Senior officials from the pharma packaging industry took part in the seminar
ACG Inspection, part of ACG Worldwide Group, and provider of high-tech camera systems, recently organised a technical seminar called ‘Índia’s Readiness for Global Track & Trace.’ Senior officials from the pharma packaging industry took part in the seminar to explore the latest developments in the field of serialisation. Express Pharma was the exclusive media partner for the event.
ACG Inspection fills the gap between effective online checks and product quality. As an advanced inspection company, it provides its expertise in both manufacturing and packaging. With the Indian pharma companies making efforts to adapt global standards in serialisation, the seminar gave them crucial inputs on how to manage this transformation with greatest degree of success while also minimising business disruption.
Ettore Cucchetti, CEO, ACG Inspection Systems gave the welcome address.
The chief guest for the event, Rahul S Shakhapure, Assistant Drug Controller (India), (Air Port), Central Drug Standard Control Organisation (Mumbai), said, “Many deliberations have taken place at various forums on serialisation. There are few regulations in countries like China, Brazil etc. European Union and India too have issued their guidelines and circulars in this regard in a phased manner. The US has passed the resolution in 2013 on serialisation and track and trace system. The Government of India (GoI) is of the view that we can have barcode systems of international standards. These barcodes will be 14 digits barcodes which will have GTI number, batch number, expiry date and unique identification number. The information in the 14 digit barcode will be uploaded on the national server given by the GoI. There can be advantages and disadvantages of the entire process. It can make it easier to trace the product but implementation of serialisation can al so add to the cost. Harmonisation depending on different regulations will also be a challenge.”
Bill Fletcher, Managing Partner, Pharma Logic Solutions, US, spoke on the topic, ‘understanding Drug Supply Chain Security Act (DSCSA) and sharing its implementation experience across 33 companies. Fletcher said, “Indian companies are facing problems while exporting because different countries have different regulatory requirements. Many times, genuine companies suffer because counterfeiters counterfeit their drugs and final consumer and also the doctor think twice before prescribing that particular brand. Global trade will drive counterfeiting to areas of the world lacking adequate traceability regulations. Variations in product identification and requirements for uniqueness necessitates data system agility.”
According to Abhijit Puradkar, Implementation Officer, GS1 India, who was also one of the speakers at the event, such events help pharma companies to get knowledge about the regulatory requirements in several countries. They also get a chance to clarify their doubts regarding the regulatory requirements by the expert panelists. These events also help to spread awareness about Indian regulatory requirements on pharma exports.
“Implementing track and trace systems leads to secure healthcare supply chain and also help in tackling the healthcare industry challenges like counterfeits , authentication, traceability and recall. Due to this reason, many countries are enforcing regulatory laws and hence it’s important for Indian companies to make themselves aware of such requirements,” said Puradkar.
A very stormy debate on GS1 standards was the highlight of the seminar where almost every attendee tried to clear their doubt by asking different queries to the speaker. Professionals present for the seminar expressed their desire to attend more such seminars in future as well.