Page 134 - CW E-Magazine (27-5-2025)

Pharmaceuticals Hydrocarbons

qualifi ed institutional placement (QIP) In addition, the board has announced markets aren’t conducive right now for a REGULATION
and private placements, to be executed in the evaluation of a merger between public listing. The board has constituted
one or more tranches. “The QIP process Biocon Biologics and Biocon Ltd., a a committee to explore all strategic Oil regulator mandates registration for LNG terminals,
has just begun, and we aim to complete move that replaces earlier plans to list the options that can unlock greater value for
the fi rst tranche by the end of Q1 FY26,” biologics business separately. “While the our stakeholders. A merger is one of those drops common carrier capacity requirement
Mr. Mittal said. company is well-positioned, the capital options,” Mr. Mittal noted.
The oil regulator has made it man- The PNGRB nod in both cases will need to “submit the business plan and
LACK OF SCIENTIFIC VALIDATION datory for companies planning to establish hinge on “promoting competition among detailed evacuation plan of LNG or re-
‘Irrational’ fi xed dose combinations harmful, may new liquefi ed natural gas (LNG) import entities, avoiding infructuous investment, gasifi ed natural gas from its LNG terminal,
terminals or expand existing ones to obtain maintaining or increasing supplies or along with copy of its approved Detailed
face ban: Panel prior approval, but dropped the require- securing equitable distribution or ensur- Feasibility Report (DFR)” to PNGRB.
ment to reserve a portion of the terminal ing adequate availability of natural gas
capacity for third-party access. throughout the country, protecting custo- The clause for the expansion of
Personal care products ingredients in a fi xed ingredients, dosage forms, it’s strength, mer interest and availability of gas evacua- existing terminals is not there. As per the
containing aloe vera, jojoba dose ratio, but in amount of usual ingredients per dosage The Petroleum and Natural Gas tion facility from the terminal,” according notifi ed rules, PNGRB can suspend or
oil and orange oil may be India several FDCs form and the countries where the drug is Regulatory Board (PNGRB) has notifi ed to the rules. terminate the registration of a terminal or
harmful and are likely to are found to be irra- marketed, approved, withdrawn, among Registration for Establishing and Ope- forfeit its bank guarantee if it is found to
be banned soon after the tional or are not sci- other details. rating Liquefi ed Natural Gas Terminals The rules, however, do not contain be involved in unfair trade practices or
expert committee looking entifi cally validated Regulations, 2025. the requirement of new LNG import breaching regulatory obligations. Compa-
into these fi xed dose combi- for safety or effi cacy FDCs were earlier considered as facilities reserving a fi fth of the capacity nies also need to furnish a bank guarantee
nations (FDCs) found they through rigorous tests “irrational” by a panel led by Chandrakant “These regulations lay down a robust for third-party access on a common carrier equal to 1 percent of the estimated project
may pose a risk to human beings. Consi- for patients. Kokate, vice-chancellor of KLE Univer- framework focused on registration and principle. cost of the terminal or Rs. 25-crore, which-
dering that they are “irrational,” the experts sity in Karnataka. However, a sub-com- oversight of LNG terminals, (and) pro- ever is less.
have recommended their prohibition. Earlier in March 2023, companies mittee formed under the chairmanship of motion of competition among entities and PNGRB had, in the fi rst draft rules
producing such FDCs were asked to give Nilima Kshirsagar, former dean of G.S. prevention of infructuous investments,” for the LNG terminal registration in 2018, The regulator will approve the “com-
There are about 16 odd FDCs in- a presentation, representing their case Medical College and KEM Hospital in the regulator said, adding that the rules proposed fi rms off ering “at all times, after pletion schedule” of the LNG terminal
cluding Aloe vera+Jojoba oil+Vitamin justifying the need for these products. Mumbai, was asked to examine and re- are a step in alignment with India’s vision registration, 20 per cent of its short-term and can impose a fi nancial penalty on the
