Pharmaceuticals
USFDA pulls up Granules India for lapses in maintaining storage facilities, equipment at Telangana plant
The USFDA has issued a warning to Granules India for contamination and improper equipment maintenance at its Telangana facility. Inspectors found significant contamination, bird droppings, and torn CGMP records during their visit. The agency demands prompt corrective actions from the company to rectify these violations, emphasizing the need for effective oversight and improved quality systems.
Indian Pharmaceutical Alliance calls for zero import duty on US drugs to boost local industry
The Indian Pharmaceutical Alliance (IPA) has proposed reducing the import duty on pharma products from the US to zero. Currently, India imposes a 10% tariff on US drugs, but the US does not charge any import duty on Indian drugs. This suggestion aims to support the Indian pharma industry by lowering costs.
Surge in fake medicines in retail markets leaving druggists distraught: Traders' body
The All India Organisation of Chemists and Druggists (AIOCD) reports a 50% surge in counterfeit medicines post-COVID-19. Contributing factors include consumer preference for discounts, ineffective government regulations, and inadequate legal penalties for violators. Urgent intervention is required to address this public health threat.
AstraZeneca gets nod to import, sell hyperkalaemia treatment drug in India
AstraZeneca Pharma India Ltd has received approval from India's drug regulator to import and sell sodium zirconium cyclosilicate powder for treating hyperkalaemia in adults. This clearance enables the launch of Lokelma in India, contingent on obtaining related statutory approvals.
Clinical research entities asked to register by April 1
India's drug regulatory authority mandates all clinical research organisations to register through the SUGAM portal by April 1 to enhance transparency and accountability in the industry. This move aims to hasten clinical trials and create a comprehensive database of clinical research organisations, with India currently contributing just 3-4% to global trials, while China gains dominance.
Zydus Lifesciences launches breakthrough drug for transplant patients
Zydus Lifesciences introduces ANVIMO (Letermovir) for CMV prevention in transplant patients, offering a safer, better-tolerated alternative to traditional treatments. The new medication, made available at significantly reduced costs, aims to improve transplant outcomes and accessibility for Indian patients. Zydus' move marks a significant milestone in affordable post-transplant care.
Aurobindo unit terminates pact with Singapore firm to develop pentavalent vaccine
Aurobindo Pharma has terminated a license agreement through its subsidiary Auro Vaccines with Hilleman Laboratories for developing a pentavalent vaccine for children. The company asserted that this step would not materially affect its financial situation, as Auro Vaccines is not a crucial subsidiary. Despite this, Aurobindo Pharma shares rose 3.83% to Rs 1,092.05 on the BSE.
India set to introduce list of OTC drugs this month
India is set to receive a list of drugs transitioning to over-the-counter (OTC) status from prescription-only status soon. The committee responsible is finalizing the report to ensure public health is not at risk, with the report to be submitted to the Drugs Technical Authority Board shortly.
Senores Pharma to acquire 14 ANDAs from Dr Reddy's Laboratories
Senores Pharmaceuticals of Gujarat has signed an agreement to acquire 14 Abbreviated New Drug Applications from Dr Reddy's Laboratories. The acquisition, funded through IPO proceeds, includes 13 USFDA-approved ANDAs. This expands Senores' product offerings in the US and other regulated markets, addressing an opportunity worth USD 421 million.
Zydus to develop combination vaccine for shigellosis and typhoid
Zydus Lifesciences is set to develop a combination vaccine against shigellosis and typhoid with the Gates Foundation's support. The vaccine aims to protect children under five in regions where both diseases are prevalent. Early-stage development and studies are scheduled to begin in March 2025. Collaboration with partners leverages Zydus' expertise in creating high-quality, affordable vaccines.
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AstraZeneca Pharma India gets CDSCO approval to import, sell cancer treatment medicine
AstraZeneca Pharma India has received approval from CDSCO to import and distribute the cancer treatment drug Durvalumab solutions. This approval allows the marketing of Durvalumab in combination with Tremelimumab for treating unresectable hepatocellular carcinoma in India, pending related statutory approvals.
Sun Pharma aims to launch anti-obesity and type 2 diabetes drug Utreglutide in five years: Dilip Shanghvi
Sun Pharmaceutical, India's largest drugmaker by revenue, plans to launch its experimental anti-obesity and type 2 diabetes drug Utreglutide in the next four to five years, said Managing Director Dilip Shanghvi. The drug is a GLP-1 receptor agonist and has shown promising results in early trials. Sun Pharma is focusing on launching the drug in India and global markets.
Glenmark acquires Acetylcysteine injection, launches in US market
Glenmark Pharmaceuticals Ltd acquired the generic version of Acetylcysteine injection from Aspen Pharma USA Inc and launched it in the US market. The injection is used to treat acetaminophen overdose and is expected to have the same therapeutic effect as the listed drug Acetadote Injection.
Glenmark recalls 15 lakh bottles of ADHD medication in US: USFDA
Glenmark Pharmaceuticals is recalling around 14.76 lakh bottles of Atomoxetine Capsules due to detected CGMP deviations and the presence of N-Nitroso Atomoxetine impurity above FDA recommended limits. The recall is classified as Class II, indicating potential temporary or medically reversible adverse health consequences.
Reciprocal tariffs may make Indian generic drugs costlier in US: Pharma giants on Trump stance
Indian pharmaceutical industry leaders indicate that proposed US tariffs on pharmaceutical exports may lead to increased drug costs and potential shortages in the US. They argue that the tariffs might be absorbed by consumers and stress the significant cost savings that affordable Indian generics provide to the US healthcare system.
Tariffs should not dictate how Indian drugmakers do business, Cipla CEO says
Tariffs should not drive decisions at Indian drug companies despite potential U.S. import taxes, warns Cipla's CEO, as Trump suggests duties on pharmaceutical imports. Drugmakers like Sun Pharma and Dr Reddy's find relocating production to the U.S. impractical due to higher costs and insufficient capacity.
