NEW DELHI: The Centre is moving to place the painkiller Tapentadol under stricter narcotics control, a step that would bring its manufacture, sale and distribution under the country’s toughest drug law amid rising concerns over abuse and diversion.
The finance ministry has begun the process to classify Tapentadol as a psychotropic substance under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, according to two government officials and a document reviewed by Mint.
The department of revenue has also sought feedback from pharmaceutical and chemical industry bodies, including the Indian Drug Manufacturers' Association (IDMA), Pharmexcil, the Indian Chemical Council and Chemexcil, as part of the consultation process, the officials said.
The move, if implemented, would significantly tighten oversight of the opioid-like medicine across its supply chain—from production and storage to transport and retail sale—backed by criminal penalties including imprisonment and heavy fines for violations.
Policy shift
A 17 June document from the department of revenue said, “This department is in process of Scheduling of Tapentadol in the Schedule of Psychotropic Substance under the NDPS Act, 1985, to curb their illegal sale/illicit use.”
Officials said the intent is to curb diversion and non-medical use.
“Scheduling the drug under NDPS act will help check their illegal sale, illicit use and prevent street-level diversion, non-medical exploitation and substance abuse,” one of the government officials said, speaking on condition of anonymity.
The review also seeks extensive inputs from companies, including five-year data on IUPAC, HSN and CAS classifications, along with details on manufacturing, imports and exports, trade flows, and quantities in kilograms with free-on-board values in US dollars.
Firms have also been asked to provide distribution details, formulation data, seizure records, and any trafficking cases linked to Tapentadol, as well as note whether the substance is regulated under other laws and flag operational constraints if brought under NDPS control.
Currently, Tapentadol is classified as a Schedule H1 drug, requiring a valid prescription for sale and mandating pharmacies to keep detailed purchase records for three years. It is not classified as a controlled substance under the NDPS Act in India.
In India, substances under the NDPS Act are scheduled and regulated by the Department of Revenue in the Ministry of Finance, which oversees control of cultivation, import, export and trade of narcotic and psychotropic substances.
The Ministry of Health and Family Welfare, through the Central Drugs Standard Control Organisation (CDSCO) and the Drugs Controller General of India (DCGI), regulates therapeutic approvals, manufacturing licences and prescription rules, including classification under schedules such as H and H1 to restrict over-the-counter misuse.
Tapentadol was first approved by the US Food and Drug Administration (US FDA) on 20 November 2008. It is used to treat moderate to severe pain, including nerve-related conditions such as diabetic neuropathy, and is typically reserved for cases where alternatives are limited. In the US, it is listed under Schedule II of the Controlled Substances Act and is regulated in several other countries.
The review follows growing concern over misuse. A government sub-committee formed in January 2024 flagged high consumption levels, linking abuse to increased risk of Hepatitis C infection and citing easy availability and low cost as key drivers.
Queries sent to the ministries of finance and health and family welfare, and DCGI on Monday went unanswered till press time. Queries to manufacturers Sun Pharma, Aurobindo, Cipla, Dr Reddy’s Laboratories and Hetero Labs on Tuesday also drew no response.
Tightening control
Experts said India’s move mirrors earlier action on similar opioids but warned of the need to balance access with control.
“Tapentadol is a painkiller of the opioid group of drugs…India has decided to regulate Tramadol earlier and now the decision to subject Tapentadol also to the same degree of regulations is correct,” said Dr. Atul Ambekar, professor of psychiatry at National Drug Dependence Treatment Centre, AIIMS.
“Cases of Tapentadol misuse and addiction are rising in many parts of India. However as with other painkiller medications, it will be crucial to balance the regulation of the market to prevent diversion and misuse and ensure availability for genuine medical purposes,” he added.
The push is being reinforced by enforcement action, including the seizure of 1,720 Tapentadol tablets in Bengaluru.
An industry executive, speaking on condition of anonymity, warned of export risks.
“Tapentadol as a formulation is currently not classified as a narcotic under the NDPS Act. Bringing it entirely under narcotic regulations would severely impact Indian exporters, as the compliance rules for narcotics are exceptionally stringent. We would lose a significant amount of export business,” the executive said.
“If there are concerns about its habit-forming potential, a more balanced approach would be to regulate and restrict specific dosage strengths—such as capping formulations at 1 gm or 650 mg—rather than imposing a blanket narcotic classification.”
Mint earlier reported that the DCGI had banned export of unapproved Tapentadol–Carisoprodol combinations to West African countries amid concerns they were contributing to an opioid crisis. The Department of Pharmaceuticals has also flagged multiple medicines, including Tapentadol, for suspected widespread abuse.