'Produce local medical devices'

Experts urge govt to address regulatory delays, support local manufacturers

KARACHI:

Pakistan medical fraternity has called for locally manufacturing medical devices to reduce the country's reliance on imports, with 98% of devices currently being imported. The government must encourage made-in-Pakistan products and prioritise the emerging indigenous medical device industry to cut the import bill and boost exports, leveraging the country's reputation as the "land of competent doctors and engineers."

The global medical device industry is valued at $600 billion with Pakistan's market standing at hardly 1% of this figure.

Hi-tech engineering services in Pakistan provide a range of engineering solutions in many fields globally and require the government's support to grow, they said. For example, the first locally-manufactured AlnnoVent AVB-100 ICU Ventilator, recently approved by the Drug Regulatory Authority of Pakistan (DRAP) and set for market release in 2025, is world-class standard.

Alsons Group leveraged its expertise in precision engineering, with support from Saman-e-Shifa Foundation, to venture into medical technology with the AlnnoVent AVB-100. After five years of undergoing checks and processes, the company secured official approval from DRAP.

The AlnnoVent AVB-100 is an electro-mechanical ICU ventilator, locally designed, developed, and manufactured that meets international standards of quality and reliability. It supports adult patients across five invasive and two non-invasive ventilation modes, making it suitable for a range of critical care scenarios. The ventilator was created in response to the acute shortage of respiratory aid devices during the COVID-19 pandemic.

Akbar Allana, Director of Alsons Group, said, "We offer a locally manufactured solution to critical healthcare needs. The AlnnoVent represents our belief in Pakistan's potential to contribute meaningfully to global healthcare challenges." Of 50 prototypes inspected, only two ventilators – one developed by National Engineering & Scientific Commission (NESCOM) and the other by Pakistan Atomic Energy Commission (PAEC) – were granted approval by DRAP four years ago under emergency protocols early on. However, neither of these were commercialised due to DRAP's stringent protocols.

"In our case, we had to undergo full clinical trials, as per the complete protocols of DRAP and, in fact, even had to run extended human trials. During this development and extensive trial period, we also had the opportunity to run our machines on long endurance tests and therefore have the data to prove the reliability and performance of the product. This puts us in a unique position of being the only ventilator developer in Pakistan whose product has undergone, and even exceeded, all required regulatory testing, human trials, and engineering qualifications and is also ready for manufacturing and commercialisation," he said.

Saman-e-Shifa Foundation Chairman Professor Dr Shahid Noor said the ventilator is of world-class standard. "Promoting made-in-Pakistan medical devices and equipment will save precious foreign currency. The federal government should prioritise locally-made and DRAP-approved medical devices once tenders are floated in this respect," he urged.

All hospitals – public, private, and teaching – need ventilators depending on their respective healthcare services, he explained. Health Device Association of Pakistan Chairman, Syed Omer Ahmed, said that 98% of medical devices are imported in Pakistan, with the surgical instrument industry in Sialkot exporting $200-250 million annually. If medical devices are locally manufactured, they will scale down the healthcare budget and improve infrastructure.

The surgical disposable industry is an import-based one, and there are about two million medical devices in the world, according to WHO. Depending on risk factors, medical devices are divided into various classes from A to D. Half of pharmaceutical products are dependent on medical devices, including ECG machines, ventilators, and others. There are 1,100 medical device importers; if they are given incentives, they will be eager to set up manufacturing units

The experts noted that there are two major hindrances – an unfavourable taxation system and high energy tariffs. The pharmaceutical industry pays 1% sales tax; however, 18% sales tax is imposed on medical devices at the time of import or sale after manufacturing products, while both products go to hospitals for use by patients. This is an anomaly and step-motherly attitude.

They also stressed that ongoing delays in the registration process for Class C and D medical devices, with a missed deadline of December 31, 2023, have already caused significant disruptions in the supply chain. The approaching deadline for Class A and B devices on December 31, 2024, could worsen the situation, risking severe shortages of critical medical equipment by January 2025. These shortages will severely impact surgeries, blood transfusions, diagnostics, and critical care arrangements (including ventilators, patient monitors, and infusion pumps). This crisis can bring the entire healthcare system to a standstill, they warned.