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You are here: Home / Archives for Dr.Manoj Karwa

Ethics Committee Accreditation and Registration in India: Introduction

June 7, 2017 By Dr.Manoj Karwa Leave a Comment

There are around 1200 registered independent and institutional ethics committees. All registered ethics committees have to go through accreditation process which was introduced recently by NABH and responsibility is assigned to quality council of India (QCI) to accredit all registered ethics committees in India. The ethics committee should review and accord its approval to a […]

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DTAB recommends not using vegetarian indicator on cellulose capsules and prohibits use of PET bottles for packaging pharmaceutical drugs

June 8, 2016 By Dr.Manoj Karwa Leave a Comment

In the 71st meeting of the Drugs Technical Advisory Board (DTAB) recommended that there is no need to indicate vegetarian on cellulose based capsules. They also recommended prohibiting the use PET/ plastic bottles for primary packaging of certain liquid drug formulations. At the minutes of meeting there was an agenda to consider the proposal and […]

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A report by AIIH&PH on the use of PET or plastic bottles for packaging of pharmaceutical preparations, soft drinks and alcohol

June 8, 2016 By Dr.Manoj Karwa Leave a Comment

Plastic bottles are used on a large scale for packaging of liquid products like water, soft drinks, cooking oils, cosmetic products like shampoo, pharmaceutical preparations and many other products. Plastic has become popular because it is lightweight, has superior resistance to breakage and relatively low production and transportation costs besides it provides ease of transportation […]

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Arbro Pharma & Auriga Research Exhibiting in ASIA LABEX 2015

August 19, 2015 By Dr.Manoj Karwa Leave a Comment

ASIA LABEX 2015 is a Premiere Exhibition and Conference for Analytical, Diagnostic, Laboratory, Biotechnology, Research and Testing Instruments and Consumables. Asia Labex has organized the event with the aim of bringing together professionals and stakeholders under one roof. All large and small laboratories and other testing units will have the opportunity to showcase their competencies. Delhi […]

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Conference on Challenges in Design and Conduct of Clinical Trials of Medical Devices

July 15, 2015 By Dr.Manoj Karwa Leave a Comment

Conference on Challenges in Design and Conduct of Clinical Trials of Medical Devices 22nd August, 2015 (Saturday) Venue – Jamia Hamdard, Convention Center, Delhi Timing – 8:30 am to 5:30 pm Chief Guest: Dr. S. Eswara Reddy, Joint Drugs Controller (India), CDSCO Medical device is a 1 trillion US dollars market all over the world. Though we have […]

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Great News! Auriga BE Center is now approved by NPCB, Malaysia

March 20, 2015 By Dr.Manoj Karwa Leave a Comment

We are excited to share with you that our Bioequivalence (BE) center has been approved by NPCB (National Pharmaceutical Control Bureau), Ministry of Health Malaysia. We are one of only five BE centers in India having approval from NPCB, Malaysia. Here is the link of their website with details of approval. http://portal.bpfk.gov.my/index.cfm?&menuid=31&parentid=82&highlightid=78 As Malaysia is […]

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Conference on Accreditation of Sites, Investigators and Ethics Committees

March 18, 2015 By Dr.Manoj Karwa Leave a Comment

Conference on Accreditation of Sites, Investigators and Ethics Committees – 17th Apr 2015 Workshop on Causality Assessment for Clinical Trials in the Indian Scenario – 18th Apr 2015 Venue – Hotel Royal Orchid Central, Gurgaon Timing – 9:00 am to 5:00 pm (Both the days) In the last 3 years, the Clinical Research industry of […]

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Free e-Course : Regulation on Medical Devices and Diagnostic Kits in India

January 6, 2015 By Dr.Manoj Karwa Leave a Comment

Regulatory Authority that governs the regulations of Registration and Import of medical devices in India is Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India , FDA Bhavan, ITO, Kotla Road, New Delhi -110002 Phone: 91-11-23236965 / 23236975, Fax: 91-11-23236973, […]

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Webinar on CTD Dossier- Expected CMC Queries and Things to Remember

May 23, 2014 By Dr.Manoj Karwa Leave a Comment

Reserve your spot now! Wednesday, June 4, 2014 @ 3:00 PM IST Regulatory approval timelines can be reduced significantly by submitting a quality dossier to the Health Agencies. It is important to understand the expectations of the respective Agency while compiling the dossier in order to reduce the number of queries and inturn the approval […]

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Webinar on Current Regulatory Landscape for Clinical Trials in India

April 24, 2014 By Dr.Manoj Karwa Leave a Comment

Regulatory requirements for conducting clinical trials in India have rapidly evolved and become very stringent with the introduction various requirements such as SAEs reporting timelines, compensation guideline, and mandatory audio-video recording of consent for all clinical trials. Sponsors, investigators, CROs and all stakeholders need to understand these recent requirements and ensure compliance to these requirements. […]

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News

  • CIIE, Shanghai, China (5th-10th November 2019) Booth No M5, at Hall 7.1 H
  • Ethics Committee Accreditation and Registration in India: Introduction
  • DTAB recommends not using vegetarian indicator on cellulose capsules and prohibits use of PET bottles for packaging pharmaceutical drugs
  • A report by AIIH&PH on the use of PET or plastic bottles for packaging of pharmaceutical preparations, soft drinks and alcohol
  • Arbro Pharma & Auriga Research Exhibiting in ASIA LABEX 2015
  • Conference on Challenges in Design and Conduct of Clinical Trials of Medical Devices
  • Great News! Auriga BE Center is now approved by NPCB, Malaysia
  • Conference on Accreditation of Sites, Investigators and Ethics Committees
  • Free e-Course : Regulation on Medical Devices and Diagnostic Kits in India
  • Webinar on Clinical Trial Insurance in Current Perspective of Compensation Requirements in India

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Approved Drugs Clinical Research Compensation Dcgi Drug Approved Drug List Fdcs Fixed Dose Combination Informed Consent Process Not Approved Webinar

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