Schedule X Drugs List in India – Regulations, Licensing, Labeling & Packing Requirements

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Schedule X is a special category of prescribed medicines in India, outlined in the Drugs and Cosmetics Act of 1940 and the Rules of 1945. These drugs cannot be sold by retailers without a valid prescription from a registered medical practitioner. Furthermore, records of prescriptions must be maintained for two years post-sale, and a sale and purchase register is required to document transactions. These records must be presented during inspections by drug authorities.

Schedule X drug is a category that is highly regulated in India due to their ability to addiction and abuse. In this category, most Narcotics drugs are covered which are controlled under NDPS Laws. 

The purpose of Schedule X drugs is to treat serious medical conditions that require a higher level of supervision. These medicines are used to treat 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]

  • Amobarbital 
  • Glutethimide 
  • Pentobarbital 3
  •  [Ketamine hydrochloride] 
  • Amphetamine 
  • Meprobamate
  • Phencyclidine
  • Barbital
  • Methamphetamine 
  • Phenmetrazine 
  • Cyclobarbital   4 [***]   5 [***] 
  • Dexamphetamine 
  • Methylphenidate 
  • Secobarbital 
  • Ethchlorvynol 
  • Methylphenobarbital

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:

  1. Therapeutic Uses
  2. Severe pain management by opioids like morphine
  3. Treatment of Anxiety and sleep disorder

Side effects of Schedule X drugs: 

  • Lead to Drowsiness
  • Can create constipation
  • This can lead to respiratory depression.
  • 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 sell, stock, the exhibit on the license obtained on Form-20, Form-20A, and Form-B and Form-21. 

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:

  • The Punishment can be imprisonment for a term of up to 3 years with a fine of Up to Rs. 10000/- or three times the value of the drugs seized whichever is greater. 
  • The license to manufacture, distribute, or sell drugs can also be terminated or suspended.
  • The severity of punishment will depend on the nature of the drug and the type of violation.
  • If the Schedule X drug misused is found to be controlled under the NDPS Act, then the punishment will be given according to NDPS Act regulations.
  • Punishment under the NDPS act may be up to 20 years imprisonment and a fine up to Rs. 2 lakhs for Financing drug trafficking.
  • If a person is found guilty of possession of a commercial quantity of drugs can be punished with imprisonment of up to six months or a fine of up to Rs. 10000/- 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” 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 in India 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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