FDA restricts sale and distribution of Tramadol and Tapentadol in Punjab

Chandigarh, August 1, 2019: Upholding the determination to curb the menace of intoxication in the State, Directorate Food and Drug Administration 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 retailsale licencees, with immediate effect.

A notification in this context has been issued by the State Government, informed KS Pannu, Commissioner Food & Drugs Administration, Punjab.

Ensuring that the legitimate requirements of these drugs shall 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. They 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 / Capsules of each drug at a time, informed Pannu.
Besides, the wholesalers who are the direct stockiest of the manufacturing companies are allowed to possess the drug Tramadol and Tapentadol oral solid dosage form up to the extent of 5000 Tablets / Capsules of each drug at a time and the C&FA Licencees are allowed to possess 50,000 Tablets/Capsules of each drug at a time after obtaining the special permission from the State Licensing Authority, he said.

Reiterating the prohibitory orders, Commissioner Food & Drugs Administration informed that ordinary wholesale chemists are hereby restricted by this order not to possess / sale / distribute the drug Tramadol & 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 06 drugs formulations containing Dextropropoxyphene, Dipenoxylate, Codeine, Pentazocine, Buprenorphine & Nitrazepam.

To adjudge the accountability of the stockists, 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, informed Pannu.

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

It is pertinent to mention that various media reports and huge recoveries of Tramadol and Tapentadol orals solid dosage forms made by Food & Drugs Administration and by the other agencies do underline the need to check the misuse of the aforementioned drugs having habit forming potential.