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Pondicherry drugs control department issues recall for three ‘Not of Standard Quality’ products
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Peethaambaran Kunnathoor, Chennai
January 31 , 2026
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The department of drugs control in Pondicherry has issued an urgent regulatory alert following the discovery of three medicinal products that have failed to meet essential safety and quality benchmarks.
In two separate circulars released on January 27, Dr E Anandakrishnan, the licensing and controlling authority, officially declared these specific drug batches as ‘Not of Standard Quality’ (NSQ). The move comes after laboratory reports from the Central Drugs Testing Laboratory in Hyderabad and the office of the CDSCO in Chennai flagged the products for failing to adhere to pharmacopoeial standards.
Among the flagged items is Iron Sucrose Injection USP, manufactured by Acro Life Sciences (India) Pvt. Ltd, (Batch No. 7505). This medication is critical for patients suffering from iron-deficiency anaemia, particularly those with chronic kidney disease. Health officials also identified tranexamic acid injection I.P, sold under the brand name Traxage (Batch No. TG-156) by Marc Laboratories Ltd as substandard.
Tranexamic acid is a vital anti-fibrinolytic agent used to prevent or reduce heavy bleeding in surgical and trauma cases.
The second circular specifically addressed manufacturers and distributors regarding Neosorb 70/70B-SIROP DE SORBITOL (Batch No. 599646), produced by the French firm Roquette Freres. Sorbitol liquid is a common excipient used as a sweetener and humectant in various liquid oral medicines and semi-solid preparations. The failure of this batch to meet USP/NF standards raises concerns for pharmaceutical manufacturers who use it as a raw material in their own formulations.
In response to these findings, the department has enforced an immediate ban on the purchase and sale of these specific batches across the Union Territory. All pharmaceutical establishments, including retail outlets, wholesalers, and major medical institutions like JIPMER and the government pharmacies, have been directed to freeze their existing stock. Continued sale or distribution of these batches is now a punishable offense under the Drugs and Cosmetics Act.
Distributors and retailers are required to conduct an immediate audit of their inventories and report the exact quantities of the affected batches to the department of drugs control. Besides, the circulars mandate a full recall process, where all identified stock must be returned to the respective manufacturers or primary distributors. This process must be documented and communicated back to the department to ensure that the substandard products are entirely removed from the supply chain.
The Pondicherry State Chemist and Druggist Association (PCDA) and the Pondicherry Drugs Manufacturers Association (PDMA) have been tasked with disseminating this information to their members to ensure widespread compliance. While the specific nature of the lab failures, such as purity, potency, or sterilization issues, was not detailed in the public circular, the ‘NSQ’ designation serves as a high-priority warning to healthcare providers to avoid using these batches to prevent potential adverse reactions in patients.
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