THE GIST of Editorial for UPSC Exams : 12 December 2018 (Manufacturing drugs on demand)

Manufacturing drugs on demand

Mains Paper 3: Economy
Prelims level: 3D printing technology
Mains level: Infrastructure

Context

•  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.

•  It has 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.

Planning an approach

•  The 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.

Important findings observed by MIT

•  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.

Way forward

•  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 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.

•  The 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.

•  The apparent benefits of this new technology, the government would do well to figure out how to redesign regulations to facilitate its adoption.

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General Studies Pre. Cum Mains Study Materials

Prelims Questions:

Q1. Which of the following best describes 'nonfactor services'?

(a) Services that are unaccounted for in the national income accounting.
(b) Services that do not generate any income from international trade.
(c) Invisible receipts that are not attributable to any of the conventional 'factors of production'.
(d) Remittances received from any nontrade or merchandise activity.
Answer: C

Mains Questions:
Q1. How 3D printing and desktop manufacturing will revolutionise industrial production?