Page 13 - CW E-Magazine (Oct-Nov-2023)

API Manufacturing

Indian API industry: Recent trends

ndia’s pharmaceutical industry has
had an impressive run over the past
Idecade, despite recent challenges
and some high-profile failures on the
regulatory front. The achievements – ar-
guably only surpassed by the country’s
Information Technology (IT) industry
– have come about through sustained
efforts, significant investments in high
quality manufacturing assets, as well as
strong marketing presence in some of
the advanced markets which have been
the focus areas. It has been widely re-
ported, with justifiable pride, that India
has the highest number of US FDA ap-
proved plants in the world – 665 at the
last count – and the industry has cumu-
latively filed an impressive 44% of all
abbreviated new drug applications (AN- ingredients (APIs), their intermediates even set up small offices in China, to
DAs), needed to sell generic substitutes and key starting materials (KSMs). For scrounge the country’s vast fine chemi-
of patent-expired drugs in regulated some time, this did not seem to matter, cals industry for reliable suppliers.
markets of which the US is the most im- and senior management across the in-
portant. dustry rewarded purchase managers for The vulnerability has been widely
having shaved a buck by procurement discussed for some time, but the attitude
Weak foundations from overseas, in preference to sourc- seemed that China was too big to avoid.
But this success, figuratively speak- ing locally. Soon, China became the ‘go That first changed – temporarily – with
ing, is built on weak foundations. In- to’ destination for raw materials – dem- the Beijing Olympics (in 2008), when
dia’s pharmaceutical industry is woe- onstrated, for one, by the massive at- several units were shut down to clean up
fully dependent on imports to meet its tendance of Indian buyers at API trade the toxic environment, and more widely
needs for several active pharmaceutical shows in China. Some Indian companies from 2018, when China’s authorities
embarked on an unprecedented and still
ongoing crackdown on polluting units,
Indian pharma market: Rs. 3,746-bn forcing closures, clean-ups and reloca-
tions. The Covid-19 pandemic has added
another dimension to the uncertainties of
complex supply chains, and rebuilding
Formulations: APIs & intermediates:
Indian capabilities in APIs, intermedi-
Rs. 2,802-bn Rs. 963-bn ates and KSMs, is now high priority.

Dependence on China
Domestic: Rs. Exports: Domestic Exports: Just how acute is the dependence on
1,578-bn Rs. 1,204-bn consumtion: Rs. 3,3-bn China? According to official trade data,
Rs. 660-bn
India’s imports of APIs alone reached
Rs. 249-bn in 2019, and two-thirds
Semi- Semi-
Regulated: Regulated: came from China. Crucially, the KSMs
regulated: regulated:
Rs. 683-bn Rs. 134-bn for drugs to tackle several high-burden
Rs. 521-crore Rs. 169-bn
diseases such as diabetes (metformin,
Fig. 1: Structure of Indian Pharma Industry glimipiride), cardiovascular disease
Source: Indian API Industry – Reaching its Full Potential, a report by KPMG and CII, April 2020 (losartan), tuberculosis (isoniazid, strep-

Chemical Weekly October / November 2023 9