Centre gives psychopharmaceutical manufacturers the riot act

“It has been noticed that many companies that deal in psychotropic substances and are registered with the Drug Enforcement Agency have not yet registered on the CBN online portal,” says a message from the Drug Enforcement Agency to all companies supported by Mint.

“All previously registered companies that have not yet registered on the CBN online portal are advised to register on the said portal no later than September 30, 2024. The previous registrations of companies that do not register on the CBN online portal by September 30, 2024 will be deemed cancelled,” it added.

The Narcotic Drugs and Psychotropic Substances Act (NDPS) regulates the manufacture, transportation and consumption of narcotic drugs and psychotropic substances.

The NDPS rules require that a person obtaining a licence to manufacture psychotropic substances must register with the Narcotics Commissioner for each substance. The registrations were done offline until October 25, 2023, after which the system was converted to online.

“There are numerous cases in which these psychotropic substances are diverted from legal to illegal channels. Such diversions are in most cases noticed at the level of the dealers,” the statement said.

The national policy on narcotic drugs and psychotropic substances provides that the Government shall consider introducing an obligation for dealers in psychotropic substances to register and submit declarations to the Central Bureau of Narcotics.

Retailers should also register

Dealers in psychotic substances doing business internationally must also register on the CBN portal.

“In order to achieve uniformity, all dealers in psychotropic substances dealing in large quantities and preparations domestically are therefore required to register with the Narcotics Commissioner on the CBN's online portal and submit quarterly returns in a prescribed format,” the statement said.

Rule 65(2) of the NDPS Rules, 1985 requires the filing of quarterly returns by the registered parties to the Narcotics Commissioner. However, most of the companies have not filed their quarterly returns in the prescribed manner and have not complied with the time limits.

“In this context, a new format for quarterly reporting has been developed and there are five categories for quarterly reporting: manufacturers of unpackaged medicines, manufacturers of preparations, distributors of unpackaged medicines, distributors of preparations and research and development. The quarterly report must be submitted separately for unpackaged medicines and preparations for each psychotropic substance. Reports submitted after the due date will not be considered,” the statement said.

The Commissioner also advised suppliers of bulk goods and preparations of psychotropic substances to ensure that they supply these psychotropic substances only to those parties who have registered on the CBN online portal after September 30, 2024.

The National Drug Dependence Treatment Centre (AIIMS) in its 2019 report stated that there are about 7.7 million people with opioid use disorder in the country, of whom 2.5 million use pharmaceutical opioids in some form.

mint reported that the Ministry of Pharmaceuticals wants to collect data and review these drugs to bring them under the Narcotic Drugs and Psychotropic Substances Act (NDPS), as is practiced in Europe, the United States, Canada, Japan and Australia.

There are about 600-700 companies that produce psychotropic drugs. Most of these drugs are widely used to treat mental illnesses, neurological disorders, etc.

Inquiries addressed to the spokesperson of the Ministry of Health remained unanswered at the time of going to press.