Pharmacovigilance

Zydus Pharmacovigilance Philosophy

We at Zydus believe that patient safety is our prime concern, ahead of commercial or other interests. All medicines have potential risks as well as benefits. The aim of pharmacovigilance is to protect public health by identifying, evaluating and minimizing safety issues to ensure that the overall benefits of medicines outweigh the risks.

Adequately assessing product safety is essential to the success of all clinical research projects and diligent pharmacovigilance is essential for keeping products on the market. Drug Safety encompasses all aspects of drug reaction right from side effects, adverse effects, lack of efficacy, or any response reported once a medication is administered to a patient.

The Pharmacovigilance practice spans two key areas:

  • Clinical trials
  • Post marketing

Zydus is committed to continuously evaluating the benefit/risk profile of medicines for which policies are in place to detect and act on any side effects that may be associated with our medicines.

We have well-established and rigorous, global pharmacovigilance system in place to monitor the safety of approved medicines.

A centralised database called PVNet is being developed for global pharmacovigilance system.

     

Data Collection:
We mainly receive information on possible side effects of medicines from several sources including:

  • Spontaneous reports from health professionals, patients etc
  • Regulatory authorities
  • Scientific literature

We have local Pharmacovigilance personnel who are responsible for the collection of safety information and reporting the information to the Global Pharmacovigilance Cell. When necessary, further information is sought from individuals who have reported the potential side effect.

Case Processing:
These adverse event data are captured and coded using MedDRA through a sophisticated Safety database which helps us easy retrieval, data analysis and to accomplish Global Good Pharmacovigilance practices. After final medical evaluation, quality checks are deployed on the data being processed, the cause and effect relationship is confirmed. 

Regulatory Reporting:
Appropriate safety information is reported to relevant regulatory authorities in expedited manner in format required by regulatory or in periodic safety updates.

Action:
Information that changes the benefit/risk profile of a Zydus medicine will result in certain actions to characterise, communicate and minimise the risk. Proposed actions are discussed with regulatory authorities and can include modifying the prescribing information, communications to physicians and other healthcare providers and sometimes carrying out further clinical trials. In certain cases it may be appropriate to stop clinical trials or to withdraw the medicine from the market.

Training Policy:
We have set up training processes to ensure that all employees who are concerned with pharmacovigilance activity of Zydus are competent enough.

TO REPORT THE ADVERSE EVENT:

  • To report a adverse event occurred with Zydus drug

Click to open online fillable ADR reporting form

OR

Please download/request the Adverse Event Reporting Form, complete it, and send it to us in any one of the following ways:
(Click to download Adverse Event Reporting Form)

  • Submit the completed adverse event reporting form to the company representative
  • Fax the form on: 02717-666620          
  • Scan the form and email at drugsafety@zyduscadila.com
  • Courier the form at:
                   Global Pharmacovigilance cell
                   International Regulatory Affairs department
                   Zydus Cadila, PTC, Sarkej-Bavla N.H No 8A,
                   Moraiya, Tal: Sanand. Dist: Ahmedabad – 382210, India

OR

You can also obtain the adverse event reporting form from the company representative.

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