Government of India API Traceability Regulation - Blog

Drug counterfeiting has become a global problem, with underdeveloped and developing countries bearing the brunt of it.

Burdened by its growing population, and COVID-19, the pharmaceutical industry in India – one of the largest developing countries – is bent up to the point of breaking. This stress has introduced many cracks in the supply chain, which are wide enough to allow counterfeit drugs to enter.

The presence of counterfeit drugs in any supply chain can be detrimental to public health. For starters, it might not have the desired effect on the patients’ conditions. In the worst cases, it can irreversibly harm their health.

Moreover, as a pharmaceutical supply chain member, the presence of counterfeit drugs can severely hurt your business and harm your reputation. Most importantly, it also reduces the public’s trust in the healthcare system.

To battle this problem, the Government of India has issued an API Traceability Regulation that outlines track-and-trace requirements for active pharmaceutical ingredients.

What are they? Well, they’re the stuff all medicines are made of. They can either furnish pharmacological activity or directly affect the cure, diagnosis, or treatment of a medical condition.

Read on to find out everything that you must know about API traceability.

THE NEED FOR API TRACEABILITY

There are various reasons why increased supply chain traceability is essential in the case of APIs.

For API manufacturers, traceability is of the utmost importance, as it guarantees quality and safety. By implementing a centralized way of working and a robust set of processes, manufacturers can ensure visibility throughout the supply chain. This means, in the event of any problem, you can quickly identify the source — at any stage of production — thereby preventing unsafe or inadequate products from reaching patients.

However, this doesn’t only pertain to manufacturers. Each and every supply chain member can contribute towards enhanced supply chain visibility by following the traceability requirements. What do they get? Well, an end-to-end traceability solution can help supply chain members streamline their inventory management process, leading to fewer delays, and consequently, reduced losses.

WHAT’S IN THE API TRACEABILITY REGULATION?

According to the API Traceability Regulation, every active ingredient imported or manufactured in India must bear a Quick Response (QR) code on its label, and that too at each level packaging.

The presence of the QR code will allow supply chain members to read the product info just by scanning the code. In a nutshell, it will allow stakeholders to track and trace the product throughout its entire supply chain journey.

THE QR CODE MUST CONTAIN VITAL INFORMATION, SUCH AS:

Name of the API
Unique product identification code
Brand name (if any)
Batch number
Manufacturing licence number
Name and address of the manufacturer
Batch size
Date of expiry or retesting
Serial shipping container code
Date of manufacturing
Special storage conditions required (if any)

HOW WILL API TRACEABILITY BENEFIT THE PHARMACEUTICAL INDUSTRY

Serialization and traceability will allow pharmaceutical supply chain members to keep tabs on all APIs traversing through the supply chain. This will not only help stakeholders identify unauthenticated, potentially counterfeit products, but will also enable them to initiate swift product recalls and investigations.

Moreover, the online system envisaged will help traders and manufacturers utilize and generate secondary and tertiary-level coded data in a user-friendly manner, allowing for the seamless aggregation of pharmaceutical products.

Apart from this, an end-to-end track-and-trace system will allow manufacturers, repackagers, dispensers, and other supply chain members to carry out efficient distribution. Plus, with all data logged in a centralized system, inventory management will no longer be a hassle.

PARTING THOUGHTS

With this API regulation, India has clearly taken a massive step towards building a sustainable supply chain. When fully implemented, the track-and-trace system will fill all the chinks in the armour, creating a robust pharmaceutical supply chain free of any fake or low-quality products.