Page 148 - CW E-Magazine (5-12-2023)

Pharmaceuticals Hydrocarbons

REGULATOR’S RECOMMENDATION POLICY PUSH

Cipla advised to hire cGMP consultant for Pithampur Govt. makes biogas blending mandatory for domestic

facility use from FY26

The United States Food and Drug lity, undertaken between February 6 and gations to other potentially affected The government has announced a In October 2018, the government
Administration has recommended that 17, 2023, the company had informed in batches,” it said, adding that the fi rm roadmap for mandatory blending of had launched the Sustainable Alter-
Cipla engage a consultant to assist in the fi ling. The site manufactures inha- received “a very high number of com- compressed biogas (CBG) in the trans- native Towards Affordable Transportation
meeting the current Good Manufac- lers, among other things, and played a plaints (approximately 3,000) from portation and domestic segments of (SATAT) scheme, under which 5,000
turing Practices (cGMP) requirements. crucial role in the launch of its generic the start of commercial manufacturing the city gas distribution (CGD) sector CBG plants were envisaged by 2023
The recommendation is part of the ‘Advair’ in the US. Cipla’s management in April 2020 to December 2022,” the in a phased manner. The government to produce 15-million tonnes of CBG.
USFDA’s warning letter to the drug- have in the past indicated, they were USFDA said. expects this decision will push manu- The scheme’s objective was to encour-
maker, following cGMP violations de-risking the process and transferring facturing and consumption of CBG, age entrepreneurs to set up CBG plants
at its Pithampur plant in Indore (Madhya the product to another site. In other transgressions that were which has so far failed to take off in the Blending obligation across the country and supply the gas
Pradesh). red-fl agged, the regulator said, the country. The key objectives of the CBO to public sector oil companies. SATAT,
Regulator’s observations company had failed to establish and (compulsory blending obligation) are however, has so far failed to attract
The regulator has raised multiple In its letter, the USFDA said, the follow appropriate written procedures In its recent meeting, the National to stimulate demand for CBG in the enough entrepreneurs. As per latest
issues including data integrity, bacterial company had failed to thoroughly in- that are designed to prevent microbio- Biofuels Coordination Committee CGD sector, import substitution for offi cial data, just 48 CBG units have
contamination, among other things, and vestigate any unexplained discrepancy logical contamination of drug products (NBCC), chaired by oil Minister Liquefi ed Natural Gas (LNG), saving been set up under the scheme, and the
this has industry analysts concerned on or failure of a batch, or any of its com- purporting to be sterile, and that include Mr. H. S. Puri, gave its nod to mandatory in forex, promoting the circular economy total number of letters of intent (LoIs)
the possible escalation of the situation ponents to meet any of its specifi cations, validation of all aseptic and sterilisation blending of CBG with compressed natu- and assisting in achieving net zero issued under SATAT stands at 2,176. So
to an import alert. whether or not the batch had already processes. The USFDA also pointed to ral gas (CNG) for transportation and emissions, the ministry informed. far in FY24, just 9,548 tonnes of CBG
been distributed. “Your investigations repeat violations from multiple sites, piped natural gas (PNG) for households have been sold.
In a stock exchange fi ling, Cipla had into quality defect complaints of referring to the Goa plant that had been starting 2025-26 (FY26), the oil minis- Mr. Puri said the order would
said that it was responding to the letter Albuterol Sulphate Inhalation Aerosol hauled up by the USFDA over issues try said in a statement. encourage investment of around Sustainable aviation fuel
and would comply. It has 15 days to re- were inadequate because they lacked including, “inadequate equipment clean- Rs. 37,500-crore and facilitate establish In another important announcement,
