Page 147 - CW E-Magazine (25-3-2025)

Pharmaceuticals Pharmaceuticals

“This programme aims to develop remarkable clinical successes, recent immune infi ltration), suppress tumour The nearly Rs. 5,000-crore Scheme for we are anticipating launch of 30 products and biological entities and phyto-pharma-
a fully human monoclonal antibody studies suggest our novel target has as metastasis and make the refractory Promotion of Research & Innovation in or technology in the market by end of ceuticals; complex generics and bio-simi-
against a novel immune checkpoint pro- a highly attractive therapeutic potential tumours susceptible to chemotherapy Pharma MedTech Sector (PRIP) is likely fi ve years (FY28),” he added. Pan-India lars, precision medicines – stem cell and
tein that enables T cell activation and in various immuno-oncological states as well and is applicable in various to see the fi rst set of disbursals happening roadshows and stakeholder meetings have gene therapies and biomarkers – used for
generation of strong immune responses both as a monotherapy and combina- cancers, including lung cancer, head towards the end of this year, he said in an also been planned. cancer treatment, orphan drugs (for rare
against tumours akin to the well-estab- torial therapy. This approach has the and neck squamous cell carcinoma, and interview with the Hindu BusinessLine. diseases), and drug development for
lished PD-1/PD-L1 blockade. While potential to convert cold tumours (poor hematologic malignancies,” Shilpa said Funding breakup anti-microbial resistance.
PD-1/PD-L1 blockade has demonstrated immune cell infi ltration) hot (good in a press note. “Government will either pick up The funding has been broken up into
equity in these selected projects or look various components. The fi rst component – Under the fi rst category of component
QUALITY ISSUES at a fund infusion with a milestone based with a Rs. 700-crore outlay – is already B, which will cover established Indian
Sun Pharma, Zydus, Dr. Reddy’s recall products in US approach,” he said. The Expression of implemented, including the setting up of pharma companies willing to collabo-
Interest (EoI) under the Scheme has been Centre of Excellences in NIPERs (National rate with academia, funding will be for
fl oated with the fi rst deadline, April 7, Institute of Pharmaceutical Education and 9 projects with a maximum government
Sun Pharma and Zydus Pharmaceu- is initiated in a situation in which use mislabelled product will likely experi- primarily covering stakeholder feedback. Research). support of 35 percent or Rs. 125-crore
ticals are recalling products in the US of, or exposure to, a violative product ence adverse events. Because the infu- Selection of suitable projects are likely to for each, whichever is lower.
market due to manufacturing issues, may cause temporary or medically sion bag is labelled as 500mg/100mL be completed by April-end to early-May, Seven such institutes – one each in
according to the US Food and Drug reversible adverse health consequences but actually contains 1,000 mg/100 mL while fi rst round of disbursals could be Mohali, Ahmedabad, Hajipur, Hyderabad, The second segment of Component
Administration (USFDA). or where the probability of serious ad- dose, the patient could receive double around six months later. Kolkata, Guwahati and Rae Bareli – are B, where 30 projects will be selected
verse health consequences is remote. the dose of intravenous levetiracetam operational across various categories with each having a maximum support of
The New Jersey-based Sun Pharma- than intended which could lead to imme- “The PRIP Scheme has been launched that include anti-viral and anti-bacterial 35 percent or Rs. 100-crore (whichever
ceutical Industries Inc. is recalling Dr. Reddy’s recalls levetiracetam diate and serious side effects including to transform India into a global powerhouse drug development, medical devices, is lower), will cover those that require
9,840 bottles of Morphine Sulphate sodium chloride injection hypersensitivity reactions, liver injury, for R&D in the Pharma MedTech sector. bio-therapeutics, bulk drugs R&D, fl ow higher support level to bring products at
extended-release tablets for “failed dis- In another development, Dr. Reddy’s haematological toxicity, somnolence, The scheme has a total fi nancial outlay of chemistry and continuous manufacturing, a commercial or marketable stage. And
solution specifi cations”, the US health Laboratories said it is recalling one fatigue, dizziness, coordination diffi - Rs. 5,000-crore, of which Rs. 4,250-crore phtyo-pharmaceuticals and novel drug in the third category, for projects by
