Understanding Schedule H1 Drugs: Regulations, Implications, and Precautions


The schedule h1 drugs list is a list of medications that are classified as being highly addictive and having a high potential for abuse. These medications are typically prescribed to patients who are suffering from serious conditions, such as opioid addiction or bipolar disorder.

Drugs of the new Schedule H1 category will be distributed by pharmacists without a prescription from a licensed physician within the meaning of the Medicines and Cosmetics Act on 1 March 2014. In accordance with the provisions of the Medicines and Cosmetics Act of 1945, class H medicinal products may only be sold by practitioners without a prescription. Under these rules, a Plan

H1 drug cannot be purchased without a prescription from a registered MBBS physician.

Restrictions for Schedule H1 Drugs

Schedule H1 drugs

The medicines specified in list H1, are sold on prescription by practitioners in general practice, and the standards for which medicines fall under this list are very strict.

  • The delivery of medicines according to List H 1 shall be recorded at the time of delivery of these medicines in a separate register
  • Displaying the name and address of the prescriber
  • The name of the patient
  • Names of the medicines and
  • The quantity delivered.

These records are kept for at least three years and made available for inspection.

Under the rules

  1. Pharmacists and pharmacists will have to maintain and sell registered medicines containing Schedule H1 medicines, regardless of their composition.
  2. Such records must contain the medicine or substances listed in the H1 formulation, on a label with a red icon in the upper left corner of the label, followed by the words “Boxed” on a red background, as mentioned in the warning section.
  3. In accordance with the notification of the inclusion of medicinal products in the new list H1, all medicinal products must bear a warning that they may not be sold unless an authorized doctor has issued a prescription for self-medication or the preparation of medicinal products is dangerous.

Schedule H1 Drugs list

List of Schedule H1 drugs

  1. Alprazolam
  2. Balofloxacin
  3. Buprenorphine
  4. Capreomycin
  5. Cefdinir
  6. Cefditoren
  7. Cefepime
  8. Cefetamet
  9. Cefixime
  10. Cefoperazone
  11. Cefotaxime
  12. Cefpirome
  13. Cefpodoxime
  14. Ceftazidime
  15. Ceftibuten
  16. Ceftizoxime
  17. Ceftriaxone
  18. Chlordiazepoxide
  19. Clofazimine
  20. Codeine
  21. Cycloserine
  22. Diazepam
  23. Diphenoxylate
  24. Doripenem
  25. Ertapenem
  26. Ethambutol Hydrochloride
  27. Ethionamide
  28. Feropenem
  29. Gemifloxacin
  30. Imipenem
  31. Isoniazid
  32. Levofloxacin
  33. Meropenem
  34. Midazolam
  35. Moxifloxacin
  36. Nitrazepam
  37. Pentazocine
  38. Prulifloxacin
  39. Pyrazinamide
  40. Rifabutin
  41. Rifampicin
  42. Sodium Para-aminosalicylate
  43. Sparfloxacin
  44. Thiacetazone
  45. Tramadol Hydrochloride
  46. Zolpidem

Types of Drugs in Schedule H1

Class H1 includes third- and fourth-generation Antibiotics, Tuberculosis drugs, certain Habit-forming drugs, and Psychotropic drugs.

H1 medicines are a list introduced to restrict the sale of antibiotics for over-the-counter use and not for sale as non-prescription medicines. List H comprises the 3rd / 4th generation of antibiotics (for TB), tuberculosis drugs, and certain habit-forming drugs, as well as psychotropic drugs.

Precautions to take when taking Schedule H1 drugs:

Schedule H1 drugs are classified as narcotics and carry a high potential for abuse. Because of this, it is important to take precautions when taking these drugs. One such precaution is to make sure that you have a prescription from a doctor before taking them.

It is also important to take the drugs exactly as prescribed by your doctor and not to increase or decrease the dosage without consulting your physician. Schedule H1 drugs should not be taken with alcohol or other medications that can cause drowsiness, as this can increase the risk of an overdose. Finally, it is important to keep track of how much of the drug you have taken and where it is stored, so that you can avoid taking too much

Some History of H1 Drugs

H1 Drugs

The ministry had exercised powers conferred on it by the central government in accordance with Section 26B of the Medicines and Cosmetics Act 1940 [23] to direct the sale of retail preparations containing the drug hydroxychloroquine in accordance with the conditions for the sale of drugs specified in the list H1 drugs and cosmetics of 1945.

The 536 Schedule H medicines were allocated to restrict the sale of antibiotics through OTC sales, but it is noted that a number of these medicines can be bought without restriction in any pharmacy in India. In defiance of this rule, many pharmacies and stores sold life-saving antibiotics that fell under the H1 rule in cities and counties at a time when the irrational and unrestrained use of antibiotics increased drug resistance in patients.

Indian evidence suggests that Schedule H and DCA antimicrobials in private pharmacies are available in addition to unplanned medicine over-the-counter.17 In 2013 a new Schedule H1 was introduced to regulate drug and cosmetic regulations to regulate the sale and use of 46 medicines.

The timetable was introduced in a Gazette Notification (GSR 588-E of 30 August 2013) to review the indiscriminate use of antibiotics, tuberculosis, and other medicines in the country. The new timetable provides for the regulation of a new class of antimicrobial substances such as third and fourth-generation cephalosporins and certain habit-forming drugs against TB18.

Prescribers will be required to register the prescription and patient profile as it is expected to be retained for a period of three years.

Latest News About H1 Drugs

Stakeholders were invited to submit their comments and proposals for publication in the Official Journal on the proposed amendments to the pharmaceutical and cosmetics legislation, with a view to moving oxytocin from category H to category H1 on 17 August.

The move came as a surprise to the medical profession, as the new category of retail chemists requires more detailed documentation of sales. A statement from the Ministry of Health states that medicines that have existed for several decades are Schedule H1 medicines with a warning on the packaging and may only be sold if prescribed by a doctor.

The sale of the drug must be in accordance with the conditions for the sale of medicines laid down in Schedule-H1 Medicines and Cosmetics Code of 1945, which means that preparations that contain the drug should have warnings and only prescription sales for self-medication.


In conclusion, Schedule H1 drugs are a vital category in pharmaceutical regulation, designed to address addiction and misuse issues while ensuring patients receive necessary treatments under proper medical supervision.

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