In the pharmaceutical industry, Tramadol is not banned in India, but it is strictly regulated as a Psychotropic Substance. As of 2026, it remains an essential analgesic for moderate to severe pain, but its legal status is governed by the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985.
At your WHO-GMP facility in Mumbai, this means your manufacturing, trading, and export operations for Tramadol must comply with rigorous licensing and “Schedule X” (or equivalent) documentation.
Regulatory Status & Compliance
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NDPS Classification: On April 26, 2018, the Union Government declared Tramadol a psychotropic substance under the NDPS Act. It moved from being a standard “Schedule H” drug to one that requires a Psychotropic Substance License for every stage of the supply chain.
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Manufacturing & Sale: Only licensed manufacturers and chemists can stock and sell Tramadol. Selling it without a valid prescription or proper documentation can lead to severe penalties, including rigorous imprisonment under the NDPS Act.
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Export Controls: For your firm’s export goals, you must obtain a NOC (No Objection Certificate) or Export Authorization from the Narcotics Commissioner for every single consignment.
Mechanism: Dual-Action Analgesic
Tramadol is unique because it works on the body’s pain signals through two different “lanes”.
Opioid Pathway: It is a weak mu-opioid receptor agonist, binding to receptors in the brain to change how you perceive pain.
Monoamine Pathway: It inhibits the reuptake of Norepinephrine and Serotonin, effectively increasing the levels of these natural “pain-blockers” in the spinal cord.
The “Fighter Drug” Label: In the media, it has been dubbed the “fighter drug” due to reports of its abuse in conflict zones to suppress pain and fatigue.
The Pharmacist’s “Technical Warning”
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Seizure Risk: Tramadol can lower the seizure threshold, especially in patients already taking antidepressants (SSRIs/SNRIs). This can lead to life-threatening Serotonin Syndrome.
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Addiction Potential: While less potent than morphine, it still carries a significant risk of physical and psychological dependence.
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Respiratory Depression: Excessive doses or combination with alcohol/benzodiazepines can cause breathing to slow dangerously.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Combination” USP: On your marketplace, market your Tramadol + Paracetamol or Tramadol + Aceclofenac Fixed-Dose Combinations (FDCs). These are highly sought after for surgical and orthopedic pain management.
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Secure Supply Chain: In 2026, international buyers prioritize firms that demonstrate 100% NDPS compliance. Highlighting your “Track and Trace” capabilities for batch-wise monitoring is a major competitive advantage.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders, ensuring all narcotic and psychotropic regulations are met for the destination country.