for biologics and supply chain management. The symposium focused on the need to initiate activities to develop references substances for biological products in India and how it can be achieved with close collaboration with other international standard setting bodies.

This event provided a platform to highlight efforts related to the medicines compendium (MC) which included USP’s free, on-line compendium comprising quality standards for medicines moving in international commerce.

The meeting is part of an on going collaborative efforts between the IPC and the USP in promoting access to good quality medicines not only those being exported but also those intended for the people of India. The sessions were focused to understand how science and quality standards can be used to ensure good quality medicines in the country.

The focal point of discussion was India’s role in global pharmaceutical market in bringing together regulators, manufacturers and other stakeholders under the same roof for the good of the global public health. According to Dr Roger Williams, managing director and chief executive officer of USP, there is a need to develop and conduct research on biological reference substances to ensure safety of the public in general. “We are extremely happy to see that the Indian government and IPC are taking pro-active initiatives towards patient safety by taking steps to adopt and keep up with good science, good manufacturing practices and developing good standards for making drugs,” Dr Williams added.

In an interesting presentation, Dr Anurag Rathore from the IPC informed that IPC is working towards creating IP reference substances for rDNA therapeutic products as there is need for the same. “One of our important aim is to create ideal monographs that can be used to ensure public safety with in our partnership with the DCGI's office. IPC will be playing an important role in developing references substance and new standards for the biotech drugs in the future,” he informed.

“When it comes to medicines, good quality begins with good science. The science and standards symposium brings together stakeholders from different countries and regions and fosters a dialogue about the science that is the basis of high quality medicines,”said Dr Praveen Tyle, executive vice president and chief science officer at USP.

According to Dr V Srini Srinivasan, USP’s executive vice president for international sites and standards and moderator for the Symposium’s opening session, “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. At the same time, those in pharmaceutical and regulatory circles in India—and throughout the world—must look to increasingly robust measures to protect the quality of pharmaceutical products sourced and developed through a complex network of global partnerships and supply chains.”

The event opened with a keynote address delivered by Pankaj Patel, chief executive officer, Zydus Cadila, and a guest lecture by K V Subramaniam, chief executive officer of Reliance Life Sciences—a part of Reliance Group, one of India’s largest private sector enterprises. Subramaniam discussed biosimilar products—biologic drugs manufactured to be similar in therapeutic impact to innovator products—and the role that Indian manufacturers play in today’s biologics market.

Other speakers on the global biologics market included Dr Ivana Knezevic of the World Health Organization (WHO) quality and safety of biologicals group, presenting on WHO’s approaches to biologic and biosimilar medicines.

In addition to vaccines, other topics of discussion included therapeutic proteins, another important class of drugs for India’s growing biologics manufacturing sector; 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.

Other Representation was made by organisations like the National Institute for Biological Standards and Control (NIBSC) from United Kingdom, the Central Research Institute, Kasauli), and the Serum Institute of India, Pune as well as Indian manufacturers, Biocon and Biological Evans.

The symposium was co-sponsored by 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 Organisation of Pharmaceutical Producers of India (OPPI).