On April 26, 2018, Department of Revenue, Ministry of Finance, vide its notification S. O. 1761(E), declared Tramadol as a Psychotropic substance to control its abuse/misuse4 in exercise of the powers conferred by section 3 of the Narcotic Drugs and Psychotropic Substances Act, 1985. As a result, the sale & distribution of Tramadol will now be under the supervision and control of Narcotics Control Bureau (NCB).
On April 09, 2018, days before the above notification, during the 53rd meeting of the Drugs Consultative Committee (DCC) 5 at Central Drugs Standard Control Organization (CDSCO), the issue of abuse and trafficking of pharmaceutical preparations in the country especially Codeine based cough syrups and Tramadol was considered. The Deputy Director (Operations), NCB had addressed the members of DCC and raised serious concerns about the issue of abuse and trafficking of pharmaceutical preparations in the country as the official records show that huge quantities of Tramadol were seized in the country last year. The Deputy Director had requested all the State Licensing Authorities to re-consider the proposal of reduction in batch size for manufacturing such drugs to control their abuse and misuse.
The Deputy Director also insisted to verify the existence of sale premises before a license is granted by the states and to conduct surprise raids in this regard. He had also informed that the proposal for considering inclusion of Tramadol under Narcotics Drugs and Psychotropic Substances (NDPS) was under active consideration and, notification in the regard to be issued shortly. DCC deliberated and agreed for considering Tramadol under NDPS, so that the drug could be placed under restrictions of production as API and under controls on import into and export out of India. This will ensure the availability of the drug to persons who need it for pain management yet also restrict its illicit movement.
Earlier on March 19, 2014, the Drugs and Cosmetics (Fourth amendment), 20136, had introduced Schedule H1 for regulating sale of certain antibiotics, anti-TB Drugs and habit-forming drugs, where Tramadol was one of those habit-forming drug listed under Schedule H1. According to Schedule H1, the drugs should carry a Boxed Label Warning saying – Not to be sold without a prescription issued by Registered Medical Practitioner and selfmedication of the drug preparation can be dangerous7.
Note – The government's decision to declare Tramadol as a psychotropic substance under Narcotics Drugs and Psychotropic Substances (NDPS) will make strict monitoring of its movement possible and also empower NCB to curb the ongoing drug-abuse trend in the country. It will also enable rigorous punishment to the offenders if the drug is found illegally stocked or distributed.
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