Schedule X drugs are a special category of prescribed medicines in India governed by the Drugs and Cosmetics Act of 1940 and the Rules of 1945. Retailers cannot sell these drugs without a valid prescription from a registered medical practitioner. Additionally, prescriptions must be recorded and maintained for two years after sale. A sale and purchase register is required to document all transactions, and it must be presented during drug authorities’ inspections.

Schedule X drugs are highly regulated in India due to their potential for addiction and abuse. Most narcotic drugs in this category are controlled under the NDPS Laws.

Schedule X drugs are intended to treat serious medical conditions that require strict supervision. They are commonly used to manage chronic pain, anxiety, and attention-deficit/hyperactivity disorder (ADHD).

Also Read: Schedule H1 Drug List

Schedule X drugs list:

[SCHEDULE X ]

[See Rules 23, 61, 75, 97, and 105A]

Schedule X Drugs Flowchart

Schedule X Drugs (India)

Amobarbital is a tightly controlled barbiturate: Sedative and sleep-inducing effects. Historically was used to treat insomnia and anxiety. Highly addictive and dangerous in overdose. Therefore, strictly controlled under India’s Schedule X due to these risks.

Glutethimide is a tightly controlled non-barbiturate sedative. It has Calming, relaxing, and sleep-inducing (sedative-hypnotic) effets. Historically it used to treat insomnia and anxiety (introduced in the 1950s). Highly risky as addictive, similar to barbiturates. Strictly controlled due to its habit-forming nature.

Pentobarbital is a short-acting barbiturate sedative-hypnotic.It was used medically for short-term treatment of insomnia and as an anticonvulsant in emergency seizure control. Pentobarbital works by potentiating GABAA_A receptors in the brain, causing strong CNS depression.

Ketamine hydrochloride is a dissociative anesthetic with hallucinogenic effects. It is used for anesthesia and pain relief, inducing sedation and a trance-like dissociative state. In anesthetic doses, ketamine causes sedation, analgesia and amnesia, which contributes to its therapeutic and addictive potential.

Amphetamine is a central nervous system stimulant that increases dopamine and norepinephrine. It is used medically to treat ADHD and narcolepsy, improving alertness and concentration. Misuse of amphetamines can lead to substance use disorder and addiction, so their distribution is tightly controlled.

Meprobamate is a carbamate derivative used as an anxiolytic (tranquilizer). It produces muscle relaxation and sedation. Once a blockbuster tranquilizer (brand name Miltown), it was widely used in the 1950s but has been largely replaced by benzodiazepines. Because meprobamate can cause dependence similar to other sedatives, it remains regulated as a Schedule X substance.

Phencyclidine (PCP) is a dissociative anesthetic and hallucinogen, It causes severe mind-altering effects, including hallucinations and distorted perception. PCP primarily blocks NMDA glutamate receptors, which adds to its dissociative and toxic effects. Due to its high neurotoxicity and addiction liability, PCP is a strictly controlled Schedule X drug.

Barbital (veronal) is one of the earliest barbiturate hypnotics. It was introduced in 1903 and used as a sleep aid until the 1950s. Like other barbiturates, barbital depresses the central nervous system, and its misuse potential places it under Schedule X control.

Methamphetamine is a powerful synthetic stimulant with very high addiction potential. It produces intense euphoria, increased energy and alertness, but also dangerous cardiovascular and psychiatric effects. While methamphetamine is FDA-approved in low doses for ADHD and obesity treatment, most of it is illicitly produced and abused due to its severe health risks.

Phenmetrazine is a stimulant drug originally used as an appetite suppressant. It is chemically related to amphetamines and causes increased alertness and reduced hunger. It was withdrawn from the market in the 1980s due to widespread misuse, and because of its high abuse potential it is now a Schedule X substance.

Cyclobarbital is a barbiturate analog with sedative and anxiolytic effects. It was used in some countries to treat anxiety and insomnia. Because it shares the CNS depressant and dependence properties of barbiturates, cyclobarbital is regulated under Schedule X.

