By Rishika Sadam
HYDERABAD, July 1 (Reuters) - An Indian
government-approved expert panel has advised the country's drug
regulator to approve the import and sale of U.S. drugmaker Eli
Lilly's ( LLY ) Mounjaro, a blockbuster diabetes drug and a
wildly popular obesity treatment, a document on a government
website showed on Monday.
Lilly's Mounjaro, chemically known as tirzepatide, and
Zepbound and Danish rival Novo Nordisk's Wegovy and
Ozempic belong to a class of therapies known as GLP-1 receptor
agonists, developed to control blood sugar in patients with type
2 diabetes.
They also slow digestion, helping patients feel full longer,
making them a wildly popular choice for weight loss.
"After detailed deliberation, the committee recommended for
grant of permission for import and marketing" of certain doses
of tirzepatide "for chronic weight management subject to the
condition that firm should conduct Phase 4 clinical trial
(post-marketing surveillance)," the Subject Expert Committee
said in a notification dated June 19.
The committee advises India's drug regulator on approvals of
drugs and trials.
"A recommendation from the subject expert committee is like
the penultimate step of the approval," said Sheetal Sapale, vice
president of research firm Pharmarack.
Lilly did not immediately respond to a Reuters request for
comment. CEO David Ricks had told Reuters a few months back that
the company expected to launch Mounjaro in India as early as
next year.
India has the world's second-highest number of people with
type 2 diabetes and high obesity rates. Around 11% of Indian
adults will be obese by 2035, per the World Obesity Federation
Atlas. The global weight-loss drugs market is estimated to reach
at least $100 billion by the decade's end.
Lilly should also submit the required manufacturing and
controls data, the expert panel added.
The notification was first reported by a local medical
journal, The Indian Practitioner.