Schedule-G Drugs List: Warning Labels and Medical Uses.

Drugs are classified in various Schedules on the basis of their category and the potential for addiction, abuse, and other medical uses. Similarly, Schedule G drugs are Scheduled drugs that are advised to be used after the prescription only. These are prescription medicines and should not be used without a valid health professional prescription.   

 These drugs bear a special warning on the outer label of their packing as “Caution: It is dangerous to take this preparation except under medical supervision”.

These medicines are subject to strict regulation and control due to their higher potential for addiction and abuse. 

Classification of Schedule G Drugs and Warning:

Schedule-G drugs list is an important list of Drugs and Cosmetics Act Rules 1945. Drugs covered in this list have to bear a special labeling manner as per Rule 97 on the packaging in which they are packed. The label of these drugs is mandatory to show a Schedule G Drug warning on the label in a specified manner so that medicine can avoid taken without a medical professional’s prescription. The Schedule-G Drugs list warning is listed below: 

Caution: It is dangerous to take this preparation except under medical supervision.

Example of Schedule G drug warning:

As per recent amendments in the Drugs & Cosmetics Act 1945, every Drug covered under Schedule G has to write a specific warning on every packaging material of drugs. The warning should be written in white font and red background of the box. The matter should not go out of the box and should not be crossed. The drugs intended for external uses need not be written Schedule-G drug warnings on the label. 

SCHEDULE G DRUGS LIST:

• Aminopterin 
• L-Asparaginase
• Bleomycin
• Busulphan; its salts
• Carbutamide
• Chlorambucil; its salts
• Chlorothiazide and other derivatives of 1, 2, 4 benzothiadiazine
• Chlorpropamide; its salts
• Chlorthalidone and other derivatives of Chlorobenzene compound.
• Cis-Platin
• Cyclophosphamide; its salts
• Cytarabine
• Daunorubicin
• Di-Isopropyl Eluorophosphate
• Disodium Stilboestrol Diphosphate
• Doxorubicin Hydrochloride
• Ethacrynic Acid, its salts
• Ethosuximide
• Glibenclamide
• Hydantoin; its salts; its derivatives, their salts
• Hydroxyurea
• Insulin, all types
• Lomustine Hydrochloride
• Mannomustine; its salts
• Mercaptopurine; its salts
• Metformin; its salts
• Methsuximide
• Mustine, its salts
• Paramethadione
• Phenacemide
• Phenformin; its salts
• 5-Phenylhydantoin; its alkyl and aryl derivatives; its salts
• Primadone
• Procarpazine Hydrochloride
• Quinthazone
• Sarcolysine
• Sodium-2-Mercaptoethanesulfonate
• Tamoxifen Citrate
• Testolactone
• Thiotepa Tolbutamide
• Tretamine; its salts
• Troxidone
• Antihistaminic substances the following, their salts, their derivatives, salts of their derivatives
• Antazoline
• Bromodiphenhydramine
• Buclizine
• Chlorcyclizine
• Chlorpheniramine Clemizole
• Cyproheptadine
• Diphenhydramine
• Diphenylpyraline Doxylamine
• Succinate Isothipendyl
• Mebhydrolin Napadisylate
• Meclozine
• Phenindamine
• Pheniramine
• Promethazine
• Thenalidine
• Triprolidine
• Substances being tetra-N-Subs. derivatives of Ethylene Diamine or Prophylenediamine.

Note.– Preparations containing the above substances excluding those intended for topical or external use are also covered by this Schedule.

Penalties for disobeying Schedule G drugs regulations

Penalties for disobeying Schedule G drug regulations in India are very severe. The Drugs and Cosmetics Act 1940, declared strict laws and provisions in place to ensure the safe use, distribution, and sale of such drugs. If a person or organization violates the laws can lead to criminal charges and imprisonment. 

If a person is found guilty of manufacturing, selling, and distributing drugs covered in Schedule G drug without holding a valid license can be entitled to imprisonment of a minimum of one year and a maximum of 10 years, additionally, he can be fined Rs. 10000/- to 100000/-.