Dexamphetamine (dextroamphetamine) is the dextro-isomer of amphetamine, a central nervous stimulant. It is used in ADHD treatment similarly to amphetamine and increases neurotransmitters to enhance focus and alertness. Because it has high abuse potential and is pharmacologically similar to amphetamine, dexamphetamine is classified under Schedule X.

Methylphenidate is a CNS stimulant commonly prescribed for ADHD and narcolepsy. It raises brain levels of dopamine and norepinephrine to improve attention and wakefulness. Methylphenidate is FDA-approved for ADHD and narcolepsy:contentReference[oaicite:22]{index=22}, but its distribution is tightly controlled to prevent abuse.

Secobarbital is a short-acting barbiturate originally used to treat insomnia. It was once widely prescribed, but because it was heavily abused (known as “reds”) and carries a particularly high risk of addiction, it is now largely obsolete and replaced by safer hypnotics. This high abuse and overdose risk is why secobarbital is classified as Schedule X.

Ethchlorvynol is a GABAergic sedative-hypnotic that was marketed as Placidyl. It was used to induce sleep in patients with insomnia. Abbott Laboratories discontinued Placidyl production in 1999 due to widespread abuse of the drug, and it is tightly regulated under Schedule X.

Methylphenobarbital (mephobarbital) is a barbiturate used primarily as a sedative, anxiolytic, and anticonvulsant. It is the N-methylated analogue of phenobarbital with similar therapeutic effects. Like other barbiturates, methylphenobarbital can cause tolerance, dependence and withdrawal, which places it under Schedule X control.

Note: 1. Any stereoisomeric form of the substance specified in this Schedule, any salt of the substance, and preparation containing such substances are also covered by this Schedule.

2. Preparations containing the above substances are also covered by this Schedule.

Provided, however, preparations containing Meprobamate 5 [***] in combination with other drugs may be exempted by the Licensing Authority specified in clause (b) of rule 21, from the provisions of this Schedule, if satisfactory evidence is adduced that these preparations are not liable to be misused.]- CDSCO

Also Read: Schedule-G Drugs List

Uses of Schedule X Drugs

Common uses of Schedule X drugs List are the following:

Therapeutic Uses
Severe pain management by opioids like morphine
Treatment of Anxiety and sleep disorder

Side effects of Schedule X drugs:

Lead to Drowsiness
Can create constipation
This can lead to respiratory depression.
It can cause dizziness, confusion, and memory impairment

It is always suggested the use of Schedule X drugs should be done under the guidance of a registered health practitioner, you should follow the instructions given by the health professional to minimize the risk of adverse effects.

Labeling manner of Schedule-X drugs:

The medicines containing substances specified in Schedule X should be labeled in the following manner,:-

“If it contains a substance specified in Schedule X, be labeled with the symbol XRx which shall be in red conspicuously displayed on the left top corner of the label and be also labeled with the following words: – ”Schedule X drug -Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only‘.” – Rule-97 ( Drugs And Cosmetic Act 1940, and Rules 1945)

Packing of Schedule-X Drugs:-

Packings of drugs specified in Schedule X.- The drugs specified in Schedule X shall be marketed in packings not exceeding-

(i) 100 unit doses in the case of tablets/capsules;

(ii) 300 ml in the case of oral liquid preparations;

(iii) 5 ml in the case of injections:

Provided that nothing in this rule shall apply to packing meant for use of a hospital or a dispensary subject to the conditions that–

(i) Such supplies are made by the manufacturers or distributors directly to the hospital/dispensaries; and

(ii) hospital packs shall not be supplied to a retail dealer or to a Registered Medical Practitioner.] -Rule-105A ( Drugs And Cosmetic Act1940, and Rules 1945)

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Import Licence for Schedule-X drugs:

For general drugs, Import Licence is obtained on FORM-10, but in the case of Schedule X drugs another form is applied, An import license in Form 10-A shall be required for the import of drugs specified in Schedule X.

Schedule-X drugs License:

According to the Drugs and Cosmetic Act 1940, Rule-61, drugs specified in Schedule X can not be sold or stocked, and the exhibit on the license obtained on Form-20, Form-20A, Form-B, and Form-21 cannot be sold or stocked.

