Serum Institute pauses covid 19 vaccine trials in India on DGCI instructions

Agencies
September 10, 2020

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New Delhi, Sept 10: The Serum Institute of India (SII), which was conducting the India trials for the coronavirus vaccine being developed by Oxford University, on Thursday paused the clinical trials of the vaccine in India.

In a statement, the Serum Institute of India said: "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials."

The declaration by the Pune-based vaccine manufacturer came a day after the Drug Control General of India (DCGI), V.G. Somani, issued a show-cause notice to them asking for an explanation as to why the institute decided to go ahead with the clinical trial of Covid-19 vaccine candidate while doubts about patient safety are yet unclear.

The notice was issued in the wake of an advert incident where one of the participants in the UK reported a suspected severe adverse reaction when administered a booster dose of Covishield, a vaccine candidate developed jointly by pharma giant AstraZeneca and University of Oxford, on Tuesday.

"Whereas, Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns," the notice by DGCI read.

The DGCI further asked the institute why the authority does not suspend the permission given to the SII for the clinical trials of Covishield.

"In view of the above, I, Dr V G Somani, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause as provided under rule 30 of the New Drugs and Clinical Trials Rules, 2019, why the permission granted to you August 2 shall not be suspended till patient safety is established," the notice further said.

SII is the partner of the University of Oxford's Jenner Institute's to conduct the vaccine trials. SII is currently progressing the second and third phase study of the vaccine candidate at 17 trial sites across India.

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News Network
December 3,2025

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IndiGo, India’s largest airline, is battling one of its worst operational disruptions in recent years, with hundreds of delays and cancellations throwing domestic travel into chaos.

Government data on Tuesday showed its on-time performance plunging to 35%, an unusual dip for a carrier long associated with punctuality.

By Wednesday afternoon, airports in Delhi, Mumbai, Bengaluru and Hyderabad had collectively reported close to 200 cancellations, stranding travellers across the country.

Crew Shortage After New Duty Norms

A major trigger behind the meltdown is a severe crew shortage, especially among pilots, following the rollout of revised Flight Duty Time Limitation (FDTL) norms last month.

The rules mandate longer rest hours and more humane rosters — a shift IndiGo has struggled to incorporate across its vast network.

Sources said several flights were grounded due to lack of cabin crew, while some delays stretched upwards of eight hours.

With IndiGo controlling over 60% of India’s domestic aviation market, the ripple effect has impacted airports nationwide.

IndiGo Issues Apology, Lists “Compounding Factors”

In a statement, IndiGo acknowledged the large-scale disruption:

“We sincerely apologise to customers. A series of unforeseen operational challenges — technology glitches, winter schedule changes, adverse weather, system congestion and updated FDTL norms — created a compounding impact that could not have been anticipated.”

To stabilise operations, the airline has begun calibrated schedule adjustments for the next 48 hours, aiming to restore punctuality. Affected passengers are being offered refunds or alternate travel arrangements, IndiGo said.

What the FDTL Rules Require

The FDTL norms, designed to reduce pilot fatigue, cap duty and flying hours as follows:
•    Maximum 8 hours of flying per day
•    35 hours per week
•    125 hours per month
•    1,000 hours per year

Crew must also receive rest equalling twice the flight duration, with a minimum 10-hour rest period in any 24-hour window.

The DGCA introduced these limits to enhance flight safety.

Hyderabad: 33 Flights Cancelled, Long Queues Reported

Hyderabad’s Rajiv Gandhi International Airport saw heavy early-morning crowds as 33 IndiGo flights (arrivals and departures) were cancelled.

The airport clarified on X that operations were normal, advising passengers to contact IndiGo directly for latest flight status.

Cancellations included flights to and from Visakhapatnam, Goa, Ahmedabad, Delhi, Bengaluru, Chennai, Madurai, Hubli, Bhopal and Bhubaneswar.

Bengaluru: 42 Flights Disrupted

Bengaluru’s Kempegowda International Airport recorded 42 cancellations — 22 arrivals and 20 departures — affecting routes to Delhi, Mumbai, Chennai, Hyderabad, Goa, Kolkata and Lucknow.

Passengers Vent on Social Media

Irate travellers took to X to share their experiences. One passenger stranded in Hyderabad wrote: “I have been here since 3 a.m. and missed an important meeting.”

