India’s pharma ingredient barcoding plan advances

India is moving ahead with plans to introduce a traceability scheme for active pharmaceutical ingredients in order to clamp down on falsified medicines.

A proposal by the Drug and Technical Advisory Board (DTAB), first published in April, will make it mandatory for APIs to carry QR codes that will allow them to be traced from the ingredient producer to the manufacture of finished pharmaceutical products “through a system of networking”.

The requirement will apply to both imported and domestically produced ingredients, affecting some 2,500 APIs used in Indian pharmaceutical products. It complements India’s established barcoding system for exported finished medicines, as well as ongoing plans to develop a traceability system for drugs distributed in the domestic market.

In addition to helping to guard against the production of falsified medicines and making sure APIs are shipped in suitable conditions to maintain their quality, the API measure could help the government monitor products subject to Goods and Services (GST) tax.

A recent study by the Bureau of Pharma Public Sector Undertakings of India (BPPI) found 25 batches of generic drugs sourced 18 different pharmaceutical companies to be of substandard quality, reports The Hindu Business Line.

The move follows the introduction of guidelines in Europe in 2015 which also require full traceability of APIs from the start to the end of their supply chain.

India’s requirements go one step further by mandating a barcoding system, while the EU guidelines rely on conventional Good Distribution Practice (GDP) elements but do not preclude the use of coding to facilitate raw material traceability.

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