Page 150 - CW E-Magazine (11-3-2025)

Pharmaceuticals Fertilisers

USFDA INSPECTIONS POLICY TWEAK
Indian drugmakers see OAI classifi cations halving Government recognises organic carbon enhancers

in 10 years from CBG plants as fertiliser

In last 10 years, Indian drugmakers data integrity or lab handling issues The pharma sector has also seen a The Ministry of Agriculture and and plant growth. This amendment is ment, saying, it will help improve soil’s
have seen more regulatory inspections to observations on aseptic practices or surge in green manufacturing initia- Farmers Welfare has amended the Ferti- expected to encourage sustainable agri- health as well as mitigate global warm-
from the USFDA, but a halving of contamination of written procedures; tives, with 10 of India’s top 20 pharma liser (Inorganic, Organic or Mixed) cultural practices by promoting the ing. Organic fertiliser which is pro-
OAI (offi cial action indicated) classi- gaps in maintenance of facility to companies pledging for over 30% (Control) Order, 1985, to include use of OCEs derived from renewable duced through the fermentation process
fi cations, according to a McKinsey ensure sanitary conditions; and emissions reduction by 2030. Organic Carbon Enhancers (OCEs) from bioresources. It also aligns with India’s in the biogas plant will allow the indus-
report. failure to review unexplained dis- Compressed Bio Gas (CBG) plants as a efforts to reduce chemical fertiliser try to earn additional income, IBA said.
crepancies, for example. Critical challenges recognised category of fertilisers. The dependency and enhance soil organic
The last decade has seen OAIs Despite these progresses the indus- amendment was notifi ed through S.O. matter, contributing to improved farm Organic carbon enhancers enrich soil
fall 50% from 23% in 2014 to 11% 8% CAGR growth try faces critical challenges. Disrup- 897 (E) under the Essential Commodi- productivity and environmental conser- with organic carbon, which increases
in 2024, said Mr. Sathya Prathipati, According to the report, the Indian tions such as digital transformation, ties Act, 1955, on February 17, 2025. vation. The move is likely to support plant growth, and sustains agricultural
senior partner McKinsey & Co. There pharma sector has grown at 8% CAGR, smart automation, and the rise of new CBG projects and encourage waste-to- productivity, the IBA said, pointing out
were 109 USFDA inspections in 2014, twice the global average, and has also treatment modalities could reshape With this change, the defi nition of wealth initiatives in the agriculture sec- that Soil Organic Carbon (SOC) content
and 25 OAIs, while 2024 saw 166 seen a 9% increase in exports in 2024. pharmaceutical operations. Geopoliti- fertilisers now explicitly covers nano ferti- tor. The amendment came into effect on in India has decreased to 0.3 percent
inspections and 19 OAIs. In 2024, Currently, India meets 20% of global cal shifts, nearshoring trends, and in- lisers and OCEs from CBG plants. The the date of its publication in the Offi cial from 1 percent in the last 70 years. Addi-
India had a network of 752 FDA- demand. This includes over 40% of creasing sustainability demands also government has also introduced Schedule Gazette and is expected to pave the way tionally, it said, there will be signifi cant
approved, 2,050 WHO GMP-certifi ed, generic medicines being supplied to pose potential risks, the report said. VIII in the existing order to specify for wider adoption of OCEs in Indian profi t margins and income generating
and 286 EDQM-approved plants. the US, and 25% to the UK. India also regulations and classifi cations for OCEs. agriculture. from this development for the industry.
supplies over 60% of the world’s vac- “With disruptions on the horizon, India currently produces around 1-million
Inspections of global pharma cines and 70% of antiretroviral drugs it is crucial for the industry to embrace OCEs refer to organic materials Biogas sector enthused by govt’s move metric tonnes of fermented organic
decreased from 1,849 to 940, in the for HIV treatment. Further, India is also these strategic themes and fundamen- produced through fermentation pro- The government’s initiative to pro- manure (FOM), a byproduct from CBG
same period, and OAIs increased marching ahead in emerging areas like tally transform operating model to cesses, either as a main product or a by- mote the use of organic fertiliser could plants. This fi gure could soar to 7-mil-
from 6% to 14%, he pointed out. mRNA, cell and gene therapies, and unlock a high-performance future,” product in CBG plants. When applied add a revenue of $2.6-bn for the biogas lion metric tonnes with the expansion of
Further, the nature of observations in antibodies, which are witnessing a said Mr. Vishnukaant Pitty, Partner, to soil or plant growth media, they help industry, according to the Indian Biogas biogas projects and would be suffi cient
India have also evolved from typical growth at 13-14% CAGR. McKinsey & Co. increase or maintain organic carbon Association (IBA). IBA President to cover the fertiliser needs for whole
content, thereby improving soil health Mr. A. R. Shukla hailed the recent amend- parts of regions like Rajasthan, it stated.
Senores Pharmaceuticals begins operations TRADE TRENDS

at greenfi eld API facility India’s fertiliser imports double in January; sales
also surge
Ahmedabad-based Senores Pharma-
ceuticals has inaugurated and commen- After record sales of fertilisers during 2.27-lt against 0.44-lt, muriate of potash by over 35 percent during November-
ced manufacturing activities at its the October-December 2024 quarter, (MoP) 2.19-lt against 1.45-lt and December. All these four types of
greenfi eld Active Pharmaceutical the Indian government seems to have complex fertilisers (combination of fertilisers have recorded total sales
Ingredient (API) plant in Mehsana, decided to ramp up fertiliser imports all nutrients) 2.31-lt against 0.63-lt. of 589.62-lt against 539.79-lt a year ago.
Gujarat. as January saw the import of the key Government data also show that sales
crop nutrients double to 12.31-lakh of urea reached 345.85-lt during April Output up
Spread across approximately tonnes (lt). This may potentially help 2024-January 2025 of the current Meanwhile, production of all ferti-
230,000 sq. ft. with an installed capa- India to avert a crisis in the next Kharif fi scal, which is 8.9 percent higher from lisers was up by 1.7 percent at 436.51-lt
city of about 100 metric tons per season unlike 2024, when farmers had 317.51-lt a year ago, while those of during April-January period from
annum, this is Senores’ second API to stand in long queues to buy one bag of MOP moved up to 18.75-lt from 13.95-lt 429.03-lt a year ago, which included
manufacturing facility. di-ammonium phosphate (DAP). (34.4 percent up) and complex ferti- urea at 258.45-lt (against 265.82-lt a
missioning of this API facility will CDMO/CMO business.” Senores also lisers to 134.72-lt from 105.3-lt (27.9 year ago), DAP 34.25-lt (37.67-lt),
Commenting on the inauguration, help Senores broaden its offerings and operates two manufacturing facilities According to offi cial data, the urea percent up). Only sales of DAP dropped complex 93.18-lt (81.85-lt), SSP 44.16-lt
Mr. Swapnil Shah, Managing Director, strengthen its competitiveness in the for formulations – one in Atlanta, US, import was 5.54-lt in January against to 90.3-lt from 103.03-lt mainly due to (38.37-lt) and ammonium sulphate
Senores Pharmaceuticals said, “Com- regulated markets, especially in the and the other in Chhatral, Ahmedabad. 3.62-lt a year ago, that of DAP was scarcity till October 2025 as it was up 6.47-lt (5.32-lt).

150 Chemical Weekly March 11, 2025 Chemical Weekly March 11, 2025 151

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