Schedule H Drugs List India — What Every Pharmacy Must Know
Schedule H is one of the most important classifications under the Drugs and Cosmetics Act, 1940. As a pharmacy owner, knowing which medicines fall under Schedule H — and what your obligations are when dispensing them — is not optional. Non-compliance can result in licence cancellation, fines, and criminal prosecution.
What is Schedule H?
Schedule H lists medicines that cannot be sold without a valid prescription from a registered medical practitioner. These are medicines that carry significant risk if misused — antibiotics, antidepressants, antihypertensives, hormones, and many others. The schedule is defined under Rule 65 of the Drugs and Cosmetics Rules, 1945.
Key rule: Schedule H medicines must be sold only on a valid prescription. The prescription must be retained by the pharmacy for a minimum of 2 years and produced on demand by a Drug Inspector.
Common Schedule H Medicine Categories
| Category | Examples | Why Scheduled |
|---|---|---|
| Antibiotics | Amoxicillin, Azithromycin, Ciprofloxacin, Cefixime | Risk of antibiotic resistance if self-medicated |
| Antidepressants / CNS | Sertraline, Escitalopram, Clonazepam, Alprazolam | Addiction potential, serious side effects |
| Antihypertensives | Amlodipine, Atenolol, Telmisartan, Ramipril | Require diagnosis and monitoring |
| Antidiabetics | Metformin, Glimepiride, Sitagliptin, Insulin | Require dose titration under supervision |
| Hormones | Levothyroxine, Prednisolone, Dexamethasone | Systemic effects requiring medical supervision |
| Antiulcer / GI | Pantoprazole, Rabeprazole, Domperidone | Mask serious conditions if self-medicated |
| Analgesics | Tramadol, Diclofenac injection, Ketorolac | Abuse potential, serious adverse effects |
Schedule H vs Schedule H1 vs Schedule X
| Schedule | Prescription Required | Register Required | Examples |
|---|---|---|---|
| Schedule H | Yes | No (retain prescription) | Antibiotics, antihypertensives |
| Schedule H1 | Yes (stricter) | Yes — separate H1 register | Second-line antibiotics, strong analgesics |
| Schedule X | Yes (in duplicate) | Yes — strict narcotic register | Morphine, Codeine, Tramadol HCl |
Your Obligations as a Pharmacy for Schedule H
- Demand a valid prescription before dispensing any Schedule H medicine
- Check prescription validity — must be signed by a registered medical practitioner with their registration number
- Retain prescriptions for minimum 2 years, available for Drug Inspector inspection
- Label properly — the label must carry "Schedule H Drug — Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only"
- Do not refill a Schedule H prescription without a fresh prescription unless it explicitly allows refills
Penalty for violation: Selling Schedule H drugs without prescription is punishable under Section 27 of the D&C Act — imprisonment up to 3 years and/or fine up to ₹5,000 for first offence; up to 5 years for repeat offences.
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