Drug Label And FDC

Pharmacology, the study of drug effects, is a fascinating yet vast field of medicine. It demands careful study as the drugs we consume can lead to serious complications if not administered in strict doses. This underscores the importance of understanding drug labels to avoid potential risks.

Let us start from the basics so that it becomes easy to follow and understand. Starting from the drug label, it tells us about the composition of the drug, and the form- either in tablet, capsule, or syrup. We also get to know about the Generic name and the major Side effects that may occour because of the drug. The  Red line over the packing of the drug indicates that it requires

a prescription. The date of Manufacturing and expiry date are also mentioned on the drug label itself. The Expiry date indicates that after that date, the quality of the drug is significantly reduced. 

In india, the National Formulary of India(NFI) is an organisation that gives details about the drug. NFI tells about the Available form of the drug and the Dosage level for adults, children, senior citizens

Certain storage conditions must be followed when these drugs are stored, as abnormal temperatures can affect their efficacy. The temperature of the Freezer should be maintained at 20° Celsius to -10° Celsius. The Cold temperature at which medicines are stored is from  2° Celsius to 8° Celsius, and the Cool temperature is  8° Celsius to 25° Celsius. For Example: Insulin should be stored at 2° Celsius to 8° Celsius. If it is kept in the freezer, since insulin is a protein, it denatures. Hence, patients should be educated while prescribing insulin.

There are various schedules of the drugs, which means there are certain laws for different drugs that need to be followed for the proper legalized sale and purchase of drugs. These are in effect so that the normal population does not buy them without a reason and abuse them. Following are the various scheduled drugs:

Schedules Description

Schedule A Contains various forms and formats of letters for licensing applications, etc.

Schedule B Contains fee structure for government-run labs.

Schedule C Contains various biological products and their regulation. Examples: Serums, Adrenaline and Vitamins, etc.

Schedule D List of drugs exempted from the provision of import of drugs.

Schedule E Contains various poisons and their regulation. Examples: Sarpa Visha (Snake venom), Parada (Mercury), etc.

Schedule F This contains regulations and standards for running a blood bank.

Schedule F-I This contains regulations and standards for vaccines.

Schedule F-II This contains regulations and standards for surgical dressing.

Schedule F-III This contains regulations and standards for umbilical tapes.

Schedule F-F This contains regulations and standards for ophthalmic ointments and solutions.

Schedule G List of drugs taken under registered medical practitioner supervision.

Schedule H Contains prescription drugs under the Drug and Cosmetic Act 1945.

Schedule K Contains various drugs that can be taken over the counter.

Schedule M Contains various regulations for manufacturing, premises, waste disposal, and equipment.

Schedule N Contains various regulations and requirements for a pharmacy.

Schedule O Contains various regulations and requirements for disinfectant fluids.

Schedule P Contains regulations regarding the life period and storage of drugs.

Schedule P-I Contains regulations regarding the retail package size of various drugs.

Schedule Q Contains various regulations and requirements for record-keeping

Schedule R Contains various regulations and requirements for condoms and other mechanical contraceptives.

Schedule S Lists various cosmetics and toiletries and directs cosmetics manufacturers to conform to the latest Bureau of Indian Standards requirements.

Schedule T Contains various regulations and requirements for manufacturing Ayurvedic, Siddha and Unani products

Schedule U Contains various regulations and requirements for record-keeping

Schedule V Contains standards for drug patents.

Schedule W Contains Generic Drugs List.

Schedule X Contains a list of highly narcotic and Psychotropic. Example – Ketamine, Phencyclidine, Secobarbitone.These drugs should be given two prescriptions- one should be kept by the pharmacist in a locker for two years and it should be shown to the drug inspector when asked for.

Schedule Y Contains requirements and guidelines for clinical trials.

Another noteworthy thing here is the “NRx”. This Means New Prescription. Suppose a cancer patient is prescribed Morphine and purchases it from a pharmacy. The patient cannot use the

same prescription for the purchase of morphine the second time. The doctor has to write NRx indicating it is a new prescription.

There are some important definitions that also must be remembered for theoretical as well as multiple-choice questions.

Misbranded drugs: these are the Drugs that have labeling errors.

Spurious drugs: These are fake drugs that are made that lack any active ingredients. These drugs don't have an actual action. 

Adulterated drugs: These are drugs containing filthy and harmful substances which are dangerous for human consumption.

It becomes important to mention the nomenclature of the drugs as that will really help young doctors understand how medicine is prescribed in India. It is classified into chemical, generic, and brand names. For Example: The chemical name is acetylsalicylic acid; the generic

name is aspirin. And the brand name is Ecosprin. So next time your senior consultant writes off a medicine, you will be crystal clear about the prescription, although the same can't be said about their handwriting. 

The last topic that a young doctor should understand before they enter the hospital and start prescribing drugs in the real world is fixed-dose drug combinations(FDC). When two or more drugs are given in fixed-dose ratios, then it is called a fixed-dose drug combination. Here, A single tablet contains two or more drugs. For example, in the image below single drug contains rifampicin, isoniazid, pyrazinamide, and ethambutol hydrochloride.

You might get a question in your theoretical exams to write about the advantages and disadvantages of FDC, and rest assured you can just can copy the information in the table below and pass with flying colors.

Also Read: INI-CET High Yield Questions for Pharmacology

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