• Feature ArticlesFeature Articles

    Draft National Medical Device Policy—2015: A Review and Analysis

    This article reviews the Draft National Medical Device Policy (NMDP-2015) proposed by the government of India and evaluates potential pros and cons of its most important feature. On 3 June 2015, the Indian government developed a draft National Medical Device Policy ( NMDP-2015 ), which was made public for review by all stakeholders. 1 The objective of NMDP—2015 is "to strengthen the Make in India drive, a government initiative to promote manufacturing sector in ...
  • Regulatory NewsRegulatory News

    House Committee Questions FDA Oversight of China, India Manufacturing Facilities

    Members of the House Committee on Energy and Commerce are calling on the Government Accountability Office (GAO) to investigate whether the US Food and Drug Administration (FDA) is properly overseeing the pharmaceutical supply chain, particularly in China and India. Reps. Fred Upton (R-MI), Frank Pallone (D-NJ), Tim Murphy (R-PA) and Diana DeGette (D-CO) acknowledge FDA’s work on meeting the rising demands of more foreign active pharmaceutical ingredient (API) and finishe...
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    Indian Regulators, Medical Device Associations Focus on New Guidelines, Increasing Exports

    India’s Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) met with medical device association representatives earlier this month to discuss how the country can become a hub for device manufacturing and begin to align with global regulations. According to the minutes of the meeting, most of the discussion centered on increasing device exports and evaluating new guidance for industry. Draft guidance on good manufactu...
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    Asia Regulatory Roundup: China Pushes to Improve Generic Drug Quality (8 December 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Releases Medical Device Adverse Event Reporting Form for Consultation The Indian Pharmacopoeia Commission (IPC) has released a medical device adverse event reporting form for consultation. IPC has drafted the template as part of the drive in India to establish a materiovigilance program to monitor the safety of medical devices. Once the form is finalized, filers o...
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    FDA Warns Sandoz, Dr. Reddy’s Indian Sites Over Data Integrity Violations

    Serious data integrity violations, including the backdating of records and failing to provide pertinent data to regulators, were included in warning letters for five manufacturing facilities from both Sandoz and Dr. Reddy’s in India, according to the US Food and Drug Administration (FDA). Both companies previously disclosed receiving the FDA warning letters in October and November, though the contents of the violations were not released until now. And like a number of ...
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    Asia Regulatory Roundup: China FDA Seeks Comment on Generic Drug Quality Guidance (24 November 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. FIA Remands 4 Senior Pakistani Officials in Fraudulent Drug Approval Case The Federal Investigation Agency (FIA) has remanded four senior officials at the Drug Regulatory Authority of Pakistan (DRAP). FIA took the action after investigating the alleged issuance of a fake drug registration letter for a treatment for premature ejaculation. DRAP’s deputy director general o...
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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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    Health Canada Overruled on Apotex Import Ban

    A Canadian federal court has ruled against Health Canada’s decision to restrict pharmaceutical imports from two Apotex facilities in India, though the US FDA still bans products from these facilities. In its ruling from 14 October, the court noted that Health Canada and Health Minister Rona Ambrose proceeded unfairly and acted for an improper purpose. The ruling also requested Health Canada and Ambrose retract its statements on Apotex, which they did Tuesday. And altho...
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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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    India Unveils New Guidelines for Clinical Research Involving Children

    India for the first time in its history has released comprehensive guidance related to the ethical specifics of biomedical research in neonates and children. The pragmatic guidelines from the Indian Council of Medical Research (ICMR) set out general principles that can be applied in most situations to cover the ethical and legal issues that researchers need to consider when carrying out such biomedical research. General Guidance First and foremost, the guidance calls f...