The top 300 pharmaceutical brands in the country will now bear a quick response (QR) code on their packaging to rein in spurious drugs and ensure better traceability.
'Interim Budget has ignited the entrepreneurial spirit.'
Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market. The development follows an inspection of the facility by the US Food and Drug Administration (USFDA) from April 26 to May 9, 2022. "We now wish to inform you that the company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.
An acute drug shortage in the US and stable pricing along with product launches are likely to boost revenues of India's pharmaceutical companies during the first quarter of this financial year, analysts said. Most brokerages estimate a top line growth of around 14-15 per cent, with earnings before interest, taxes, depreciation, and amortisation (Ebitda) growth of 24-30 per cent for Q1 of FY24. Hospitals are, however, likely to report lower occupancy rates, and diagnostics companies may witness an impact from delayed monsoon.
Rishad Premji, chairman of IT services major Wipro, saw his compensation for FY23 decline by almost 50 per cent year-on-year, due to a fall in the firm's profit. According to the Form 20-F, filed with the US Securities and Exchange Commission by Wipro, Premji's compensation for FY23 was $951,353, down 50 per cent from $1,819,022 in FY22. "Rishad A Premji is entitled to a commission at the rate of 0.35 per cent on incremental consolidated net profits of Wipro Limited over the previous fiscal year. However, in light of the fact that the incremental consolidated net profits for fiscal year 2023 was negative, the Company determined that no commission was payable for fiscal year 2023 to Mr Rishad A. Premji," said the company in the filing.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
Notwithstanding the fact that the country's pharmaceutical (pharma) pricing regulator has allowed a 12 per cent price increase for medicines listed under the National List of Essential Medicines (NLEM) in 2023, analysts and industry insiders predict that the overall domestic pharma industry will only witness a price hike of 5-6 per cent. This is attributed to higher competitive intensity in the market. Krishnakumar V, executive director and chief operating officer (CEO) of Eris Lifesciences, a domestic-focused pharma company, noted that the NLEM segment experienced growth suppression of around 150 basis points due to price reductions during the January to July period this year.
Sun Pharmaceutical Industries (Sun Pharma) reported a turnaround in the January-March quarter of the 2022-23 financial year (Q4FY23), declaring a profit after tax (PAT) of Rs 1,984 crore versus a loss of Rs 2,277 crore in Q4FY22. However, that loss in FY22 was due to several exceptional one-time items -- with Rs 3,723.15 crore allocated to settlement of lawsuits in the US and other Exceptional Items adding up to Rs 3,935.75 crore. Adjusted for exceptional items, PAT in Q4FY22 amounts to Rs 2,155 crore, which is a year-on-year (YoY) growth of about 36 per cent.
The domestic benchmark indices - the S&P BSE Sensex and the National Stock Exchange Nifty50 - had lost close to 1.5 per cent in three days recently before gaining slightly. Notwithstanding weakness and volatility, the Nifty50 has managed to hold on to the 18,000 mark, while the Sensex has managed to stay above the 61,000 level. The performance of the stocks that comprise these front-line indices remains polarised.
Investors' wealth on Friday tumbled by over Rs 4.65 lakh crore as markets suffered a heavy selloff following weak global trends and continued selling by foreign institutional investors. The 30-share BSE benchmark Sensex plunged 889.40 points or 1.54 per cent to close at 57,011.74. During the day, it tumbled 950.16 points to 56,950.98. The market capitalisation of BSE-listed companies declined by Rs 465,570.82 crore to Rs 2,59,37,277.66 crore amid weak sentiments.
Hospitals to recover from sluggish Q3; diagnostics' growth rate at pre-Covid levels.
Sun Pharmaceutical Industries on Tuesday said its arm DUSA Pharmaceuticals Inc has reached settlement with Biofrontera to resolve a litigation over misappropriation of trade secrets and unfair practice, following which DUSA will receive $22.5 million (nearly Rs 170 crore). In 2018, DUSA Pharmaceuticals had filed a suit at the US District Court of Massachusetts against Biofrontera Inc Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, and Biofrontera AG (together known as Biofrontera) alleging "misappropriation of trade secrets, tortious interference of contract and unfair trade practices".
Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Pharma is recalling a drug used to increase the production of natural tears in eyes. Similarly, Jubilant Cadista is recalling a drug which is used to treat different inflammatory conditions.
India's largest listed pharmaceutical (pharma) company - Sun Pharmaceutical Industries (Sun Pharma) - is expected to maintain its outperformance vis--vis the sector's, as its multiple bets on specialty products, improving product mix, recent acquisitions, and branded business are finding favour with brokerages. While it has gained 7 per cent over the past year, the Nifty Pharma Index is down 13.6 per cent. Its outperformance over two years has been fairly evident, with the market leader gaining 66 per cent to Nifty Pharma's minus 1.4 per cent.
