List of medicines with their details which have been declared not of standard quality/counterfeit/mislabeled/adulterated by central drug control laboratories. is uploaded regularly and is available on the Central Drugs Standard Control Organization (CDSCO) website under the title Drug Alert.
Hindustan Antibiotic Limited (HAL)
According to the information provided by the pharmaceutical department, Metronidazole Tablet 400 mg (Batch No. HMAA04) manufactured by Hindustan Antibiotic Limited (HAL) and Paracetamol Tablet 500 mg (Batch No. 2508323) manufactured by Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) were tested during the trial and found to be “Not Standard Quality” (NSQ).
As per the information provided by the Department of Pharmaceuticals, HAL and KAPL have withdrawn/replaced the required NSQ stock for the recipient. All manufacturers are required to comply with the license conditions as per the Drug Rules, 1945. Which includes Good Manufacturing Practices (GMP) prescribed in Schedule M of the Drug Rules, 1945.
Amendment in 1945 of 12/28/2023
The Central Government has amended the Drugs Rules 1945 dated 28.12.2023 to amend Annexure M relating to good manufacturing practices. Requirements for premises, facilities and equipment for pharmaceutical products Whenever questions relating to the quality or safety of medicinal products are reported. Action is then taken by the appropriate licensing authorities in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and its rules, including prosecution in the appropriate court.
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As part of control and surveillance activities, drug inspectors take samples of drugs from the supply chain at regular intervals to check their quality. If the sample is found to be NSQ/counterfeit/adulterated/mislabeled, action is taken in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder.
Manufacturing of adulterated/substandard medicines etc. is an offense punishable under the provisions of the Drugs and Cosmetics Act, 1940 and the relevant licensing authorities are empowered to take action in such cases. He said that use of any counterfeit/falsified/substandard medicines etc. is harmful and may have adverse effects on the patient’s health. The minister said that on receipt of individual complaints regarding these drugs, inquiry is made to the concerned licensing authorities so that action can be taken in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.