Pharma department seeks report on drug misuse, eyes NDPS Act inclusion

New Delhi: The Department of Pharmaceuticals has sought urgent details from the health ministry and industry on 10 medicines it suspects are being widely abused.

The medicines, which include Fentanyl, Norfentanyl, Zopiclone, Zolpidem, Tapentadol and Naloxone, are used for pain management and treatment of patients with neurological problems.

However, although they are prescrption drugs, they can be used as narcotics and abused.

Also read | Rampant fakes of lifesaving drugs found in Delhi, Jharkhand

The department wants to collate data and review these medications in order to bring them under the Narcotic Drugs and Psychotropic Substances Act (NDPS). This is the practice followed in Europe, US, Canada, Japan and Australia.

NDPS Act

The NDPS Act regulates the manufacture, transport and consumption of narcotic drugs and psychotropic substances.

“The undersigned is directed to seek inputs/comments with respect to the licit medical use or reported cases of drug abuse of following substances such as Zopiclone; Zolpidem; Tapentadol; Naloxone; Pregabalin; Xylazine; Fentanyl; Norfentanyl; Piperidine and Ibloc piperindine (Fentanyl analogues),” said an official communication to the health ministry and industry stakeholders reviewed by Mint.

Also read | Amid global concerns over India-made drugs, Govt plans an exports revamp

Notably, none of these medicines are currently listed in the United Nations Conventions on Narcotics Drugs except Fentanyl and consequently not controlled in India, as of now.

Tapentadol has been categorized in the US under Schedule II of the Control Substances Act. In India it is kept under surveillance and is being analyzed for its scheduling under the NDPS Act, 1985.

Last year, the Drug Consultative Committee (DCC) of the health ministry considered a proposal for listing Tapentadol to schedule X of the drugs rule, 1945.

The committee also discussed a proposal for including pregabalin and its drug formulations in schedule H1 of the drug rules because of misuse for intoxication.

Drug Misuse

The Punjab food and drug administration, last year, found that the drug formulations containing Pregabalin 150mg/300mg were being misused for intoxication, seized these from licensed chemists as well as illegal manufacturers. 

At present the drug formulations containing Pregabalin are neither Schedule H nor in Schedule H1 of the Drugs Rules1945.

Also read | Centre takes away state powers for issuing NOC for export of drugs

“Drug abuse is a serious problem, and we should find ways to reduce it. But it is also important to know that the legitimate use far outweighs the possible abuse of these medicines. We need to understand the quantum of these substances being manufactured & sold in the country Vs the abuse of these medicines. As per NCB data of seizures of pharmaceutical medicines, we found that drug abuse is not even 0.5% of the total legitimate manufacturing and its medical use, which means more than 99.5% of drugs are going into the legitimate market,” said Devesh Malladi, chairman, NDPS Committee at Indian Drugs Manufacturing Association (IDMA).

Way Forward

According to a report jointly published by the ministry of social justice and empowerment, and the National Drug Dependence Treatment Centre, AIIMS, around 2.5 million Indians were addicted to pharmaceutical opioids in 2019.

Also read | Centre expands committee participation to usher in drugs pricing reforms

“Bringing these medications under NDPS Act attracts draconian provisions for widely used drugs and hence, undesired harassment of manufacturers, dealers, chemists & doctors, ultimately reducing its prescription and availability. Bringing these drugs under NDPS impacts availability of these drugs to actual needy patients. To mitigate the drug abuse problem, it is pertinent to focus on demand reduction, create active surveillance & monitoring using GST IT backbone, fix the leakages in the system and catch the wrong doers and punish them,” Malladi said.

Queries sent to the department of pharmaceuticals remained unanswered till press time.