DCGI puts restrictions on use of tramadol, tapentadol and their FDCs

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The Drugs Controller General of India (DCGI) has put restrictions on the formulations of tramadol, tapentadol as wells as fixed dose combinations containing tramadol, in line with the recommendations of the new rug advisory committee as these drugs had potential for respiratory depressions and addiction.

Formulation of tramadol has been approved by the Central Drugs Standard Control Organisation (CDSCO) on January 27, 1993 for purpose of severe acute and chronic pain, diagnostic measures and surgical pain. Further the formulation of tapentadol had been approved on April 18, 2011 for relief of moderate to severe acute pain in adults 18 years of age or older.

“The NDAC (analgesics, anaesthetics and rheumatology) at its meeting held on March 22, 2013 deliberated that tramadol as well as tapentadol has high potential for respiratory depressions and addictions. The committee recommended that all preparations of tramadol as well as tapentadol should be used for severe acute pain only for a period not exceeding five days,” said a directive by the DCGI.

“You are therefore requested to direct all the manufacturers manufacturing the preparation containing tramadol or tapentadol under your jurisdiction to comply with the aforesaid indication.  The labels, package inserts and other promotional literature of such products should be revised as above and submitted to the Directorate for further necessary action,” the notice sent to all the state licencing authorities said.

The DCGI, in his letter, also directed the manufacturers to communicate the changes made and compliance to the amendment to his office.

More than 100 companies, mostly lesser known entities, manufacture the painkiller tramadol, while only leading companies are selling tapentadol. However, hundreds of fixed dose combinations involving these two drugs are in the market.

Source: PharmaBiz

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