What are the requirements for a drug to be sold over-the-counter?
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What are the requirements for a drug to be sold over-the-counter?
Generally drugs can become OTC if:
- They have low potential for misuse and abuse.
- They are used for self-diagnosed conditions.
- They can be used safely and effectively without a health care provider’s instruction.
- They can be adequately labeled.
What drugs are OTC in India?
Acetaminophen and Hydrocodone Bitartrate.
Is it illegal to sell drugs in India?
Legal Background The Narcotic Drugs and Psychotropic Substances Bill, 1985 was introduced in the Lok Sabha on 23 August 1985. Under the NDPS Act, it is illegal for a person to produce/manufacture/cultivate, possess, sell, purchase, transport, store, and/or consume any narcotic drug or psychotropic substance.
Are OTC regulated?
The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process.
What OTC is not FDA approved?
A few current (and some previously) unapproved medications include:
- colchicine.
- nitroglycerin tablets.
- morphine concentrated solution.
- morphine sulfate solution.
- phenobarbital.
- chloral hydrate.
- carbinoxamine.
- pheniramine maleate and dexbrompheniramine maleate (in cough and cold combination drugs)
Is OTC non prescription drugs?
Over-the-counter medicine is also known as OTC or nonprescription medicine. All these terms refer to medicine that you can buy without a prescription. They are safe and effective when you follow the directions on the label and as directed by your health care professional.
Is paracetamol an OTC drug in India?
One of the most common OTC drug used in case of a fever, headache, or cold is the paracetamol, easily available at all pharmacy stores without a prescription.
Who can sell drugs in India?
42 of the Pharmacy Act is very clear. The dispensation of medicine can only be done by a qualified pharmacist and a medical practitioner for his own patients or with the general or special sanction of the State Government for the patients of another medical practitioner.