Rise in input costs, inventory write-off, and pricing pressures led to a drop in gross margins. Higher competitive pressures led to cuts in operating profit margins and earnings estimates for FY24 and FY25. Most brokerages have a 'neutral' or a 'reduce' rating on the stock on account of valuations.
These things are cheaper than equivalent branded drugs, to patients, says Modi
Indian pharmaceutical companies, which are increasingly choosing to settle patent litigation with global drug majors in the US, would have to be more cautious now.
Health economist and advisor to the High-Level Expert Group on Universal Health Care, S Selvaraj says that tackling lack of doctors in India will take time to sort out, but providing free drugs can be done immediately.
'The deaths of the children in the Gambia would batter India's reputation as the developing world's pharmacy.'
Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
In an exclusive interview with PTI video, the minister also said an extensive risk-based analysis is done continuously to ensure the production of quality medicines in the country, and the government and regulators are always alert to ensure that no one dies due to spurious medicines.
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.
Negotiations for a trade deal between India and the UK have run into fresh controversy, after the proposals under a leaked chapter of the deal on intellectual property (IP) are believed to put access to affordable, lifesaving generic medicines from India at risk. According to the draft IP chapter put out by an international trade portal bilaterals.org, the UK is seeking continuous extension of patent period and rights through small tweaks in the drug, known as evergreening. This may prevent patents from expiring, impacting cheaper drug availability and its production by Indian generic drug manufacturers.
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.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
Once a difficult market to crack, in recent years, China has relatively opened up its drug market, enacting reforms and speeding up approval time.
'With Trump, the relationship was very transactional, whereas with President Biden it is very structured.'
USFDA has extended the timeline for granting tentative approval to generic drug applications filed under Para IV of its rules by 10 months.
The US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products
Insurers may be burning their fingers in urban health portfolios for some time now, but the government's rural healthcare initiatives, including its decision to provide free generic drugs to public hospitals, are set to offer fresh avenues of growth for them.
Dying To Survive, on its way to becoming China's biggest box office hit, may compel the Xi Jinping government to change its policy towards Indian pharmaceutical companies, says Tarun Vijay.
Yoga guru Ramdev, who had said he does not need the Covid vaccine as he has protection of yoga and Ayurveda, on Thursday did a somersault, saying he will soon get the jab and described doctors as 'God's envoys on earth'.
India and Brazil raised a trade dispute against the European Union before the World Trade Organization on Tuesday over seizure of generic drugs by EU member countries on high seas.
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.
Competition in the US pharmaceutical market swelled in recent years, with increasing generic penetration.
An end to Sun Pharma founder Dilip Shanghvi's woes are not in sight.
The Melbourne-headquartered Generic Health markets generic prescription and over-the-counter products in the Australian market, in a partnership model with established global generic drug makers. The company sells approximately $500 million (nearly Rs 2,150 crore) worth of drugs in Australia, which has Rs 11,300 crore (A$3 billion) worth generics market. The total drug market in Australia is worth A$10 billion (Rs37,800 crore).
Last year, the USFDA had banned 30 generic drugs produced at Ranbaxy's plants at Poanta Sahib.
Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics
The Indian major is eyeing German Merck's generic drug business.
Keeping its word to make drugs affordable to consumers, the government on Thursday announced caps on margins on the sale of pharmaceutical products.
Sun Pharmaceutical, which is growing its dermatology and ophthalmic specialty business in the US will spend $460 million on R&D.
Some Indian generic drugmakers are, however, uncertain about the pace of approvals in the near future.
The fees for facility inspection of foreign companies have been reduced
Despite unprecedented levels of uncertainty in Samvat 2077, investors have little to complain about on the returns front. The BSE Sensex delivered returns of 38 per cent in this period, while the Nifty registered a return of over 40 per cent. As is the case in bull markets, companies in the small- and mid-capitalisation basket outperformed the benchmarks, with returns almost twice those of frontliners.
Weak scientific capabilities, lack of desire to advance knowledge, and regulatory uncertainty are some of the hurdles Indian drug companies face, says Chirantan Chatterjee.
Sun Pharmaceutical said Ranbaxy shareholders will get 0.8 Sun Pharma shares for each Ranbaxy share.
As marketing rights for off-patent drugs in the US become less exclusive, companies are scrambling for fresh strategies to make up for the revenue loss.
In May this year, Ranbaxy had pleaded guilty to 'felony charges' for violating manufacturing norms and agreed to pay $500 million penalty to US authorities.
Ranbaxy's troubled plants in India could see a turnaround as Sun Pharma has experience in doing so.
Large pharmaceutical firms feel that if the quality parameters and assurance levels are brought up to the level of branded generics, then Jan Aushadhi medicines would find it difficult to retain their affordability.
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