Page 14 - CW E-Magazine (Oct-Nov-2023)

API Manufacturing

Environmental clearances should
also permit flexibility to companies to
alter their product slate without a re-
appraisal, as long as sanctioned effluent
norms are not violated.
Greener path through novel tech-
nologies
Industry, on its part, must ensure
production processes use the ‘greenest’
of technologies. Several chemistries
employed in the API industry need to
be relooked in the context of their envi-
ronmental impacts and every effort must
be made to reduce their ‘e-factor’ – the
quantum of waste generated per unit of
tomycin) – all listed in the National List It has shown its commitment to rem- the desired product. At the same time,
of Essential Medicines – are almost edy the situation by allocating significant adequate investments need to be made in
exclusively procured from China. The resources – nearly Rs. 10,000-crore – to ‘end-of-pipe’ effluent treatment systems
situation is even more acute for fermen- aid local manufacturing efforts. While and operationally given the attention it
tation products; India’s entire Penicillin some funds (about Rs. 3,000-crore) will deserves. Together, such measures will
G requirement is now imported, and go to build three new Bulk Drug Parks, lay the base for sustained and sustain-
five plants set up at substantial invest- with state-of-the-art infrastructure that able growth.
ment have been junked due their inabil- will enable businesses to quickly get op-
ity to stand up to Chinese competition. erations going, the balance (nearly Rs. Flow chemistry, a process intensifi-
Ditto for several other anti-infectives, 7,000-crore) will go into a production- cation technique, for instance, involves
including cephalosporins and macro- linked incentive (PLI) scheme that will atom- and energy-efficient, highly-
lides. Even for the humble paracetamol financially reward enhanced manufac- controlled reactions with very low resi-
– widely used for treating pain and fever ture (over 2019-20 levels) of 53 APIs (26 dence times, resulting in high reaction
– the entire requirement of para-amin- chemically synthesised and 27 fermenta- selectivity, high product purity, and ex-
ophenol, the key intermediate, is met tion based) and their raw materials. cellent productivity. Importantly, it can
through imports. be conducted safely and precisely in
The recent decision to simplify the miniaturised highly-flexible continuous
The one instance where India has process of environmental clearance for plug-flow reactors, with very low down-
global scale and integration is the anti- new API projects – now at the State stream clean-up operations, dramatic
inflammatory drug, ibuprofen. Not only level, rather than the more cumbersome reduction in use of solvents, excess re-
is there sufficient capacity for the API Centre – is another welcome step. How- agents and energy.
amongst a handful of producers, but a ever, it seems to be a temporary measure
couple are fully backward integrated to tide over Covid-related bottlenecks. Biocatalysis has also emerged as a
to the KSM, isobutylbenzene (IBB). powerful tool for synthetic chemistry,
The technology-driven growth of these Fast tracking clearances and is currently employed globally for
companies, hold valuable lessons for Several industry representatives have the production of several APIs and in-
how India can go about building similar repeatedly called for a single-window termediates (e.g., antibiotics, statins, and
capabilities in other APIs and their raw clearance of investment proposals, in a enantiomerically pure building blocks),
materials. time-bound manner. Today’s approval fine chemicals (e.g., amino acids and
processes are complex, cumbersome, vitamins), and food ingredients (e.g.,
Recent government measures involve multiple agencies and take any- sweeteners, lipids, and nutraceuticals).
The central Government is under- where from two to four years – an un- Novel enzymes, discovered in research
standably peeved with the situation – acceptable timeframe for any industry, labs just a decade ago have already been
both for the vulnerability it exposes in and all the more so for one as dynamic engineered and applied at scale. Its scope
India’s stretched healthcare system, as as pharmaceuticals. China is reported to will expand in the years to come, as part
also for geopolitical reasons. give nods in six-months. of a portfolio including homogeneous,

10 Chemical Weekly October / November 2023