Our regulators simply do not have the tools to deal with distributed manufacturing of small-dose pharmaceuticals
In 1958, Leonard Reed published a simple first-person essay entitled I, Pencil to describe the complexity of modern economics. By tracing the lineage of a simple wooden lead pencil—from the cedar tree that is cut down and shaped into the pencil length slats that are smoothed, waxed and lacquered to the form we can identify, to the graphite that is mined in Sri Lanka, mixed with clay, tallow and ammonium hydroxide before being extruded and baked into the thin black “lead" that we recognize—Reed vividly describes the number of steps that go into the production of an object as commonplace as a pencil. He ends the essay by remarking that even though the skill and labour of millions of people have had a hand in the manufacture of each pencil, no one person on the planet has the complete knowledge that is required to make it. While the essay was written to explain Adam Smith’s concept of the invisible hand in free-market economics, it is a handy illustration of the incredible complexity of modern manufacturing. Unlike in the days before the Industrial Revolution when shoemakers, tailors, carpenters and other artisans made every last bit of their products by hand, very few production facilities today are capable of producing the entire finished product from scratch. The process of modern manufacturing at industrial scale involves the establishment of multiple production facilities designed to individually produce vast quantities of components that are themselves designed to be combined, in even larger assembly lines, into the final finished product.
While this approach has given us the ability to manufacture products at a scale that was completely inconceivable before the invention of these industrial machines, it has left us at the mercy of the vast intercontinental supply chains that feed into these production facilities so that minor variations in quality and unpredictable disruptions in production anywhere in the chain of suppliers can have a devastating effect up the line.
This is of particular concern in the context of the pharmaceutical industry where non-continuous, “batch" processes are the heart and soul of the drug manufacturing process. Most manufacturers produce the active pharmaceutical ingredient (API) using molecular fragments obtained from different sources. The API is then mixed with excipients in a separate facility and the final drug product is formulated at yet another plant.
Thanks to this complex multi-stage process, it can take up to 12 months to produce the final finished product and manufacturing units throughout the supply chain are required to maintain large inventories of intermediates at all steps along the way. It goes without saying that this sort of a manufacturing process is particularly susceptible to variations in quality and supply—a fact that could literally mean the difference between life and death in the event of an epidemic when the production of life-saving drugs needs to be accelerated rapidly. While there has been some talk about how 3D printing and desktop manufacturing will revolutionise industrial production, making it possible to produce small-batch custom designs at affordable prices, it is only recently that excitement has begun to build up around the possibility of a similar approach to the manufacture of pharmaceuticals.
A couple of years ago, a team of scientists from Massachusetts Institute of Technology (MIT) were able to demonstrate how a manufacturing platform that combined the synthesis and final-product formulation of a drug into one continuous process would work. They built a single refrigerator-sized unit that was capable of synthesizing four commonly used drug molecules—Benadryl (used in the treatment of the common cold), Lidocaine (a local anaesthetic and antiarrhythmic drug), Diazepam (a central nervous system depressant better known as Valium) and fluoxetine hydrochloride, an antidepressant that is widely prescribed under the name Prozac. In time, it is likely that machines like this will be able to synthesize many more drugs—eventually, in time, all the drugs on the World Health Organization’s essential list. Since the machine is completely reconfigurable, it will be possible for trained operators to synthesize drugs on demand with basic materials and reagents that are easily available.
The advantages of a desktop manufacturing system like this are self- evident. It allows medical staff in small patient populations to only produce those pharmaceuticals that are necessary to meet patient needs. For drugs with a short shelf life, the ability to manufacture the active ingredient on demand removes the requirement to include complex formulations that are included to improve their long-term stability. In a country like India, where healthcare benefits need to reach the far corners of this vast country, machines that can manufacture essential drugs on demand in rural medical facilities will be invaluable.
That said, producing drugs this way runs contrary to everything our existing regulatory framework says we should do. Our laws, like those of countries around the world, are designed to monitor large centralized pharmaceutical facilities through tests and periodic inspections. Our regulators simply do not have the tools to deal with distributed manufacturing of small-dose pharmaceuticals. Given the apparent benefits of this new technology, the government would do well to figure out how to redesign regulations to facilitate its adoption.
Rahul Matthan is a partner at Trilegal and author of Privacy 3.0: Unlocking Our Data Drive Future. Ex Machina is a column on technology, law and everything in between. His Twitter handle is @matthan.
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