Drug Companies Must Notify MOH Six Months Ahead Of Shortages, Says Dzulkefly

Drug makers must notify authorities six months before potential shortages. MOH keeps one to three months of medicine stock and appoints multiple suppliers to reduce supply risks, while monitoring supply and using pool procurement to secure critical drugs.

KUALA LUMPUR, Feb 27 — Product registration holders (PRH) are required to notify authorities at least six months in advance of any potential drug supply disruption, or immediately if a shortage occurs unexpectedly, Health Minister Dzulkefly Ahmad told Parliament.

In a written Dewan Rakyat reply on February 10, Dzulkefly said information on medicine shortages and discontinuations is published on the National Pharmaceutical Regulatory Agency’s (NPRA) Medicine Shortage and Discontinuation Database that can be accessed by industry players, health professionals, and the public.

The database includes details such as the reason for discontinuation or shortage, supply impact start and end dates, mitigation plans by the product registration holder and NPRA, as well as available registered alternative products.

Dzulkefly added that, in general, Ministry of Health (MOH) facilities maintain between one and three months of medicine stock based on usage patterns, delivery lead times, and storage capacity. The ministry also appoints more than one supplier as a mitigation strategy.

“In terms of procurement, to reduce dependence on a single supply source, MOH implements a strategy of appointing more than one supplier and strengthening the local industry to reduce the risk of reliance on a single source. 

“In addition, MOH implements various other procurement mechanisms including central contracts, pooled procurement with the Ministry of Defence and the Ministry of Higher Education, logistics concessions, and zoning-based procurement,” Dzulkefly said.

Dzulkefly was responding to a question from Wee Jeck Seng (BN-Tanjung Piai) on the ministry’s strategic plans to ensure continuous supply of critical medicines, vaccines, and ancillary medical supplies, including national stock capacity, responsible agencies, alternative suppliers, and replenishment lead times in preparation for future health crises.

Beyond stock management, Dzulkefly said MOH continuously monitors medicine, vaccine, and medical supply levels through the Pharmacy Information System (PhIS) to track inventory, usage patterns, and distribution needs in real time.

To further secure critical supplies, MOH also implements the Plus Off-Take Agreement Programme (PPO Plus), a targeted procurement approach involving companies that make new domestic investments to produce critical pharmaceutical products and medical devices.

Dzulkefly said collaborative supply management is carried out across key MOH divisions and agencies, alongside logistics concessionaires, contract suppliers, multinational pharmaceutical firms, product registration holders, and local manufacturers to strengthen national stock capacity and supply-chain preparedness during emergencies.

He added that MOH works with other ministries and agencies – including the Ministry of Science, Technology and Innovation, the Ministry of Investment, Trade and Industry, and the Malaysian Investment Development Authority – particularly on vaccine development and strengthening the domestic pharmaceutical supply chain under the National Vaccine Roadmap.

At the regional level, Malaysia leads the Asean Drug Security and Self-Reliance (ADSSR) initiative and participates in the Asean Vaccine Security and Self-Reliance (AVSSR) framework as part of broader efforts to enhance medicine and vaccine security in Southeast Asia.

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