It has been approved by the European Medicines Agency for conditional marketing authorisation.
In 2009, Ranbaxy had to recall about 4,000 cartons of Sotret Isotretinoin through its US-based subsidiary.
The Electronic Privacy Information Centre, an advocacy group, last week filed a complaint against Facebook and asked the FTC to investigate recent changes made by the company that make more information public by default and automatically share information with other websites.
Air India's passenger service system provider SITA faced a sophisticated cyberattack in February this year leading to leak of personal data of 4.5 million passengers -- which included passengers of the national carrier -- from across the world, an official statement said on Friday. Personal data -- including name, date of birth, contact information, passport information, ticket information and credit card data -- which was registered between August 11, 2011, and February 3, 2021, has been leaked of a certain number of Air India's passengers, the statement issued by the airline said. "While we and our data processor continue to take remedial actions...We would also encourage passengers to change passwords wherever applicable to ensure safety of their personal data," it said.
Tamil Nadu, Kerala, West Bengal, Assam and the Union Territory of neighbouring Puducherry are likely to go to polls in April or May.
An online company would show a particular price to the customer and then quickly increase the cost after analysing consumer behaviour or detecting any kind of desperation.
Viagra has landed 109 people in their graves, say reports. According to the Medicines and Healthcare Products Regulatory Agency, the anti-impotence drug had triggered 44 fatal heart attacks, along with perpetrating 29 other sudden deaths.Seven people allegedly lost their sight and two became deaf after taking the drug, reports The Sun.
Calling for 'equal recognition of vaccines', COVAX on Thursday urged all governments to recognise as 'fully vaccinated' those people who have received COVID-19 vaccines deemed safe by World Health Organisation, saying any move that restricts travel of people based on the vaccines they have received is 'counter-effective, both in spirit and outcome'.
The suspect medicines and the companies include Sudarshan tablets made by Zandu Pharmaceuticals, India, Shilajit capsules made by Dabur India Ltd, Safi liquid made by Hamdard Wakf-India
Jet Airways, which is yet to resume operations under its new owner, will reduce salaries for various staff and send many employees on leave without pay, amid uncertainty over resumption of its operations. The measures, which will be effective from December 1, were revealed hours after the winning bidder Jalan-Kalrock Consortium (JKC) said it might take "difficult" near-term decisions to manage cashflows. The once-storied airline shuttered operations in April 2019 and JKC's resolution plan was approved under the insolvency process by the National Company Law Tribunal (NCLT) in June last year.
The government today said the proposed Financial Stability and Development Council, an inter-regulatory agency headed by the finance minister, would not act as a super regulator.
In what could result in a complete overhaul of the Insolvency and Bankruptcy Code (IBC), the insolvency regulator has sought public comments on the regulations it notified under the code to date. The Insolvency and Bankruptcy Board of India (IBBI) has given a window of eight months ending December 31 to all stakeholders to share their views on its regulations. IBBI has called the exercise "crowdsourcing of ideas".
The Supreme Court on Wednesday refused to interfere with the Delhi government's order putting a comprehensive ban on manufacturing, storage, sale and bursting of firecrackers in the city, saying people's health is important.
Of late Speak Asia (www.speakasiaonline.com) has been in the news and is being investigated by various regulatory agencies of the government, including the ministry of corporate affairs.
The Supreme Court is scheduled to pronounce on Thursday its order on a batch of PILs on the recent Adani group shares crash triggered by the Hindenburg Research's fraud allegations.
Regulatory capacity, hyperactivity and excessive prescription are the biggest challenges the financial sector is facing, said Meleveetil Damodaran, former chairperson, Securities and Exchange Board of India (Sebi). Speaking at the Business Standard BFSI Summit on Wednesday, Damodaran highlighted the need for simpler, clear, and continuous regulations in the financial sector. He opined that the industry had felt it challenging to keep pace with the changing regulations.
The government is finalising appointment of at least nine public sector bank chiefs and a dozen executive directors who would replace them or fill existing vacancies.
