Page 156 - CW E-Magazine (9-7-2024)

Pharmaceuticals

IMPROVED PERFORMANCE
India pharma units fare better in US regulatory

checks in 2023

Indian drug manufacturing sites inspections, while everyone out of around lab controls and core manu-
exporting to the US have fared better four inspections in India was OAI in facturing processes in 2023, versus
on regulatory inspection outcomes the same year. 2018. USFDA conveys its concerns
compared to global average in 2023. on manufacturing practices through
USFDA classifi es its inspection as Form 483 observations at the end of
The drug regulator, United States OAI for plants found in an unaccep- a facility inspection. Companies that
Food and Drug Administration (USF- table state of compliance with receive its observations must respond
DA), has classifi ed 13%, or 19 out of current good manufacturing practices in writing with a corrective action
145 inspections it carried out against (cGMP). The agency will intimate plan and implement it quickly.
Indian facilities, as Offi cial Action the company about the classifi cation
Indication (OAI) in 2023, which is within 90 days of the inspection. “While the industry has addressed
lower than the global average of 15% While an OAI classifi cation doesn’t several critical areas over the last few
OAIs, according to a report by Indian impact existing supplies and reve- years, quality expectations continue
Pharmaceutical Alliance and McK- nues from operations of the facilities, to evolve where some areas remain
insey & Company. USFDA inspected it blocks new product approvals fi led to be addressed,” said Mr. Sathya
906 facilities globally, out of which it from the site. In addition, it may even Prathipati, senior partner, McKinsey &
classifi ed 133 facilities as OAIs. OAI trigger a warning letter or import ban, Company.
means regulatory and/or administra- if companies fail to satisfactorily
tive actions will be recommended. address the concerns raised by the He pointed to some areas where
USFDA. The OAI also increases the there has been an increase in observa-
The report titled ‘Quality & manu- spend on remediation. tions in recent years. “There is 35%
facturing excellence charting the increase in observations around ‘Faci-
next decade of Indian pharma’ said A fi ve-year analysis of USFDA lities and Ancillary infrastructure’ in
inspection outcomes also improved inspection data pointed to 20% reduc- 2023, versus 2018, 25% increase in
signifi cantly from 26% OAIs in 2014 tion in observations around essential observations around ‘Investigations and
to 13% in 2023. In 2014, the global cGMP training and capabilities and Root Cause Analysis’ (same period),”
average for OAIs was 7% out of 1839 around 45% reduction in observations Mr. Prathipati said.

AIMING FOR SELF-SUFFICIENCY
‘India to make drugs for diabetes, obesity under PLI

by 2026’

India is planning to offer incen- Danish drugmaker Novo Nordisk’s patent after patent expiries, we will give
tives to promote local manufacturing of on semaglutide – a GLP-1 agonist and them the incentive,” said Mr. Chawla,
GLP-1 drugs used to treat diabetes and the key ingredient in its wildly popular without disclosing the names of these
obesity, in 2026, a Reuters report said obesity drug ‘Wegovy’ and diabetes companies.
quoting Mr. Arunish Chawla, Secretary drug ‘Ozempic’ – is set to expire in
of Department of Pharmaceuticals. India in 2026. The anti-obesity medication market
could reach $100-bn by 2030, according
GLP-1 (Glucagon-like peptide-1) “The (Indian) companies (plan- to a report by Goldman Sachs Research.
drugs, originally approved to treat ning) manufacturing GLP-1 drugs have As of 2022, India ranked third globally
diabetes, are also widely being used applied for the government’s produc- in the number of obese individuals, trail-
to treat obesity as they slow diges- tion-linked incentive (PLI) scheme. ing only China and the US, according to
tion, helping patients feel full longer. Once they start manufacturing in 2026 a study published in The Lancet.

156 Chemical Weekly July 9, 2024

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