Understanding how to read a prescription needs familiarity with each component. In total, there are 16 criteria to make a drug label compliant in India. Here are some of the crucial ones that every patient should be able to read.
Name of the Drug: Generic vs. Brand Name
The generic name of the drug must be more prominently visible than the brand or trade name. Also, the name of the drug should appear immediately after or below the name of the drug. This is essential to prevent duplication of medicines and for people who might be taking the same salt but with some other brand.
Strength and Dosage Form
A well-packaged and compliant medicine label will display the quantity of all the active ingredients per unit. Be it tablets, capsules, pills, or any other form, the composition is mentioned in terms of the content. (What is in the medicine?) Never assume two drugs with the same salt but different brands are the same. Their dosage might vary, so always double-check before consumption.
Batch Number and Manufacturing Licence Number
Another crucial part of the prescription label is the licence number and batch number. You must have observed the figure that represents the manufacturing licence number as follows:
- Manufacturing Licence Number
- Mfg. Lic. No. or M.L.
In case of a quality issue, where the authorities want to trace a particular product, these regulatory labels help a lot.
Date of Manufacture and Expiry Date
The medicine manufacturer must bear the date of manufacture and the date of expiry on their label. Ideally, it should go beyond sixty months from the date of manufacture.
Medical Disclaimer: Never consume a medicine after its expiry date, as the degraded active ingredient can be ineffective or harmful, in some cases.
Name and Address of the Manufacturer
The patient label must include the manufacturer’s name and full address as part of regulatory accountability. Pharmacy stickers applied at the dispensing stage should never hide this information.
Composition: Active and Inactive Ingredients
The label medicine must declare the composition of the true formula or the list of active ingredients. These medicinal ingredients make the medicine work, while the inactive agents can cause some side effects, like allergic reactions. So, an individual must check the components before use.
Storage Instructions
Mentioning storage conditions is a mandatory part of pharmaceutical product labelling. Some of the common instructions include:
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Store in a cool, dry place
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Protect from light
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Store below 25°C
When these instructions are overlooked, and medicines are stored in humid bathrooms or direct sunlight, they degrade the quality of the medicine.
Schedule Classification and Regulatory Labels
Schedule classifications are the most important parts of any prescription label in India. Let’s know some of them:
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Schedule G Drug Label: Medicines with a Schedule G drug label include hormonal medications, anticonvulsants, hypoglycaemic drugs, and antihistamines like metformin and insulin. These labels also display a “Caution”, which means that it is dangerous to take the medicine if not under medical supervision.
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Schedule H Drug Label: Drugs with this label can not be sold without a prescription from a Registered Medical Practitioner (RMP). The medicines must also display the symbol "Rx" and the warning: "Schedule H drug - Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.”
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Schedule H1 Drug Label: This includes third and fourth-generation antibiotics, along with some psychotropic drugs and anti-TB drugs. Labels must show the symbol "Rx" in red with the warning: "Schedule H1 Drug — Warning: It is dangerous to take this preparation except in accordance with medical advice."
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Schedule X Drug Label: Medicines such as narcotics and psychotropic substances require a prescription from a Registered Medical Practitioner. Also, the label medicine must display "XRx" in red with the warning: "Schedule X drug — Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only."
