Pharmaceutical supply chain security: Combating counterfeit drugs
The recently enacted Drug Quality and Security Act establishes a national track and trace program targeting counterfeit medicines. The new law – to be phased in over 10 years – is expected to cost drugmakers $10 million to $50 million. For now, manufacturers should focus on the requirements set to take effect in 2015 and 2017.
Implications of the pharmaceutical supply chain legislation:
- Drugmakers must work closely with distributors and develop an open dialogue with regulators to guide and monitor changing requirements.
- Companies should develop a global strategy with local application to meet national and international mandates.
- Executive-led governance structures and strong program management teams are required to meet evolving regulations.