When a critically ill patient requires access to an unlicensed medicine, every hour matters.
In December 2020, BAP Pharma received an urgent request from the Indian division of a multi-national healthcare company to source and deliver an unlicensed medicine for a four-month-old infant in India.
The challenge required rapid regulatory coordination, compliant international supply, and flawless execution to ensure treatment could begin without delay.
The Challenge
A critically ill four-month-old patient urgently required access to a medicine that was not licensed in India. To make treatment possible, the product needed to be sourced internationally and imported under exceptional regulatory provisions.
The situation presented several time-critical challenges:
- Securing regulatory approvals from both UK and Indian health authorities.
- Ensuring compliance with complex import requirements for an unlicensed medicine.
- Verifying the receiving storage facility in India met al applicable quality standards.
- Coordinating internal logistics with no margin for delay, as patient treatment depended on rapid delivery.
The BAP Pharma Approach
BAP Pharma mobilised immediately, collaborating closely with the Indian healthcare company to fully understand the patient’s clinical needs and the regulatory pathway required.
Once the specific import requirements for supplying the unlicensed medicines into India had been assessed, an urgent import request was submitted to the UK Health Authority, which was rapidly approved.
Upon notification that the medicine would be stored on the hospitals behalf at a licensed wholesaler in India, BAP Pharma confirmed the location met all required quality and compliance standards before shipment.
Approval of importation was granted by the Indian Health Authority, enabled the sourcing and shipment of the medicine to proceed. BAP Pharma managed each stage of the process with full regulatory oversight and compliance maintenance to minimise any delays.
The Outcome
Following the receipt of all the regulatory approvals, the medicine was received by BAP Pharma on the 21st January 2021, where it underwent a full immediate quality inspection before being dispatched to India the following day.
The shipment arrived at its destination on the 24th January and on the 27th January, BAP Pharma received confirmation from the patient’s father that the medicine has been received by the hospital and the first dose had been successfully administered.
Key Insight
Providing access to unlicensed medicines is far more than international shipping.
Success depends on navigating regulatory requirements, assuring product quality, coordinating multiple stakeholders and executing every step without compromising compliance – all while working against critical patient timelines.
Why It Matters
For patients with serious or life-threatening conditions, delays in accessing treatment can have significant consequences.
A trusted medicines access partner can accelerate access by managing the regulatory, quality and logistical complexities involved in cross-border supply, allowing healthcare providers and pharmaceutical companies to focus on patient care with confidence.
BAP Pharma Perspective
Urgent named patient requests demand speed, precision and complete regulatory control. BAP Pharma combines global sourcing expertise, regulatory knowledge and compliant international logistics to deliver unlicensed medicines safely and efficiently, ensuring patients can access critical treatments when licensed alternatives are unavailable.
By managing complexity behind the scenes, we help transform urgent access requests into successful patient outcomes.
