Page 150 - CW E-Magazine (4-3-2025)

Pharmaceuticals Fertilisers

QUESTIONABLE PRACTICES GROWTH IMPERATIVES
DCGI bans production, export of all combinations Fertiliser industry urged to focus on improving

of tapentadol, carisoprodol effi ciency

Acting on recent reports regarding state regulators, had focused on audit- is fully cooperating with government The fertiliser industry and the per- Chaudhari, Director General, Fertiliser like drones, in agriculture. Inaugurating
the export of unapproved combination ing fi rms manufacturing and exporting authorities in the probe. sonnel working in the industry must Association of India (FAI), New Delhi, the event, Mr. Sanjiv Kanwar, Chair-
drugs containing tapentadol and cariso- drugs covered by the Narcotic Drugs focus on improving effi ciency at every while speaking at a training programme man, FAI-NR and Managing Director,
prodol, the Drugs Controller General and Psychotropic Substances Act 1985. According to a statement issued by level of operations – from production on ‘Improving Professional and Personal Yara Fertilisers India Pvt. Ltd.,
of India (DCGI) has imposed a ban on “Based on analysis of observations the FDA, the action was taken after the to end-use, and promote the use of new Effectiveness’ at Jaisalmer (Rajasthan) Gurugram, dwelt on facets of regene-
their production and export. from the audit, important decisions BBC’s investigative report highlighted generation products such as specia- from February 12-15, 2025. rative agriculture. Mr. Siba Prasad
were taken to strengthen regulatory that tapentadol and carisoprodol manu- lity fertilisers, water soluble fertilisers Mohanty, Managing Director, Hindustan
“The Ministry of Health and Family oversight on export of NDPS drugs factured in India were illegally exported (WSFs), customised fertilisers, new Dr. Chaudhari stressed the applica- Urvarak & Rasayan Ltd., Noida, who
Welfare has taken immediate and from India,” the health ministry said in to African countries, where those were formulations, etc. tion of WSFs through automised drip was the Chief Guest at the valedictory
decisive action following some news its statement. misused for recreational purposes. fertigation systems, as well as use of session, distributed certifi cates to the
reports highlighting concerns regarding This was stated by Dr. Suresh Kumar unmanned aerial vehicle technology, participants.
the export of unapproved combination As part of the exercise, a joint team Going forward, CDSCO is updating
drugs containing tapentadol and cariso- from the CDSCO and the state regula- the Export NOC checklist, to ensure that PRODUCTION FIGURES
prodol by Indian pharmaceutical manu- tory authorities conducted a compre- either the Product Registration Certi-
facturer M/s. Aveo Pharmaceuticals, hensive audit of Aveo Pharmaceuticals fi cate from the importing country’s India’s fertiliser output rises 4% in 2023-24 to 503.35
Mumbai to certain countries in West between February 21-22, 2025. The National Regulatory Agency (NRA) or
Africa,” a press release from the minis- audit’s fi ndings led to the issuance of a approval from the Indian Regulatory lakh tonnes
try stated. DCGI has asked all State ‘Stop Activity Order’, halting all opera- Authority (CDSCO) is required for all India’s total fertiliser production Table 1: Fertiliser production and subsidy trends Based Subsidy
Drugs Control Authorities and Zonal tions at the company’s premises. medicines being exported from India. rose 4% annually to 503.35-lakh tonnes Policy with effect
Offi ces to immediately withdraw export This updation of the checklist is expected during 2023-24 fi scal. Fertiliser production Fertiliser subsidy from April 2010.
NOCs and manufacturing licenses Aveo Pharmaceuticals, however, to address the root cause of the problem [lakh tonnes] [Rs. Crore] Under the policy,
granted for any combination of tapen- has denied the allegations and said it and settle the issue once for all. In a recent written reply to Lok Sabha, 2019-20 425.95 83,466.51 a fi xed amount of
tadol and carisoprodol. Lupin receives EIR from US FDA for its Somerset Minister of State for Chemicals and 2020-21 433.68 1,31,229.51 subsidy decided

The same communication has also facility Fertilizers Ms. Anupriya Patel shared 2021-22 435.95 1,57,640.08 on an annual/
the year-wise quantum of all fertilisers
bi-annual basis, is
been sent to all Customs offi ces at Mumbai-based pharma major “This milestone underscores our produced in the country from 2019-20 2022-23 485.29 2,54,798.88 provided on noti-
notifi ed ports to route all consignments Lupin announced that it has received the commitment to upholding the highest to 2023-24 (see Table). 2023-24 503.35 1,95,420.51 fi ed P&K fertili-
of referred products through Central Establishment Inspection Report (EIR) standards of quality and compliance, and potassic) fertilisers, the govern- sers depending on their nutrient content,
Drugs Standard Control Organisation from the US FDA for its manufacturing solidifying our position as a leading DAP details ment has implemented the Nutrient she said.
(CDSCO) Port offi ces. Tapentadol facility in Somerset, New Jersey, for pharmaceutical manufacturer,” said In reply to a separate query, the
is an opioid medication used to treat the inspection conducted from January Mr. Nilesh Gupta, Managing Director, minister said the requirement of DAP NFL takes 18% stake in Namrup IV
moderate to severe pain. Carisoprodol 27-31, 2025. Lupin. (di-ammonium phosphate) during
is a muscle relaxant that works on the Orchid Pharma’s Alathur API facility completes 2023-24 was 110.18-lakh tonnes against fertiliser project in Assam
centre of the brain and spinal cord to which the domestic DAP production was
relieve pain. Both tapentadol and cariso- USFDA inspection 42.96-lakh tonnes. The demand-supply National Fertilizers Ltd. (NFL), The joint venture aims to set up an
prodol are individually approved by Orchid Pharma has announced the tain to the data integrity of the facility. gap in DAP was met through imports and a Navratna company, has announced ammonia-urea complex at Namrup,
CDSCO in India. However, the combi- successful completion of a surprise “This successful inspection maintains existing stocks in the states, she added. its decision to become a part of the Assam, marking a signifi cant step in
nation of tapentadol and carisoprodol is USFDA inspection at its Active Pharma Orchid Pharma’s distinguished position proposed Joint Venture Company for boosting fertiliser production in the
not approved in India. Neither of these ceutical Ingredient (API) manufac- as India’s only USFDA-approved faci- In 2024-25, DAP output is estimated the establishment of the Namrup IV region.
drugs is included in the NDPS (Narcotic turing facility in Alathur, Tamil Nadu. lity for sterile cephalosporins,” the com- at 40.15-lakh tonnes. The country has Fertiliser Plant in Assam. The Board of
Drugs and Psychotropic Substances) pany stated. The company said the seen production of 31.5-lakh tonnes till Directors of NFL, at a recent meeting, The project is expected to be com-
list in India. The inspection, which commenced Alathur API facility has also secured the December. approved the proposal put forward by pleted within 48 months from the
on 10 February 2025 and concluded renewal of its EU Good Manufacturing the Department of Fertilisers, agree- zero date and will contribute signifi cantly
The ministry said that in January, on 18 February 2025, resulted in seven Practice (GMP) certifi cate following a P&K fertilisers ing to hold an 18% equity stake in to India’s self-reliance in urea production,
the CDSCO, in collaboration with minor observations, none of which per- successful inspection. With regard to P&K (phosphatic the venture. NFL said in a stock exchange fi ling.

150 Chemical Weekly March 4, 2025 Chemical Weekly March 4, 2025 151

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