The Central Drugs Standard Control Organisation (CDSCO) has issued drug alerts for specific batches of Tofacitinib Tablets IP 5 mg (marketed as TOFAJAK TABLETS) and TELMA AM, declaring them as potentially spurious following investigations into their quality. These notifications was issued on April 18, 2025.
Drug Alert for the Month of November–2024 (Revised)
A drug alert for the month of November 2024 (revised) flagged a batch of Tofacitinib Tablets IP 5 mg (TOFAJAK TABLETS), bearing batch number 4F30009, with a manufacture date of May 2024 and an expiry date of April 2026. The reason for failure was related to the “Identification and Assay of Tofacitinib citrate calculated as Tofacitinib.”
Crucially, the purported manufacturer (as per the label claim) has informed authorities that this specific batch was not manufactured by them and is believed to be a spurious drug. The alert, issued by the Drugs Control Officer in Gurugram, notes that while the product is suspected to be spurious, this is subject to the outcome of ongoing investigations.
Drug Alert for the Month of January–2025 (Revised)
Similarly, a revised drug alert for January 2025 highlighted a batch of TELMA AM, bearing batch number 5240367, manufactured in March 2024 and expiring in February 2027. This batch was found to not conform to Indian Pharmacopoeia (I.P.) standards.
In a concerning parallel to the Tofacitinib case, the actual manufacturer (as per the label claim) has also stated that this impugned batch of TELMA AM was not manufactured by them and is also suspected to be a spurious drug. This alert also emphasizes that the spurious nature of the product is subject to the results of ongoing investigations.
These drug alerts serve as a serious warning to patients, healthcare professionals, and pharmacies. Spurious drugs can be ineffective and potentially harmful, as their contents, quality, and manufacturing processes are not verified.
Key Takeaways
- Specific batches of Tofacitinib Tablets IP 5 mg (TOFAJAK TABLETS) and TELMA AM have been flagged as potentially spurious.
- The purported manufacturers of both batches have denied producing them.
- Investigations are currently underway to determine the authenticity and source of these drugs.
- The public is urged to exercise caution and purchase medications only from trusted and licensed sources.
The drug alerts were part of a broader list released for January 2025 and for November 2024, which identified various drugs, medical devices, vaccines, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded. Consumers and healthcare providers are advised to stay informed about such alerts issued by regulatory authorities to ensure the safety and efficacy of the medications they use or dispense.
