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Nearly 50% Indian pharma cos under pressure to opt out of US market over DSCSA mandate
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Laxmi Yadav, Mumbai
October 26 , 2016
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Even as the November 2017 deadline for implementation of second phase of
US Drug Supply Chain Security Act (DSCSA) is approaching fast,
approximately 50 per cent of Indian pharma companies are under pressure
to lose their US market share due to their inadequacies to comply with
pharmaceutical serialization regulation and traceability.
DSCSA is being implemented in three phases starting from January 1, 2015 through November 27, 2023.
Phase
1 is already effective since January last year 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.
Phase 2 starts from
November 27, 2017 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.
The DSCSA will have
tremendous benefits in terms of consumer safety, protecting
pharmaceuticals from fraud and counterfeiting and improving product’s
efficiency.
Serialisation of saleable packs (bottles) to pallets
of pharmaceuticals mandated by DSCSA will immensely affect supply chain
of pharma business. Indian companies, exporting to the US market will
have to implement a slew of upgrades of existing lines and make
additional investments into aggregation lines and reporting software to
fulfill US DSCSA mandate. A chunk of companies does not have adequate
space at manufacturing plants to put in place serialisation system. 50
per cent pharma manufacturing plants need to expand their packaging
space to incorporate serialization and aggregation workstation unit.
Besides, the warehouses, logistics and distribution set ups also carry
out repackaging works and will need re-aggregation units within these
facilities, said Arjun Guha Thakurta, director-operations, Life Science
Consulting Pvt Ltd, a Conval Group company.
A majority of Indian
companies, faced with space crunch at manufacturing site, are
encountering hurdles to comply with serialisation requirements at level 3
(site level software and hardware. Master data such as customer,
product and work order information are generally managed in this layer)
and level 4 i.e business logistics systems, said Thakurta.
They
have so far put in place serialisation at first and second line levels.
Level 1 encompasses line level systems such as printers, scanners,
cameras, code readers and controls. Level 2 denotes line level control
systems consisting of software that controls data, serial number
management. The software also aggregates data across all layer 1 devices
on a specific packaging line, he said.
In order to make changes
in the facility layout of the packaging area, the companies have to stop
production, carry out civil work, replace HVAC system, ensure
re-qualification of the packaging hall and subsequently implement track
and trace system. This will entail additional investment and loss of
production.
In a bid to save on cost, most small and medium
Indian companies are opting for local vendors over global suppliers
which cost generally 30-40 per cent higher than local supplier. Local
suppliers lacking knowledge of GxP data integrity, compliance mandates
of US FDA and EU, the Indian pharma company is very likely to fail
catering to the needs of the companies, said director, Life Science
Consulting.
As per the US DSCSA mandate, manufacturers,
repackers, wholesale distributors need to provide applicable TI, TH, TS
not later than one business day, not exceed 48 hours after receiving
request for information from US FDA or other appropriate federal or
state official in the event of a recall or for the purpose of
investigating a suspect product.
Without putting in place
effective serialization solutions from level 1-4, manufacturers are not
able to respond to the request of wholesalers and Repackers within
stipulated time, he concluded.
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