DeclutterPharma

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...

NDMA, also known as N-Nitrosodimethylamine, and other nitrosamines are significant concerns for the pharmaceutical industry. USFDA and other health agencies, especially in strict regulatory markets (SRM), require nitrosamine risk assessments in the dossiers submitted to the respective authorities.  Many countries have banned the drug products which would have the potential to form nitrosamines during the manufacturing process or storage. Ranitidine is one of them. CDSCO has also recently issued a circular on 12 July 2025. The circular can be found here .  The circular addresses concerns about NDMA impurity in Ranitidine. It informs State/UT Drug Controllers of recommendations from the Drugs Technical Advisory Board (DTAB), following a report by an expert committee.  The DTAB recommends forming a larger committee to examine all aspects of Ranitidine, the ICMR (Indian Council of Medical Research) conducting a safety assessment on NDMA impurity, and manufacturers monitoring ...

The Central Drugs Standard Control Organisation (CDSCO) in India outlines guidelines and procedures for obtaining permission to import drugs in bulk for non-medical uses. This process is managed through the SUGAM portal, an e-governance solution. The guidelines include circulars, annexures detailing required documents, guidance documents, and a user manual for the online system. Key Points from the Circular Streamlining the Process: CDSCO has streamlined the process for issuing Dual Use No Objection Certificates (NOCs) for drugs imported in bulk for non-medicinal use via the SUGAM portal, enhancing the ease of doing business. One-Year NOCs: To reduce compliance burdens, CDSCO has initiated the issuance of 1-year NOCs, subject to specific conditions for the drugs. Revised Checklist: The SUGAM checklist and related procedures have been revised, and a guidance document is attached. Online Submission: Applications for Dual Use NOCs must be submitted through the SUGAM portal with fresh r...