• Regulatory NewsRegulatory News

    India's Supreme Court Denies Petitions Challenging CDSCO

    • 11 March 2016
    Dinesh Thakur, the now-famous Ranbaxy whistleblower who won more than $48 million for calling out the company’s drug safety issues to the US Department of Justice, failed on Friday to get the Supreme Court of India to hear two petitions seeking to challenge the law under which India’s drug regulator Central Drugs Standard Control Organization (CDSCO) operates. Thakur told Focus that the petitions “challenge how CDSCO works and the commitments it makes” to keeping subst...
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    FDA Begins Training Hundreds of Indian Regulators

    The push to get India’s pharmaceutical and medical device regulators up to speed with international norms and the US Food and Drug Administration’s (FDA) regulations is progressing with new cooperative training sessions. Recently, in Ahmedabad and Bengaluru, India, FDA officials conducted training sessions for about 200 Indian regulators, the majority of which were new inspectors, representing the Central Drugs Standards Control Organization (CDSCO) and some state drug c...
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    India’s CDSCO Warns Against Using Roche’s Avastin as Eye Treatment

    India’s Central Drugs Standards Control Organization (CDSCO) issued an alert Thursday notifying state and local authorities that Roche’s blockbuster drug Avastin has not been approved to treat any ophthalmology conditions and can lead to vision loss. The notice comes just two days after officials in two Indian states put sales of the cancer drug on hold after injections of the drug damaged the vision of 15 patients in the western state of Gujarat. According to Reuters, ...
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    Asia Regulatory Roundup: India Pushes Back Track and Trace Deadline Again (12 January 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Moves Back Deadline for Implementation of Track and Trace India has pushed back the deadline by which manufacturers must comply with aspects of its system to track and trace drug exports. Having originally set a deadline of July 2015, the government has now once again delayed the date on which the export monitoring system must be implemented. The Directorate Genera...
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    Asia Regulatory Roundup: China Looks to End Regional Variation in Trial Oversight (22 December 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Pushes to End Regional Variation in Strength of Clinical Trial Oversight The China Food and Drug Administration (CFDA) has committed to ending region-to-region variation in the strength of clinical trial oversight as it’s found that some regions are failing to comply with the more rigorous approach to clinical trial inspections and data quality. CFDA began its clam...
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    Asia Regulatory Roundup: CFDA Chips Away at Backlog of Applications (15 December 2015)

    Welcome to our Asia Regulatory Roundup, a weekly overview of the top regulatory news in Asia . Fresh Batch of Withdrawals and Rejections Chips Away at CFDA Backlog China Food and Drug Administration (CFDA) has wiped almost 150 drug filings from its backlog. Most of the applications were pulled by the companies themselves, with CFDA only actively rejecting 13 of the submissions. The withdrawals affected 131 filings by 82 companies. CFDA put pressure on companies ...
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    Asia Regulatory Roundup: CFDA Clampdown on Clinical Trial Data (17 November 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Trial Data Quality Drive Leads to Rejection of Applications China Food and Drug Administration (CFDA) has rejected 11 applications from eight manufacturers as part of its clampdown on the quality of clinical trial data included in submissions. The rejections come four months after CFDA began a drive to root out applications with incomplete or subpar data. None of the...
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    India’s CDSCO Offers Four New Updates to Promote Clinical Research

    India’s Central Drugs Standard Control Organization (CDSCO) issued four new circulars on Tuesday that all seek to help promote clinical research on the subcontinent. The new circulars come as pharmaceutical research in India has been on the decline in recent years. CDSCO approved 19 trials through the first four months of 2015, which compares with 76 trials approved through the first five months of 2014, and 24 approved over the same time in 2013. Academic Research ...
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    FDA Form 483s From India: A Deep Dive Into the Problems

    Untitled Document A Focus review (thanks to the Freedom of Information Act) of 50 Form 483s issued by the US Food and Drug Administration (FDA) to Indian pharmaceutical and active pharmaceutical ingredient (API) manufacturers over the past two years reveals a slew of detailed quality concerns from the agency. And although the products described in the 483s have been redacted, and a majority of the FDA observations are for relatively commonplace documentatio...
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    Asia Regulatory Roundup: India Looks to Raise Drug Inspection Standards (20 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CDSCO Creates Induction Program to Raise Standards at Inspectorate The Central Drugs Standard Control Organization (CDSCO) has set up an induction program to train assistant drug inspectors. A three-month training program, in which CDSCO will cover the regulatory framework in India and other topics, is the centerpiece of the induction strategy. CDSCO has introduced ...
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    MHRA, CDSCO Sign Agreement to Increase Regulatory Collaborations

    • 05 October 2015
    As more drugs and active pharmaceutical ingredients (APIs) are manufactured in India, foreign regulators are increasingly looking to strengthen relations with India's Central Drugs Standard Control Organisation (CDSCO). On Monday, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) did just that, signing a Memorandum of Understanding (MOU) with CDSCO, as part of plans to increase collaborations between the two countries to keep medicines and medical devic...
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    India Unveils New Online Submission System for Clinical Trials

    India's Central Drugs Standards Control Organization (CDSCO) has launched a new online submission system for clinical trials as part of efforts to increase transparency, accountability and efficiency in processing trial applications. CDSCO says the new online system will help in the collection and organization of information on sponsors, contract research organizations, investigators, ethics committees and trial subjects. The release of the submission system comes as...