Pharmaceutical Regulations Quiz

Schedule G drugs must carry which warning on the label?

• Sold by prescription only

• Caution: To be sold by licensed chemist only

• Caution: It is dangerous to take this preparation except under medical supervision

• For external use only

What symbol must appear on the label of a Schedule H drug?

• NRX

• OTC

• C+

• Rx

What does NRX indicate on a drug label?

• Schedule G drug

• Over-the-counter drug

• Narcotic and psychotropic substance under Schedule H

• Non-registered drug

What is the primary aim of Schedule M?

• Licensing retail pharmacists

• Rules for advertisement of drugs

• Good Manufacturing Practices (GMP) for drugs

• Pricing of medicines

What is the minimum area required for tablet manufacturing as per Schedule M?

• 50 sq. mt.

• 20 sq. mt.

• 10 sq. mt.

• 30 sq. mt.

What is covered under Schedule T of the Act?

• Cosmetics manufacturing

• Blood products

• Ayurvedic, Siddha and Unani medicines manufacturing requirements

• Homeopathy formulations

What information must be included in manufacturing records as per Schedule U1?

• Price details

• Details of advertising expenses

• Serial number, ingredients, duration and conditions of manufacturing process

• Only expiry date and batch number

Schedule V relates to which type of medicines?

• Narcotic drugs

• Cosmetic products

• Patent or proprietary medicines containing vitamins

• Ayurvedic medicines

Which schedule includes particulars to be recorded for both parenteral and non-parenteral drugs?

• Schedule T

• Schedule M

• Schedule U

• Schedule Y

What is the focus of Schedule F?

• GMP for Ayurvedic medicines

• Labeling and color coding

• Standards for biological and blood products

• Details of drug testing equipment