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Restriction on use of formulations of Tramadol,Tapentadol as well as FDCs containing Tramadol

A circular dated 14.02.2014 by office of drug controller general (India) to all state / UTs Drug Controller requested to direct all manufacturers manufacturing preperations containing Tramadol or Tapentadol to comply with indication recommended by NDAC committee.

NDAC ( Analgesics , Anesthetics & Rheumatology ) committee in its meeting on 22.03.2013 recommended that all preperations of Tramadol as well as Tapentadol should be used for severe acute pain only for a period not exceeding 5 years.

The label, package inset and all literature of such products should be revised as above recommendation.

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2/20/2014 9:32:20 AM