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    Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (21 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes Electronic Platform to Monitor Drug Supply Chain The Indian government is proposing to create an electronic platform to monitor the drug supply chain. Officials want all manufacturers, distributors and pharmacies to register on the platform and upload details of batches they supply and receive in an attempt to raise drug standards in India. India’s Mini...
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    New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India

    The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March. The letter for Talegaon Dabhade, India-based Badrivishal follows a three-day inspection from last August in which FDA uncovered that the site’s water purification system was not adequately monitored and controlled. FDA investigators also found...
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    Asia Regulatory Roundup: India Applies Price Controls on Stents (21 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Prevalence of Substandard Drugs in India’s Supply Chain Prompts Regulatory Proposals The Indian Ministry of Health has recommended increasing regulatory oversight of government facilities after a survey found 10% of drugs in the state supply chain are substandard. That figure is seven percentage points higher than at retail outlets, raising concerns the government is ...
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    CDRH and CDER Send Warning Letters to Six Asian Companies

    The flurry of US Food and Drug Administration (FDA) warning letters continued on Tuesday with the release of six new warning letters for pharmaceutical and medical device companies in China, India, Taiwan and Japan. The most recent letter, sent from FDA’s Center for Drug Evaluation and Research (CDER) to Bangalore, India-based active pharmaceutical ingredient (API) manufacturer Resonance Laboratories on 3 February, following a four-day inspection last May, says in...
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    Asia Regulatory Roundup: India Asks China to Expedite GMP Inspection to Resolve a Drug Shortage (14 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Asks China to Expedite GMP Inspections, Resolving Essential Medicine Shortage India has resolved the shortage of a rare disease drug after asking China to expedite the inspection of a manufacturer of active pharmaceutical ingredients (APIs). The Drug Controller General of India (DCGI) made the cross-border intervention to accelerate the resumption of API supply ...
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    Asia Regulatory Roundup: India Adopts New Medical Device Regulations (7 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Medical Device Rules, Marking Long-Sought Split From Drug Regulation India has finalized its long-awaited medical device rules. The legislation is set to ease regulation of medical device manufacturing and development by freeing the industry from rules designed for the pharmaceutical sector. Until now, a lack of dedicated regulations covering the majori...
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    Do FDA’s Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown

    A new Government Accountability Office (GAO) report offers some good news and some bad news for the US Food and Drug Administration’s (FDA) foreign offices: The good news is that foreign inspections of drug, medical device and food manufacturing sites are increasing year over year, but the bad news is that FDA has yet to determine whether these foreign offices meaningfully contribute to US drug safety. Back in 2008, FDA opened its first foreign offices as part of its res...
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    Asia Regulatory Roundup: India Adopts Risk-Based Approach to Biologic Licenses (20 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Risk-Based Approach to Biologic Licenses, Ending Mandatory Inspections The Drug Controller General of India (DCGI) has scrapped the need for manufacturers to undergo a joint inspection before receiving certain biologics licenses. Instead of conducting pre-approval visits, Indian regulators will award Form 29 licenses within three days of receiving applications ...
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    FDA Warns Chinese Heparin Manufacturer, Reigniting Questions of Contamination

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to a China-based manufacturer of heparin—the same manufacturer warned by French regulators last March. The letter says the company used crude heparin batches that potentially were out of specification (OOS) to manufacture heparin sodium for the US market and shows that previous issues related to heparin sourced from Chinese active pharmaceutical ingredient (API) manufac...
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    FDA Finalizes Contract Manufacturer Quality Arrangement Guidance From 2013

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on contract manufacturer quality agreements. FDA said the differences between the draft from May 2013 and the final guidance focus on areas that needed to be clarified. “In particular, our revisions clarified the scope and applicability of the guidance and key terms used in the guidance. Regarding scope and applicability, we have clarified that the guidance is limited to commercial manufacturing...
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    Asia Regulatory Roundup: India Looks to Meet WHO Standards for GMPs (11 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes to Bring GMPs up to WHO Standard, Scrap Need to Renew Licenses The Drug Controller General of India (DCGI) is proposing to bring the country’s good manufacturing practices (GMPs) up to the standard set by the World Health Organization (WHO). DCGI Dr. GN Singh unveiled the proposal alongside plans to end the need for manufacturers, sellers and testers of ...
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    EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection

    A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators. Pfizer decided to temporarily suspend operations at the site earlier this month and MHRA is now calling on EU member states’ National Competent Authorities to evaluate how ...