Glenmark Pharmaceuticals is recalling 45,504 bottles of Ryaltris Nasal Spray and 11,568 tubes of Ciclopirox Gel in the US due to manufacturing defects, including a clogged dip tube and broken tube seals. The USFDA has classified the recalls as Class II and Class III respectively.
The PE firms are up against Dr Reddy’s, which has an alliance with Novartis for marketing some of its off-patent products and is also expected to bid. Alkem Labs is also in the fray. Novartis India has a market capitalisation of around ?2,500 crore though bids are likely to value it lower, as per those in the know. Non-binding bids are due later this month.
Wockhardt’s new antibiotic, Miqnaf, has received a favourable recommendation from the Central Drugs Standard Control Organisation for treating community-acquired bacterial pneumonia in adults. The drug offers a convenient, once-a-day, three-day treatment. This could lead to final approval by the DCGI, benefiting patients with multi-drug resistant infections. Wockhardt shares rose by 5 percent.
Novo Nordisk is broadening its Bengaluru operations by increasing senior leadership, doubling global process leaders in India, and boosting headcount by 16% next year. The company is also collaborating with Indian AI startups to improve efficiency, particularly for regulatory document checks. These moves aim to mirror their Denmark headquarters and enhance drug development.
A WHO-led team reviewed India’s vaccine regulatory system from September 16 to 20. The system was declared functional by meeting WHO’s global standards and benchmarks. India’s regulatory system has retained maturity level 3 with top marks in several functions. This achievement highlights India’s significant role in the global pharmaceutical industry.
Alkem Laboratories has partnered with US-based Sonnet BioTherapeutics to develop and commercialise a new drug ‘SON-080’ for diabetic peripheral neuropathy in India. The clinical development will be supported by Sonnet. Alkem holds exclusive rights for this drug in India. This agreement aims to boost treatment options for diabetic peripheral neuropathy patients.
Zydus Lifesciences has received the USFDA’s final approval to produce a generic version of Paliperidone extended-release tablets, which are used to treat schizophrenia and schizoaffective disorders. The approval covers strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg, with production set at the SEZ facility in Ahmedabad.
The Indian government has mandated QR codes on all vaccines to combat counterfeiting and ensure authenticity. The Drug Controller General of India indicated an aggressive campaign against non-compliance, supported by strict enforcement and prosecution measures. Future expansions include QR code implementation on more products.
India’s drug regulator has ordered the recall of around 45 medicines that did not meet quality norms, while action has been taken against makers of five spurious drugs. The CDSCO clarified that these were of substandard quality, not fake, only five identified as spurious.
India’s pharmaceutical and meditech exports continue to grow despite global economic slowdown, with robust double-digit growth. Government-backed drug development initiatives have 16 blockbuster molecules in the pipeline for cancer, diabetes, HIV, and more. The industry is also expanding in imaging devices, body implants, and diagnostics.
GlaxoSmithKline Pharma is shifting focus to specialty treatments and preventive healthcare, emphasizing adult vaccines and oncology in India. The company plans to innovate through new therapies and vaccines, maintaining competitive pricing, and aligning its portfolio with a global biopharma focus to enhance healthcare.
The government is likely to ban more fixed dose combinations (FDCs) this month. An expert committee found that these FDCs lack therapeutic justification and may pose risks to humans. This follows earlier bans on 156 FDCs, including antibiotics and painkillers, for similar reasons. The decision is based on recommendations from the Drug Technical Advisory Board.
ChrysCapital is finalizing a deal to acquire a 20% stake in HealthKart, valuing it at $450 million. Peak XV will sell their stake in the round, with ChrysCapital investing $90 million. HealthKart, a leading nutrition platform in India, has shown significant growth, reporting ₹832 crore in operating revenue for FY 2023.
Amneal Pharmaceuticals announces a significant investment of up to USD 200 million in India over the next four to five years. The funds will be used to build two new manufacturing facilities in Ahmedabad, focusing on peptide synthesis and advanced sterile fill-finish manufacturing.
Aurigene Oncology has announced promising phase-1 results for its novel CAR-T cell therapy, Ribrecabtagene autoleucel, in patients with multiple myeloma. All patients achieved clinical response, with no high-grade safety events reported. The Indian drug regulator has approved the commencement of a phase-2 trial.
India’s leading drug makers, through the Indian Pharmaceutical Alliance, have petitioned the Supreme Court to enable police and drug inspectors to investigate and prosecute counterfeit drug manufacturers. They argue that without proper enforcement and protection, the prevalence of counterfeit drugs has increased, affecting public health and India’s global pharmaceutical reputation.
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