Another said: “My flight was pushed from 1:55 PM to 2:55 PM and now 4:35 PM. I was informed only three minutes before entering the airport.”

Delhi Airport Hit by Tech Glitch

At Delhi Airport, the disruption deepened due to a slowdown in the Amadeus system — used for reservations, check-ins and departure control.

The technical issue led to longer queues and sluggish processing, adding to delays already worsened by staff shortages.

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News Network
December 5,2025

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New Delhi, Dec 5: IndiGo CEO Pieter Elbers issued a public apology this evening after more than a thousand flights were cancelled today, making it the "most severely impacted day" in terms of cancellations. The biggest airline of the country cancelled "more than half" of its daily number of flights on Friday, said Elbers. He also said that even though the crisis will persist on Saturday, the airline anticipates fewer than 1,000 flight cancellations.

"Full normalisation is expected between December 10 and 15, though IndiGo cautions that recovery will take time due to the scale of operations," the IndiGo CEO said. 

IndiGo operates around 2,300 domestic and international flights daily.

Pieter Elbers, while apologising for the major inconvenience due to delays and cancellations, said the situation is a result of various causes.

The crisis at IndiGo stems from new regulations that boost pilots' weekly rest requirements by 12 hours to 48 and allow only two night-time landings per week, down from six. IndiGo has attributed the mass cancellations to "misjudgment and planning gaps".

Elbers also listed three lines of action that the airline will adopt to address the issue.

"Firstly, customer communication and addressing your needs, for this, messages have been sent on social media. And just now, a more detailed communication with information, refunds, cancellations and other customer support measures was sent," he said.

The airline has also stepped up its call centre capacity.

"Secondly, due to yesterday's situation, we had customers stranded mostly at the nation's largest airports. Our focus was for all of them to be able to travel today itself, which will be achieved. For this, we also ask customers whose flights are cancelled not to come to the airports as notifications are sent," the CEO said.

"Thirdly, cancellations were made for today to align our crew and planes to be where they need to start tomorrow morning afresh. Earlier measures of the last few days, regrettable, have proven not to be enough, but we have decided today to reboot all our systems and schedules, resulting in the highest numbers of cancellations so far, but imperative for progressive improvements starting from tomorrow," he added.

As airports witnessed chaotic scenes, the Directorate General of Civil Aviation (DGCA) stepped in to grant IndiGo a temporary exemption from stricter night duty rules for pilots. It also allowed substitution of leaves with a weekly rest period. 

Civil Aviation Minister Ram Mohan Naidu has said a high-level inquiry will be ordered and accountability will be fixed.

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News Network
December 4,2025

Mangaluru: Chaos erupted at Mangaluru International Airport (MIA) after IndiGo flight 6E 5150, bound for Mumbai, was repeatedly delayed and ultimately cancelled, leaving around 100 passengers stranded overnight. The incident highlights the ongoing country-wide operational disruptions affecting the airline, largely due to the implementation of new Flight Duty Time Limitations (FDTL) norms for crew.

The flight was initially scheduled for 9:25 PM on Tuesday but was first postponed to 11:40 PM, then midnight, before being cancelled around 3:00 AM. Passengers expressed frustration over last-minute communication and the lack of clarity, with elderly and ailing travellers particularly affected. “Though the airline arranged food, there was no proper communication, leaving us confused,” said one family member.

An IndiGo executive at MIA cited the FDTL rules, designed to prevent pilot fatigue by limiting crew working hours, as the cause of the cancellation. While alternative arrangements, including hotel stays, were offered, about 100 passengers chose to remain at the airport, creating tension. A replacement flight was arranged but also faced delays due to the same constraints, finally departing for Mumbai around 1:45 PM on Wednesday. Passengers either flew, requested refunds, or postponed their travel.

The Mangaluru delay is part of a broader crisis for IndiGo. The airline has been forced to make “calibrated schedule adjustments”—a euphemism for widespread cancellations and delays—after stricter FDTL norms came into effect on November 1.

While an IndiGo spokesperson acknowledged unavoidable flight disruptions due to technology issues, operational requirements, and the updated crew rostering rules, the DGCA has intervened, summoning senior airline officials to explain the chaos and outline corrective measures.

The ripple effect has been felt across the country, with major hubs like Bengaluru and Mumbai reporting numerous cancellations. The Mangaluru incident underscores the systemic operational strain currently confronting India’s largest carrier, leaving passengers nationwide grappling with uncertainty and delays.

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