Proposed Changes to Shelf-Life Requirements for Imported Medicines
關於進口藥品有效期要求的擬議修訂
Introduction
The Union Ministry of Health and Family Welfare has released a draft amendment to the Drugs Rules, 1945, concerning the minimum remaining shelf life for imported medications.
聯邦衛生及家庭福利部已發佈一份關於《1945年藥品規則》的修訂草案，涉及進口藥品的最低剩餘有效期。
Main Body
The proposed change suggests replacing the current rule, which requires imported drugs to have more than 60% of their total shelf life remaining, with a fixed minimum of 12 months at the time of import. This change was developed after discussions with the Drugs Technical Advisory Board. The ministry emphasized that this move is intended to improve the efficiency of the pharmaceutical supply chain and create a better environment for business within the sector.
擬議的修訂建議將現行規則（要求進口藥品必須保留總有效期的 60% 以上）改為在進口時需具備至少 12 個月的有效期。此項變更是在與藥品技術諮詢委員會討論後制定的。該部強調，此舉旨在提高製藥供應鏈的效率，並為該產業創造更好的商業環境。
However, the government has stated that biological products and radiopharmaceuticals will still follow the original 60% rule. This exception is based on the special nature of these products and general public health concerns. The ministry asserted that a 12-month minimum provides enough time for distribution and use, which will consequently reduce the amount of medicine wasted due to strict rules.
然而，政府表示生物製品和放射性藥品仍將遵循原有的 60% 規則。此例外情況是基於這些產品的特殊性質以及一般公共衛生考量。該部堅稱，至少 12 個月的有效期已足以應對分銷與使用，進而減少因規則過於嚴格而導致的藥物浪費。
Furthermore, the ministry maintains that this update will improve inventory management and lower costs, thereby increasing the availability of essential medicines. It has been clearly stated that this amendment only affects import shelf-life and does not change existing laws regarding the safety, quality, or effectiveness of medicines. The draft was published on June 22 for a thirty-day period to collect feedback from stakeholders before the final rule is announced.
此外，該部認為此次更新將改善庫存管理並降低成本，從而增加基本藥品的可用性。官方已明確表示，此次修訂僅影響進口有效期，並不改變現有關於藥品安全性、質量或療效的法律。草案於 6 月 22 日公布，為期 30 天，旨在於公布最終規則前收集利益相關者的回饋。
Conclusion
The health ministry is now waiting for feedback from stakeholders before finalizing the shift from a percentage-based to a time-based shelf-life requirement for most imported drugs.
衛生部目前正等待利益相關者的回饋，隨後將敲定將大多數進口藥品的有效期要求從百分比制改為時間制的方案。
Vocabulary Learning
⚡ The 'B2 Power-Up': Moving from Simple to Sophisticated Connections
At the A2 level, you likely use words like because, and, and but. To reach B2, you need to use Logical Connectors that show a professional relationship between ideas.
Look at these specific transitions used in the text to change the 'flavor' of the writing:
1. The "Result" Shift Instead of saying "So, it will reduce waste," the text uses:
*"...which will consequently reduce the amount of medicine wasted..."
The B2 Secret: Consequently sounds official. Use it when one action leads directly to a specific result in a professional setting.
2. The "Adding Weight" Shift Instead of saying "Also, the ministry says..." the text uses:
*"Furthermore, the ministry maintains..."
The B2 Secret: Furthermore is used when you aren't just adding a random fact, but adding a stronger argument to support your point.
3. The "Contrast" Shift Instead of saying "But biological products are different," the text uses:
*"However, the government has stated..."
The B2 Secret: However creates a clean break. It signals to the reader: "Stop, now I am going to show you the opposite side or an exception."
🛠 Quick Upgrade Guide
| A2 Word (Basic) | B2 Word (Professional) | When to use it |
|---|---|---|
| So | Consequently | When the second event is a direct result of the first. |
| Also | Furthermore | When you want to add an important, supporting point. |
| But | However | When you introduce a contradiction or a special case. |