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FDA bans substandard batches of 6 drugs

The state Food and Drug Administration (FDA) has prohibited distribution and sale of certain batches of six drugs meant to treat stomach ulcers, inflammation, fever and excess gastric acid on the ground of substandard quality .

The report:

  • As a part of its routine random inspections of drugs marketed across the state, the FDA seized some samples and tested those at its designated laboratories. Six drugs were found substandard in May , stated the FDA report.
  • Among the batches of seven drugs that have been prohibited for sale are those used to treat gastric ulcers, corticosteroids mainly prescribed for treating inflammation, certain fever reducing tablets, pediatric syrups and medicines primarily used in treating gastroesophageal reflux disease.
  • Certain batches of dexamethasone, pantoprazole, rabeprazole and paracetamol both in tablet and syrup form sold under various brand names were found not meeting standards set by the Indian Pharmacopoeia (IP). This is in violation of various provisions of the Drug and Cosmetic Act 1940 and rules 1945.
  • The samples were drawn from distributors and chemists by the drug inspectors in Nashik, Chandrapur, Nagpur, Amaravati, Mumbai and Thane for test and analysis.
  • The samples were analysed at the designated FDA laboratories and were found not fully complying with the standards set by the Indian Pharmacopoeia.


  • Most manufacturers of substandard drugs found by the FDA are from Himachal Pradesh and Madhya Pradesh.
  • Government hospitals, medical colleges attached to hospitals and doctor’s association have also been provided with the names and batches of the drugs that have been banned for sale in Maharashtra.
  • Statistics by the Central Drug Standard Control Organisation, an ombudsman under the Union government, show that the percentage of spurious drugs is quite low and substandard drugs are a far bigger cause for worry.

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