Page 148 - CW E-Magazine (22-10-2024)

Pharmaceuticals

kets, positioning the country as a rising
power in these critical sectors.

‘Signifi cant growth in biotech startups’
Dr. Jitendra Singh, Minister of State
(I/C) of the Ministry of Science and
Technology, expressed the Govern-
ment’s commitment to supporting the
biotechnology sector, referencing the
launch of venture funds and policies that
have spurred signifi cant growth in bio- has been introduced to reduce approval need for the pharmaceutical and bio-
tech startups. He noted that the number times from 20-60 days to under three technology sectors to triple in size,
of biotech startups has risen from just days. India, added, is also now accept- aiming to reach $300-bn by 2047. He
50 in 2014 to over 5,000 now, refl ecting ing clinical data from select countries praised the reforms undertaken by the
India’s increasing focus on bioeconomy. to avoid repeated trials, fostering faster Government in the last decade, which
He urged for stronger collaboration market entry for new, superior drugs. have helped the industry thrive, particu-
between the public and private sectors. larly through structural and process im-
Dr. Vinod Paul, Member, NITI Aayog, provements. He urged the Government
Dr. Singh also highlighted the need emphasised the importance of industrial to continue the support through initia-
to create a robust research ecosystem, capabilities, including manufacturing tives like the PLI scheme, which directly
with biotechnology being a focal point vaccines across multiple platforms. He impacts industry growth. He further
for the next industrial revolution. He urged stakeholders to adopt a “100-day recommended simplifying regulatory
emphasised the growth of India’s bio- mission” to ensure quicker response processes, reducing redundancy in ap-
economy, which has seen a ten-fold times for future outbreaks, advocating plications, and promoting inter-minis-
increase since 2014, and reiterated the for pre-approved vaccine pipelines and terial coordination to facilitate ease of
need for an inclusive innovation eco- international collaboration. doing business and improve effi ciency.
system that balances intellectual pro- He also urged the government to pub-
perty, data protection, and clinical trials. ‘Simplify regulatory processes’ lish a list of vaccines for the industry to
Dr. Rajesh Jain, Chairman, CII focus on, which would align innovation
Dr. Rajesh Gokhale, Secretary, National Committee on Biotechnology efforts with public health priorities and
Department of Biotechnology, under- and Chairman & Managing Director, expand the Universal Immunisation
scored the BioE3 Policy, which stresses Panacea Biotec Ltd., highlighted the Programme.
the importance of biotechnology in
driving economic growth, protecting Alembic receives USFDA nod for Paliperidone
the environment, and generating XR tablets
employment. He called for a paradigm
shift in technological innovation, Alembic Pharmaceuticals (Alembic) at US$ 480-mn for the 12 months ending
emphasising the need to build R&D has received fi nal approval from the June 2024.
capacity, increase industry investment, USFDA for its Abbreviated New Drug
and focus on biotech advancements to Application (ANDA) for Paliperi- ICT development
propel India forward. done Extended-Release (XR) Tablets in The product was developed in the labo-
strengths of 1.5-mg, 3-mg, 6-mg, and 9-mg. ratory of the Department of Pharmaceuti-
‘CDSCO revamping old regulations’ The approved product is therapeutically cal Sciences, Institute of Chemical Tech-
Dr. Rajeev Singh Raghuvanshi, equivalent to Invega XR Tablets, the nology (ICT), Mumbai, under the guid-
Drugs Controller General India, Central reference listed drug from Janssen Pharma- ance of Prof. Padma Devarajan (PVD).
Drugs Standard Control Organisation ceuticals, Inc. “This is the second example of translation
(CDSCO), stressed upon how CDSCO is from the ICT-PVD research laboratory to
revising old regulations to speed up drug Paliperidone XR tablets are an a typi- the clinic. The fi rst is a veterinary product
approvals, particularly for biologics and cal antipsychotic used in the treatment Ubera Dry, which was launched in UK
innovative therapies, while eliminating of schizophrenia. According to IQVIA, and Europe and as Nova Dip in India,”
redundant processes. An online system the market size for the doses is estimated Prof. Devarajan said in social media post.

148 Chemical Weekly October 22, 2024

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