This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for the month of May 2021 (Revised).
Key Changes
Rosuvas 20 (Rosuvastatin Tablets I.P.), batch number EMX0685, manufactured in March 2020 and expiring in August 2023, has been declared Not of Standard Quality due to Dissolution and Assay issues.
The drug was allegedly manufactured by M/s. Sun Pharma Laboratories Ltd., located in East Sikkim.
The sample was drawn by CDSCO, CDL, East Zone, Kolkata.
Impact Analysis
Sun Pharma Laboratories Ltd.
Action Item: Immediately investigate the cause of the Dissolution and Assay failure for batch EMX0685. Implement corrective and preventive actions (CAPA) to address the root cause. Coordinate with CDSCO for any required actions.
Patients/Consumers
Action Item: Issue a public advisory, in coordination with CDSCO, regarding the affected batch of Rosuvas 20, advising patients to discontinue use and consult their healthcare provider.
CDSCO
Action Item: Continue monitoring the market for substandard drugs and take appropriate action to protect public health.
Pharmacies and Distributors
Action Item: Ensure that all pharmacies and distributors are informed about the recall of batch EMX0685 and have a system in place to return the affected product to the manufacturer.
Key Entities Referenced
CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India.
CDL, Kolkata: Central Drugs Laboratory, Kolkata, a drug testing laboratory under the CDSCO.
Rosuvas 20 (Rosuvastatin Tablets I.P.): A drug containing Rosuvastatin, used to lower cholesterol levels.
Sun Pharma Laboratories Ltd.: The alleged manufacturer of the substandard drug, located in East Sikkim.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard
Quality/Spurious/Adulterated/Misbranded, For the Month of May- 2021(Revised)
Sl. Name of Batch No./Date of Reason for Drawn By From
No. Drugs/medical Manufacture/Date of failure
device/cosmeti Expiry/Manufactured By
cs
2 Rosuvas 20 B. No.: EMX0685, Dissolution and CDSCO, CDL,
(Rosuvastatin Mfgdt: 03/2020, Assay East Zone, Kolkata
Kolkata
Tablets I.P.) Expdt: 08/2023,
Allegedly Mfd by (as
indicated on label): M/s.
Sun Pharma Laboratories
Ltd., Plot No. 107-108, Namli
Block, P.O. Ranipool, East
Sikkim-737135