Page 141 - CW E-Magazine (29-4-2025)

Pharmaceuticals Hydrocarbons

FLAWED EVALUATION PROCESS RISING SHARE

Drug regulator bans 35 combination drugs over Over 30% rise in Indian crude oil imports from US

safety issues in 2024: US EIA

The Central Drugs Standard Control for diabetes, cilnidipine + metoprolol lack of scrutiny poses a serious risk to India’s crude oil imports from the 32 percent in 2024, bouncing back from crude oil exports to India in 2024,”
Organisation (CDSCO) has mandated succinate for hypertension, and dextro- public health, the letter highlighted. US rose to a two-year high in the 2024 relative lows in 2023, the US agency the US EIA said.
that drug regulators across all states and methorphan hydrobromide + phenyl- calendar year (CY) as cargoes from the said.
Union territories halt the production, sale ephrine hydrochloride used to treat Following the issuance of show North American country helped bridge The US is India’s sixth largest
and distribution of 35 fi xed-dose com- cough and nasal congestion. cause notices to the manufacturers, the defi cit due to lower Russian shipments. In 2023, India increased imports of energy trade partner currently, including
bination (FDC) drugs. These include it was reported that these companies relatively cheap crude oil from Russia, the fi fth largest source of crude oil and
various pain relievers, nutritional supple- In a communication dated April 11, claimed their licenses were granted by According to the US Energy Infor- following sanctions that limited the second largest for liquefi ed natural gas
ments, and medications for diabetes. Dr. Rajeev Raghuvanshi, the Drugs the respective drug licensing authori- mation Administration (EIA), India’s price Russia could charge for crude oil (LNG). Bilateral trade in hydrocarbons
Controller General of India (DCGI), ties and that they had not contravened crude oil imports from the US rose by exported using the shipping and insu- between the two nations hit $13.7-bn in
In addition, the regulators have referenced a letter from January 2013 any regulations. This has led to incon- 32.74 percent year-on-year (y-o-y) to rance services of sanctioning countries, FY24.
been instructed to reassess their ap- which raised alarms about the issuance sistent enforcement of the NDCT Rules 223,000 barrels per day (bpd) in 2024. the US EIA said.
proval procedures for such FDC drugs, of manufacturing licenses for FDC 2019 across the nation, as pointed out Cargoes in 2023 had hit a 5-year low Oil and gas imports from the US are
ensuring that they adhere rigorously to drugs categorised as “New Drugs” in the letter. Given these circumstances, of 168,000-bpd. India’s oil consumption growth expected to rise as India tries to balance
the stipulations outlined in the Drugs without obtaining the requisite appro- the letter urged all state and Union overtook China’s in 2024, increasing its trade defi cit with the former. However,
and Cosmetics Act of 1940 and its asso- vals from the DCGI. This issue has been territory drug controllers to re-evaluate The US exports to Asia (overall) Indian demand for imported LNG seems to have a higher scope.
ciated regulations. FDCs are classifi ed consistently fl agged, with various letters their approval processes for such FDCs decreased by 131,000-bpd to 1.58-mil- crude oil. However, despite this ris-
as drugs that consist of two or more sent to the state licensing authorities that and to ensure strict adherence to the lion bpd as increased exports to South ing demand, Indian imports of crude In FY24, the US accounted for just 3
active pharmaceutical ingredients (APIs) have granted permission for the produc- provisions of the Drugs and Cosmetics Korea, Singapore and India were offset oil from Russia fell in 2024 as the percent of India’s cumulative crude oil
combined in a specifi c fi xed ratio. The tion and sale of these unapproved FDCs. Act and its regulations. Furthermore, by the decrease in shipments to China, price discount on oil from Russia imports, compared to its record share
directive from CDSCO came after it The latest such correspondence was the communication provided a list of it pointed out. narrowed, it added. “With the during the COVID years due to lower