'In the long run, I don't foresee major ramifications [about Trudeau's allegations].' 'There's just enough hypocrisy among Western nations for India to douse the outrage.'
The Indian startup ecosystem has lauded the inclusion of startups in the New Delhi Leaders' Declaration for the first time ever in the history of G20. Industry stakeholders say that the move will lead to easier access to capital, reduce regulatory hurdles, and may revive funding activity. The Declaration, through the Startup20 initiative, recognised startups as "natural engines of growth" and key to socio-economic transformation by driving innovation and creating employment.
Demanding a probe by central regulatory agency into the financial irregularities committed by software company Satyam Computer Services, the Bharatiya Janata Party (BJP) on Friday alleged that a scam of such proportions was not possible without the support of SEBI, MCA, Planning Commission and the Andhra Pradesh government.
Biju Janata Dal member of Parliament Baijayant 'Jay' Panda on Monday supported the Bill to amend Telecom Regulatory Authority of India Act, which seeks to remove a legal hurdle in the appointment of former chairman of telecom regulatory body Nripendra Misra RPT Misra as principal secretary to Prime Minister Narendra Modi.
The WHO on Tuesday issued a product alert over contaminated syrup by an Indian manufacturer, warning that it is unsafe for use, especially in children, and may result in serious injury or death.
The Centre has no objection to a proposal for setting up a panel of domain experts to look into strengthening the regulatory mechanisms for the stock market, the Supreme Court was told on Monday while it was hearing pleas relating to the Adani stocks rout after the Hindenburg report.
The drug regulatory agencies of India and Canada are planning to collaborate on improving the quality of drugs traded between the two countries, besides helping the industry in both the countries to tap the opportunities in the field of generic medicines and drug development.
Drug firm MSD has decided to enter into voluntary licensing agreements for investigational oral antiviral drug candidate 'Mmolnupiravir', which is being studied for the treatment of Covid-19, with Indian drug firms Sun Pharma, Cipla, Dr Reddy's, Emcure Pharma and Hetero Labs, its Indian arm said on Tuesday.
The Rs 1,027-crore (Rs 10.27 billion) company has filed 13 abbreviated new drug applications and 22 drug master files with the US Food and Drug Administration and regulatory agencies in Europe for supply of formulations and active pharmaceutical ingredients. Some of the ANDAs challenge innovator patents and the company's strategy will be to partner with established companies in the US and Europe for marketing formulations, said Pranav Amin, director, Alembic.
Assume Voot, JioCinema and Disney+ Hotstar are merged into one entertainment app, and you have a streaming service with more than 233 million unique visitors. That is a reach just under half of India's largest streaming app: YouTube. 'This level of consolidation does not exist even in the US.'
A team of central agencies and the Uttar Pradesh drug department had carried out an inspection at the firm's office in Noida on December 29 and taken six more samples for testing.
Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available in India.
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.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
The Supreme Court on Friday said it has no reason to "discredit" SEBI, which probed allegations against the Adani group, as there was no material before it to doubt what the market regulator has done and the court does not have to treat what was set out in the Hindenburg report as a "true state of affairs".
Kochhar retires by rotation, and being eligible, has offered herself for reappointment as director, said the broking arm in a notice for its Annual General Meeting to be held on August 30
Zydus Cadila Healthcare Ltd on Tuesday said it has received approval from the French regulatory agency, AFSSAPS, to market Sertraline capsules 25 mg and 50 mg, in the French market.
The government wants a collaborative model with a public-private partnership to fact-check social media content.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
The federal agency said it conducted raids against a director of Zanmai Lab Pvt Ltd, which owns WazirX, on August 3 in Hyderabad and alleged he was "non-cooperative". The agency's probe against the crypto exchange is linked to its ongoing investigation against a number of Chinese loan apps (mobile applications) working in India.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
Reserve Bank carried out the investigation and noted the deficiencies which were reflective of weaknesses and failures in internal control mechanisms