This article is part of our special focus on "traditional" pharma: The Small Molecule Manufacturer (read more here). You can find more articles from The Small Manufacturer here.
Though the global demand for generics is on the rise, so too is the domestic need for medicines in India. Price pressures are forcing producers to consider more efficient processes. In turn, equipment developers are now working in a more integrated manner with pharma companies to better understand their manufacturing processes and find opportunities for optimization.
As well as generic products manufactured using conventional technologies, there is a growing need to produce more advanced medicines, which has resulted in a demand for equipment with high containment capabilities to meet overall exposure limits (OEL) norms as stringent as OEL IV and V.
Everyone from patients to regulators to pharmaceutical companies themselves. They are all stakeholders in the industry and, as such, their opinions shape how machinery manufacturers respond. In recent years, concepts like digitization, the Internet of Things, and Industry 4.0 have influenced the equipment being developed. As new trends emerge, India’s equipment manufacturers must meet the industry’s expectations to maintain their competitive edge.
The previously mentioned trends have contrasting equipment needs. Whereas generics require high output, high efficiency, and large batches, advanced medicines are manufactured in smaller, contained batches with highly automated cleaning capabilities. Equipment manufacturers will have to work closely with their clients to create solutions for these varied needs.
Irrespective of the product, equipment providers must continue to meet the industry’s high standards for manufacturing. The Code of Federal regulations recently introduced electronic validation for the manufacture of pharmaceutical machinery. And that means companies must integrate powerful computer- and programmable logic controller-driven processes into their protocols to reduce human intervention in the drug development process to drive a higher level of quality and efficiency in pharmaceutical manufacturing technologies.
Stakeholders’ needs are rapidly changing and many emerging technologies have attractive cost benefits. Continuous manufacturing, for example, offers companies an alternative to conventional processes, as well as the opportunity to cost-effectively produce large volumes of product. Traceability technologies must also be prioritized to help secure products in the supply chain.
Though it’s important to address customer requirements, equipment manufacturers must also assess the benefits of developing new machinery for their own operations. They must ask themselves what the long-term value of producing new equipment is and how it will affect their perception among customers. Simply put, companies must weigh up the pros and cons before developing equipment for trends that may be short-lived.
Newsletters
Receive the latest analytical science news, personalities, education, and career development – weekly to your inbox.