became evident that some of these FDC dispatched in February of this year. 35 unapproved FDCs that had previ- decrease in Russian imports, US crude costs. During FY21, the US accounted
drugs were authorised for manufacture, ously been licensed by state or Union Higher Indian cargoes oil helped fi ll in the gap, resulting in for 7.31 percent of India’s total imports,
sale, and distribution without undergo- The letter emphasised that it has territory drug controllers for manufac- Crude oil exports to India increased a nearly 55,000-bpd increase in US which rose to 8.21 percent in FY22.
ing necessary evaluations of their safety come to the attention of the directorate ture, sale, and distribution without the
and effectiveness, thereby presenting a that the licensing of certain FDC drugs necessary safety and effi cacy evalua-
signifi cant threat to public health. occurred without the essential evalua- tions conducted by the CDSCO, which Gas allocation to CGD fi rms on advance quarterly
tion of their safety and effi cacy, as man- were subsequently cancelled by Drug
Some of the extensively prescribed dated by the New Drug and Clinical Licensing Authorities or voluntarily basis: Oil ministry
FDCs in the banned list include dapag- Trial (NDCT) Rules of 2019 under the surrendered by manufacturers follow-
lifl ozin + glimepiride + metformin Drugs and Cosmetics Act of 1940. This ing the issuance of show cause notices. The Ministry of Petroleum & Natu- ments to the domestic gas allocation with a quarterly pro-rata allocation to
ral Gas (MoPNG) has said that city policy, the Ministry said. ensure timely and reliable supply.
GAIL will allocate NWG to CGD
Shilpa Medicare gets marketing approval for liver gas distribution (CGD) fi rms will be “From Q1 FY26, domestic natural entities in proportion to their require-
allocated natural gas two quarters in
disease IND advance to aid them in better demand gas allocations for CNG (T) and ments, in accordance with prevai-
forecasting, effi cient supply manage-
PNG (D) segments will be done on a ling MoPNG guidelines. The Minis-
Shilpa Medicare has announced NAFLD, the most common liver adverse events were reported in this ment and ensuring supply predictabi- two-quarter advance basis. Alloca- try emphasised that despite increasing
the approval of its IND (Investiga- disease, if not treated in a timely manner, is phase 3 study and the treatment was lity. tion will also now include New Well demand in the CGD sector, allocation
tional New Drug) – Nor Ursodeoxy- likely to lead to more severe non-alcoho- well tolerated at the dose of 1500-mg Gas (NWG) from nomination fi elds ratios of domestic gas have broadly
cholic Acid (Nor UDCA) tablets lic steatohepatitis (NASH) which could per day for the duration of 24 weeks. With a focus on ensuring the sus- of ONGC and Oil India. Estimations been maintained.
500-mg, by the Subject Expert Com- have fatal implications for the patient. Nor UDCA will be a fi rst-in-class treat- tained availability and affordability by GAIL and ONGC will help ensure
mittee of drug regulator, CDSCO. ment option for NAFLD in India and of natural gas for key public-facing supply visibility to CGD entities in The development comes after GAIL
The Committee has further recom- Shilpa Medicare had earlier com- has signifi cant advantages over UDCA segments – Compressed Natural Gas advance, enhancing planning and deli- had informed the CGD fi rms about the
mended grant of marketing authori- pleted phase-3 clinical studies of this like enhanced choleretic effect, resis- (CNG) used in transport and Piped very effi ciency,” it added. 15-20 percent cut in administered price
sation for the IND for the treatment novel product ‘SMLNUD07’ (Nor tance to amidation, anti-infl ammatory Natural Gas (PNG) used in domestic mechanism (APM) gas from April 16
of non-alcoholic fatty liver disease UDCA tablets), and presented the properties and reduction in fi brosis, the households for cooking – the MoPNG Besides, the auction-based allo- due to a fall in production at ONGC. The
(NAFLD). results of the trial to the SEC. No serious company said. has introduced important enhance- cation for NWG has been replaced lost volumes were supplied from NWG.

140 Chemical Weekly April 29, 2025 Chemical Weekly April 29, 2025 141

Contents Index to Advertisers Index to Products Advertised