Drug Schedules to the Rules, List of Schedule H1 Drugs
Multiple Choice Questions and Answers to assist you improve your knowledge.

Please leave a remark at the bottom of each page with your useful suggestion.

Pharmacist's Guide

Table of Contents

Drugs Banned in India
  1. Tetracycline liquid oral suspension
  2. Penicillin skin/eye ointement
  3. Methaquinone
  4. Oxytetracycline liquid oral preperations
  5. Demeclocycline liquid oral preperations
  6. Rosiglitazone
  7. Astemizole
  8. Terfinadine
Drug Schedules to the Rules

Drugs that possess similar chemical structures or similar therapeutic effects are grouped into classes. Most drugs within a class produce similar benefits, side effects, adverse reactions and interactions with other drugs and substances.

A Perform for application for the licences, issues and renewal of licences, for sending memoranda under the Act.
B Rates of fee for test or analysis by the Central Drugs Laboratory or the Government analysist.
C List of biological and other special products whose import, sale, distribution and manufacturing are a governed by special provision.
C1 List of other special products whose import, sale, distribution and manufacturing are governed by special provision.
D List of drugs exempted from the provisions of import of drugs.
E1 List of poisionous substances under the Ayurvedic (including Sidha) and Unani systems of medicine
F & F1 Provisions applicable to the production, testing, storage, packing and labeling of biological and other Special products.
F2 Standards for surgical dressings.
F3 Standards for sterilized umbilical tapes.
FF Standards of ophthalmic preparations.
G List of substances that are required to be used only under medical supervision and which are to be labeled accordingly.
H List of prescription drugs.
J Disease or ailments which a drug may not purport to prevent or cure.
K Drugs exempted from certain provision relating to manufacture of drugs.
M GMP requirement of factory premises, plants and equipment.
M1 Requirement of factory premises etc. for manufacture of homoeopathic preparation.
M2 Requirement of factory premises etc. for manufacture of cosmetics.
N List of minimum equipment for efficient running of a pharmacy.
O Standard for disinfectant fluid.
P Life period of drug.
Q List of coals tar color permitted to be used in cosmetics.
R Standard for mechanical contraceptive. CONDOMS
S Standard for cosmetics.
T Requirement of factory premises and hygienic condition for Ayurvedic (including Sidha) and Unani drugs.
U Particulars to be shown in manufacturing, raw material and analytical records of drug.
U1 Particulars to be shown in manufacturing, raw material and analytical records of cosmetics.
V Standard for patent or proprietary medicines.
W List of drug which is to be marketed under generic names only.
X List of drugs whose import, manufacture and sale, labeling and packaging are governed by special provision.
Y Requirement and guideline on clinical trials for import and manufacture of new drug.

Drug Classifications, Schedule I, II, III, IV, V

Drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules

Drug Schedule I Controlled Substances

Schedule I drugs have no currently accepted medical use and aren’t considered safe to use even under medical supervision. They have a high potential for abuse and dependency.

Other Schedule I drugs are: heroin, LSD (lysergic acid diethylamide), marijuana (cannabis), peyote, methaqualone, and Ecstasy (3,4-methylenedioxymethamphetamine).

Drug Schedule II/IIN Controlled Substances (2/2N)

This category is for drugs that have a high potential for abuse which may lead to severe psychological or physical dependence. Drug Schedule II/IIN substances are considered to have medical value.

Examples of Schedule II controlled drugs include: OxyContin and Percocet (oxycodone), opium, codeine, morphine, hydromorphone (Dilaudid), methadone, Demerol (meperidine), and fentanyl.

Examples of Schedule IIN stimulants include: amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn), and methylphenidate (Ritalin).

Drug Schedule III/IIIN Controlled Substances (3/3N)

The potential for abuse for Schedule III/IIIN medicines is less than substances in drugs classified as Schedule I or II/IIN and abuse may lead to moderate or low physical dependence or high psychological dependence.

Examples of Schedule III narcotics include: Ketamine, Vicodin (combination products containing less than 15 milligrams of hydrocodone per dosage unit), Tylenol with Codeine (products containing not more than 90 milligrams of codeine per dosage unit), and buprenorphine (Suboxone).

Examples of Schedule IIIN non-narcotics include anabolic steroids such as Depo-Testosterone.

Drug Schedule IV Controlled Substances

The medicines in drug classification Schedule IV /Schedule 4 can and are abused and can be addictive or create a dependency, but less than those of Schedules 1, 2 and 3.

Examples of Schedule IV substances include: Tramadol, Xanax (alprazolam), carisoprodol (Soma), Klonopin (clonazepam), Valium (diazepam), Ativan (lorazepam (Ativan).

Drug Schedule V Controlled Substances

These drugs are considered to have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

Examples of Schedule V drugs: Lyrica/pregabalin, cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC, Phenergan with Codeine), and ezogabine.

For more information and a complete list of substances: Drug Enforcement Administration Office of Diversion Control.

List of Schedule H1 Drugs.

-It is Dangerous to take this preparation except in accordance with the Medical Advice

-Not to be Sold by retail without the prescription of a Registered Medical Practitioner.”

Alprazolam Doripenam
Balofloxacin Ertapenem
Buprenorphine Ethambutol Hydrochloride
Capreomycin Ethionamide
Cefdinir Feropenam
Cefditoren Gemifloxacin
Cefepime Imipenem
Cefetamet Isoniazide
Cefixime Levofloxacin
Cefoperazone Meropenem
Cefotaxime Midazolam
Cefpirome Moxifloxacin
Cefpodoxime Nitrazepam
Ceftazidime Pentazocine
Ceftibuten Prulifloxacin
Ceftizoxime Pyrazinamide
Ceftriaxone Rifabutin
Chlorodiazepoxide Rifampicin
Clofazimine Sodium Para-aminosalicylate
Codeine Sparfloxacin
Cycloserine Thiacetazone
Diazepam Tramadol
Diphenoxylate Zolpidem

Note:- Preparations containing the above drug substances and their salts excluding those intended for topical or extrenal use (except ophthalmic and ear or nose preparations) containing above substances are also covered by this Schedule.


The Supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such record shall be maintained for three years and be open for inspection.

If it contains a drug substance specified in Schedule H1, the drug formulation shall be labelled with the symbol Rx which shall be in Red and conspicuously displayed on the left top corner of the label and shall also be labelled with the following word in a box with red background as mentioned below in warning section.

Difference between Schedule H and Schedule H1:

There is not any major difference between schedule H and schedule H1 drugs but antibiotics, anti-TB drugs and habit forming that were fall under schedule H category was moved to a new sub category that is known as Schedule H1. Schedule H and H1, both categories shall be sold under prescription of a Registered Medical Practitioner only but norm regarding drug fall under Schedule H1 are strict. A proper record of every sale, purchase, prescription copy, patient detail, doctor details under which prescription drugs are sold out etc. shall be maintained for at least three years for schedule H1 drugs where there is no requirement for maintaining record for drug which fall under schedule H drugs.

Why there is need of Schedule H1?

In recent time, number of cases of antibiotic resistance diseases are increasing. One of the main cause of antibiotic resistance is easy availability and self medication. There was urgent requirement of implementation of any strict laws that Schedule H was not available to implement.

Write Your Comments or Suggestion...