Equity benchmark Sensex rallied 936 points on Monday, helped by heavy buying in banking and IT counters along with decline in oil prices amid hopes of headway in renewed diplomatic talks between Russia and Ukraine. A fresh round of talks is expected on Monday between Ukrainian and Russian officials. Rising for the fifth straight session, the BSE Sensex jumped 935.72 points or 1.68 per cent to settle at 56,486.02.
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.
Under terms of the agreed deal, Ranbaxy shareholders will get 0.8 of a Sun Pharmaceutical share for each Ranbaxy share they own.
Shanghvi founded Sun Pharmaceuticals in 1983 with five psychiatry products and a marketing team of just two persons.
Stocks of Indian companies with exposure to Europe fell on Tuesday amid concerns about the impact on their sales in case the Russia-Ukraine crisis worsens and the US and its allies impose economic sanctions on Russia. While top conglomerates, including Reliance Industries, the Tata group, and Aditya Birla Group, said they did not have any significant exposure to Russia, executives of some of the oil and gas, pharmaceutical, and tea companies said they were monitoring the situation closely as they earned substantial income from the region. Russian President Vladimir Putin on Monday ordered troops into two breakaway regions of eastern Ukraine after announcing that Russia would recognise their independence.
The central government has for the first time allowed a private company, Bajaj Healthcare, to process opium to extract alkaloids used to make pain-killers, cough syrups, and even cancer drugs. Two government factories in Ghazipur, Uttar Pradesh, and Neemuch, Madhya Pradesh, do the work yet, processing some 800 tonnes of opium gum annually to extract alkaloids. The government on Tuesday gave Thane-based Bajaj Healthcare an initial contract to process 500 tonnes of opium gum annually and wants production to be at 800 tonnes per annum (tpa) in the next five years, indicating the state's exit from the highly-regulated sector.
He said Sun Pharmaceutical will continue in manufacturing , infrastructure as well in Research and Development
Shanghvi needs to deploy this excess cash.
The Netherlands has emerged as India's fifth-largest export destination in 2021-22 (FY22), jumping from its 10th position a year ago. Exports to the fifth-largest economy in the European Union (EU) bolted 94 per cent to $12.5 billion in the financial year ended March 31. In FY22, the Netherlands surpassed Hong Kong, Singapore, the UK, Germany, and Nepal to become India's largest export destination in the EU. Germany, which was earlier India's top European export destination (eighth position), has now dropped two ranks to 10th place.
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.
Sun Pharmaceutical Industries said on Monday it will acquire Israel-based Taro Pharmaceutical Industries Ltd, a multinational generic manufacturer, in an all cash deal for $454 million.
Indian drug firms get a shot in the arm in the $12 bn Australian drug market as the Therapeutic Goods Administration (TGA), Australia agrees to accelerate the drug approval process in that country for Indian players who already have an approved plant and product from one of the stringent regulatory authorities like US, EU or Canada. From current sales of $340 mn, the Indian firms can see a significant upside in sales; felt Dinesh Dua, former chairman of the Pharmaceutical Exports Promotion Council of India (Pharmexcil), and the MD of Nectar Lifesciences. He highlighted that only 12 percent of the Australian drug market is generic, as against 80-90 per cent in the US or EU. Of this $1.5 bn generic drug market in India, Indian companies have a small share.
Since 2013, the FDA has banned around 30 Indian drug manufacturing units for various violations
Domestic firm Sun Pharmaceuticals has prepared a war chest of $500 million for acquisitions in the US, as it bets big on the world's largest drugs market.
Sun Pharmaceutical Industries Ltd on Monday said its Michigan-based wholly owned subsidiary,
'The deaths of the children in the Gambia would batter India's reputation as the developing world's pharmacy.'
Favipiravir is the only oral anti-viral treatment approved in India for potential treatment of patients with mild to moderate Covid-19 disease.
Recently, Ranbaxy and Wockhardt too were hauled up.
Stock markets are expected to remain under pressure this week due to the overhang of US presidential polls and uncertainty over global growth due to resurging cases of coronavirus, according to analysts.
Sun Pharmaceutical Industries Ltd has posted a 47.24 per cent rise in consolidated net profits at Rs 247.5 crore (Rs 2.47 billion) in the financial year ended March 31, 2003, compared to Rs 168.09 crore (Rs 1.68 billion).
The deal will provide Suzlon with much needed liquidity.
Last year, Ranbaxy had to pay a fine of $500 million to the US authorities after it pleaded guilty to fraudulent activities and misrepresenting data to seek fast approvals.
The company sold over 21 crore (210 million) shares in Sun Pharma.
Regulator likely to probe possible violation of insider-trading norms.
Sun Pharmaceutical said Ranbaxy shareholders will get 0.8 Sun Pharma shares for each Ranbaxy share.
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