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The Maharashtra Food and Drug Administration (FDA) has sent a proposal to the state government to launch a quality assurance portal to ensure that safe and efficacious medicines are provided to the consumers and patients.
The portal will facilitate the manufacturers and wholesalers to be accountable towards effective traceability of the medicines from the production to the end consumer and patient. This will also be able to enhance 100 % transparency in terms of keeping a regulatory oversight on the drug supply chain in the state.
According to Maharashtra FDA Commissioner Abhimanyu Kale, “This portal will be called as quality assurance portal. It will help the manufacturers to keep a track on the production of medicine batches in a particular month and also the distribution data. This will also help the wholesalers and the state drug controllers to keep a track on from where the medicines have been procured and distributed in the retail supply chain in a real-time and seamless manner.”
This regulatory step comes at a time when the pharma industry is gearing up towards the implementation of the QR code August 1, 2023. The implementation is a part of the Drugs (Eighth Amendment) Rules, 2022 which mandates barcodes on the label of top 300 brands of formulations. This QR code will help identify misbranded or counterfeit medicines as well as recall the products if its quality gets compromised during manufacturing.
Counterfeiting is found to be most prevalent in key sectors, specifically pharma and the Gambian cough syrup tragedy and the recall of eye drops from India are a case in point. It constitutes almost 25% to 30% of the products (State of Counterfeiting in India 2022).
The Central government had also mandated QR code on the label of all APIs manufactured or imported in India, at each level packaging to enable tracking and tracing of the pharmaceutical ingredients. The amendment Rule is scheduled to come into force from January 1, 2024.
“Track-and-Trace digital technologies can provide actionable intelligence to brand owners through electronic means so that they can pinpoint unauthorized sellers on the internet. This can help in track-and-trace products through the distribution chain. It can also remotely authenticate a product anywhere and anytime by scanning a product label with a smartphone or by entering a code into a web-platform,” according to experts.
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