E, Aloe vera+orange oil, Aloe vera+ The companies were asked to submit a view the safety, effi cacy and therapeutic of increasing the share of natural gas to 15 (less than 5 years contract) uncommitted operator for not sticking to the completion
Vitamin E+herbal, Aloe vera+Jojoba summary with the “highest level of evi- justifi cation of these drugs. The sub- per cent in the energy mix by 2030. re-gasifi cation capacity or 0.5-million schedule.
oil+wheat germ oil+tea tree oil, among dence,” supporting the claim of postulated committee recommended “prohibition” tonnes per annum, whichever is higher, as
others, which are likely to be part of a advantage/rationale, along with the of these FDCs, saying they could pose The norms also seek to ensure equita- common carrier capacity”. This capacity India currently has seven operating
list of products to be banned. The other published data regarding safety and effi - a risk to human beings. ble and adequate natural gas availability could be booked by a third party to import LNG terminals – a 17.5-million tonnes
FDCs which fall under the same cate- cacy of FDC. They were asked to share across the country, protection of consumer its own LNG. After opposition from the import facility of Petronet LNG Ltd. at
gory are paracetamol+lidocaine, acetyl whether these FDCs are marketed in the The report was recently submitted interests through improved access and industry, PNGRB dropped the clause in Dahej in Gujarat, Shell’s 5-million tonnes
salicylic acid+ethoheptazine used as EU, UK, Canada, Australia, Japan and before India’s top technical body on supply reliability, and facilitate infrastruc- another draft regulation issued in June terminal at Hazira, GAIL India’s 5 million
pain relievers. They have been under the US. drugs, which agreed with the recommen- ture availability for evacuation of regasi- last year. The fi nal rules notifi ed now are tonnes Dabhol facility in Maharashtra,
the government scanner from 2021. dations of the subcommittee. The recom- fi ed LNG through pipelines. An entity based on the draft issued last year. Petronet’s 5-million tonnes Kochi terminal
The companies were also told to mendations have now been sent to the wanting to build an LNG terminal will in Kerala, IOC’s 5 million tonnes Ennore
A FDC contains two or more active mention country-wise product names, health ministry for further action. have to inform PNGRB before taking the Companies seeking nod for setting terminal in Tamil Nadu, Gujarat State
Dr. Reddy’s receives two USFDA observations fi nal investment decision (FID). The same up new LNG terminals need to “have a Petroleum Corp’s 5-million tonnes facility
will have to be done for expanding the credible business plan for utilisation of at Mundra and Adani Total Gas’ 5-million
for US API facility capacity of an existing LNG terminal. capacity in the LNG terminal” and will tonnes Dhamra terminal in Odisha.

FORECAST
Hyderabad-based Dr. Reddy’s Labo- pany’s API (active pharmaceutical ingre- address within the stipulated timeline,”
ratories said the US health regulator has dients) Middleburgh facility in New York, the company said. As per USFDA, Form OPEC expects India’s oil demand to rise 3.4% in 2025,
issued a Form 483 with two observations Dr. Reddy’s said in a regulatory fi ling. 483 is issued to a fi rm’s management
after inspecting its US-based facility. The inspection was conducted during at the conclusion of an inspection when double the pace of China
May 12-16, 2025, it added. the investigator has observed any con-
The US Food and Drug Administra- ditions that may constitute violations of India’s oil demand is expected to grow and 2026, Organization of the Petroleum India’s oil demand is projected to rise
tion completed a Good Manufacturing “We have been issued a Form 483 the Food Drug and Cosmetic (FD&C) at the fastest pace among major economies Exporting Countries (OPEC) said in its from 5.55-million barrels per day (bpd)
Practice (GMP) inspection at the com- with two observations, which we will Act and related Acts. and double the rate of rise in China in 2025 latest global outlook. in 2024 to 5.74-mn bpd in 2025, up 3.39

134 Chemical Weekly May 27, 2025 Chemical Weekly May 27, 2025 135

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