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.
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of Pharmaceuticals, both Hindustan Antibiotic Limited and Karnataka Antibiotic and Pharmaceuticals Limited have withdrawn/replaced the requisite 'Not of Standard Quality' (NSQ) stocks to the consignee with fresh stocks, Union Minister of State for Health Anupriya Patel said in a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"As informed by the Department of Pharmaceuticals, both HAL and KAPL have withdrawn/replaced the requisite NSQ stocks to the consignee's with fresh stocks," Patel said.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.
In the cases concerning the quality or safety of drugs as and when reported, actions are taken by the licensing authorities concerned under the provisions of the Drugs and Cosmetics Act, 1940, and its rules, including prosecution in the appropriate court of law.
As a part of surveillance and monitoring activities, the drug inspectors draw drug samples from the supply chain at regular frequency for quality checks. In case the sample is found to be NSQ/spurious/adulterated/misbranded, actions are initiated as per provisions of the Drugs and Cosmetics Act, 1940, and the rules thereunder.
"Manufacture of spurious/adulterated/Not of Standard Quality drugs etc. is a punishable offence under the provisions of Drugs and Cosmetics Act, 1940, and concerned licensing authorities are empowered to take action in such cases," Patel said.
Use of any spurious/adulterated/not of standard quality drugs etc. is detrimental and may cause adverse effects on the patient's health, she said.
Isolated complaints regarding such drugs as and when received are investigated along with the licensing authorities concerned for taking action as per the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, the minister added.
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