DeclutterPharma

FDA Works to Speed Up Biosimilar Development and Reduce Drug Prices The FDA has announced new measures to accelerate the development of biosimilar medicines, which are lower-cost alternatives to biologic drugs. These updates include simplifying biosimilarity studies and reducing unnecessary clinical testing, aiming to make it easier for biosimilars to be developed as interchangeable with brand-name biologics. Expensive biologic medications account for a significant portion of U.S. drug spending. While the FDA has approved 76 biosimilars, their market share remains below 20%. The new guidance reduces the resource-intensive requirement for developers to conduct comparative human clinical studies, allowing them to rely more on analytical testing. This is based on the FDA's data since the first biosimilar approval in 2015. The FDA aims to promote competition in markets dominated by high-cost biologics and provide additional treatment options for conditions like cancer, rheumatoid a...

The Directorate General of Health Services has issued a directive regarding the monitoring of high-risk solvents in the pharmaceutical supply chain due to recent reports of cough syrup contamination with DEG.  A Digital Monitoring System has been established on the ONDLS ( Online National Drugs Licensing System  )  portal for this purpose.  All state and UT drug controllers are requested to direct pharma-grade solvent manufacturers to obtain manufacturing licenses through the ONDLS portal. Manufacturers already holding licenses must register and submit data.  Solvent manufacturers must also upload batch details, including quantity and vendor information, to the ONDLS portal. Compliance with these directions is mandatory to ensure no non-compliant batches are available in the market. Table of High-Risk Solvents News from DrugsControl Media Services: Here The USFDA has also taken note of issues arising in India and published the following information on its websi...

General Information: Facility: Hetero Labs Limited, Unit-IX, located in Narasapuram Village, Andhra Pradesh, India. Inspection Dates: 09/19-26/2025. Type of Establishment: API (Active Pharmaceutical Ingredient) Manufacturer. Key Observations: 1. Unregistered Testing Laboratory: The facility used an unregistered testing laboratory for API testing, which was not referenced in their Drug Master Files (DMFs). This laboratory was located away from the main facility. Finished API samples with matching batch numbers and dates were discovered, indicating collaboration with the unregistered lab. The firm did not have a quality agreement established with this unregistered testing facility conducting analysis on products manufactured by your firm. Multiple examples of API intermediate samples were found at the unregistered testing laboratory. Numerous uncontrolled notebook pages containing analytical test results for APIs and API intermediates manufactured at this facility were found in the ...

The FDA announced a new pilot program to prioritise the review of abbreviated new drug applications (ANDAs). This initiative aims to encourage investment in U.S. drug manufacturing, research, and development, while also strengthening the domestic pharmaceutical supply chain. The program will offer faster reviews for generic companies that manufacture and test their products in the U.S. Currently, over half of the pharmaceuticals used in the U.S. are manufactured overseas, and the U.S. relies heavily on foreign sources for active pharmaceutical ingredients (APIs). As of 2025, only 9% of API manufacturers are in the U.S., while China and India account for 22% and 44%, respectively. Additionally, pivotal studies for drugs, including bioequivalence testing, are increasingly performed outside the U.S., which weakens the country's pharmaceutical infrastructure. The FDA's pilot program incentivises U.S. generic drug manufacturing and testing. ANDA applicants who conduct bioequival...

The Central Drugs Standard Control Organisation issued a document on 15 September 2025 that clarifies the regulatory pathway for cocrystals in India. It addresses representations seeking clarity on the approval process for cocrystals. The document defines cocrystals as crystalline materials composed of two or more different molecules, typically an active pharmaceutical ingredient (API) and a coformer. It highlights the advantages of cocrystals, such as enhanced bioavailability, stability, and processability of APIs. The applicant must demonstrate that the physicochemical and pharmacokinetic properties of the cocrystal are superior to those of a physical mixture of the same chemical components. Characterisation methods like X-ray diffraction and spectroscopic analysis are used to define the cocrystal. If these criteria are met, it's considered a pharmaceutical cocrystal; otherwise, it's treated as a mixture. For cocrystals of already approved active substances, additional val...

