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.
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 UK government is under increasing pressure on Monday to review its COVID-19 vaccine protocol in place for travellers from India, after its updated rules effective from next month failed to recognise Indian vaccines under an expanded list of countries.
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.'
The government wants a collaborative model with a public-private partnership to fact-check social media content.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
The permission right now is for delivery only for stationary usage. This limits the service to those who operate units like diesel generation sets.
The government is considering setting up air freight stations to enable direct movement of vaccines from pharmaceutical factories to the aircraft.
The CBI has arrested Joint Drugs Controller S Eswara Reddy for allegedly receiving a Rs 4 lakh bribe to waive the phase three clinical trial of the Insulin Aspart injection, a product of Biocon Biologics under development to manage Type 1 and Type 2 diabetes, officials said on Tuesday. Biocon Biologics is a subsidiary of the Kiran Mazumdar Shaw-led Biocon. The company has denied allegations. The agency has also arrested Dinesh Dua, director at Synergy Network India Private Limited, who was allegedly giving Reddy a bribe, they said.
The Supreme Court observed on Tuesday it is more concerned about the risk factors than anything else when it comes to the conditional approval granted by the Centre for environmental release of genetically modified (GM) mustard. On October 25 last year, the Genetic Engineering Appraisal Committee (GEAC) under the Union environment ministry had approved the environmental release of transgenic mustard hybrid DMH-11 and the parental lines containing barnase, barstar and bar genes so they can be used for developing new hybrids. The apex court is hearing separate pleas by activist Aruna Rodrigues and NGO 'Gene Campaign' seeking a moratorium on the release of any genetically modified organisms (GMOs) into the environment pending a comprehensive, transparent and rigorous bio-safety protocol in the public domain conducted by agencies of independent expert bodies the results of which are made public.
A key lesson for the pharmaceutical sector in this case is to not downplay the significant impact that regulatory non-compliance can have on operations.
The crackdown also targeted 10,603 websites, leading them to be closed down or suspended through having their domain name or payment facilities removed.
Former RBI governor Raghuram Rajan has asked why SEBI has not yet got to the bottom of ownership of the four Mauritius-based funds who are said to have parked 90 per cent of their $6.9 billion in Adani group stocks, saying does the market regulator need help of investigating agencies for this? The funds -- Elara India Opportunities Fund, Cresta Fund, Albula Investment Fund and APMS Investment Fund -- have been under cloud for last couple of years after allegations that they may be shell companies. They came into focus once again in January when a US short seller alleged that Adani Group used offshore shell companies to inflate stock price.
A probe has been initiated by India's drug regulator after the World Health Organisation (WHO) issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to the death of children in The Gambia, official sources said.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
Global rating agency Fitch said on Monday that bank credit growth in excess of 13 per cent year on year in FY23 could put pressure on core equity tier ratios (CET1) of banks, especially public sector lenders. It may limit the buffers of Indian banks to absorb potential future losses. Bank credit expanded by 11.5 per cent in FY22. Full-year loan growth for FY23 will represent a modest slowdown from the 17 per cent YoY pace in H1FY23.
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications seeking emergency use authorisation for the shots, official sources said.
In a setback to Tata Power, the Supreme Court on Wednesday dismissed the company's challenge to the Maharashtra Electricity Regulatory Commission's (MERC's) decision to award a Rs 7,000-crore transmission project near Mumbai on a nomination basis to Adani Electricity. The court upheld the order by the Appellate Tribunal for Electricity (APTEL) in this case and directed all State Electricity Regulatory Commissions to frame guidelines on tariff determination in accordance with Section 61 of the Electricity Act and the national policy. The verdict has implications for the Mumbai power market, said Ashok Pendse, an energy expert based in the city.
