Stricter Control Over Painkiller and Epilepsy Drug
The Indian government is planning to impose stricter controls on the painkiller Tapentadol and epilepsy drug Pregabalin to curb their misuse for substance abuse. Authorities are considering listing Tapentadol under Schedule X of the Drugs Rules 1945 and including Pregabalin and its formulations in Schedule H1.
Regulatory Discussions Underway
The Drugs Consultative Committee, chaired by Drugs Controller General of India (DCGI) Rajeev Raghuvanshi, recently discussed these regulatory changes. A government official stated that Tapentadol, like Tramadol in the past, is frequently misused due to its sedative effects. Similarly, Pregabalin is also being increasingly abused.
Need for Enhanced Monitoring
Despite being prescription drugs, both Tapentadol and Pregabalin have been used as narcotics. To prevent intoxication and ensure restricted use, the government aims to enforce stringent monitoring mechanisms. The proposed regulations will require chemists to maintain detailed sales and purchase records of these drugs.
Global and Domestic Regulations
Tapentadol is categorized under Schedule II of the Controlled Substances Act in the United States and is controlled in several other countries. However, in India, it is not yet covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act or any international conventions.
Medical Experts Highlight Addiction Risks
Dr. Atul Ambekar, professor at the National Drug Dependence Treatment Centre, AIIMS, confirmed that these drugs are being used for non-medical purposes, leading to addiction. He noted that patients often seek medical help to quit these substances after prolonged misuse. However, he emphasized that since these drugs have valid medical applications, a complete ban would not be practical. Instead, better regulatory mechanisms should be implemented.
Evidence of Misuse and Law Enforcement Actions
Several reports highlight the widespread misuse of these drugs:
- In 2023, the Punjab Food and Drug Administration found that formulations containing Pregabalin 150mg/300mg were being used for intoxication. Authorities seized these from both licensed chemists and illegal manufacturers.
- In Karnataka, law enforcement agencies seized 1,720 Tapentadol tablets from a drug peddler in Bengaluru.
Government’s Broader Strategy on Drug Abuse
As reported by msn, the Department of Pharmaceuticals has been reviewing the misuse of multiple medicines, including Fentanyl, Norfentanyl, Zopiclone, Zolpidem, and Naloxone. These drugs, widely used for pain management and neurological treatments, may also come under stricter regulation.
Rising Pharmaceutical Opioid Addiction in India
A 2019 report on substance abuse in India, published by the Central government, revealed that approximately 2.5 million people in the country were addicted to pharmaceutical opioids. The new regulatory measures aim to address this growing crisis and prevent further misuse of prescription drugs.