The US Food and Drug Administration (USFDA) recorded a significant decline in serious regulatory findings at Indian drug manufacturing facilities between January and December 2025. Data reveals that 'official action indicated' (OAI) cases - the most severe classification - nearly halved over the past year.
Concerns over weakening demand for Indian pharmaceutical (pharma) drugs in the US - their largest export market - have weighed heavily on investor sentiment this year. While the Nifty 50 has gained 6.02 per cent year - to - date (as on September 15), the Nifty Pharma index has declined 5.18 per cent, National Stock Exchange data shows.
Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market. The development follows an inspection of the facility by the US Food and Drug Administration (USFDA) from April 26 to May 9, 2022. "We now wish to inform you that the company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
MG Motor India on Tuesday said it will shut its manufacturing unit at Halol in Gujarat for seven days to curb the spread of COVID-19 as the second wave of the pandemic is sweeping across the country. The company follows Hero MotoCorp, which had last week announced temporarily stopping of operations at all of its six manufacturing facilities located at Dharuhera and Gurugram, Haryana; Chittoor in Andhra Pradesh; Haridwar in Uttarakhand; Neemrana in Rajasthan, and Halol in Gujarat along with its Global Parts Center (GPC) at Neemrana as COVID-19 cases surged in India.
After a six-week tussle, the strike at General Motors India's Halol factory, 35 km from Vadodara, has finally been called off, with the workers and management reaching an understanding.
In 2015, the auto major had announced that it would cease production at the plant, a move that affected around 1,100 employees.
Sources claim that 68-70 per cent of the workers at Halol are permanent ones, while the balance is tilted towards contractual workers at Talegaon.
Company officials have maintained that the closure is a routine exercise and is not a fallout of the ongoing global meltdown. "There will be no production at the company's Halol unit for about two weeks," said P Balendran, vice-president, GM India. The company has shut production from December 13 to December 30.
The contractual workers at Halol were severed by 2016 as the contracts were not renewed, while the permanent workers were offered a separation package in the form of a voluntary retirement scheme
Contrary to the General Motors India's expectations of starting work at its beleaguered Halol plant from Monday, the deadlock over wage revision seems far from over.
MG Motor India is investing Rs 2,500 crore by the end of next year to increase the production capacity at its Halol plant in Gujarat, as it gears up to launch its mid-size SUV Astor, according to a top company official. Despite the worsening semiconductor shortage situation, which is likely to continue for at least another six months, the company expects its sales this year to grow by up to 100 per cent over last year. "We have done an investment of Rs 3,000 crore already, and by the end of next year, we will do another Rs 2,500 crore. "We will reach a total of Rs 5,500 crore," MG Motor India president and managing director Rajeev Chaba told PTI.
'Two would be premium products and three would be mainstream products.'
In a chat with Sohini Das, GM India president and managing director Karl Slym says, with the launch of the new compact car, Beat, and a positive response to the Cruze, GM plans to cross the 100,000-unit mark this year in sales.
Traction for its specialty portfolio, a strong showing in the domestic market, and better regulatory compliance are positives for the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries. Given the triggers, some brokerages have increased their earnings per share estimates and target price for 2024-25 (FY25). This should sustain the momentum for the stock, which has been one of the major pharma gainers in 2023-24 (FY24), rising 57 per cent. It is currently trading at Rs 1,547 per share.
In its order of June 12, which was made available on June 15, the court of additional sessions judge Harsh Trivedi also slammed pseudo-secular media and politicians for claiming that the riots were planned.
Hospitals to recover from sluggish Q3; diagnostics' growth rate at pre-Covid levels.
Drug major Sun Pharma is recalling over 34,000 bottles of a generic medication, used to treat high blood pressure, in the US market due to failed dissolution testing. As per the US Food and Drug Administration's Enforcement Report, the US-based arm of Sun Pharmaceutical Industries is recalling lots of Diltiazem Hydrochloride extended-release capsules which are used to treat angina, high blood pressure and some types of irregular heartbeats.
It is a general rule not to convict anybody until the body has been found, the court said.
The promoter entities of JSW Group are in talks with several electric-car manufacturers in China to launch an electric car for the Indian market at Rs 15-20 lakh, a source close to the development said.
It further said the UK government must not remain a mute bystander.
Of the total 39 accused, 13 died during the case pendency and the trial against them was abated.
An acute drug shortage in the US and stable pricing along with product launches are likely to boost revenues of India's pharmaceutical companies during the first quarter of this financial year, analysts said. Most brokerages estimate a top line growth of around 14-15 per cent, with earnings before interest, taxes, depreciation, and amortisation (Ebitda) growth of 24-30 per cent for Q1 of FY24. Hospitals are, however, likely to report lower occupancy rates, and diagnostics companies may witness an impact from delayed monsoon.
India's largest listed pharmaceutical (pharma) company - Sun Pharmaceutical Industries (Sun Pharma) - is expected to maintain its outperformance vis--vis the sector's, as its multiple bets on specialty products, improving product mix, recent acquisitions, and branded business are finding favour with brokerages. While it has gained 7 per cent over the past year, the Nifty Pharma Index is down 13.6 per cent. Its outperformance over two years has been fairly evident, with the market leader gaining 66 per cent to Nifty Pharma's minus 1.4 per cent.
British Prime Minister Boris Johnson will arrive in Ahmedabad on Thursday morning as part of his two-day India visit, and will be accorded a grand welcome on a four-km route from the city airport to a hotel, officials said.
According to the prosecution, the victims were killed on February 28, 2002, and their bodies burnt with an intention to destroy evidence.
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
Benchmark BSE Sensex rose by 160 points on Thursday in choppy trade following gains in select banking and auto counters amid mixed global cues. The 30-share index gained 160 points to settle at 62,570.68 as 13 of its components advanced while 17 declined. The barometer opened lower but later gained momentum to touch a high of 62,633.56 in the day's trade.
Both are finding it difficult to sell one each of their plants -- Chennai Maraimalai Nagar (Ford) and Talegaon near Pune (GM) -- and are finding the road blocked by employee severance snarl-ups, report Sohini Das and Shine Jacob.
The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.
Around 625 workers have been fasting since Monday; no disruption of production at the plant
The country's top carmaker Maruti Suzuki India (MSI) on Wednesday said it has decided to advance maintenance shutdown at its two Haryana-based manufacturing plants by a month amid a surge in the COVID-19 cases across the country. The auto major was supposed to take the shutdown at its two plants in Gurugram and Manesar in June, but due to the tsunami of COVID-19 cases, it decided to take it one month earlier to save oxygen for medical needs. MSI noted that as part of the car manufacturing process, it uses a small amount of oxygen in its factories, while relatively much larger quantities are used by the manufacturers of components.
Hopes to launch full-size SUV MG Gloster by Diwali 2020, and have four products in the market in one-and-a-half years of its operations in India.
This is also because Johnson's visit will follow at the end of Modi's three-day visit to Gujarat for inaugurating projects, reports Vinay Umarji.
Credit Suisse analysts cut their rating on Sun Pharma stock to 'neutral' from 'outperform
He is the first British prime minister to visit Gujarat.
GM has also exited from four other international markets, including Russia and Europe.
The MG Motor India management is focused on scaling up and launching smaller cars to play the long game in the country, says Pavan Lall.
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