Centre reads out riot act to psychotropic drug makers

The Centre has directed all pharmaceutical companies manufacturing psychotropic substances to submit their data and register on the Central Bureau of Narcotics (CBN) online portal by 30 September, failing which their licence with the Narcotics Commissioner will be cancelled.

“It has come to notice that many companies who are dealing with psychotropic substances and registered with the Narcotics Commissioner have not registered themselves on the CBN online portal till date," said a communication issued by Narcotics Commissioner to all the firms seen by Mint. 

"All such previously registered companies but yet to be registered on the CBN online portal are advised to register themselves on the said portal latest by 30 September 2024. The previous registrations of companies who fail to register themselves on the CBN online portal by 30 September 2024 are deemed cancelled,” it added.

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

NDPS rules mandate a person issued a licence to manufacture psychotropic substances must mandatorily register with the Narcotics Commissioner for each substance. Registrations were done through offline mode till 25 October 2023, when the system switched to online.

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“There are lot of instances of diversion of these psychotropic substances from the legal channel to illicit channels. Such diversions in most cases are noticed at the level of traders,” the communication said.

The national policy of narcotics drug and psychotropic substances provides that the government will consider making it mandatory for traders of psychotropic substances to register and submit returns to the Central Bureau of Narcotics.

Traders should register too

Traders of psychotic substances doing international business are also required to register on the CBN portal.

“Therefore, in order to bring uniformity, all the traders of psychotropic substances doing domestic business in bulk and preparations are also essentially required themselves with Narcotics Commissioner on the CBN online portal and to submit quarterly returns in a prescribed format,” the communication said.

the Rule 65 (2) of NDPS Rules, 1985 mandates submission of quarterly returns by the registered parties with the Narcotics Commissioner. However, most of the firms have not submitted quarterly returns in a prescribed manner and have not adhered to the timelines.

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“In view of these, a new format for quarterly returns has been devised and there are 5 categories of quarterly returns—Manufacturers of the bulk drug, manufacturers of preparations, Traders of Bulk, Traders of preparations and research and development. The quarterly return shall be submitted separately for bulk drug and preparations for each psychotropic substance and submissions after the due date will not be considered,” the communication said.

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

The National Drug Dependence Treatment Centre, AIIMS, in 2019, in its report stated that there are approximately 7.7 million people with opioid use disorders in the country, out of which, 2.5 million use pharmaceutical opioids in any form.

Mint reported that the Department of Pharmaceuticals wants to collate data and review these medications to bring them under the Narcotic Drugs and Psychotropic Substances Act (NDPS), as is the practice followed in Europe, US, Canada, Japan and Australia.

There are about 600-700 firms manufacturing psychotropic drugs. Most of these drugs are commonly used for mental health illnesses, neurological disorders etc.

Queries sent to the health ministry spokesperson remained unanswered till press time.

“The Central Bureau of Narcotics has directed the manufacturers to register on its online portal by 30 September failing which, their old registration would be cancelled as per Rule 65, sub-rule (5)…Neither industry nor trade was consulted by the CBN on this. This could have far reaching implications,” said Devesh Malladi, Chairman, NDPS Committee, Indian Drugs Manufacturers Association (IDMA).

Such a move could affect the availability of essential medicines across various disease categories, impacting patients nationwide, Malladi said, adding that with 800,000 distributors, stockists, and chemists across the country, it's unclear how the CBN intends to manage such a large volume of registrations and quarterly returns, or what the government's objective is in bringing the trade under this scope.