Systech’s UNIQUITY India Conference Throws Light On Global Brand Protection

Systech International, a global leader in serialization and brand protection technologies, organised ‘UNIQUITY India conference’ – one day global conference on serialization, global brand protection and consumer safety in Mumbai recently.

The event provided pharmaceutical industry leaders, supply chain and global brand managers, and analysts deeper insight into complex regulatory mandates with a focus on the DGFT’s track and trace system, US DSCSA and EU FMD as well as effective technologies to meet those demands.

UNIQUITY focused on complex regulatory mandates unfolding around the world in regard to pharmaceutical serialization compliance and traceability, and witnessed participation of more than 75 delegates including representatives of pharma companies, government establishments like commerce and health ministries, and serialization consultants.

The US is the largest market for healthcare products in the world, and India is one of the largest sources of drugs and APIs for US market. Within this ecosystem, drug manufacturers, contract manufacturers and third-party logistics providers based in India need to carefully follow the applicable sections of the US Drug Supply Chain Security Act (DSCSA). Indian companies that manufacture finished pharmaceuticals for US market must make some very specific changes to their packaging and business processes by November 2017, or they will be in violation of the DSCSA law, said Dirk Rodgers, Systech’s regulatory strategist, while addressing the audience.

The US Drug Supply Chain Security Act triggers new business requirements from wholesale distributors that are above and beyond the regulatory requirements, and they are not optional. In addition, aggregation is not required by the DSCSA at this time; however, US wholesale distributors will likely buy only from companies that can provide it in 2018.

Emphasizing the need for anti-counterfeiting mechanisms to protect the quality of pharmaceutical products and patient safety, Dr. Hemant Koshia, commissioner, FDA, Gujarat, highlighted the government’s initiative to implement a domestic anti-counterfeiting programme and shared the Gujarat experience in tackling the spurious drug issue.

Anice Joseph Chandra, director, ministry of commerce & industry, discussed the ministry’s track and trace system to protect the quality of Indian drugs being exported. The track and trace system was put in place in response to troubling findings in overseas markets where counterfeit products with a “Made in India” label started appearing with alarming frequency.

Arjun Guha Thakurta, director operations, Life Science Consulting Pvt Ltd, a Conval Group Company, explained the specific changes that drug manufacturers must make to meet the DGFT/DAVA compliance and at the same time ensure that the databases for other global regulations remain unaffected. The focus of his talk was how to achieve compliance by developing a custom strategy for meeting these diverse regulations and provided insights into the complexities of the market.

Systech is the global technology leader in product safety, and consumer and brand protection. Systech pioneered serialization and is defining the future of authentication. The world’s largest pharmaceutical companies trust their brands to Systech’s technology solutions. Systech unifies and optimizes enterprise serialization, track and trace, and authentication technologies to ensure regulatory compliance, mitigate risk, and drive efficiency and profitability, and its innovation has led best practices for key brands across the pharmaceutical, life science, food and beverage, and consumer packaged goods industries.

Originally Published In Pharmabiz