China Orders Strict Checks on Capsules
China's food and drug safety watchdog confirmed Monday it has pressed local authorities to strictly implement a new requirement on the testing of gel capsules, vowing to hand down prompt and severe punishments for producers of unsafe pharmaceuticals.
The State Food and Drug Administration (SFDA) said in a statement on its website that reports by local authorities have shown that some pharmaceutical makers lack the knowledge or equipment to carry out in-house testing on pharmaceutical gelatin, capsules and capsule drugs.
Some local supervisory government departments have failed to take the new requirements seriously as well, the SFDA noted.
Pharmaceutical gelatin and capsule manufacturers that fail to check every batch of raw materials on time will have their production suspended, the SFDA warned.
Sales of enterprises that fail to complete checks before June 1 will also face suspensions, the SFDA said, adding companies must recall defective or contaminated products if they are found during in-house tests.
Companies that do not effectively recall unsafe products will be given harsh punishments, the SFDA warned.
Several Chinese pharmaceutical companies were recently implicated in a scandal involving the production of drug capsules with industrial gelatin, which contains a greater amount of chromium than edible gelatin.
Chromium can be toxic and carcinogenic if ingested in excessive amounts.
The agency said it will launch a nationwide quality review for capsule drugs by the end of May to see if further action must be taken.
The SFDA ordered food and drug regulatory departments to supervise drug manufacturers' in-house tests by randomly checking products that were put on shelves before April 30.
The SFDA said every batch of raw materials used in the manufacture of pharmaceutical gelatin and capsule drugs should be checked starting from May 1.
Some local supervisory government departments have failed to take the new requirements seriously as well, the SFDA noted.
Pharmaceutical gelatin and capsule manufacturers that fail to check every batch of raw materials on time will have their production suspended, the SFDA warned.
Sales of enterprises that fail to complete checks before June 1 will also face suspensions, the SFDA said, adding companies must recall defective or contaminated products if they are found during in-house tests.
Companies that do not effectively recall unsafe products will be given harsh punishments, the SFDA warned.
Several Chinese pharmaceutical companies were recently implicated in a scandal involving the production of drug capsules with industrial gelatin, which contains a greater amount of chromium than edible gelatin.
Chromium can be toxic and carcinogenic if ingested in excessive amounts.
The agency said it will launch a nationwide quality review for capsule drugs by the end of May to see if further action must be taken.
The SFDA ordered food and drug regulatory departments to supervise drug manufacturers' in-house tests by randomly checking products that were put on shelves before April 30.
The SFDA said every batch of raw materials used in the manufacture of pharmaceutical gelatin and capsule drugs should be checked starting from May 1.