spond. The USFDA warning letter, dated appropriate and timely corrective ac- ing procedures, inadequate investi- Biogas is an energy-rich gas pro- ment of 750 CBG projects by 2028-29. initial indicative blending percentage
November 17, 2023, follows a routine tions and preventive actions (CAPAs). gations of high effi ciency particulate duced by anaerobic decomposition of The CBO will be voluntary till FY25 targets for Sustainable Aviation Fuel
cGMP inspection at the Pithampur faci- You also failed to extend your investi- air (HEPA) fi lter integrity test failures...”. biomass. It is produced from sources and mandatory blending obligations (SAF/Bio- ATF) were set by the com-
like agriculture residue, cattle dung, would start from FY26. It will be kept mittee. This was based on comments re-
CORPORATE INSOLVENCY sugarcane press mud, municipal solid at 1 percent, 3 percent and 4 percent of ceived from the stakeholders, including
waste, and sewage treatment plant the total CNG/PNG consumption for the Ministry of Civil Aviation (MoCA),
NCLAT dismisses PNB’s plea against sale of Sterling waste, among others. It can be burned FY26, FY27 and FY28, respectively. Niti Aayog and oil marketing compa-
directly as a fuel, or purifi ed and From FY29 onwards, CBO will be 5 nies (OMCs), the capacity of Sustain-
Biotech to US-based Perfect Day upgraded by removing carbon dioxide, percent. able Aviation Fuel plants coming up in
hydrogen sulphide, and then com- the country and projected ATF sales.
The National Company Law However, this was challenged by port, which was obtained by Andhra Bank A Central Repository Body (CRB) The initial indicative blending percent-
Appellate Tribunal (NCALT) has set aside Punjab National Bank (International) from Gajjar Techno-Economic Consultant, pressed to make CBG. The CBG has
methane content of more than 90%, will monitor and implement the age of SAF in ATF is 1 percent in 2027
the plea of a UK-based subsidiary of Ltd., a stakeholder in Sterling Biotech, the value was more than three times. The which is similar to commercially avail- blending mandate based on the ope- (initially for international fl ights) and
Punjab National Bank (PNB) against before the appellate tribunal NCLAT, liquidator neglected to fetch the maximum able natural gas in composition and rational guidelines approved by the 2 percent in 2028 (initially for inter-
the NCLT (National Company Law contending that the value of the Corpo- price and auctioned the corporate debtor at energy potential. Minister. national fl ights).
Tribunal) order, approving the sale of rate Debtor was much higher than the a throwaway price, it alleged. “We do not
Sterling Biotech to US-based food one mentioned in the e-auction notice. fi nd any merit in any of the submissions
technology startup, Perfect Day. It had prayed to stay the auction pro- raised by the appellant in the Appeal. The HPCL announces pact to market lubes in Sri Lanka
cess, direct the liquidator to maintain Appeal is dismissed,” said a two-member
The Mumbai bench of the NCLT the status quo and invite fresh bids. NCLAT bench. A corporate insolvency Hindustan Petroleum Corporation The agreement was signed in “This remarkable achievement was
on November 11, 2022, approved a resolution process (CIRP) was initiated Ltd. (HPCL) has announced the suc- Colombo. Sri Lanka, on November made possible through invaluable sup-
Rs. 638-crore bid of Perfect Day in an According to the PNB’s subsidiary, the against the Sandesara brothers-promoted cessful execution of an agreement with 22, 2023, between Mr. MPDUK Mapa port extended by the Ministry of Petro-
auction conducted by the liquidator of value of Sterling Biotech was much higher Sterling Biotech over a petition fi led by Government of Sri Lanka, for market- Pathirana, Secretary, Ministry of Power & leum & Natural Gas and the High Com-
Sterling Biotech under the Insolvency & than Rs. 548.46-crore mentioned in the Andhra Bank (now Union Bank of India) ing of its lubricants in the island Energy, Govt. of Sri Lanka, and mission of India in Colombo,” HPCL
Bankruptcy Code. e-auction notice. As per the valuation re- petition on June 11, 2018. country. Mr. Sanjay Kumar, ED-Lubes, HPCL. said.

148 Chemical Weekly December 5, 2023 Chemical Weekly December 5, 2023 149

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