DeclutterPharma

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...