Maharashtra FDA Submits proposal to state govt to launch quality assurance portal to ensure only quality drugs reach patients

The Maharashtra Food and Drug Administration (FDA) has proposed to the state government the establishment of a quality assurance portal to ensure that safe and effective medicines are provided to consumers and patients. The portal will assist manufacturers and wholesalers in being accountable for effective traceability of medicines from production to end consumer and patient. This will also improve 100% transparency in terms of maintaining regulatory oversight over the state's drug supply chain. "This portal will be called the quality assurance portal," said Maharashtra FDA Commissioner Abhimanyu Kale.

It will assist manufacturers in keeping track of the production of medicine batches in a given month, as well as distribution data. This will also assist wholesalers and state drug controllers in keeping track of where medicines are procured and distributed in the retail supply chain in a real-time and seamless manner." This regulatory step comes as the pharmaceutical industry prepares for the implementation of the QR code on August 1, 2023. The implementation is part of the Drugs (Eighth Amendment) Rules, 2022, which require barcodes on the labels of the top 300 formulation brands. This QR code will aid in the identification of misbranded or counterfeit medicines, as well as the recall of products if their quality is compromised during manufacturing.

Counterfeiting has been found to be most prevalent in key sectors, particularly pharma, as evidenced by the Gambian cough syrup tragedy and the recall of eye drops from India. It accounts for approximately 25% to 30% of all 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.