Reinvent and innovate will be the key mantra for the Indian pharma industry in the New Year as the 'pharmacy of the world' looks to move from volume to value leadership, amid emerging challenges of inflation and pricing pressures in the global markets. While R&D investment, market competitiveness, regulatory scrutiny, and domestic price regulations are expected to shape the growth of generics and injectable products, concerns such as price control and customs duties on medical equipment will continue to bother the healthcare industry in 2023. The industry believes that in view of India's G20 Presidency, digital health innovation, achieving universal health coverage, improving healthcare infrastructure and delivery will continue to be the key driving factors in 2023.
The guild said that already multiple laws exist to deal with content that is found to be factually incorrect.
The country would see more economic progress if the private sector was left to run business without government interference, Infosys founder N R Narayana Murthy has said at the Jaipur Literature Festival.
While Etihad has told Securities and Exchange Board of India that it has not violated any securities law by not making an open offer, the capital market regulator is now seeking further clarity on the issue from other agencies including fair trade watchdog CCI, Finance Ministry and Aviation Ministry, sources said.
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".
Etihad has purchased 24 per cent stake in Jet Airways in a deal worth about Rs 2,060 crore deal which was announced in April 2013.
Ruling Trinamool Congress in West Bengal on Thursday met the full bench of the Election Commission of India (ECI) and alleged that the Border Security Force (BSF) is threatening people in the border areas of the state to cast their votes in favour of a particular political party.
Fitch Ratings has affirmed ICICI Bank's ratings at 'BB+' with a negative outlook and retained the lender's viability rating at BB. The negative outlook comes despite the agency recently revising upwards the operating environment outlook of domestic banks to stable from negative, citing better than expected recovery in business and economic activity following the COVID-19 second wave. Economic momentum and regulatory measures should support modest improvements in the domestic banks' financial profiles over the next 12-24 months, even though challenges remain the agency said in a late Monday note.
'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
A plea has been filed in the Supreme Court seeking investigation under the supervision of a sitting apex court judge against the Adani group of companies in light of the allegations made by the US-based Hindenburg Research.
This means fully vaccinated Indian passengers will no longer be subjected to a compulsory 10-day hotel quarantine on their arrival in Britain.
The World Bank must become Archimedes's lever to help change the world into a more prosperous, inclusive, and sustainable planet in the 21st century. The change in leadership now provides that opportunity, observes Ajay Chhibber.
Dispelling impression of widespread corruption in India, Finance Minister P Chidambaram on Wednesday asserted that not everyone here is corrupt and asked the regulatory agencies to intervene only when there is a clear case of criminality.
The BCCI and its officials did not open a separate bank account in South Africa
Reliance Industries (RIL's) annual report released on Sunday highlighted the company's focus on new energy solutions, with chairman and managing director (MD) Mukesh Ambani stating that the age of fossil fuels will not continue much longer. RIL has sought shareholders' approval to give Ambani another five-year term as MD till 2029 at nil salary. The recently demerged Jio Financial Services, which "will leverage the prowess of digital and retail businesses", was expected to be listed soon.
The Organised Crime and Corruption Reporting Project (OCCRP) on Thursday trained its guns on the Adani Group, alleging hundreds of millions of dollars were invested in publicly traded group stocks through Mauritius-based 'opaque' investment funds managed by partners of promoter family, charges the conglomerate denied vehemently.
State-level reports every quarter for service quality and artificial intelligence-based solutions may be officially mandated as part of a set of more stringent, updated quality-of-service (QoS) norms by the Telecom Regulatory Authority of India (Trai) soon. The new norms will also factor in user experience for 5G networks, officials informed Business Standard. In February, Trai asked telecommunication (telecom) service providers (TSPs) to submit updates on measures taken to reduce call drops and lags and raise the quality of connection.
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The company had in May announced that the US Food and Drug Administration had issued an import alert on its Waluj facility, which makes injectables and solid dosages.
The temple town is likely to witness a major jump in tourist inflow once flagship projects are commissioned. In the first six months of 2022, more than 20 million tourists visited Ayodhya.
According to the chairman, there will be an annual loss of Rs 100 crore due to the MHRA alert on Waluj plant
Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.
A technical advisory group of the UN health agency which met on Tuesday has sought "additional clarifications" from Bharat Biotech for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
