2-year-old APIs flood market, fear of spurious drugs looms

Ambika Sharma

Solan, January 31

With the Union Health Ministry mandating a compulsory quick response (QR) code to check the sales of spurious drugs, the market has been flooded with pharmaceutical raw material manufactured way back in 2021, triggering fears it could lead to the production of substandard medicines. The raw material includes active pharmaceutical ingredients (APIs), excipients and solvents. Drug manufacturers fear that leftover stock was being relabelled and sold in the garb of exhausting old inventory. As the quality of these components could not be vouched for, the final product could turn out to be substandard, said a pharmaceutical firm owner. India imports more than 65 per cent of APIs and other such components from China. The manufacturers have for long been flagging non-availability of quality APIs, claiming suppliers were relabelling and repackaging the original product after its import. Calling it a surprising trend, Himachal Drug Manufacturers Association president Dr Rajesh Gupta said, “It is shocking to note that the market is flooded with APIs, excipients and solvents showing January 2021 as the date of manufacturing. It is equally intriguing why this inventory did not appear in 2022 and how components manufactured in 2021 are being sold in 2023.” The association has warned manufacturers to be cautious while purchasing this material as its quality could be inferior, which could lead to substandard drugs.

Relabelled stock?

• It is feared old drug raw material may have been relabelled to escape mandatory QR coding
• The usage of old inventory could lead to manufacture of substandard drugs, say drug firms

Echoing similar sentiments, another drug manufacturer said, “Since a tendency to hoard APIs, solvents and excipients is often seen among traders to create an artificial shortage, it appears the old inventory has flooded the market with new labels.”

Dr Gupta said as QR code had become mandatory on such material, the old inventory being sold now should also bear QR code. “This will promote quality drug manufacturing and will specially help manufacturing states like Himachal where 650 pharmaceutical units are housed in the industrial hubs of Baddi-Barotiwala-Nalagarh, Kala Amb, Paonta Sahib, Parwanoo, etc,” he said.

The QR code system became operational from January 1 and no material can now be sold without this code.

The step was taken to ensure quality of drugs manufactured in the country as APIs and other inactive components used in the manufacturing were at times found contaminated with toxic contents. The image of the country’s pharmaceutical industry had taken a hit particularly after spurious cough syrups were allegedly blamed for the death of 12 children in Udhampur in February 2021 and nearly 70 children in the Gambia recently.