Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics
Karmayog, a leading NGO which recently carried out a CSR rating of top 500 Indian companies, says that only two drug companies - Dr Reddy's and Lupin - have done work on this front. While the two firms scored three out of five, 30 other drug firms failed to perform satisfactorily. Nine of the companies, including leading ones such as Nicholas Piramal, Panacea and Glenmark did not score at all.
The Indian pharmaceutical companies are involved in patent litigations of a mere 40 drugs, out of the 135 known patent litigation drugs in the US. This is despite the claims by major Indian players such as Ranbaxy and Dr Reddy's at having secured over 20 first to file status abbreviated new drug applications with the US Food and Drug Administration.
Trade generic drugs (medicines that are sold directly through distributors) are fast becoming a key segment for domestic pharma firms as volume growth slows in the overall market. Big companies like Cipla and Alkem have a significant presence in the segment but recently, players like Torrent Pharmaceuticals and Dr Reddy's Laboratories (DRL) have also entered this market. What is driving big pharma's focus on trade generics? The volume growth in the Indian Pharma Market (IPM) has come down from 5.6 per cent in FY16 to 0.1 per cent in FY23.
Benchmark indices failed to hold on to early gains and closed in the red for the seventh straight session on Thursday, with participants remaining in wait-and-watch mode ahead of the RBI's interest rate decision. Unabated selling by foreign funds added to the pressure, though a modest recovery in the rupee cushioned the fall, traders said. After rallying in early trade, the 30-share BSE Sensex came under selling pressure in the afternoon session and closed 188.32 points or 0.33 per cent lower at 56,409.96.
Generic drug sales in the US, that power the business of such leading Indian drug manufacturers as Ranbaxy, Dr Reddy's, Sun Pharma, Lupin and Zydus Cadila, will face competition soon, as big US wholesalers decide to outsource their requirements from upcoming Indian manufacturers.
The R&D plan, focused on diseases affecting poor nations, is expected to be ready by 2008 and may benefit Indian drug firms and contract research organisations in a big way.
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 company has entered into a tie-up with the US-based FSC Laboratories as its authorised generic partner for FSC's hypertension medicine Isoptin SR (Verapamil SR) in the US.
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
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.
Alkem, the largest manufacturer of Fructo-Oligo Saccharides, which helps the growth of good probiotic bacteria, is planning to roll out more products in the national and global markets, said Sharad.
In comparison, Indian companies received only 23 out of 139 final approvals (16.54 per cent) in the corresponding period in 2006.
A recent court ruling in the US on allowing the declaratory judgment provision in the US patent law has come as a boost to Indian pharmaceutical companies such as Ranbaxy, Dr Reddy's, Sun Pharma and Lupin.
Ranbaxy is understood to have pulled out of the race to acquire German pharmaceutical company Merck's generic business on concerns of over-valuation.
Analysts feel this decision is yet another example of big-ticket acquisitions turning sour for Indian pharma firms, as happened in the case of Dr Reddy's acquisition of Betapharm of Germany for Rs 2,250 crore (Rs 22.5 billion).
As many as 15 companies across the world have lined up generic variants of Pfizer's Zoloft (Sertaline HCL), for which the exclusive six-month marketing period granted to the successful patent challenger, Teva of Israel, ends on Tuesday.
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.
Let's delve into India's T20I track record against Australia
This will be the largest M&A by an Indian firm, to be complete by January-end.
The booming real estate markets in the National Capital Region, Mumbai and Bangalore registered the highest global yields in 2003, according to the latest updates by Chesterton Meghraj, a global real estate consulting group.
Thirty stocks from various sectors form the Sensex.
Not too long ago, authorised generics were used by the big US-based pharmaceutical companies to thwart competition from makers of generic drugs
Participants will watch out for the Brexit poll outcome in the late morning trades tomorrow.
Only half India's population has received the first shot of Covishield and Covaxin and the government's immediate task is to first vaccinate its adult population before placing its focus on children.
This import duty exemption would remain in force till October 31 this year.
PowerGrid was the top loser in the Sensex pack, slumping over 4 per cent, followed by ONGC, IndusInd Bank, Kotak Bank, L&T, Asian Paints and Bajaj Auto. NSE Nifty tanked 258.40 points to 14,359.45.
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 Bharatiya Janata Party (BJP) held the core group meeting of five states on Saturday at the party headquarters in New Delhi.
On June 19 evening, Upasana was admitted to the Apollo Hospital in Jubilee Hills, Hyderabad.
Amazon Web Services (AWS) will invest nearly $4.4 billion (Rs 36,000 crore) in India by 2030 and support more than 48,000 jobs externally through a new regional service launched on Tuesday, said the on-demand Cloud computing company. AWS Asia Pacific (Hyderabad) is the company's second infrastructure region in India, six years after it opened its first Cloud region in Mumbai in 2016. The Hyderabad region will give customers access to AWS technologies for data analytics, security, machine learning, and artificial intelligence.
Karnataka Chief Minister B S Yeddyurappa on Friday called on Governor H R Bhardwaj, who is gunning for the removal of Reddy brothers from the state ministry, and conveyed the government's stand against a CBI inquiry into the illegal mining scam at this stage.