Page 173 - CW E-Magazine (17-9-2024)

Special Report

Novel and cost-effective technologies for synthesis

of APIs

he Department of Pharma- are manufactured through fermenta- led to substantial lack of success
ceuticals (DoP), Ministry of tion and 29 APIs through chemical between 2000-2010 and made the
TChemicals and Fertilisers, synthesis (Financial Express, Dec Indian industry shy away from future
Government of India, recently 22, 2021). efforts towards drug discovery.
conducted a survey to encourage
adoption of novel and cost-effective The Department of Pharmaceu- The CRO industry flourished
technologies for synthesis of active ticals (DoP), Ministry of Chemicals from 1995 and became the know-
pharmaceutical ingredients (APIs). and Fertilisers, Government of ledge hub of new technologies and
The main objectives of the study, India has drawn up a list of 56 APIs drug discovery in a service mode,
carried out through the Centre for to prioritize them for the Make-in- creating shareholder value for multi-
Market Research & Social Deve- India initiative. These include APIs nationals headquartered abroad,
lopment, New Delhi, were to under- and raw materials that go into the rather than a discovery hub that
take an assessment of adoption of making of essential drugs, such as enhanced India’s intellectual property
technology in the Indian industry, antibiotics, anti-HIV medicines, portfolio and long-term strategic
as compared to global counterparts, and the humble but indispensable competitiveness.
and explore opportunities to fill the paracetamol. The plan to make APIs
technology gap, including by facili- in India has been in the works for The Chinese Government’s sup-
tating vibrant industry-academia some time but the CSIR was engaged port for the development of bio-
engagement and networking. only recently. technology in the 1990s led to the
emergence of a fermentation-based
The following sections look at Current developments API industry in China. Chinese fi rms
the major fi ndings of the study (edited India has dropped from its leader- were able to develop cost-effective
for clarity). ship position in the pharma sector technologies, which contributed to
as a manufacturing hub of APIs but their acquiring a competitive edge
Introduction continues to be a leader in finished globally. The huge scale at which
Despite having the third-largest products and formulations. Chinese fi rms operate enables them
pharmaceutical industry by volume to reduce the cost of production.
in the world and being the largest Indian pharma industry is in a trap
manufacturer of generic medicines of depending primarily on China- Crackdown on polluting pharma-
globally, India is heavily dependent origin supplies as economics was ceutical fi rms in and around Beijing
on China for imports of raw materi- the primary consideration in the in preparation for the Beijing Olym-
als, Key Starting Materials (KSMs), past couple of decades. Also, Indian pics of 2008 affected supplies from
and APIs. industry chose to stay away from China, giving India the fi rst warning
large scale manufacture of APIs due signal on the perils of excessive
India is the source of around to the compliance costs and chal- dependence on a single supplier.
60,000 generic brands across 60 lenges associated with the stringent
therapeutic categories and manufac- guidelines and inspection regimes of The National Security Advisor
tures more than 500 APIs. However, Pollution Control Boards (PCBs). of India had taken up the issue of
India imports about 70% of its APIs import dependence on APIs as a
from China as it’s a cheaper option Many Indian companies prema- national security issue in 2014. In
than manufacturing them domesti- turely started the process of drug early 2020, supplies from China were
cally. There were 58 APIs in which discovery without adequate and again affected due to the outbreak
India was heavily dependent on China. appropriate planning, for example, of COVID-19 pandemic, causing
In the case of 45 APIs, India was in ensuring a critical mass of trained panic among policymakers in India.
dependent on China for 100% of human resources or in establishing Apprehending a shortfall in produc-
imports. Out of these 58 APIs, 29 APIs panels of expert advisors etc., which tion, the export of certain medicines

Chemical Weekly September 17, 2024 173

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