Substance abuse: Painkiller Tapentadol, epilepsy drug Pregabalin may come under strict control

The proposal for listing Tapentadol under Schedule X of the Drugs Rules 1945 and inclusion of Pregabalin and its drug formulations in Schedule H1 of the same law was discussed in the Drugs Consultative Committee meeting chaired by the Drugs Controller General of India (DCGI) Rajeev Raghuvanshi.

“Tapentadol is being misused, just like Tramadol used to get misused in the past. Tapentadol is an advanced level of painkiller and one of its side-effects is sedation," said an official aware of the matter. Similarly, Pregabalin is being planned to be added in schedule H1, the official said on the condition of anonymity.

Also read |  India is cracking down on fake drugs—retailers, wholesalers could pay the price

The official said that although they are prescription drugs, they can be used as narcotics.

“For restricted use and avoid intoxication, the government is planning to have control over these drugs. These are a very stringent schedules and close monitoring of the drugs in the market [is required]," said the official. “Once this done, every chemist has to keep a record of sales and purchase of these drugs."

Queries emailed to the health ministry remained unanswered till press time.

Under controls

Tapentadol has been categorized under Schedule II of the Controlled Substances Act in the US. It is also a controlled drug in some other countries. However, it is not covered under the NDPS Act in India or any international conventions.

“One thing is certain that these drugs (Tapentadol & Pregabalin) are being used for the non-medical purposes and people are experiencing addiction due to them," said Dr Atul Ambekar, professor at National Drug Dependence Treatment Centre, AIIMS. “We do see patients seeking help to quit taking these drugs because they have developed addiction to them after using them without prescription."

Also read |  Govt may propose duty cuts for rare-disease medicines, cancer drugs in budget

Dr Ambekar, however, said since these drugs are used for valid medical purpose, one should not think of a total ban. “Rather, we need have a system to have better regulation on these drugs. One approach could be to have these drugs notified as psychotropic substance under the NDPS Act. After all, there are other, similar pharmaceutical products which are regulated in India as psychotropic substances even if they are not scheduled as psychotropic internationally."

Misuse found

In 2023, the Punjab Food and Drug Administration found that the drug formulations containing Pregabalin 150mg/300mg were being misused for intoxication, and seized these from licensed chemists as well as illegal manufacturers.

Last year, Karnataka law-enforcing agencies seized 1,720 tapentadol tablets from a drug peddler in Bengaluru.

Also read |  Union Budget 2025: 36 life-saving drugs to be exempted from customs duty

Earlier, Mint reported that The Department of Pharmaceuticals had sought urgent details from the Union ministry of health and industry on 10 medicines it suspects are being widely abused including Fentanyl, Norfentanyl, Zopiclone, Zolpidem, Naloxone and Tapentadol, widely used for pain management and treatment of patients with neurological problems. The plan was to review the data and bring the drugs under narcotics law.

A 2019 report on substance abuse in India published by the Central government said about 2.5 million people in the country were addicted to pharmaceutical opioids.