How PodTech™ helps with regulatory challenges in emerging markets
If you follow health sector news from Africa, South Asia, Latin America or even the United States, every now and then, you’ll come across a story about a product recall or adverse impacts patients have suffered from consuming substandard or fake medications. Beyond drug quality issues, there are also concerns about insufficient supply or inaccessibility of drugs, vaccines and medical devices.
Pharmaceutical supply chain concerns exist globally, but in emerging markets, the problem is often exacerbated by complex regulation, inadequate infrastructure and poor market surveillance. Regulatory agencies in each country and region carry the onus of identifying and addressing such issues – with stringent regulations, they ensure that their populations have access to safe and effective healthcare delivery.
Regulatory bodies bear a great responsibility, so it is no surprise that the stringent regulations that they frame for health products are often complex and time-consuming to implement. From good manufacturing practices (GMP) to specifications for product quality to appropriate distribution systems, health product regulations encompass a vast range of steps in pharmaceutical manufacturing and distribution.
As a drug maker, if you decide to set up a factory to produce, say, the new meningitis vaccine in Kenya, you would have to assure relevant public authorities that the product you make is of good quality. You would have to get the necessary permissions and approvals, ensure that your equipment functions as it is meant to, guarantee the quality of your process and product, and obtain market authorizations to distribute the shot.
All of these steps are non-negotiable. But they’re not usually quick and easy. That’s where PodTech™ can help.
Beyond our revolutionary podule™ technology, which can get customised pharma factory systems up and running in no time, our project management skills are unrivalled. So if you’re concerned that regulatory delays and complexities may put a spanner in the works on your next project, read on to know why you need PodTech™, with our end-to-end solutions, by your side.
Regulatory challenges in emerging pharmaceutical markets
Though regulatory frameworks vary from country to country, many emerging markets share some similar challenges.
Quality assurance.
The World Health Organisation (WHO) claims that roughly one in 10 medical products in low- and middle-income countries (LMICs) is substandard or falsified. The presence of poor-quality drugs is a result of global and opaque pharmaceutical value chains. It is also a consequence of poor market surveillance.
When poor-quality drugs are consumed by patients, the health costs of the problem are high. When poor-quality drugs are identified and removed from the market, the economic costs are quite high. In other words, poor-quality drugs always prove to be expensive. They present a regulatory challenge that can be solved best by transparent supply chains.
While the onus to fix this problem is on public regulatory bodies, it is in the best interest of drug manufacturers to gain the trust of the public by guaranteeing product quality. Non-compliance with local regulations can also prove to be expensive as you would have to rectify your errors, possibly even recalling your product, which can pose a heavy financial burden.
Fragmented regulatory landscape.
A health product maker who wants to enter a new geography has to identify and comply with all relevant legislation and industry regulations in their target market. However, the fragmented nature of regulatory systems can make compliance a stressful and onerous activity.
For instance, if a diagnostics manufacturer wants to enter the UAE market, they would have to comply with standards set by the Emirates Authority for Standardisation and Metrology (ESMA). They would also have to adhere to the regulations put in place by the Health Authority Abu Dhabi (HAAD), the Dubai Health Authority (DHA) and the Dubai Healthcare City Authority (DHCA) to sell their product in these respective regions. These fragmented regulatory systems can be challenging to navigate, especially for foreign players looking to enter the market.
Local regulatory specifications.
In every market, drugs and diagnostics must meet specific regulatory and testing requirements. These requirements are often designed keeping in mind regional needs and expected quality standards in the region. International suppliers who distribute drugs in multiple regions may find tailoring their products to meet diverse regulations a complex endeavour.
Slow speed of regulatory processes.
Particularly in an industry like pharma, where product quality and integrity are of utmost importance, getting all the required permissions, approvals and authorizations can be a fairly time-consuming process. When added to the construction and commissioning timeline, administrative and regulatory processes can extend your time to operations to as long as 12 to 24 months.
PodTech™ to the rescue: Addressing regulatory challenges in emerging markets
Given the specific regulatory challenges that plague emerging markets, at PodTech™, we offer project management and support designed specifically to accelerate your time to operations.
In-built quality control.
Opaque supply chains are key enablers of the counterfeit drug market. Localising biopharmaceutical production in the region in which the drugs will ultimately be consumed can go a long way in building trust and transparency in pharma value chains. PodTech™’s modular podule™ technology can help you do just that – bring health product manufacturing closer to the people it serves.
We don’t just help you localise manufacturing quickly, we also help you do it safely and effectively. Quality is at the heart of our processes and that translates to the work of our customers as well. Our cleanrooms and factory systems come with built-in QC features. With integrated advanced monitoring and control technologies, we help you ensure that every batch of your products meets the required standards and specifications. With real-time monitoring, you have all the data you need to assure authorities and consumers, too, of product quality.
Regulatory fast-tracking.
We provide our customers with end-to-end support. This includes regulatory support with certifications, approvals and permissions. This significantly shortens project timelines. Take, for instance, a rapid diagnostics plant we set up in the UAE. Here, we were able to fast-track permits and approvals to expedite the regulatory aspects of the project.
Pre-validation.
Validation is the process by which you produce documented evidence that a manufacturing process or piece of equipment consistently works as it is intended to, producing the predetermined desired results. There are different types of validation, like equipment validation, process validation, installation qualification, etc. which guarantee the integrity of your systems and processes.
Validation is a regulatory requirement for health product manufacturing – for example, current good manufacturing practices (cGMP) for finished pharmaceuticals (21 CFR 211) and for medical devices (21 CFR 820) mandate process validation.
PodTech™’s modular factory systems are manufactured off-site, at our production facility in the UAE. They are pre-validated before they are shipped to your factory site, where they are simply assembled. No losing time over lengthy regulatory processes after the podules are on-site.
In addition to our rapid turnaround time to build pharma factory systems, the regulatory support we provide plays a big role in shortening your project timeline. In our aforementioned UAE project, what would have taken other process partners 12 to 24 months to do – design, layout, acquisition, installation and calibration of equipment, trial runs, staff training and regulatory compliance – we achieved in just about 4 months.
If you are a drug, vaccine, diagnostic or medical device maker looking to make a difference in an emerging market, take that first step today. Reach out to us at PodTech™ and let us help you make life-saving health products available in every corner of the world.