Page 143 - CW E-Magazine (9-4-2024)

Pharmaceuticals Pharmaceuticals

ANTICANCER DRUGS Index – a comparison of healthcare a drug in India at a price they can fi x. research talent, attracting quality
Aragen operationalises fi rst phase of biologics systems, including in high-income “It is quite telling that the largest talent back to India, easing the avail-
countries – for quality, choice, science & pharmaco in India has chosen not to market ability of funding for biotechs, and
facility in Bangalore technology, and fiscal sustainabi- their marquee innovative asset in India harmonising regulatory standards for
lity – by the Foundation for Research so far,” the analysts wrote.
manufacturing and clinical trials will
on Equal Opportunity, an international be required for fostering innovation,
Aragen, the Hyderabad-based 2,000-litres and will offer integrated think-tank. The analysts also under- India, they asserted in the letter, the letter said.
Contract Research Development and solutions including process develop- lined that India does not feature in needs to create a domestic market where
Manufacturing Organization (CRDMO) ment, process validation, analytical top 10 patent publications in any health- innovative drugs can hope to command Performance-linked incentive (PLI)
for small molecules and biologics, has development, small-scale manufactur- related fi eld. the right price and enjoy profi ts. schemes and other manufacturing sops
announced that it has operationalised ing, large-scale Drug Substance manu- need to be extended to more capital-in-
the fi rst phase of its biologics manu- facturing, and stability services. It will About multinational pharmaceutical Insurance coverage for novel drugs tensive biomanufacturing to level the
facturing facility in Bangalore, through have the capability to develop and companies, the letter said they spend a provided for by the government will playing fi eld at least initially with Asian
its 100% subsidiary, Aragen Biologics manufacture mAbs, therapeutic pro- lot on clinical trials, but cannot launch go a long way, and investing in core peers, according to the analysts.
Pvt. Ltd. teins and fusion proteins to augment
the company’s bioproduction capability GROWING PRESENCE
The Bangalore facility is being set in California.
up at an investment of $30-mn, and has and development research services VAV Lipids enters Latin American market
executed its fi rst small-scale manufac- from its R&D labs in California. Ser- According to Mr. Manni Kantipudi,
turing project for a US-based organisa- vices include cell line development, CEO, Aragen Life Sciences, and Mumbai-based VAV Lipids, maker company makes plant phospholipids, Mr. Arun Kedia, Managing Director
tion for a novel anti-cancer monoclonal upstream & downstream development, Director, Aragen Biologics, once the of lipid ingredients which are used in egg phospholipids, synthetic phospho- of VAV Lipids, said, “The Latin Ameri-
antibody (mAb). The non-GMP facility protein science, and antibody discovery. facility’s expansion is fully operational mRNA vaccines among other products, lipids, and neutral lipids. The company’s can market is huge and presently under-
can undertake batch sizes up to 50-li- The biologics manufacturing facility by the end of this calendar year, “we has entered the Latin American market. other products include APIs (active served as there are very few lipid manu-
tres and includes process development at Bangalore will complement these will be able to do internal tech trans- pharmaceutical ingredients) and facturers worldwide. The potential for
and analytical labs to support manufac- services and will enable GMP and fer from our R&D labs in California to The company will supply its high- speciality proteins. VAV’s products in the Latin American
turing. non-GMP manufacturing. It will have the manufacturing site in India, thereby purity lipid ingredients to pharmaceutical, market is estimated at over $50-mn.”
advanced single-use bioreactors with enabling end-to-end integrated service nutraceutical and cosmetics manufactu- Phospholipids and lecithins are Presently, VAV Lipids exports 80% of
Aragen currently offers discovery capacities ranging from 50-litres to offering to customers.” rers through local distributors in Mexico, functional ingredients in developing its products to North America, Europe,
Brazil, Argentina, Peru and Colombia, a novel drug delivery systems (NDDS). and Asia.
WARNING note from the company said. These include applications in develop-
VAV Lipids will introduce its entire
ing vaccines, and for treating several
India ceding ground in biopharma innovation & VAV Lipids is among the world’s diseases including cancers, as well as range of products through the com-
manufacturing leading manufacturer of phospholipids in skincare, personal care and hair care pany’s distribution network in Latin
and lecithins. The biopharmaceutical products.
America., the company said.
REVIVAL
In an open letter to Prime Minister While 10 of the top 20 generic com- ing,” wrote analysts Nithya Balasubra-
Narendra Modi, analysts associated panies in the US are Indian, and Indian manian and Parth Shah. Pharma exports to US up 15% in April-Feb FY24
with asset management fi rm, Alliance- companies command over 40% of market
Bernstein, have underlined that from share in the prescription drugs sector, South Korea is also catching up Indian pharma exports to the US $7,834-mn in the April-February period accounts for 30% of overall exports
being the “pharmacy of the world”, on the manufacturing front many with more biotech start-ups reaching market are surging again this fiscal of the current fi scal as against $7,547- for Indian drug-makers.
India seems to be ceding ground to its Chinese and Korean companies are global markets with their fi rst drugs in after a lull last year, registering a double mn in the same period last year,” in-
Asian peers in biopharma innovation now investing in bio-manufacturing the recent past, they pointed out. digit growth. formed Mr. R. Uday Bhaskar, Direc- Further, the growth has come in the
and manufacturing. capacities, leaving India far behind, tor-General, Pharmaceutical Export wake of tumultuous geopolitical situa-
wrote the analysts. Low public health expenditure Driven by the boost from the US, Promotion Council (Pharmexcil). tions including the Ukraine crisis and
In the letter, the analysts pointed to At 3% of GDP, India’s public health total pharmaceuticals exports increased the Red Sea Crisis. The council data
four areas where India lags behind its “China has emerged as a global bio- expenditure is among the lowest and 9.34% at $25.04-bn in April-February of The double-digit spurt in exports also shows growth in exports to all
Asian peers even though the country’s tech hub (~25% of global pipeline) has been on a downward trend since FY24 compared to $22.90-bn in the cor- to the US this fi scal so far could augur markets except the CIS region. Going by
domestic pharmaceutical market is with strong domestic talent and signifi - 2014, the letter said. responding period of previous fi scal year. well for the Indian pharma industry, the current rate of growth, total pharma
home to thousands of manufacturers, cant funding fl owing in from investors which has been facing challenges such exports for the FY24 could close some-
providing cost effective medicines to and Big Pharma in the form of M&A It added that India fi nds no mention “There has been a signifi cant surge as increasing pricing pressure as well as where between $27.5-bn to $28-bn,
millions of patients. (mergers and acquisitions) and licens- in the Global Healthcare Innovation of 15.04% in exports to the US at regulatory issues. The US market alone as per Pharmexcil estimates.

142 Chemical Weekly April 9, 2024 Chemical Weekly April 9, 2024 143

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