💊 EU proposes changes to pharma laws; India approves new medical devices policy; Malaysia gets traditional medicine research framework

#328 | PRETing for future pandemics; Getting malaria vaccines to market; Looking at long Covid

Hello, and welcome back to The Kable on this fine Thursday. If you're one of our eagle-eyed readers who noticed the typo in yesterday's edition, that’s today, not yesterday. But like yesterday, today is also an action-packed day for the life sciences, what with the US FDA chasing more quality lapses, mpox exploring new locations, and the EU picking a fight with the pharmaceutical industry.

The US FDA is doing what the US FDA does. Issuing warning letters and Form 483s. This time, Egyptian manufacturer Pharmaplast is in the line of fire. The company received a warning letter earlier this month over its failure to properly test its ethanol and each of the components used in its production, as well as its inadequate cleaning procedures. Meanwhile, in Iceland, manufacturer Alvotech has received another Form 483 over quality unit deficiencies in lab data reviews, SOPs not being followed, and insufficient quality assurance.

The FDA has also handed out some thumbs ups though. Seres Therapeutics’ pill Vowst, made from healthy bacteria found in human poop, got the green light from the FDA as a simpler intervention to combat dangerous gut infections requiring stool-based procedures. Faecal transplants ftw!

Australia’s mRNA Victoria, South Africa’s Afrigen Biologics, and the South African Medical Research Council have signed an MoU to collaborate on improving access to mRNA technology in LMICs and train workforces in advanced mRNA manufacturing techniques.

Over in Ghana, Unichem is setting up a pharmaceutical plant in Accra to produce London United Exports Ltd (LUEX) pharmaceutical products to supply the African region.

In a bid to improve pharma product quality, Egypt wants to increase its partnerships with local as well as foreign companies, with a specific focus on localising tech for antibiotics and chronic disease treatments. The Egyptian government has announced that deliberations with local and Indian investors are in progress to launch projects worth $80 million for pharmaceutical raw material manufacturing.

Traditional medicine has its sceptics and its believers. What it doesn’t have is any research guidelines. But Malaysia’s taking care of that too. The country’s Ministry of Health is launching the world’s first traditional and complementary medicine research framework with herbal medicine research guidelines, developed with the help of the WHO.

In India, the medical devices industry is looking at steep growth in the next five years. The Union Cabinet has approved the National Medical Devices Policy 2023. With the objectives of improving access, affordability, quality and innovation of medical devices in the country, the policy comprises interventions with regard to regulatory streamlining, infrastructure and human resource development, promotion of R&D as well as attracting investments.

And finally, in neighbouring Pakistan, the National Institute of Health has confirmed the country’s first case of mpox.