Pharmaceuticals
Mankind gets CDSCO nod for Phase 1 clinical trials for molecule to treat autoimmune disorders
Mankind Pharma has received CDSCO approval to begin Phase 1 clinical trials for MKP11093, a molecule targeting multiple autoimmune disorders like rheumatoid arthritis and ulcerative colitis. Preclinical studies have demonstrated promising safety and selectivity for the drug. The trial will assess the drug's safety, tolerability, and pharmacokinetics in healthy volunteers.
AstraZeneca to invest Rs 176 cr to expand GITC in Chennai
AstraZeneca is investing Rs 176 crore to expand its Global Innovation & Technology Centre in Chennai, marking its third investment in India in two years. This expansion will enhance the center's capabilities in AI, data analytics, and machine learning, supporting the development of next-generation medicines and digital healthcare solutions.
USFDA issues Form 483 with 8 observations to Aurobindo's Telangana unit
Aurobindo Pharma faces scrutiny. The US FDA inspected its Bachupally, Telangana plant. The inspection occurred between August 25 and September 5. Following the inspection, the US FDA issued a Form 483. The form contained eight observations. Aurobindo Pharma stated the observations are procedural. The company plans to respond to the US FDA within the given timeframe.
Glenmark initiates multi-nation Phase 3 clinical trial for lung cancer drug
Glenmark Pharmaceuticals has commenced a Phase 3 clinical trial across multiple countries, including India, Russia, Brazil, and Mexico, for Envafolimab, a novel drug targeting third-stage non-small cell lung cancer (NSCLC). The trial aims to evaluate the drug's efficacy, safety, and other key parameters in NSCLC patients.
Pharma companies cheer lower drug prices, API tax gap stirs worry
Goods and Services Tax reforms are expected to reduce medicine prices in India. Experts say this will benefit patients and businesses. However, concerns exist regarding the higher tax rate on Active Pharmaceutical Ingredients. This could increase working capital pressure, especially for smaller companies. Provisional refunds may help mitigate these challenges. The government has reduced GST on several expensive medicines.
Zydus ties up with Synthon BV for multiple sclerosis drug launch in US
Zydus Lifesciences will launch a generic drug for multiple sclerosis in the United States. This is through a partnership with Synthon BV. Their subsidiary, Zydus Lifesciences Global FZE, has an agreement with Synthon. Synthon will handle regulatory approval and manufacturing. Zydus will manage the commercialization in the US. The market for this drug is estimated at USD 637 million.
India's drug regulator eyes lighter oversight, more AI to boost efficiency
India's drug regulator is set to streamline processes by establishing fixed approval timelines and exploring the use of artificial intelligence to enhance efficiency. The aim is to lighten regulations while strengthening execution, as stated by the Central Drugs Standard Control Organisation's chief.
GST cut on drugs, medical devices to provide relief to patients: Industry players
The government is reducing GST on medicines and medical devices. Lifesaving drugs are exempt. This action will help patients and families. It will also make healthcare more affordable. Sudarshan Jain and Anil Matai welcome the changes. Ameera Shah and Shobana Kamineni also support the move. Himanshu Baid says it will improve access to medical technologies.
Crucial drugs to be more affordable after GST cut
The government has significantly reduced GST rates on 41 highly priced medicines, including those for cancer, rare diseases, and heart conditions, aiming to make healthcare more affordable. Key drugs like Risdiplam and daratumumab will now have zero GST, benefiting patients with spinal muscular atrophy and multiple myeloma.
Centre set to amend rules to simplify drug testing process
The Indian government is amending drug regulations to expedite the approval process for clinical trials and bioavailability/bioequivalence studies. These changes aim to reduce the statutory processing time for test license applications from 90 to 45 days. By simplifying procedures and reducing the number of license applications, the government anticipates faster drug development and approval, benefiting stakeholders and optimizing resource allocation.
Must Watch
Singapore-based firm proposes to acquire 25% in Welcure Drugs & Pharma
Welcure Drugs & Pharmaceuticals receives an offer from Telexcell Trade. Telexcell Trade, based in Singapore, plans to acquire a 25 per cent stake. The indicative price is Rs 20 per share. This investment aims to expand Welcure's global presence. The all-cash investment is estimated at Rs 52 crore. Welcure intends to invest in an agro-pharma research lab.
Lupin gets USFDA nod for generic risperidone extended-release injectable suspension
Lupin Ltd. secured USFDA approval for its generic risperidone extended-release injectable suspension, a treatment for schizophrenia and bipolar disorder. This marks Lupin's first product utilizing Nanomi BV's technology, benefiting from 180-day competitive generic therapies exclusivity. The drug, with estimated annual sales of USD 190 million, expands access to complex injectables for patients globally.
Caplin Point arm gets USFDA nod for milrinone lactate in 5 pc dextrose injection
Caplin Point Laboratories' arm, Caplin Steriles, secured USFDA approval for its generic milrinone lactate in 5% dextrose injection. Indicated for acute decompensated heart failure, the injection is a generic version of Sanofi Aventis' PRIMACOR. The US market for this injection reached approximately USD 11 million in sales for the year ending July 2025.
Medical device manufacturers allowed to give free samples
Medical device companies in New Delhi can now give doctors free samples. There are rules for this. The sample's price must match what stockists pay. If the company bought the sample, that price counts. Company CEOs must ensure code compliance. Marketing costs must be disclosed yearly. This promotes ethical marketing and benefits both manufacturers and patients in India.
India eyes Russia, Brazil, Netherlands for pharma export growth as US tariffs concerns linger
India is strategically planning to boost its pharmaceutical exports to Russia, the Netherlands, and Brazil, aiming to reduce reliance on the U.S. market due to tariff concerns. While the U.S. remains a crucial market, India seeks to diversify its export chain and increase market share in these growing regions.
Glenmark launches generic cancer treatment drug in US
Glenmark Pharmaceuticals on Tuesday launched Eribulin Mesylate Injection, a generic cancer treatment, in the US through its subsidiary Glenmark Pharmaceuticals Inc., USA. The product, equivalent to Eisai’s Halaven Injection, will begin distribution this month.
