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Monday, February 6, 2023

27 drugs produced in Himachal Pradesh declared substandard, 5 cough syrups were made by Maiden Pharmaceuticals

The Newz Radar

The samples of 27 drugs manufactured in Himachal have failed the safety test, according to the monthly alert issued by national regulator Central Drugs Standard Control Organisation (CDSCO).

Among the 27 drugs are five samples of CSC cough syrup, which was manufactured by Baddi-based Maiden Pharmaceuticals. This has put a question mark on the quality of the medicines manufactured in the said unit, though it has been lying closed since February 2022.

The Himachal drug authorities had, as a precaution, drawn samples of the five syrups after the World Health Organization (WHO) issued an alert following the death of nearly 70 children in Gambia allegedly due to the consumption of four cough syrups. These syrups were manufactured at Maiden Pharmaceuticals’ sister unit in Sonepat (Haryana).

The five cough syrups of the Baddi plant that have failed the safety test are of LOCG21-85, LOCG21-94, LOCG21-95, LOCG21-84 and LOCG21-96 batches.

Baddi deputy drug controller Manish Kapoor said the WHO alert was issued in October last year. “The samples of these drugs were sent for testing for propylene glycol. The report confirmed that no harmful substances were found, but declared the samples substandard due to several other reasons,” Kapoor said, adding that a notice had been issued to the company.

According to the WHO alert, a toxic substance diethylene glycol and ethylene glycol were found in the cough syrups manufactured by the Maiden Pharmaceuticals Limited in Sonepat. The four cough syrups that came under the scanner after the Gambian deaths and have since been banned are Promethazine Oral Solution, Cofexmalin Baby Cough Syrup, Macoff Baby Cough Syrup and Magrip N Cold Syrup. These four products were mentioned in the WHO alert.

Himachal Drug Controller Navneet Marwah said instructions had been given to recall all medicines whose samples had failed. He said action would be taken against the companies whose samples had repeatedly failed.

The following are the medicines manufactured in Himachal that have failed the safety test:

• T&G Medicare-Baddi’s Glimepiride (Batch: TGT 12213097)

• Athene Life Science-Kala Amb’s Cookal-500 (Batch: TG 21-2346, TH 21-2565, TG 21-2564 and G 21-2539)

• T&G Medicare-Baddi’s Calbisin D Forte (Batch TGT 12213182)

• Zee Laboratories-Paonta Sahib’s Atenolol & Amladipine (Batch – Z 22-013)

• Elves Healthcare Nangal Uprala-Nalagarh’s Iron & Folic Acid Syrup 50 ML (Batch AHL 21034, AHL 21015 and AHL 21012)

• M/s Laboratories Pharmaceutical India-Paonta Sahib’s DSP (Batch LSAT-016)

• Valcure Remedies, Nahan Road Moginad, Moxian CV Dry Syrup (Batch WJD-092C)

• Nexcam-Baddi’s Ramirev (Batch NKT 22116A)

• Amster Lab Bhatolikalan-Baddi’s Atorvadoc (Batch 29 MFT 720)

• Maiden Pharmaceutical-Baddi’s CSP (Batch LOCG 21-85, LOCG 21-94, LOCG 21-95, LOCG 21-84 and LOCG 21-9)

• LV Life Science’s Orthorium-MSM

• Shivam Enterprises-Kala Amb’s Ampholis injection (Batch SI-515)

• Cipla-Baddi’s Junior Lanjol 15mg (Batch BA12571)

• G Laboratories-Paonta Sahib’s Matifex (Batch-322-797)

• DM Pharma Pvt-Baddi’s Para 120 (Batch D10086 and D10085)

• Biological Kala Amb’s Sartan-H (Batch-012259)

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