Dear Well-Wishers,

I am elated to present to you this November 2016 edition of Oviya MedSafe’s newsletter which aims to provide a quick overview of the pharmacovigilance obligations of generic drug manufacturers/marketers who are holders of Abbreviated New Drug Applications (ANDAs) in the United States (US) and how we at Oviya MedSafe help such clients of ours comply with the relevant drug safety regulations of US Food & Drug Administration (FDA).

By definition, an ANDA is an application for approval of a generic drug in the US, for an existing licensed medication or approved drug, and contains data which when submitted to FDA, provides for the review and ultimate approval of the concerned generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

In order to gain FDA approval, a generic drug must:

– contain the same active ingredients as the innovator drug (inactive ingredients may vary);

– be identical in strength, dosage form, and route of administration;

– have the same use indications;

– be bioequivalent;

– meet the same batch requirements for identity, strength, purity, and quality; and

– be manufactured under the same strict standards of FDA’s Good Manufacturing Practice regulations required for innovator products.

Although animal/human data for safety or effectiveness need not be submitted as part of an ANDA, pharmacovigilance obligations for generic drugs are no different from those for FDA-approved innovated products. Hence, having a robust pharmacovigilance system in place is an indispensable prerequisite for any current or aspiring ANDA holder, irrespective of the number of ANDAs or the composition of the products.

The system, which can be either in-house or outsourced in full/part, should be backed by written procedures and have the means in place to collect safety information from all possible sources of spontaneous Adverse Drug Experience (ADE) reports such as Healthcare Professionals, Consumers, Literature, Regulatory Authorities and others, in compliance with 21CFR314.80 for small molecules and 21CFR600.80 for biologic products including vaccines.

ANDA holders need to perform the following pharmacovigilance activities on a regular basis for all their approved ANDAs irrespective of the marketing status of the ANDAs, in order to be able to fulfil their US pharmacovigilance obligations detailed in 21CFR314.80 and 21CFR600.80:

•Processing of all reported ADEs as Individual Case Safety Reports (ICSRs);

•Electronic reporting of 15 Day reports (serious & unexpected cases);

•Global literature monitoring for identifying valid ICSRs; and

•Preparation and submission of PADERs (quarterly for 3 years and annually thereafter).

Apart from the above, FDA may occasionally ask for Risk Evaluation and Mitigation Strategies (REMS) to be submitted in order to ensure that the benefits of a product outweigh its risks, if deemed required. FDA has the authority to inspect the site(s) at which the pharmacovigilance operations of the ANDA holder are carried out, regardless of their geographical location.

An important point that any ANDA holder has to bear in mind is that the FDA expects ADE reports associated with their products marketed not only in the US but from anywhere in the world to be submitted to FDA. Hence, lack of compliance in other markets has a direct implication on the US compliance status of the said ANDA holder. FDA may withdraw approval of the ANDA and prohibit continued marketing of the product in the US, if the ANDA holder fails to comply with their pharmacovigilance obligations. Given the scenario that possession of US ANDAs directly enhances the valuation of a pharmaceutical company, prudent pharmaceutical business houses would not risk their ANDAs by compromising on pharmacovigilance.

We at Oviya MedSafe, with our strong team of experienced pharmacovigilance professionals and proven expertise in deploying 21 CFR Part 11 compliant cost-effective drug safety software databases for multiple clients, are well-prepared to provide comprehensive pharmacovigilance coverage for ANDA holders seeking a pharmacovigilance service-provider. With our formidable track record of setting up drug safety systems and performing the routine pharmacovigilance activities for many small and medium sized clients including some of those for US FDA compliance, we are proud that Oviya MedSafe is seen by emerging pharmaceutical companies across the globe as their strategic pharmacovigilance partner to support their business expansion in the US market without fearing the burden of compliance.

While speaking of pharmacovigilance as a perceived ‘fearsome burden’ to the pharmaceutical industry, I, as a pharmacovigilance aficionado, always tend to disagree. This led me to position ‘Pharmacovigilance as a Value Addition to the Pharmaceutical Industry‘ during my talk of the same name at a conference earlier this year, which was subsequently featured in Oviya MedSafe’s September 2016 newsletter. Interestingly, this led Ms Viveka Roychowdhury, Editor of leading Indian pharmaceutical industry magazine Express Pharma, to invite me to develop my presentation into a full-fledged article which was eventually published on 20-Nov-2016 in the CPhI India special issue. Along with my QA colleague Mr Karunakaran Shanmugam who assisted me in articulating my thoughts on this topic, I have highlighted in this article the significance of pharmacovigilance for the pharmaceutical industry, beyond its ethical/moral commitment to Patient Safety. I hope you will find the article which is available online at to be of interest and look forward to your comments on its contents.

Waiting to connect with you soon through our December 2016 newsletter,

With thanks & regards,
Dr J Vijay Venkatraman

Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Coimbatore, India
Phone: +91-422-2444442

Oviya MedSafe UK Ltd,
London, UK
Phone: +44-8452-733839

Follow us on: FacebookGoogle PlusLinkedIn & Twitter

Leave a comment

Your email address will not be published. Required fields are marked *