India may look again at domestic serialization proposals

India’s central drug regulatory authority has formed a working group to look into its serialization programme for domestic drugs – which have come in for strong criticism, according to local news reports.

An Economic Times article says that the Central Drugs Standard Control Organisation will ask the group to “critically appraise” the plans, which envisage print a unique serial number on medicine packages so that consumers may authenticate the product via an SMS- or call-enabled check. Critics of the move suggest the plan would not provide the level of traceability and security needed for Indian consumers.

The working group will include representatives from pharmaceutical industry associations as well as the CDSCO and is scheduled to deliver a verdict on the proposed system and provide other “suitable solutions” by October.

The current plan was drawn up by Drugs Technical Advisory Board (DTAB) in May and falls well short of the technical requirements that India’s pharmaceutical exporters have to comply with, which include the addition of serialised 2D datamatrix codes on packs that can be verified using the national Drug Authentication and Verification Application (DAVA).

While there have been reports that compliance with the requirements for exported drugs is still far from perfect, one of the reasons a deadline on aggregating parent-child packaging data to be set back, there is criticism that the plans for domestic drugs are too watered down to provide effective consumer protection.

As it stands, the proposals only cover 300 widely-used drugs, while serialization experts suggest it is not much of a challenge to reverse engineer such a an open-format system so that counterfeit or otherwise falsified medicines – such as those past their expiry – could be falsely presented as genuine.

Worryingly, the ET article – citing minutes from a meeting chaired by the Drug Controller General of India – suggests that the concerns about the system may hang more on its ease of introduction than any deficiency in its ability to protect the public against potentially dangerous medicines. It talks about the workload imposed on regulators, the cost burden on pharma companies and contract manufacturers, and the low take-up of similar, voluntary systems that are already operating in India.

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