If a person is convicted the second time his imprisonment term will be minimum of 3 years and can be extended up to 10 years. 

A similar sentence is decided for the owner of any premises that store, manufacture or distribute Schedule G drugs without a valid license.  

Medical Use of Schedule G drugs

Some drugs listed under the Schedule G drug list are amphetamines, Barbiturates, antihistamines, and Benzodiazepines that are used in the treatment of attention deficit hyperactivity disorder (ADHD), anxiety, seizures, and insomnia. 

Safe storage and disposal of Schedule G drugs

All Schedule G drugs are stored in a cool, dry, and dark place to avoid exposure to direct heat and sunlight, and should store at a place away from the reach of children. Schedule g drugs are disposed off under the guidelines provided by CDSCO with safety.

Schedule Drugs List Pakistan 2020

• Anti-Leprosy – Rifampicin Injection, Dapsone, Clofamazine, Ethionamide, and Prothionemide.
• Immunological Products, vaccines, seraant-sera – Vaccines of Anthrax, BCG, Botulisms Antitoxin, Cholera, Influenza, Measles, MMR, Rubella, Pneumococcal, Poliomyelitis, Smallpox, Typhoid, Rabies and Homophiles Influenza Type B, and Immunoglobulins.
• Products related to malignant diseases and immunosuppression – Folinic Acid, Doxorubicin HCI, Mercaptopurine, Thioguanine, Vincristine, Cisplatin, Busulphan, Carmustine, Lomustine, Cyclophosphamide, Melphalan, Fluorouracil, Mitoxantrone, Methotrexate, Vinblastine, Carboplatin, Bleoimycin, Chlorambucil, Dacarbazine, Amasascrine, Azathioprine, and Cyclosporin.
• Anesthesia and inhalation anesthetics – Propofol, Enflurane, Isoflurane, Halothane, Bupivacaine, Thiopentone, Benzodiazepine, Midazolam, Naloxone Hcl, Vancuronium, Pancuronium, Tubocuraine, Suxamethonium, and Neostigmine.
• Antibiotics – Spectinomycin, Teicoplanon, Sodium Fusidate, Vancomycin, Colistin, and Imipenem.
• Inotropics – Primacor, Enoximone, and Milrinone.
• Injection Prostaglandins – Dinoprotone, Gemeprost, AND Carboprost.
• Alpha Blocker – Prazosin Hcl, Daxazosing, Indramine and Alfuzosin.
• Biotechnological products – Interferon and Erythropoietin.
• Narcotics, an anti-psychotropic and tricyclic anti-depressant – Morphine, Buprenorphine, Nalbuphine, Fantail, Pethidine, Lorazepam, Temazepam, Chlorpromazine, Meprobamate, Chlordiazepoxide, Alprazolam, Clonazepam, Flurazepam, Loprazolam, Oxazepam, Amoxapine, Iprine Dole Codine, Pentazocine, Lithium, Dextropropoxyphene, Clomipramine, Mianserin, Maprotiline, Dothiepin, Doxepin, Nortriptyline, Trimipramine, Tranylcypromine, Flupenthixol, Tryptophan, Imipramine, and Amitriptyline.
• Anti-Viral – Acyclovir, Amantadine Hcl, Famciclovir, Inosine Pranolsex, Zidovudine, Ganciclovir, Idoxuridine, Riavirin, Vidarabrin, Trifluridine and Methisozone.
• Thrombolytic Enzymes – Alteplase, Streptokinase, Anislreplase, and Urokinase – for dialysis – Peritoneal, Haemodialysis, Hypertonic solution, Lysine solution, and Isotonic solution.
• Creams and Aerosols Steroidal Preparations – Methylprednisolone, Dexamethasone, Hydrocortisone, Prednisolone, Tramcionolone, and Beclomethasone.
• Hormones – Vasopressin, Desmopressin, Stanozolol, Nandrolone, Mesterlolone, Finasteride, Finasteride, Somatropin, Testosterone and Progestogens

FAQ

References:

• Drugs and Cosmetic Act 1940, Page: 407-409 By Vijay Malik, 21st Edition.
• PHARMACIST FEDERATION (Pakistan)

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