Introduction, definition, list of drugs, labelling requirements, sales and distribution, prescription requirements, monitoring and enforcement.

1. K.Y.D.S.C.T,s college of pharmacy, Sakegaon
D.PHARM SECOND YEAR PHARMACY LAW AND ETHICS
ASSIGNMENT NO. 1
Title: Schedule H1 drugs and its implementation in India
The implementation of Schedule H1 drugs in India began in 2014 when the government
issued a notification mandating that all such drugs be labeled with a red vertical stripe and
bear the words “Rx” on the label. This was done to make it easier for patients to identify
such drugs and to prevent their indiscriminate use.
1. Definition: Schedule H1 drugs are defined as prescription-only medicines that are
required to be dispensed by a registered pharmacist against a valid prescription issued by
a registered medical practitioner.
Examples of schedule H1 drugs include:
Codeine Tramadol
Diazepam Zolpidem
2. List of drugs: The Ministry of Health and Family Welfare has issued a list of drugs that
fall under the Schedule H1 category. This list is periodically updated based on inputs from
the Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee
(DCC).
It is d
inaccordance with the medical advice.
 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.
Not to be sold by retail without the prescription of a Registered Medical
Practitioner.
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ram hannel
SCHEDULE H1 DRUG-WARNING

2. 3. Labeling requirements: All Schedule H1 drugs must bear a label that includes the
following information:
i. Batch number
ii. Date of manufacture
iii. Expiry date
iv. Maximum retail price
v. Name and address of the manufacturer
vi. Name of the drug
vii. Strength of the drug
viii. The red vertical stripe and the "Rx" symbol
4. Sales and distribution: Schedule H1 drugs can only be sold by registered pharmacies
and licensed wholesalers to registered medical practitioners. They cannot be sold over the
counter to patients without a valid prescription.
5. Prescription requirements: Medical practitioners are required to write prescriptions
for Schedule H1 drugs in a specific format, which includes the following details:
i. Name, address, and registration number of the medical practitioner
ii. Name, age, and address of the patient
iii. Name of the drug
iv. Strength of the drug
v. Dose and duration of treatment
vi. Signature of the medical practitioner
6. Monitoring and enforcement: The government has set up a system to monitor the sales
and distribution of Schedule H1 drugs to ensure compliance with the regulations. Non-
compliance can result in penalties and even cancellation of the license to sell or distribute
such drugs.

3. Overall, the implementation of Schedule H1 drugs in India has helped to regulate the sale
distribution of prescription drugs and prevent their misuse and abuse. However, it is
important for patients and healthcare providers to remain vigilant and adhere.
Subject Teacher
Priyanka N. Deshmukh