AI Act Guide Version 1.1 – September 2025 The "AI Act Guide" offers an overview of the main aspects of the AI Act, a legal framework that regulates Artificial Intelligence (AI) within the European Union (EU). The guide aims to provide insights into the rules and regulations for organizations that develop, deploy, or use AI systems. It highlights that the legal text of the AI Act always overrides other considerations and encourages users to give feedback to improve future versions of the guide. Scope and Objectives of the AI Act: The AI Act aims to ensure the responsible development and use of AI, protecting the safety, health, and fundamental rights of individuals. It applies to businesses, governments, and other organisations operating within the EU. The regulations are being introduced in phases, with some prohibitions already in effect. Key Steps for Organisations: The guide outlines a four-step process for organisations to determine how the AI Act applies to them...

The Jan Vishwas (Amendment of Provisions) Bill, 2025 The Jan Vishwas (Amendment of Provisions) Bill, 2025, was introduced in the Lok Sabha on August 18, 2025. It aims to amend 17 central Acts to mainly decriminalise or rationalise certain offences and penalties. These include the Motor Vehicles Act, 1988; the Legal Metrology Act, 2009; the Apprentices Act, 1961; and the New Delhi Municipal Council Act, 1994. Specific Legislative Changes The gazette notification details changes to a wide array of laws. Here are some key examples: Reserve Bank of India Act, 1934: Amendments focus on offences by non-banking financial companies. Drugs and Cosmetics Act, 1940: Increases fines for certain offences. Central Silk Board Act, 1948: Reduces imprisonment for certain offences and increases monetary penalties. Road Transport Corporations Act, 1950: Replaces references to "punishable with fine" with "liable to a penalty." Tea Act, 1953: Introduces a warning system for first-t...

The report, published by the FDA's Centre for Drug Evaluation and Research and Office of Pharmaceutical Quality, dated July 2025, explores the economic and public health returns on investment (ROI) in quality management initiatives within the pharmaceutical industry. It argues that strategic investments in quality management not only improve efficiency and reduce costs for pharmaceutical manufacturers but also contribute significantly to public health by ensuring a reliable supply of medications and mitigating the impact of drug shortages. Introduction The report emphasises the importance of robust quality management as a key factor for business success, drawing from historical precedents in the electronic and automotive industries. It highlights the growing adoption of mature quality management practices in pharmaceutical manufacturing, driven by both business and patient-centric objectives. Economic Return on Investment (Part I) This section delves into the potential econom...

US FDA inspection observations for Dr. Reddy's Laboratories Limited General Information: Facility: Dr. Reddy's Laboratories Limited, located in Pydibhimavaram, Ransthalam, Andhra Pradesh, India. Inspection Dates: July 10, 2025 - July 18, 2025 Type of Establishment: Sterile Drug Manufacturer Report Issued To: Mr. Shailendra Jha, Site Head Summary of Observations: The FDA inspection revealed several observations related to the production and quality systems at Dr. Reddy's Laboratories Limited, indicating potential deviations from established regulations and guidelines. Observation 1: Microbiological Contamination Prevention Procedures designed to prevent microbiological contamination of drug products purporting to be sterile were not adequately written. Specifically, the SOP for cleaning a vial filling, stoppering, and sealing machine allows the use of non-sterile substances to clean surfaces. The SOP does not prohibit the introduction or use of non-sterile substances dur...

The USFDA released a document on 01 August 2025 outlining a Compliance Program for Drug Quality Assurance, with a focus on Active Pharmaceutical Ingredient (API) process inspections. The program aims to ensure that APIs are manufactured following Current Good Manufacturing Practice (CGMP) standards, thereby protecting the quality, identity, and purity of the drugs. Key Elements Purpose: To detail a risk-based inspection strategy for API manufacturing facilities, ensuring compliance with CGMP standards. Scope: Applies to the manufacturing of APIs for human drug products, including small molecules, polypeptides, antibiotics, and other APIs produced by chemical synthesis or microbial fermentation. Excludes APIs for blood, vaccines, allergenics, tissues, and cellular and gene therapies. Implementation Date: 09/02/2025 Revisions: Includes elements from the International Council for Harmonisation (ICH) guidances for industry, specifically Q9(R1) Quality Risk Management (May 2023), Q10 Ph...