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

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

Introduction

Schedule X is a class of prescribed medicines in India. This is a special list of annexed drugs of the Drugs and Cosmetic Act 1940 and Rule 1945. Drugs covered in the Schedule X drugs list can not be sold by retailers without a valid prescription of a Registered Medical practitioner, the record of prescription has to be maintained for 2 years of the sale. A sale and purchase register is also required to maintain a record. The record has to be produced at the time of inspection by drug authorities.

Schedule X drug is a category that refers to 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).


Schedule X drugs list
schedule-x-drugs





Schedule X drugs list:

[SCHEDULE X 

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

Schedule X drugs List : 

  • 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

Drug and Cosmetic Act 1940 Handbook;


Uses of Schedule X Drugs

Common uses of Schedule X drugs 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.
  • 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)


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 drugs 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.

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