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    Indian Sites From Pfizer, Wockhardt Face Complications After GMP Inspections

    • 08 August 2016
    Pfizer and Wockhardt are struggling to keep pace with pharmaceutical good manufacturing practice (GMP) regulations as two recent inspections of their manufacturing sites in India resulted in a US ban for Wockhardt and a temporary suspension of the Pfizer site. For Pfizer, the inspection of its Chennai-based site, acquired as part of its $16 billion purchase of Hospira, was a joint effort for officials from four regulators: the US Food and Drug Administration (FDA), UK’s...
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    India Looks to Further Ease Process of Running Clinical Trials

    India’s Central Drugs Standard Control Organization (CDSCO) on Tuesday looked to relax two clinical trial requirements that could make it easier to run trials there. In two joint circulars – from CDSCO, the Directorate General of Health Services, the Ministry of Health and Family Welfare and signed by G.N. Singh, Drugs Controller General –  India will no longer stop trial investigators from conducting more than three trials at a time, and India will revise its requireme...
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    Asia Regulatory Roundup: CFDA Offers Guidance on Revised Vaccine Distribution Regulations (21 June 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guide to Implementing Revised Vaccine Distribution Regulations China Food and Drug Administration (CFDA) has released a guide to the implementation of its revised vaccine procurement and distribution regulations. The updated policy calls for vigilant record keeping by organizations in the supply chain and stronger regulatory oversight of each step in the pr...
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    Asia Regulatory Roundup: TGA Tweaks GMP Inspection Closeout Process (17 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Updates Process for Closeout of On-Site GMP Inspections Australia’s Therapeutic Goods Administration (TGA) has revised its process for handling the closeout of on-site good manufacturing practice (GMP) inspections. The updated process ends the practice of issuing close-out letters to manufacturers, with TGA choosing to communicate its closing messages in an inspection r...
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    FDA to Pharma Companies: Indian CRO’s Clinical and Bioanalytical Studies are Unacceptable

    Another day, another issue with data integrity. This time, however, the US Food and Drug Administration (FDA) is taking the issue one step further and notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Bangalore, India-based contract research organization (CRO) Semler Research are not acceptable as a result of data integrity concerns and need to be repeated. Following its r...
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    Asia Regulatory Roundup: CFDA Revises Guidance on Device Trials (29 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Introduces Revised Guidance on Clinical Trials of Medical Devices China Food and Drug Administration (CFDA) has introduced a good clinical practice (GCP) document covering medical devices. The text describes how CFDA expects sponsors and other organizations to handle aspects of medical device trials, from the initial preparations through to the maintenance of da...
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    India Releases New Biosimilars Guidance

    India’s Central Drugs Standard Control Organization on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India's regulators look to develop more specific guidance on postmarketing studies. The new document is a slight tweak of previous guidance issued in 2012 , but includes several important changes that are now up for discussion through 30 April. India's biosimilars market currently includes ei...
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    Asia Regulatory Roundup: India Reverses Opposition to Off-Label Ophthalmic Use of Avastin (15 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Reverses Opposition to Off-Label Ophthalmic Use of Avastin India has quickly reversed its opposition to the off-label ophthalmic use of Roche’s Avastin (bevacizumab).  Drug Controller General of India Dr. GN Singh warned against using Avastin in ophthalmology conditions in January after reports linking it to loss of vision emerged, only to withdraw the alert th...
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    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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    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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    FDA Warns Two Cadila Manufacturing Plants in India

    Just before the end of 2015, the US Food and Drug Administration (FDA) warned two Indian pharmaceutical manufacturing facilities from Cadila Healthcare for major good manufacturing practice (GMP) violations. The warning letter (not to be confused with the warning letter for another Indian manufacturer that goes by the name of Cadila Pharmaceuticals) caps a year of increased scrutiny for Indian drug manufacturers from FDA. Letter Details In particular, FDA found tha...