The medicine Metronidazole 400 mg of Hindustan Antibiotic Limited and Karnataka Antibiotic and Pharmaceuticals Limited is not suitable for humans. A special batch of Paracetamol 500 mg tablets was tested which has failed the quality test. The government has disclosed about this medicine in the Rajya Sabha on Tuesday.
List of medicines along with their details which have been declared not of standard quality/counterfeit/misbranded/adulterated by the Central Drug Testing Laboratories. is uploaded regularly and is available on the website of Central Drugs Standard Control Organization (CDSCO) under the title Drug Alert.
Hindustan Antibiotic Limited (HAL)
As per the information provided by the Pharmaceutical Department, Tablet Metronidazole 400 mg (Batch No. HMAA04) manufactured by Hindustan Antibiotic Limited (HAL) and Tablet Paracetamol 500 mg (Batch No. 2508323) manufactured by Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) were tested during the trial. Found ‘Not of Standard Quality’ (NSQ).
As per information provided by Department of Pharmaceuticals, both HAL and KAPL have withdrawn/replaced the required NSQ stock for the recipient. All manufacturers are required to adhere to the license conditions as per Drugs Rules 1945. Is. Which includes the Good Manufacturing Practices (GMP) prescribed under Schedule M of the Drugs Rules 1945.
Amendment in 1945 dated 28.12.2023
The Central Government has amended the Drugs Rules 1945 dated 28.12.2023 to amend Schedule M relating to good manufacturing practices. Requirements for premises, plant and equipment for pharmaceutical products. Whenever matters relating to the quality or safety of medicines are reported. Then action is taken by the concerned licensing authorities under the provisions of the Drugs and Cosmetics Act 1940 and its rules, including prosecution in the appropriate court.
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As a part of monitoring and surveillance activities, drug inspectors take drug samples from the supply chain at regular intervals for quality checking. If the sample is found to be NSQ/counterfeit/adulterated/misbranded, action is initiated as per the provisions of the Drugs and Cosmetics Act, 1940 and the rules thereunder.
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Manufacturing adulterated/substandard quality medicines etc. is a punishable offense under the provisions of the Drugs and Cosmetics Act 1940 and the concerned licensing authorities are empowered to take action in such cases. He said that use of any fake/adulterated/substandard quality medicine etc. is harmful and can have adverse effects on the health of the patient. The minister said that on receipt of individual complaints regarding such drugs, investigation is done with the concerned licensing authorities so that action can be taken as per the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
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