Even as about eight months are left for the implementation of second phase of US Drug Supply Chain Security Act (DSCSA), 50 per cent of Indian pharma companies are still not prepared to comply with pharmaceutical serialization regulation and traceability.

To meet the November 2017 deadline of second phase of DSCSA, a number of small and medium Indian companies are opting for cost effective local track and trace solution providers without looking into wider acceptance of their services thereby facing risk to lose their US market share. Most of the local track and trace solution providers are new in the market and lack knowledge of GxP data integrity, compliance mandates of US FDA, EU. Hence they are not in a position to cater to the needs of the Indian drug makers, said Arjun Guha Thakurta, director-operations, Life Science Consulting Pvt Ltd, a Conval Group company.

On the other hand, India does not have a mechanism to ensure authentication of track and trace solution providers. Hence selection of authentic solution providers is left to the discretion of drug manufacturers, he said.

So, the pharmaceutical companies adopting track and trace solutions having global recognition are well equipped to comply with second phase of DSCSA wherein manufacturers are accountable for product tracing, product identification, suspect product, requests for verification and saleable returns product. Manufacturers have to apply a new product identifier 2D datamatrix code on saleable packs of all of their prescription drugs in the first phase before November 2017. Product identifier containing standardized application identifiers (01) (17) (10) and (21) which uniquely identifies the GTIN, expiry date, batch number and serial number for each saleable pack. 2D Datamatrix shall carry both machine-readable data as well as human readable information which is encoded in the 2D Datamatrix. From 2018, the same is applicable for repackagers, and from 2019 it is applicable for wholesale distributors and from 2020 the same is applicable for dispensers in the as-mentioned sequence.

GS1 India, affiliated to global GS1 which administers and allocates GS1 product identifiers used in barcoding for unique and universal identification of supply chain objects, i.e. - products, logistic items, trading partners, locations, documents, assets etc has listed only 8 companies offering track and trace and anti-counterfeit solutions. They included Condot Systems Pvt. Ltd, Holostik India Ltd, mPedigree Network India Pvt Ltd, PharmaSecure, Shubham Automation Pvt. Ltd, Sundaram Technologies, and TraceLink India Private Limited.

Most of the track and trace solution providers are not registered on GS1 India and their annual turnover stands less than Rs.10 crore but they are providing services to pharma industries having Rs.200 - Rs.2,000 crore turnover. Credibility of some of local track and trace solution providers is also questionable thus putting industries at risk of losing US market share. As deadline for second phase of DSCSA is approaching fast, companies opting for local vendors need to make additional efforts to make sure that their systems are Good automated manufacturing practice (GAMP) compliant to stay in US market.

As per GAMP, the drug industries should go for track and trace solution providers with global recognition to meet requirements of various regulatory agencies.

Thakurta suggested that the drug makers going for local vendors should make sure that their vendors are GAMP compliant which will help them comply with US regulatory norms.

GAMP is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.

DSCSA is being implemented in three phases starting from January 1, 2015 through November 27, 2023 and will provide huge benefits in terms of consumer safety, protecting pharmaceuticals from fraud and counterfeiting and improving product’s efficiency.

Phase 1 is already effective since January 2015 and enforcement started from May 1, 2015 wherein manufacturers are accountable for Product Tracing, work with Authorized Trading Partners, Verification (Transaction Information) TI and Transaction History (TH), Authorized Distribution of Records (relating to the distribution of drug samples) and compliance with Uniform National Policy.