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Punjab FDA Restricts Sale Of Habit Forming Drugs Tramadol And Tapentadol

Punjab FDA Restricts Sale Of Habit Forming Drugs Tramadol And Tapentadol


Chandigarh, 1 Aug 2019:

 

To curb the menace of drug menace in the state, Food and Drug Administration (FDA) Directorate Punjab has issued orders imposing specific restriction on stocking, sale and distribution of Tramadol and Tapentadol in oral solid dosage forms by the wholesale as well as retail sale licencees, with immediate effect.

 

A notification in this context has been issued by the state government, informed commissioner FDA Punjab, KS Pannu.

 

“Ensuring that the legitimate requirements of these drugs will not suffer and simultaneously their easy availability for alleged misuse be reduced, Tramadol and Tapentadol in oral solid dosage forms would be available with identified number of licencees, who are situated either inside or outside the hospitals run by government and private management,” he said.

 

Pannu said such licencees can possess the aforesaid drugs by submitting written request before the Zonal Licensing Authority of their respective area with the condition to possess 500 tablets or capsules of each drug at a time.

 

Besides, the wholesalers who are the direct stockist of the manufacturing companies are allowed to possess the drug Tramadol and Tapentadol oral solid dosage form up to the extent of 5000 tablets of each drug at a time and licensees are allowed to possess 50,000 tablets or capsules of each drug at a time after obtaining the special permission from the State Licensing Authority, he said.

 

Reiterating the prohibitory orders, the FDA commissioner informed that ordinary wholesale chemists are hereby restricted by this order not to possess, sell, distribute the drug Tramadol and Tapentadol Oral Solid dosage form with immediate effect and they have been provided 15 days periods to return the stocks of such drugs to manufacturers or C&FA or Distributors in writing and return stock statements shall be submitted before the Drugs Control Officers of their respective area.

 

“The ordinary retail sale chemists have been prohibited from the possession of Tramadol and Tapentadol drugs formulation in oral solid dosage forms in addition to already restricted six drugs formulations containing Dextropropoxyphene, Dipenoxylate, Codeine, Pentazocine, Buprenorphine and Nitrazepam,” Pannu said.

 

To adjudge the accountability of the stockist, the possessor of these drugs are required to submit their complete inventory with reference to purchase, sale and stock of these drugs in hand, every month before the concerned drugs Inspectors, he informed.

 

Pannu said that all the Zonal Licensing Authorities have been directed to immediately organise the meetings with Chemists Associations to appraise them about these orders and ensure effective implementation. The Statesman