With many industry members expressing concern over the central government’s recent decision to bring pain reliever drug tramadol under the purview of Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, from April 26 2018, the Pharmaceutical Export Promotion Council (Pharmexcil) on behalf of the industry has taken up the issue with the central government and sought exemption from seizing or initiating criminal prosecution against those players who have already manufactured and stocked huge quantities of tramadol before 26th April, 2018.
As the government has announced tramadol as a psychotropic drug and brought it under the purview of NDPS Act, according to Rules 55 and 58 of the NDPS Act 1985, no narcotic drugs and psychotropic substances specified in the Act shall be imported into, or exported out of India without an import certificate, export authorisation issued by the Narcotics Commissioner.
With this the manufacturers who have already manufactured and stocked tramadol in huge quantities are in a state of confusion. In view of this, Pharmexcil on behalf of the industry has taken up the issue with the government and sought its intervention.
“Bringing tramadol under the purview of NDPS Act has really put a large number of industry players in a quandary. As it will become a criminal offence to have stored, transported, distributed or exported tramadol drug after 26th April, 2018, the council has sought exemption from Department of Revenue not to seize or initiate any criminal action against the manufacturers who have stocked tramadol before the said date. We are hopeful that the government will consider the issue and give positive response favourable to the industry,” said Ravi Uday Bhaskar, Director General of Pharmexcil.
Tramadol comes as a tablet and as an extended-release tablet to treat persistent pain from arthritis and post surgery conditions. It comes under a class of pain medication known as opiate narcotic analgesics, which works on the brain to bring for pain relief.
As per the request of the members, the council has already shared guidelines and procedures pertaining to registration with the Narcotic Control Board. Guidelines for manufacture, import, distribute and export of this psychotropic drug is also being shared to the members. “With the new regulations coming into force from 26th April, members are advised to follow guidelines and procedures strictly so as to avoid any legal entanglement for the players,” noted the DG.
Even though the council has taken up the issue with the Department of the Revenue through Ministry of Commerce, a final nod from the central government is yet to be received and to avoid any kind of untoward eventuality the members are advised to get themselves register with the Narcotic Control Board and adhere to the guidelines issued by the government.