regulator stated in its latest Enforce- batch of Levetiracetam in 0.75 percent culties, agitation, aggression, depressed is focused on accelerating investments in discovery. Component B, is sub divided research-oriented companies, MSMEs,
ment Report. The company initiated the sodium chloride injection single-dose level of consciousness, respiratory the R&D ecosystem within the sector,” into three further categories primarily cove- start-ups, funding will be for the initial
Class II recall in the US on February 6, infusion bags to the consumer level, in depression, and coma,” the company said. Mr. Agrawal said. “The scheme will ring areas relating to promoting research stages at Rs. 1-crore each for 125-odd
2025. the United States. attract around Rs. 17,000-crore of additional and innovation in pharma and med-tech projects. Funding will be for a fi ve-year
Patients receiving high doses of investment in R&D in priority area. And including six major areas – new chemical period, and milestone based.
USFDA stated that Zydus Pharma- “The product is being recalled levetiracetam by rapid intravenous infu-
ceuticals (USA) Inc. is recalling a lot because the infusion bag is incorrectly sion for the treatment of status epilep- ‘India accounts for 60% of global vaccine supply’
of Nelarabine Injection, used in the labelled as Levetiracetam in 0.82 percent ticus would be “most at risk for severe
treatment of certain cancers, in the US. sodium chloride injection 500 mg/100 mL adverse events.” Dr. Reddy’s said it India became a vaccine superpower (RGCB) recently on the theme ‘Acceler- was quoted as saying in an RGCB
The company is recalling 36,978 vials single-dose bag, while the aluminium had not received any reports of adverse with Covaxin’s development and ate Action’ as part of RGCB’s ‘Women’s press release. Vaccine development –
of Nelarabine Injection in strength of overwrap packaging correctly iden- events related to this recall. now produces 60 percent of the world’s Day’ celebration. from funding to preclinical studies, clini-
250mg/50mL, (5mg/mL) for “failed tifi es the product as Levetiracetam in vaccines, said Prof. Balram Bhargava, cal trials, laboratory research, and physio-
impurities/degradation specifi cations,” 0.75 percent sodium chloride injection Levetiracetam sodium chloride former Director General of the Indian “Sixty percent of the world’s logical studies - has been implemented
USFDA stated. The company initiated 1,000mg/100mL,” the company said in Injections are indicated for adjunct Council of Medical Research (ICMR), the vaccines are now manufactured in Pune seamlessly with government support.
the Class II recall in February. a release. therapy in adults with some types of agency that led the country’s COVID-19 and supplied globally. In 2021, we exported A National Task Force comprising 40
seizures when oral administration is response. The Padma Shri awardee vaccines to more than 100 countries, scientists from various research domains
As per the USFDA, a Class II recall “Patients who are administered the temporarily not feasible. delivered a keynote address at BRIC- underscoring our potential in vaccine was formed to act swiftly in times of
SUPPORTING R&D Rajiv Gandhi Centre for Biotechnology research and development,” Prof. Bhargava crisis, he noted.
India’s pharma R&D to attract Rs. 17,000-crore PHARMA MEDTECH

investment by FY28: Pharma Secretary Govt. invites proposals for funding under PRIP scheme
The Department of Pharmaceuticals tion in Pharma MedTech sector (PRIP) August 17, 2023, with a total fi nancial
India is expecting nearly Rs. research, lifestyle disease prevention, ing to Mr. Amit Agrawal, Secretary, (DoP) has sought expressions of inte- scheme has been launched by the DoP outlay of Rs. 5,000-crore, of which
17,000-crore of investment towards med-tech and devices making, and Department of Pharmaceuticals under rest from interested entities for project to transform India into a global power- Rs. 4,250-crore is focused on accelerating
R&D in the pharma sector by FY28, niche segments like orphan drugs and Union Ministry of Chemicals & Ferti- funding under the PRIP scheme. The house for R&D in the Pharma MedTech investments in the R&D ecosystem
covering segments such as cancer development of new chemicals, accord- lizers. Promotion of Research and Innova- sector. The scheme was notifi ed on within the sector.

146 Chemical Weekly March 25, 2025 Chemical Weekly March 25, 2025 147

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