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Amid Naphtha Shortage, Pharma Industry Urges Easing of Small-Package Drug Rules

From Hankyoreh · (21h ago) Korean Mixed tone

Translated from Korean, summarized and contextualized by DistantNews.

TLDR

  • The pharmaceutical industry is urging the government to temporarily ease regulations on small-volume packaging due to a shortage of packaging materials caused by unstable naphtha supply.
  • The current regulation mandates that at least 10% of annual drug production or imports must be in small packages (e.g., 30 tablets or less), a rule intended to reduce waste and misuse.
  • Pharmacies oppose the relaxation, citing concerns about inventory management and the potential for regulatory rollback, while the Ministry of Food and Drug Safety is considering administrative support.

The recent global instability, particularly the conflict between the US and Israel and Iran, has sent ripples through South Korea's economy, impacting even the pharmaceutical sector. The Hankyoreh reports on the pharmaceutical industry's plea to the government for a temporary easing of regulations on small-volume packaging. This isn't just about convenience; it's a direct consequence of the naphtha supply chain disruption, a crucial component for plastic packaging. The industry argues that the current 10% mandate for small packaging is inefficient, consuming more resources for the same amount of medication. They propose reducing this to zero temporarily, which they claim would allow for the production of over 200,000 additional large-volume bottles and could help stabilize the supply of essential pediatric medicines.

We request a temporary easing of the obligation to supply small-volume packaged medicines.

— pharmaceutical industry representativesDuring a meeting with government officials, including representatives from the Ministry of Trade, Industry and Energy, Ministry of Health and Welfare, and Ministry of Food and Drug Safety, to discuss the packaging material shortage.

Adding to the industry's woes is the rigid pricing structure for prescription drugs. Unlike other sectors where rising raw material costs can be passed on to consumers, pharmaceutical companies in South Korea cannot arbitrarily increase drug prices. This makes the impact of increased packaging costs even more severe. While the Ministry of Food and Drug Safety acknowledges the industry's difficulties and is considering administrative support, the pharmacy sector remains wary. Their concerns about inventory management and the potential for a permanent rollback of patient safety regulations are valid. This situation highlights the delicate balancing act between regulatory goals and the practical realities of global supply chain disruptions, a challenge that requires careful consideration and a swift resolution from the authorities.

If we reduce the current 10% small packaging ratio to 0%, we can produce over 200,000 additional bottles of 300 or more tablets.

— pharmaceutical industry officialExplaining the potential benefits of easing packaging regulations, highlighting resource efficiency.
DistantNews Editorial

Originally published by Hankyoreh in Korean. Translated, summarized, and contextualized by our editorial team with added local perspective. Read our editorial standards.