Page 142 - CW E-Magazine (13-2-2024)

Pharmaceuticals Pharmaceuticals

SUPPORTING GROWTH PARTNERING
Pharma sector imports reduced thanks to PLI Nobel laureate moots bilateral cooperation in pharmaceu-

scheme: Govt. ticals and promotion of chemistry among school children

A signifi cant reduction in the im- The document outlined achieve- PLI outlay increased Nobel laureate and professor at Prof. Meldal said Denmark’s bio- House, said he was impressed with
port of raw materials in the pharma- ments in healthcare and the ‘Make in Meanwhile in the Budget 2024, the the Department of Chemistry at the tech and pharma cluster has a global the work done at the Biotechnology
ceutical sector is one of the most nota- India’ initiative, particularly the success government has signifi cantly increased University of Copenhagen, Denmark, reputation for cutting-edge research, Industry Research Assistance Coun-
ble achievements under the Production of the PLI scheme in spurring domestic the expenditure outlay for the PLI rela- Prof. Morten Meldal recently called on particularly in cancer, central nervous cil (BIRAC), under the Department
Linked Incentive (PLI) scheme, the manufacturing and exports across vari- ted to manufacturing in pharma, besides the Union Minister of State (Independent system (CNS), diabetes and infl amma- of Biotechnology (DBT). Welcoming
government said in a document, titled ous sectors. With an investment outlay electronics and automobiles. Charge), Science & Technology, Dr. tory & infectious diseases. The Nordic Prof. Meldal’s interest in India’s bio-
‘Indian Economy: A Review’, written of Rs 1.97-lakh crore, the PLI scheme Jitendra Singh in New Delhi and dis- nation has one of the strongest clusters tech and pharma industry, Dr. Singh
by Mr. V. Anantha Nageswaran, Chief has spurred signifi cant production, gene- Outlay allocation for PLI schemes cussed bilateral cooperation in pharma- in the world when it comes to biotech proposed framing a long term plan for
Economic Adviser, Ministry of Finance. rating over Rs 8.7-lakh crore in sales in the pharmaceutical space jumped ceuticals and promotion of chemistry and life science, based on robust pub- partnering.
and creating employment opportunities from Rs. 1,696-crore in 2023-24 to studies among school children between lic-private partnerships, and is home
The 74-page document presented for more than 700,000 individuals, Rs. 2,143-crore in the 2024-25 Budget. Part ages 5-15. to major international pharmaceuti- On the issue of tuberculosis (TB)
on January 30, was a departure from Mr. Nageswaran said in the document. of this increase in outlay of PLI scheme cal companies such as Novo Nordisk, management and treatment, Prof.
the tradition of releasing the ‘Economic “The PLI scheme witnessed exports disbursements can be attributed to the Awarded jointly the 2022 Nobel Lundbeck, LEO Pharma and ALK. Meldal noted experiments are ongoing
Survey’, which may now be released exceeding Rs. 3.4-lakh crore, with signi- nature of the scheme itself. To incen- Prize in Chemistry for the ground-break- Novo Nordisk, alone, holds a 50% in Denmark to fi nd drugs to treat the
before the full Budget after general fi cant contributions from sectors such as tivise increasing production every year, ing development of ‘Click chemistry share of the global insulin market, he disease. Dr. Singh, on his part, drew
elections. The review outlined the large-scale electronics manufacturing, the Centre committed to increase its and bio-orthogonal chemistry,’ Prof. noted. attention to the government’s fi ve-
nation’s economic trajectory over the pharmaceuticals, food processing, and tele- subsidies every year as fi rms increase Meldal pointed out that Denmark has pronged strategy to curb TB – Trace,
past decade and forecasts for the future. com and networking products,” he said. localised production. a vibrant biotechnology and pharma- Prof. Meldal, who delivered Test, Track, Treat and use Technology –

Govt. earmarks Rs. 1,000-crore for promotion ceutical industry and some of the fi nest lectures at the CSIR-Institute of and noted the scope for collaboration
laboratories, and evinced interest in Genomics and Integrative Biology in India’s National TB Elimination
of bulk drug parks R&D, academia and business tie-ups. (CSIR-IGIB), IIT Delhi and Miranda Programme (NTP).
GROWTH STRATEGY
The Government has earmarked Rs. Interim Budget FY25 for ‘Promotion of cal device parks’ has been increased
1,000-crore for the promotion of bulk Bulk Drug Parks’ was at Rs 85.15-crore. to Rs. 150-crore for FY25, up from Cipla eyes acquisitions, inorganic partnerships in
drug parks for FY25, a multi-fold According to the Expenditure Budget Rs. 64-crore in the revised estimate for
increase from Rs. 85.15-crore outlay document, the total outlay for the FY24. For the Jan Aushadhi scheme, US market
in the revised estimate for the ongoing development of the pharmaceutical the initiative to provide affordable Cipla is eyeing acquisitions and be to further strengthen growth levers
fi scal. Initially, the government had ear- industry for FY25 has been pegged at generic medicines in the country, the inorganic partnerships in the US market for wellness portfolio among others.
marked Rs. 900-crore in the Budget Rs. 1,300-crore, up from Rs. 264.67-crore outlay has been hiked to Rs. 284.5-crore while consolidating its presence across
for FY24. However, the revised esti- in the revised estimate of FY24. Simi- for FY25, up from Rs. 110-crore in the segments in the domestic market. The Cipla’s MD and CEO, Mr. Umang
mate presented in the Parliament in the larly, the outlay for ‘promotion of medi- revised estimate for FY24. Mumbai-based company is also look- Vohra, said that “derisking our top

REGULATORY HURDLE ing to improve the top line in Europe launches remains our top priority”
as the company focuses on resolving
and margin expansion in South Africa.
Panacea’s Baddi unit gets OAI status from USFDA regulatory issues at various manufac-
“Product launches through delisting turing plants. “Our focus continues on
Panacea Biotech has informed the An OAI status means that the regu- resolve these observations and achieve strategy and as well as inorganic part- regulatory efforts in Goa and Indore.
exchanges that the USFDA has clas- lator expects further corrective actions closure of the warning letter the nerships and acquisitions will remain Earlier in this quarter, we have updated
sifi ed the company’s Baddi facility and may withhold approval of any USFDA issued in September 2020. one of our key priorities for the US you of the warning letter we had
in Himachal Pradesh as an ‘Offi cial pending product applications or supple- The company said that it will continue market,” Cipla’s Global Chief Finan- received for the Indore facility, which
Action Indicated’ (OAI). The facility ments in which this facility is listed till to manufacture and distribute existing cial Offi cer, Mr. Ashish Adukia, said in folios and resolution of USFDA obser- was audited in February 2023,” he stated.
was issued a Form-483 by the drug the observations are resolved. products for the US market, and there- an analyst call recently. vations, he added.
regulator with nine observations in fore this classifi cation will not have The company has duly responded to
October 2023, which were related to The company further said it is any material adverse impact on current The company would also focus on Elaborating on the domestic busi- queries from USFDA and is now focus-
improvements in existing procedures. working closely with the regulator to business. commercial execution of existing port- ness, he stated the key focus area would ing on remediation, Mr. Vohra added.

142 Chemical Weekly February 13, 2024 Chemical Weekly February 13, 2024 143

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