Page 139 - CW E-Magazine (5-3-2024)

Pharmaceuticals Hydrocarbons

MANUFACTURING PRACTICES CONSUMPTION TRENDS
Licences of 64 pharma companies cancelled after India’s petroleum products demand to increase

govt. crackdown: Report mid-single-digit percentage in 2023-24: Fitch

Indian regulatory authorities, over Post the investigation, operations were In some cases, corrective action India’s demand for petroleum pro-
a one-year-period, have cancelled stopped at 101 pharma companies and was taken post issue of notices and ducts is likely to increase by a mid-sin-
licences of 64 pharma companies, while there were 52 instances of suspension the entire process reviewed, while gle-digit percentage in the ongoing
17 drug testing laboratories have been of licences. Another 281 companies suspension and cancellation took fi nancial year ending March 2024,
asked to shut down for non-compliance were issued show-cause notices. Action place after repeated failure to comply following a 10% post-pandemic recov-
with ‘good manufacturing practices’ and was taken against 131 drug testing labs, with good manufacturing practices. ery in 2022-23, according to American
other “continued” procedural lapses. and suspension of testing activities was The crackdown on pharma compa- credit ratings agency, Fitch Ratings.
ordered against 52 of them. “None of nies was carried out after reports of
As per a report in the Hindu Busi- the licences that were cancelled has spurious drugs being sold abroad Both petrol and diesel sales recor-
nessLine, quoting sources in the Union been renewed or re-issued so far,” the (exports) from India surfaced. Ques- ded robust 4-6% increases in the fi rst nine resilient, bolstered by the escalating increased, driven by a 5% rise in gas
Ministry of Health and Family Welfare, offi cial said, pointing out that “review tions were also raised on the quality months of FY2023-24, fuelled by heigh- demand for end-products. production in the fi rst nine months of
423 companies – including listed enti- of operations across pharma compa- of cough syrups being exported after tened economic activities in the agricul- 2023-24. “We expect production to
ties and drug testing laboratories – came nies and drug testing laboratories is an child deaths were reported in some ture and power sectors, coupled with a “The gradual normalisation of the continue to rise moderately as tech-
under the scanner in the last 12 months. on-going process.” countries. surge in holiday travel and auto sales. crude supply mix away from Russian nological investments in enhanced oil
imports is likely to narrow GRMs, recovery techniques will offset natural
COMPLIANCE CHECK Fitch said it expects Indian refi - although we expect margins to stay declines,” the rating agency said.
Risk-based inspections at pharma units to be ners’ gross refi ning margins (GRMs) to strong, supported by the rising demand Fitch forecasts the oil & gas sec-
moderate during FY2024-25 from the for end-products,” the rating agency
permanent feature: DCGI strong levels expected in FY2023-24, said. tor’s high capex intensity to continue
but remain above mid-cycle levels. By
in the medium term, particularly with
The risk-based inspections of pharma said Mr. Rajeev Raghuvanshi, Drug regulatory measures undertaken by the FY2025-26, it foresees a shift clos- In the upstream segment, domes- upstream companies investing in pro-
manufacturing units and private testing Controller General of India (DCGI) Indian government post the cough syrup er to mid-cycle levels, but remaining tic oil & gas production has modestly duction enhancement.
laboratories will be a permanent fea- on the sidelines of an award ceremony incidents have aided in boosting confi -
ture to ensure best standards and safety organised by the Indian Pharmaceuti- dence of international buyers and there PM lays foundation stone for POL terminal in Jammu
norms are followed in the industry. cal Association, MP State branch, MP has been no red fl ag in the past 8 months.
Small Scale Drug Manufacturing Asso- Prime Minister Narendra Modi
“Whatever compliance is required ciation and Indian Drug Manufacturer’s The revised Schedule M, he added, recently laid the foundation stone of a
like Schedule M or any other Schedules Association, MP. will foster the growth of Indian indus- Common User Facility (CUF) POL
will come up during the inspection and try and aid in competing in the inter- terminal in the outskirts of Jammu city.
audits will be carried out accordingly,” Mr. Raghuvanshi said a slew of national market.
The project, led by Bharat Petro-
NORM VIOLATIONS leum Corporation Ltd./(BPCL) and
Pharma companies producing drugs, supplements other participating companies, will
address critical challenges posed by the
in same unit under lens space-constrained existing depots of
state-owned oil marketing companies
in the region.
The government has decided to take manufacturing facility approved for norm, according to a report in the Eco-
action against pharma units fl outing drugs cannot be used for manufactur- nomic Tim es. Scheduled for completion in 2025,
norms by manufacturing nutraceuticals, ing other products. The Drugs Con- the terminal will be spread over 115.41
health supplements and drugs in the troller General of India (DCGI) has The regulator has also asked them acres of land and involve investment of including MS, HSD, SKO, ATF, ethanol, BPCL (Piyala/Bina via tank wagons),
same facility. now directed the State authorities to to carry out inspections with the FSSAI Rs. 676-crore. This facility is designed biodiesel, and winter-grade HSD. IOC (Panipat through a proposed pipe-
take action against units that have so that “manufacturing of spurious and
Under the revised Schedule M licences to manufacture both drugs without licence drugs in guise of nutra- to have a fully automated depot with a line extension to Jammu via tank
of Drugs and Cosmetics Act 1940, a and food products and are fl outing this ceuticals are dealt promptly”. storage capacity of 100,000-kl. It will The primary sources of bulk prod- wagons), and HPCL (HMEL, Bathinda
store a variety of petroleum products, uct supply to the terminal will be from via tank wagons).

138 Chemical Weekly March 5, 2024 Chemical Weekly March 5, 2024 139

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