
BUSINESS
IPA rejects Ohio University study linking higher adverse events to made in India generics
IPA also refuted the study's reliance on the FDA Adverse Event Reporting System (FAERS) data, stating that FAERS data is observational and does not prove causation between drugs and adverse events.

BUSINESS
Prices of diabetes drug empagliflozin falls by 80-90% as generics enter market
Mankind Pharma, Alkem Laboratories, Glenmark, CORONA Remedies are some of the companies to have launched, making the drug affordable to most Indian patients

BUSINESS
Zydus Lifesciences wants to go beyond the pill, bets big on MedTech with Amplitude buy
India still relies largely on imported devices and implants, and we want to change that, says Dr Sharvil Patel, MD, Zydus Lifesciences.

BUSINESS
Aveo's top executive says no illegal exports of banned drug combinations, blames counterfeiters
Arvind Sharma, Managing Director told Moneycontrol that the exports were done only after getting valid product permissions from the State FDA and required export no-objection certificates

BUSINESS
Indian drugmakers weigh portfolio rejig, manufacturing realignment to survive US tariffs
Indian companies operate on thin EBITDA margins of 5-15% on average for their base business, even a 10% reciprocal tariff as India charges on US exports would make them unviable, if they fail to pass on the increased import duty on to the US consumer

BUSINESS
Metropolis focuses on North India expansion, acquires Agra-based Scientific Pathology
Scientific Pathology was the second acquisition in last three months in North India for Metropolis. The company has acquired Delhi NCR-based specialty cancer testing chain Core Diagnostics for Rs 247 crore through a combination of cash and stock in December last year.

BUSINESS
Cipla Global CEO says drug companies may have to gear up for distributed manufacturing network
'We would like most of the manufacturing to be centric in locations where it is most economic. Looking at every country's ambition to be self sufficient and every country's ambition to be balanced from a tariff perspective or anything else, I actually see a little bit of a difference in the future of how (manufacturing) networks will operate,' said Umang Vohra, Global CEO and MD of Cipla

BUSINESS
Pharma industry body seeks govt to consider tariff cut on US pharma imports to zero
The industry body, which represents large homegrown pharmaceutical companies that have significant exposure to US market, feels that reducing the tariffs on US imports wouldn't cost a lot to India, and may even convince Trump administration to offer relief on tariffs.

COMPANIES
DCGI says streamlining export NoCs, test-licenses to free up regulatory capacity, examining export NoCs given to Aveo Pharma
'We have 10,000 plus manufacturing units, we have 10 lakh of sales outlets, we have 4,000 plus medical devices manufacturing units, we have whole lot of things to be imported and in terms of resources, altogether between Centre and the states, we are around 2,000 regulators to manage this whole dynamics of what I just put in numbers,' says DCGI

BUSINESS
GV Prasad of Dr Reddy's says 25% tariff on pharma exports could make medicines costlier for US consumers
Prasad said shifting all these products (manufacturing) from worldwide into US is not practical.

BUSINESS
Will Trump’s tariffs assail Indian pharma, or can it sail through?
In 2024, India exported drugs worth around $8.73 billion to the US — about 31 percent of its total pharma exports, while the US exported $635.37 million worth of pharmaceuticals to India.

BUSINESS
Amgen opens new technology & innovation site in Hyderabad, to invest $200 million
The site is expected to accelerate Amgen’s digital capabilities through artificial intelligence and data science to further advance its pipeline of medicines, while creating significant opportunities for local talent.

BUSINESS
DCGI chief Rajeev Raghuvanshi gets 1-year extension from govt
The government gave Drug Controller General of India Dr. Rajeev Singh Raghuvanshi one year extension. Raghuvanshi is set to superannuate on February 28.

BUSINESS
Immunocompromised people may need COVID-19 vaccine booster shots: Experts
All people may not need a third dose or booster shot against COVID-19. India’s priority remains getting its adult population fully vaccinated with two doses.

BUSINESS
Veeda Clinical Research files DRHP for Rs 831.6 crore IPO
The company intends to utilise the proceeds to repay debt, fund capital expenditure, invest in/fund further acquisitions by subsidiary Bioneeds and fund working capital requirements

BUSINESS
Explainer: What is Ayushman Bharat Digital Mission, what this means to patients and concerns
The digital health ID, which creates a health account, will ensure that old medical records are not lost, as every record will be stored digitally. Though the govt says no medical practitioner will be able to access a citizen’s health data without his consent, there are concerns.

BUSINESS
Bharat Biotech says working with WHO to obtain clearance, no word on approval delays
Bharat Biotech has said it doesn't 'find it appropriate to speculate or comment on the regulatory approval process and its timelines' after reports emerged of a possible delay in WHO approval

BUSINESS
Biocon gets 6 observations from USFDA for its Malaysian facility in pre-approval inspection
"We are confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan (CAPA), which will be submitted to the US FDA in the stipulated time," Biocon spokesperson said.

BUSINESS
Government’s free vaccination drive kills market for private hospitals, 25% allocation largely unutilised
With the wider availability of vaccines, people prefer to get their jabs at government centres rather than pay for shots at private hospitals.

BUSINESS
Healthtech platform Medikabazaar raises $75 million from Creagis, CDC Group
The current investment will be utilized to strengthen Medikabazaar’s digital capabilities, deepen the supply ecosystem, technology driven distribution channels and bolster capacity to provide a wider range of leading-edge quality medical supplies across diverse geographical regions.

BUSINESS
J&J says launch date of COVID-19 shots in India not decided, still in talks with govt
COVID-19 vaccines would be on the agenda of the Quad meeting scheduled on September 24 between the heads of the governments of the US, India, Japan and Australia, sources told Moneycontrol

BUSINESS
Industry says UK’s non-recognition of Indian vaccine certificates ‘unfair’
India is the leading vaccine manufacturer for the world. Not recognising India's vaccine certificate is not acceptable, Dr Alok Roy, Chair of FICCI Health Services Committee, said. India’s digital certification is far more reliable than other countries’ manual systems, tweeted Kiran Mazumdar-Shaw, Chairperson of Biocon.

BUSINESS
MSF asks Regeneron to make COVID antibody cocktail affordable; forego patent claims
Regenron has priced the antiviral cocktail at $820 (Rs 59,750) in India, $2,000 in Germany and $2,100 in the US. It has also filed patent applications in at least 11 low= and middle-income countries

BUSINESS
Aurobindo Pharma's subsidiary seeks marketing approval of its first biosimilar product from EMA
Aurobindo Pharma is developing biosimilars for global markets through its subsidiary CuraTeQ Biologics with focus on oncology and immunology segments.