With the DSCSA and other serialisation deadlines looming ahead, Uniquity India 2016 served as a timely status check By Viveka Roychowdhury
“You have 500 days to meet the November 27, 2017 deadline,” said Arjun Guha Thakurta, Director Operations, Life Science Consulting, a Conval Group Company. He was speaking at Uniquity India 2016, a recently held one-day meet organised by Systech International in Mumbai.
His statement caught the attention of all attendees as he was alluding to the next milestone of the Drug Supply Chain Security Act (DSCSA), which requires pharmaceutical manufacturers distributing and selling in the US, to print a unique product identification code on all sale units and homogeneous cases of prescription medicines.
Attendees included over a hundred industry specialists, from companies like Johnson & Johnson, Teva, GlaxoSmithKline, PharmaSecure, Merck, Abbott, Biocon, Dr Reddy’s Laboratories, industry leaders, as well as equipment manufacturers like IMA-PG India.
Setting the tone for the day, Robert ‘Bob’ DeJean, CEO, Systech urged the attendees to use Uniquity India 2016 as a forum to share experiences and best practices which will make all of us stronger together.
The Indian regulatory side was represented by Anice Joseph Chandra, Director, Ministry of Commerce & Industry, Government of India, who directs the track and trace programme, implemented by the Department of Commerce, for the promotion of Brand India, ensuring that spurious health products are not exported under a ‘Made in India’ label. In her special address, she shared details and upcoming changes to India’s track and trace initiative, the Drugs Authentication and Verification Application (DAVA).
Giving real life examples, Dr Hemant Koshia, Commissioner, Food & Drugs Control Administration, Government of Gujarat, gave his perspectives and insights as a regulator. Drawing an analogy between the gotra system of keeping track of families through generations and the present day need to track and trace medicines through the supply chain, he showed photographs of raids on sites of spurious medicine manufacturing sites conducted in his state, to illustrate the success of the anti-counterfeiting initiative in Gujarat.
The industry’s implementation challenges were highlighted by Arun Gupta, Strategic Advisor, Systech and ex global CIO, Cipla, when he commented, “Serialisation is not an IT but a business problem but IT (department) is expected to play a leadership role in this initiative.”
While Gupta spoke about his experiences in the pharmaceutical sector and gave hints of the many legacy challenges faced by pharma companies in India as they gear up to meet global serialisation mandates, other speakers gave details of the regulations that are rolling out across the globe.
Guha Thakurta, whose company advises pharma manufacturers on their serialisation strategies, spoke on ways to bridge the gaps between the DGFT/ DAVA mandate and global serialisation regulations. He further outlined the crucial nature of the challenge when he said that 84 per cent of world GDP is covered by track and trace regulations and described many ‘implementation black holes.’
Dirk Rodgers, Regulatory Strategist, Systech International conducted workshops, detailing aspects of the US DSCSA law, highlighting the hidden complexities that Indian exporters need to know, and what they should do to be complaint with multiple country-specific global regulations.
Dr Avi Chaudhuri, Senior Global Partner, Systech International, who first got involved with track and trace initiatives after falling a victim to counterfeit medication himself, gave an overview of Systech’s solutions and its unique benefits to the Indian pharma industry.
The highlight of Uniquity India 2016 was a very interactive panel discussion, moderated by Rodgers with Guha Thakurta, Koshia, Gupta and Chaudhuri fielding queries from the audience.