Facts for Prelims (FFP)
Source: TH
Context: The national public health agency of the United States Centres for Disease Control and Prevention (CDC) has expressed concern over a drug-resistant bacteria strain allegedly linked to eye drops imported from India
About the strain:
- It is “extensively” antibiotic-resistant Pseudomonas aeruginosa bacteria found in multiple open containers of eye drops.
- Pseudomonas aeruginosa can cause infections in the blood, lungs (pneumonia), or other parts of the body after surgery.
The eye drops were manufactured by Chennai-based Global Pharma Healthcare and distributed in the U.S. market by EzriCare and Delsam Pharma. Previously, WHO had issued two medical product alerts on cough syrups manufactured in India which were exported to Gambia and Uzbekistan.
Licensing requirements of drug manufacturers in India:
- Manufacturing of drugs for export needs licensing from the concerned State Licensing Authority (SLA) under the provisions of the Drugs and Cosmetics Act,1940
- All manufacturers were required to meet the requirements of the importing country.