Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
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.
He also said that there were around 620 cases of black fungus or mucormycosis in the city, but there is a shortage of Amphotericin-B injections used in its treatment.
Simvastatin goes off patent in late June; Ranbaxy gets 180-day exclusivity period; Dr Reddy's-Merck will be third player.
Which entrepreneur would willingly part with her or his hard-earned money for grasping, self-serving politicians? asks Debashis Basu.
The combined sales of the branded versions of the products in the US is about $3.5 billion.
Cipla is recalling the drug for failed impurities and degradation specifications.
The parties intend to start the production of Sputnik V in the beginning of 2021, it added. Currently, Phase III clinical trials are approved and are ongoing in Belarus, the United Arab Emirates, Venezuela and other countries, as well as Phase II-III in India, RDIF said.
The Drugs Controller General of India (DCGI) has granted permission to the Serum Institute of India (SII) to manufacture the Sputnik COVID-19 vaccine in India for examination, test and analysis with certain conditions, official sources said.
The government is hopeful of a speedy launch of single-dose COVID-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country's vaccination drive, sources said.
The emergency use of the drug will be for adult COVID-19 patients with SpO2 93 percent and who have a high risk of progression of the disease including hospitalisation or death subject to certain conditions
This import duty exemption would remain in force till October 31 this year.
These vaccines are Sputnik V vaccine (in collaboration with Dr Reddy's), Johnson & Johnson vaccine (in collaboration with Biological E), Novavax vaccine (in collaboration with Serum India), Zydus Cadila's vaccine, and Bharat Biotech's Intranasal Vaccine.
According to sources, around 10 crore doses of the Sputnik V vaccine is likely to be imported for emergency use in the country in the next six to seven months.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said Zydus Cadila, Sputnik V, Biological E and Gennova are other vaccines also in the pipeline which are in advanced clinical trials in India.
The drug comes in powder form in a sachet, which is taken orally by dissolving it in water. It accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production.
Equity benchmarks continued their winning momentum for the third day on Thursday and jumped over 1.50 per cent, tracking an overall bullish trend in Asian equities. On the political front, the BJP headed for a second straight win in politically crucial Uttar Pradesh and dominated the trends chart in three other states. The 30-share BSE benchmark Sensex opened in the green and further zoomed 1,595.14 points or 2.91 per cent to 56,242.47 during early trade.
The government should take measures to promote innovation and R&D while simplifying regulations for the sector in the upcoming Union Budget, as per pharmaceutical industry bodies. Outlining the wish list for the sector in the upcoming Union Budget, Indian Pharmaceutical Alliance (IPA) secretary general Sudarshan Jain said the domestic pharma industry is currently around $50 billion in size and aspires to grow to around $130 billion by 2030 and $450 billion by 2047. "To achieve this vision, the Union Budget 2023-2024 should help fuel innovation and R&D, which will set the pace for propelling the pharmaceutical industry forward," he told PTI.
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
US District Judge Beryl Howell in Minneapolis denied Ranbaxy's request, the court filing showed.
Favipiravir is the only oral anti-viral treatment approved in India for potential treatment of patients with mild to moderate Covid-19 disease.
A new logo, colour and tagline were unveiled last month.
The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.
Take the rediff business quiz and see how much you know about India's pharmaceutical industry.
Indian pharma firms under European drug regulator's scanner.
The headline for corporate profit growth has been very encouraging in the July-September quarter (Q2) of 2023-24 (FY24), with the combined net profit of listed companies up by 38 per cent year-on-year. However, the earnings distribution has been very lopsided, with most of the growth coming from public-sector oil-marketing companies (OMCs), banks, non-bank lenders, automobile (auto) companies, and cement producers. By comparison, companies from information technology services, fast-moving consumer goods (FMCG), retail, and consumer durables were disappointed, experiencing a sharp slowdown in net sales growth and a relatively muted increase in reported net profit.
In November, DRL registered growth of 28 per cent year-on-year (YoY), which was the highest among peers and double that of the industry growth (14.5 per cent).
The Indian pharmaceutical market (IPM) grew 6.8 per cent to touch a turnover of ~1.93 trillion in calendar year 2023, despite volumes going down marginally by 0.9 per cent. This indicates the price increase has been the major growth driver. Growth in the moving annual turnover (the previous 12 months' turnover) in December was 5.1 per cent and that in new product introduction 2.6 per cent, while volumes dipped 0.9 per cent, leading to an overall growth rate of 6.8 per cent, according to the data from market research firm Pharmatrac.
Domestic pharma major Panacea Biotec in collaboration with Russian sovereign wealth fund Russian Direct Investment Fund (RDIF) has begun the production of 'Sputnik V' COVID-19 vaccine in India, according to a joint statement issued.
In a virtual conference from Moscow, Dmitriev said Sputnik V is not only 'one of the most effective' but also among the 'affordable' vaccines in the world.
'The correction could take two to three months and traders need to be careful.' 'For investors, this could be a good time to nibble in.'
The third-quarter financials didn't excite market watchers. But equity investors can still make money if they invest in the right stocks.
This is not just a Ranbaxy or Wockhardt problem, says K Satish Reddy
