The Centre has directed all pharmaceutical companies manufacturing psychotropic substances to submit their details and register on the online portal of the Central Bureau of Narcotics (CBN) by September 30, failing which their licence with the Commissioner of Narcotics will be cancelled.
“It has been observed that many companies dealing in psychotropic substances and registered with the Commissioner of Narcotics have not registered on the CBN online portal to date,” reads a communication issued by the Commissioner of Narcotics to all companies seen by Mint.
“All companies previously registered but not yet registered on the CBN online portal are advised to register on the said portal not later than 30 September 2024. Previous registrations of companies that fail to register on the CBN online portal by 30 September 2024 will be deemed cancelled,” it added.
The Narcotic Drugs and Psychotropic Substances (NDPS) Act regulates the manufacture, transportation and consumption of narcotic drugs and psychotropic substances.
NDPS rules state that a person who has been issued a licence to manufacture psychotropic substances must mandatorily register with the Commissioner of Narcotics for each substance. Registrations were done through offline mode till October 25, 2023, when the system was moved online.
“There are many cases of diversion of these psychotropic substances from the legal channel to the illicit channel. In most cases, these diversions occur among dealers,” the statement said.
The National Policy on Narcotic Drugs and Psychotropic Substances provides that the Government will consider making it mandatory for dealers in psychotropic substances to register and submit declarations to the Central Narcotics Bureau.
Traders should also register
Psychotic substance dealers who conduct international business will also be required to register on the CBN portal.
“Therefore, in order to achieve uniformity, all dealers in psychotropic substances carrying out domestic business in bulk and preparations are also essentially required to register with the Commissioner of Narcotics on the CBN’s online portal and file quarterly returns in a prescribed format,” the statement read.
Rule 65(2) of the NDPS Rules, 1985 requires registered parties to file quarterly returns with the Commissioner of Narcotics. However, most companies have not filed quarterly returns in the prescribed manner and have not adhered to the deadlines.
“In view of the above, a new format for quarterly declarations has been designed and there are five categories of quarterly declarations: manufacturers of bulk medicines, manufacturers of preparations, traders of bulk medicines, traders of preparations and research and development. The quarterly declaration will be submitted separately for bulk medicines and preparations for each psychotropic substance and submissions after the deadline will not be considered,” the communication states.
The Commissioner also advised suppliers of bulk and in-process psychotropic substances to ensure that they only supply these psychotropic substances to those parties who have registered on the CBN online portal after 30th September 2024.
The National Drug Dependence Treatment Centre, AIIMS, in its 2019 report stated that there are approximately 7.7 million people with opioid use disorders in the country, of which, 2.5 million are consuming pharmaceutical opioids in any form.
Mint He said the Department of Pharmaceuticals wants to collate data and review these drugs for inclusion in the Narcotic Drugs and Psychotropic Substances Act (NDPS), as is the practice in Europe, the United States, Canada, Japan and Australia.
There are between 600 and 700 companies that manufacture psychotropic drugs. Most of these drugs are commonly used to treat mental illnesses, neurological disorders, etc.
Questions sent to the spokesperson of the Ministry of Health remained unanswered by the time this edition went to press.
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