REGULATORY GUIDELINES FOR SAMPLING OF DRUGS, COSMETICS & MEDICAL DEVICES BY DRUGS INSPECTORS OF CENTRAL & STATE DRUG AUTHORITIES
Drugs Inspectors of Central & State Drug Authorities have released the guidance document for sampling of drugs, cosmetics & medical devices vide their circular dated 9th feb 2024.
This guideline is mainly focused to utilize available information & identified risks for selection of sample & location to cover vast variety of drugs, cosmetic and medical devices moving in the market from manufacturing facility, wholesale outlet, retail outlet, government distribution channel etc.
This guideline will be useful for effective surveillance for quality & efficacy of drugs & cosmetic available in the market by adopting uniform drug sampling methodology for drugs inspectors under drug regulatory authorities of state and central.
The main objective of the sampling is to check the quality & efficacy of drugs & cosmetic available in the market with their approved specifications. This involves:
Monitoring the quality of the API, Excipients and finished products of drugs, cosmetic and medical devices in all parts of the distribution chain throughout the authorised shelf-life.
Ensuring that existing control methods are satisfactory.
Investigating the Not of Standard Quality (NSQ) Product.
Identifying Unapproved Products/ Without License sales outlets.
Identifying Spurious drugs in distribution chain
Identifying sales outlets where repetitive NSQ/ Spurious drugs are reported etc