India's Central Drugs Control Organisation (CDSCO) has introduced new guidelines to streamline the testing process for imported drugs from countries with a proven track record of quality, such as the United States, Australia, Japan, Canada, and the European Union. Under these guidelines, drugs from these countries will undergo reduced frequency testing, provided their samples have not failed quality tests in the past five years.
Reduced Testing Frequency:
- Sampling will be reduced to one consignment in two years or one in 20 sequential consignments, whichever comes first.
- Random sampling will occur every six months or every 10 consignments.
Quality Control Measures:
- If a sample fails the quality test, the next five consecutive consignments will undergo sampling.
- Products from new sources will be subject to mandatory testing.
- Importers can choose to reship or destroy goods that fail quality tests.
Guidance for Port Officers:
A document outlining risk-based approaches for monitoring quality at ports of import has been released to guide port officers in decision-making.
This move aims to strike a balance between facilitating trade and ensuring the quality of imported drugs. By reducing testing frequency for countries with a proven track record, India can streamline the import process while maintaining stringent quality control measures. This development aligns with international practices, where risk-based approaches are employed to optimize regulatory oversight.
International Perspective:
Similar approaches are used globally, such as the International Maritime Organization's (IMO) guidelines for port state control, which emphasize risk-based inspections. The IMO's procedures for port state control provide a framework for ensuring maritime safety and security.
Conclusion:
India's revised guidelines for testing imported drugs reflect a nuanced approach to balancing trade facilitation with quality assurance. By adopting risk-based strategies, India can enhance its regulatory framework while ensuring the availability of quality medicines for its population.
(Input from various sources)
(Rehash/Vaishnavi Dalvi/MSM)