Particular batch of metronidazole, paracetamol tablets "not of standard quality", Government tells Rajya Sabha
The Hindu
Metronidazole 400 mg and Paracetamol 500 mg tablets found "not of standard quality" by government testing.
A particular batch of Metronidazole 400 mg and Paracetamol 500 mg tablets made by Hindustan Antibiotic Limited and Karnataka Antibiotic and Pharmaceuticals Limited, respectively have been found to be "not of standard quality" during testing, the Government told Rajya Sabha on Tuesday (December 10, 2024).
As informed by the Department of Pharmaceuticals, both Hindustan Antibiotic Limited and Karnataka Antibiotic and Pharmaceuticals Limited have withdrawn/replaced the requisite 'Not of Standard Quality' (NSQ) stocks to the consignee with fresh stocks, Union Minister of State for Health Anupriya Patel said in a written reply.
A list of such drugs along with their details, which are declared not of standard quality/spurious/misbranded/adulterated by the Central Drugs Testing Laboratories is regularly uploaded and available on the website of Central Drugs Standard Control Organization (CDSCO) under the heading of drug alert.
As informed by the Department of Pharmaceuticals, Tablet Metronidazole 400 mg (Batch No. HMAA04) manufactured by Hindustan Antibiotic Limited (HAL) and Tablet Paracetamol 500 mg (Batch No. 2508323) manufactured by Karnataka Antibiotic and Pharmaceuticals Limited (KAPL) have been found to be 'Not of Standard Quality' (NSQ) during testing.
"As informed by the Department of Pharmaceuticals, both HAL and KAPL have withdrawn/replaced the requisite NSQ stocks to the consignee's with fresh stocks," Ms. Patel said.
As per the Drugs Rules, 1945, all manufacturers are required to comply with the conditions of the license including the good manufacturing practices (GMP) as prescribed under the Schedule M of the Drugs Rules, 1945.
Further, the Central Government has amended the Drugs Rules 1945 dated 28.12.2023 to revise the schedule M related to good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products.
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