JNTU Pharm. D III Year PHARMACEUTICAL JURISPRUDENCE Previous Question Paper (October/November - 2019 - R08)

As per the Drugs and Cosmetics Act, 1940:

1. Drugs (Allopathic): Includes all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder in human beings or animals, excluding substances intended to be used solely as Ayurvedic, Siddha, or Unani drugs.
2. Misbranded drugs: A drug is considered misbranded if it is so colored, coated, powdered, or polished that damage is concealed, or if it is made to appear of better or greater therapeutic value than it really is; or if it is not labeled in the prescribed manner; or if its label or container bears any statement, design, or device which is false or misleading.
3. Pharmacy: Under the Pharmacy Act, 1948, it refers to the place where pharmacy is practiced, or the profession of compounding, preparing, mixing, or dispensing of drugs and medicines.
4. Manufacture: Includes any process or part of a process for making, altering, ornamenting, finishing, packing, labeling, breaking up, or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution.

Labeling requirements for Schedule G and X drugs are as follows:

1. Schedule G Drugs: These are potent drugs that should be used only under medical supervision. The label must bear the caution:
   Caution: It is dangerous to take this preparation except under medical supervision.
   Examples include Metformin, Glibenclamide, and Hydrocortisone.
2. Schedule X Drugs: These are habit-forming drugs with high abuse potential. The label must bear the symbol X in red on the left top corner and the following warning:
   Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
   The label must also state the name and address of the manufacturer and the batch number. Examples include Amphetamine, Secobarbital, and Pentazocine.