A different license is to be obtained on Form-20F or Form-20G.

“A license [to sell, stock, exhibit or offer for sale or distribute] drugs specified

in Schedule X by retail or by wholesale shall be issued in Form 20F or Form 20G as the case may be.]” -Rule-61 ( Drugs And Cosmetic Act1940, and Rules 1945)

Manufacturing drug License for Schedule X drugs.

Schedule-X drugs manufactured under a specific mfg. Drug license which is granted on Form-27B, on this License maximum of 10 items can be manufactured.

Form of application for a license to manufacture for sale or distribution of drugs specified in Schedules C and C(1) and X [excluding those specified in Part XB and Schedule X].

Application for grant or renewal of the license to manufacture for sale or distribution of drugs specified in Schedules C, C(1), and X shall be made to the licensing authority in Form 27-B, and [shall be made up to ten items for each category of drugs

[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be accompanied by a license fee of rupees six thousand and an inspection fee of rupees one thousand five hundred for every inspection or for the purpose of renewal of licenses]-Rule-75 ( Drugs And Cosmetic Act1940, and Rules 1945)

Punishments for Schedule X drug misuse

Penalties and punishment for Schedule X drug misuse depend on the basis of the particular drug’s case, some drugs in Schedule X drugs are also covered in the NDPS act, and misuse of those drugs also attracts the punishments of NDPS act. Some common punishments are given below:

Penalties for the misuse of Schedule X drugs vary based on the specific drug and violation. Some Schedule X drugs are also covered under the NDPS Act, which imposes additional punishments. Common penalties include:
Imprisonment for up to 3 years with a fine up to Rs. 10,000 or three times the value of the drugs seized, whichever is greater.
Termination or suspension of the license to manufacture, distribute, or sell drugs.
For drugs controlled under the NDPS Act, penalties can include imprisonment for up to 20 years and a fine of up to Rs. 2 lakhs for financing drug trafficking.
Possession of a commercial quantity of drugs can result in imprisonment of up to six months or a fine of up to Rs. 10,000, or both.

FAQ

What are Schedule X drugs in India?

Schedule X drugs are a highly regulated class of medications in India due to their potential for addiction and abuse. These drugs are typically used to treat severe medical conditions like chronic pain, anxiety, and ADHD but require a higher level of supervision due to their risks.

How can I buy Schedule X drugs?

You can only obtain Schedule X drugs with a valid prescription from a registered medical practitioner. Pharmacies cannot sell these drugs without a prescription, and they are required to maintain a record of the sale for two years.

How can I identify a Schedule X drug?

Schedule X drugs will have a red “NRx” or”XRx” symbol displayed conspicuously on the top left corner of the label. Additionally, the label will state “Schedule X drug – Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.”

Are there any special requirements for selling Schedule X drugs?

es, selling Schedule X drugs requires a specific license (Form 20F or 20G) obtained under the Drugs and Cosmetics Act. Additionally, these drugs must be stored securely and records of purchase and sale must be maintained.

What are the consequences of misusing Schedule X drugs?

Misusing Schedule X drugs can lead to serious consequences. Penalties range from imprisonment for up to 3 years and fines to license suspension or termination. The severity depends on the specific drug, the nature of the violation, and whether the drug falls under the NDPS Act (Narcotic Drugs and Psychotropic Substances Act), which carries even harsher punishments.

Summary

The Schedule-X drugs list [2025 Update] is a vital tool of the Drug Regulatory body CDSCO in the fight against drug abuse and addiction. By understanding the risks associated with these substances and adhering to the legal framework, we can contribute to a healthier and safer society. The Schedule X Drugs list is a written guideline for drugs that can harm the consumer’s health if used without proper supervision or misused by someone, to identify the prohibited drugs.

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References:

Drugs and Cosmetics Act 1940, by Vijay Malik, 21st Edition-Page-569-570
CDSCO-Schedule drugs
Department of Revenue| Ministry of Finance- Punishment for offenses