Pharmaceuticals
Wockhardt aims to launch antibiotic with USD 25 bn mkt potential by early FY26
With strong financial backing and successful research, Wockhardt is poised for the launch of Zaynich, an antibiotic targeting high resistance levels globally. The company's strategic pricing and partnership approaches enhance its market penetration, setting the stage for a significant impact on the pharmaceutical industry.
India to make drugs for diabetes, obesity under PLI by 2026, says report
India plans to incentivize local manufacturing of GLP-1 drugs, crucial for treating diabetes and obesity, starting in 2026, as per a government official speaking to Reuters. These drugs, originally approved for diabetes treatment, are also used for obesity due to their ability to slow digestion and reduce appetite. Novo Nordisk's patent on semaglutide, a key ingredient in popular drugs like Wegovy and Ozempic, is set to expire in India by 2026. Indian companies are already preparing to manufacture these drugs under the government's production-linked incentive (PLI) scheme.
Risk-based audits of drug units to begin from July 1
The revised Schedule M, which is considered more stringent than the World Health Organization's (WHO) good manufacturing practices (GMP) in certain areas, was notified on December 28, 2023. Companies with turnover of over ₹250 crore will have to comply with the upgraded version of Schedule M, starting July 1, and the remaining others, which are largely micro, small, and medium enterprises (MSMEs), have been given a year's time to comply. Inspections on those firms will begin from January 1, 2025.
Indian regulator says 36% of inspected drug-making units had to be shut
India's drug regulator has ordered the closure of over 36% of its 400 drug manufacturing units since last year due to concerns over sub-standard cough syrups. The country, known as the world's pharmacy due to its large drug production, is working to restore confidence after the deaths of over 300 children worldwide linked to these syrups.
Indian Pharma exports: 'USD 10 billion opportunity up for grabs in off patent drug market by 2029'
A senior official of the Pharmexcil said drugs such as Merck's Pembrolizumab (Keytruda) whose revenue were at USD 25 billion and Bristol-Myers Squibb's Eliquis (Apixaban)-USD 12 billion, among others would be off-patented in the next few years.
India pharma units fare better in US checks in 2023
The drug regulator United States Food and Drug Administration (USFDA) has classified 13%, or 19 out of 145 inspections it carried out against Indian facilities, as Official Action Indication (OAI) in 2023, which is lower than the global average of 15% OAIs, according to a report by Indian Pharmaceutical Alliance and McKinsey & Company said.
Dr Reddy's to buy nicotine replacement brands from UK-based Haleon for $632 million
The portfolio to be acquired consists of Nicotinell, a global leader in the NRT category with an extensive footprint in over 30 countries spanning Europe, Asia including Japan, and Latin America, and local market-leading brand names of the product – Nicabate in Australia, Thrive in Canada, and Habitrol in New Zealand and Canada. The proposed acquisition will be inclusive of all formats such as lozenge, patch, gum as well as pipeline products, in all applicable global markets outside of the US.
Jubilant Pharmova's US arm prepays Rs 626 crore term loan
Jubilant Pharmova's US subsidiary secured a $75 million term loan, as of March 31, 2024, the company's gross debt stood at Rs. 3,414 crore and net debt at Rs. 2,457 crore. In FY24, the company reported revenue of Rs. 6,772 crore and a net profit of Rs. 195 crore. The net debt to Ebitda ratio improved from 2.93x to 2.48x.
US lawmakers questions FDAs drug inspection programme in India and China
Three top American lawmakers have raised concerns about the FDA's foreign drug inspection program in India and China. In a letter to FDA Commissioner Robert Califf, they highlighted inconsistencies in inspection outcomes from January 2014 to April 2024. Some inspectors reported no compliance issues in numerous inspections, while others found issues in almost every inspection. The lawmakers, Cathy McMorris Rodgers, Brett Guthrie, and Morgan Griffith, pointed out these discrepancies and called for an investigation into the skill and thoroughness of FDA inspectors to ensure rigorous and consistent inspections.
Government considers ban on two antibiotics
The government is considering banning the production, import, and distribution of chloramphenicol and nitrofurans antibiotics used in food-producing animal rearing systems, due to misuse in poultry and animal feed supplements.
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Jashvik Capital buys into Futura Surgicare
Jashvik Capital, an India-based private equity firm, has acquired a minority stake in Futura Surgicare, a Bangalore-based medical products, consumables, and devices player, founded by A.D. Setty in 1994. Futura Surgicare is a leading Indian manufacturer of wound closure and surgical consumables and devices, with a manufacturing facility in Bangalore and a wide market presence in India and globally.
Sun Pharma completes merger of Taro
As part of this merger, Sun Pharma acquired all outstanding ordinary shares of Taro other than the shares already held by Sun Pharma or its affiliates. As a result of the merger, Taro will be delisted from the NYSE and it becomes a privately held company 100% owned by Sun Pharma.
High costs of orphan drugs: Patients pay the price for policy hurdles in India
India manufactures APIs for over 400 FDA-approved orphan drugs, but patients face high costs due to Indian pharmaceutical companies' reluctance to develop these drugs domestically.
Biocon Biologics gets EMA nod to produce biosimilar Bevacizumab at Bengaluru plant
Biocon Biologics received EMA approval to manufacture biosimilar Bevacizumab in Bengaluru, providing additional capacity to address patients' needs in Europe for treating cancer. The Bengaluru facility was also approved for biosimilar Trastuzumab manufacturing. EMA renewed GMP certificates for Biocon's facilities in Bengaluru and Malaysia. USFDA issued four observations after inspecting Biocon's Andhra Pradesh plant, concluding inspections on June 21, 2024.
Govt widens composition of drug, medical devices pricing reforms panel
The government has expanded a committee to look into pricing reforms for drugs and medical devices, including civil rights activists like All India Drug Action Network (AIDAN), Patient Safety and Access Initiative of India Foundation, and Medecins Sans Frontieres (MSF). The committee will evaluate availability and pricing of essential medicines, incentivize industry growth and exports, and consider a new Drug (Prices Control) Order (DPCO) as the current one is over a decade old.
Taller, stronger, sharper: Desi pharma is on a roll
The Avendus Capital report attributed the eye-catching growth of large Indian pharma brands to lifestyle diseases, prevalent quality issues that made doctors and customers rely more on big, well-known brands, along with aggressive sales and marketing push by pharma companies.
