CDCSO issues distribution guidelines for pharma products in market to curb substandard medicines: Is Supply Chain Traceability a Necessity?

CDCSO issues distribution guidelines for pharma products in market to curb substandard medicines
The guidelines are set to apply to all individuals and establishments engaged in any phase of the storage and distribution of pharmaceutical products, starting from the manufacturer’s facilities to the individual dispensing the products to a patient or their representative.

The document outlines measures to aid stakeholders in meeting their obligations at various phases within the supply chain to prevent the entry of ‘sub-standard’ products in the market.

Is Supply Chain Traceability a Necessity?

Yes. It is the need of the hour.

For suppliers accountable for end products, understanding product origins is paramount. It enables tracking each product’s journey back to its source, ensuring transparency throughout production and distribution. This importance is magnified in the pharmaceutical sector, where products are medicines.

Why supply chain traceability is crucial in the pharmaceutical industry: The Importance of Traceability

In the pharmaceutical supply chain, numerous players of varying sizes, roles, and capabilities participate in manufacturing a single tablet. Consequently, traceability becomes a legal obligation rather than just an industry requirement.

Traceability offers unique benefits that make it indispensable in the pharmaceutical supply chain.

Here are a few reasons why it’s imperative across the pharma supply chain:

1. Traceability empowers suppliers to trace a product’s origin from inception to its current stage. Given suppliers’ sole responsibility for the products they deliver, comprehensive knowledge of the supply chain is essential. This heightened visibility ensures every participant can trace the product across every stage, unlike in the past, where the supply chain was disconnected, leading to increased complexity.
2. Increased supply chain visibility informs suppliers at every stage about supply chain events, aiding in maintaining medicine effectiveness and reducing costs related to counterfeits, recalls, and substandard drugs. Comprehensive traceability enhances efficiency, reduces waste, fosters collaboration, improves resilience, and prepares for potential crises by securing supply.
3. The pharmaceutical supply chain faces product quality concerns like ingredient variance, contamination, formulation, or manual errors. Developing a digital supply network, web-based authentication platform is crucial for comprehensive traceability, product quality, and safety assurance.
4. Enhanced visibility enables thorough supply chain investigation, pinpointing errors and determining their root causes to prevent future occurrences.

While supply chain complexities persist, traceability offers visibility and numerous benefits, proving advantageous in overcoming challenges. With evolving legal requirements, traceability emerges as a sustainable solution and a necessity in the pharmaceutical industry.

www.tracesci.in

News: https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/regulator-issues-distribution-guidelines-to-ensure-no-substandard-pharma-products-in-market/articleshow/109409554.cms