Pharmaceuticals
Glenmark, Dr Reddy's recall products in US: USFDA
Indian drugmakers Glenmark and Dr Reddy's Laboratories are recalling products in the United States. Glenmark is recalling oral contraceptive medication due to failed impurities. Dr Reddy's Laboratories is recalling muscle relaxant medication due to out-of-specification results. These recalls are initiated by the US Food and Drug Administration. India has many USFDA-compliant plants outside the US.
India develops first indigenously discovered antibiotic "Nafithromycin" effective against resistant respiratory infections
India has proudly introduced Nafithromycin, its first homegrown antibiotic, tackling stubborn respiratory infections with groundbreaking efficacy. Coupled with a significant leap in gene therapy for Haemophilia, these innovations underscore India's commitment to self-sufficiency in the pharmaceutical arena. The country is now embracing a model that fosters collaboration with the private sector, setting the stage for international acclaim in biomedical research.
Strides Founder raises Rs 1000 crore to refinance debt
Arun Kumar, founder of Strides Group and OneSource, has secured ₹1,000 crore by pledging shares. This move refinances existing loans, extending maturities and simplifying repayments. The transaction aims to consolidate smaller borrowings into larger, long-term facilities. It reflects a broader effort to clean up the promoter's balance sheet and shows a decline in pledged shares, indicating deleveraging.
Biocon Biologics expands collaboration with Civica to supply affordable insulin in US
Biocon Biologics is expanding its partnership with Civica. This new agreement will bring affordable Insulin Glargine to patients in the United States. Biocon Biologics will manufacture the insulin. Civica will then distribute and sell it under its own label. This move aims to improve access to essential diabetes medication for more people.
Roche Vs Natco: Supreme Court clears decks for launch of Natco Pharma's Risdiplam generic in India
The Supreme Court has allowed Natco Pharma to launch its generic version of the spinal muscular atrophy drug Risdiplam in India, dismissing F. Hoffmann-La Roche's appeal. The court upheld the Delhi High Court's decision, which prioritized public access to the life-saving medication at a significantly lower price.
Indian firms explore localisation of pharma production in Russia
The Russian market is attracting growing interest from Indian pharmaceutical companies exploring opportunities to establish production facilities across various regions of the country. This was announced by Moscow Government Minister and Head of the Department for External Economic and International Relations, Sergey Cheremin, during the " Russia-India. Mutual Efficiency" forum.
US Senator raises alarm over poor-quality drug imports from India and China, seeks tougher FDA inspections
In a letter to FDA Commissioner Martin Makary, Banks said the agency must "do more to protect the US drug supply," warning that lax oversight could endanger American consumers. He pointed out that inspections of foreign drug plants have not yet returned to pre-pandemic levels, even as the number of manufacturers continues to grow.
India to force drugmakers to upgrade plants after fatal cough syrup crisis
India has denied drugmakers more time to upgrade manufacturing facilities. This decision follows the deaths of at least 24 children from contaminated cough syrup. The government mandated World Health Organization standards after similar incidents abroad. Despite pleas from smaller firms, officials are firm on the deadline.
Alchem International moves Delhi HC against single-judge order on ‘Alchem’ trademark
Alchem International is challenging a court order that stops it from using its name. The order prevents Alchem from selling products with the name 'Alchem' due to similarity with Alkem Laboratories' trademark. A division bench is reviewing the case. The court previously found the names phonetically identical. Alkem has used its trademark since 1973. Alchem started using its mark later.
Under the scanner, yet generic cough syrups hit shelves
Worry is spreading regarding the multitude of cough syrup brands circulating in India, with alarming revelations of toxic diethylene glycol detected in some, resulting in heartbreaking instances of child mortality. This situation sheds light on the questionable efficacy of regulatory measures, as many small-scale producers evade scrutiny.
Must Watch
Lilly's weight-loss pill shows better blood sugar control in late-stage trials
Eli Lilly's experimental oral weight-loss drug, orforglipron, demonstrated superior blood sugar control in diabetic patients across two late-stage trials. The drug, designed to mimic the GLP-1 hormone, showed significant A1C reductions and weight loss, potentially setting a new standard of care for type 2 diabetes.
Centre plans new law for stricter quality checks and surveillance of drugs, medical devices, and cosmetics
India is creating a new law to improve drug quality and safety. This legislation will give more power to regulators for checking medicines, medical devices, and cosmetics. The aim is to prevent fake and substandard products. This move follows global concerns and recent incidents.
Centre to bring law for strict quality checks, surveillance of drugs and cosmetics
India is creating a new law to improve drug quality and safety. This legislation will give more power to regulators for testing and monitoring medicines, medical devices, and cosmetics. The aim is to ensure stricter compliance and accountability. This move follows global concerns and recent incidents.
CDSCO seeks views on level playing field for new drugs
In a significant shift for the pharmaceutical market, India's drug regulator is crafting new legislation regarding drug approvals. Under this proposal, the first entity to introduce a novel drug will be mandated to perform clinical trials, while subsequent entrants will be allowed to forego these tests.
Roche moves SC against Natco’s launch of generic Risdiplam in India
F. Hoffmann-La Roche AG has approached the Supreme Court. This follows a Delhi High Court decision permitting Natco Pharma to introduce a generic version of Risdiplam. Risdiplam treats spinal muscular atrophy. The High Court rejected Roche's plea to halt Natco's manufacturing. Natco plans to sell the drug at a significantly lower price.
India accuses Balaji Amines of making pharma-grade chemical without a drug-making licence
Balaji Amines faces accusations from Indian authorities for producing pharma-grade propylene glycol without a necessary drug manufacturing license. This comes after some batches were found to be substandard. The company states it only manufactured technical and food-grade PG for non-pharma clients. Investigations are ongoing, and the company's stock has seen a decline.
