Patients Safety-Our Prime Motto

The safety of patients using Amazeal Life Science medicines is our highest priority.

Beginning with the discovery of a potential new drug and for as long as it is available to patients, our goal at Amazeal Life Science is to ensure that the benefits and risks of a medication are continuously monitored and well-understood by regulators, doctors and patients.

Amazeal Life Science maintains a system of collection and reporting of adverse events (AE) throughout the lifecycle of each marketed product. This system is designed to continually maintain and evaluate the product’s benefit/risk profile. When important safety issues arise, Amazeal communicates them to doctors, patients and regulatory agencies.

At Amazeal a team consisting of over 350 physicians, pharmacists, nurses, and other healthcare providers, are dedicated to the collection, monitoring, evaluation, and reporting of safety information.

Physician’s role in reporting of Adverse Events(AEs)

Why Report Adverse Events (AEs)?

  • Regulatory agencies and pharmaceutical manufacturers use a risk assessment and decision making process to preserve patient safety.
  • Once a product is on the market, it is still important to report adverse events. This ensures that we have the best information available to make decisions about benefit and risk for a specific patient. It is important for physicians to try and collect all available information when an adverse event is first reported.
  • Amazeal requests physician to report all adverse events, both non-serious and serious events, regardless of severity or outcome so that we can ensure that we provide the Physician the best understanding that we have about the risk profile of a medication.
  • Amazeal, the regulatory agencies, and your patients rely on you to voluntarily report adverse events so that patients can be served better.

Patient’s role

Learn how patients play an active role in medication safety:

  • Responsible Role: Taking medications exactly as your doctor prescribes is the first and most important step on the road to better health.
  • Prompt Reporting of Problems: If you find you are not responding well to a medication or having any untoward reaction, call your doctor immediately and talk about it. There may be other dosing options or even other medications available and your doctor may want you to try something else.

If you are having any untoward reaction on your medication: PLEASE CALL YOUR DOCTOR IMMEDIATELY.

Amazeal’s role

Safety From Discovery to Market Approval and Beyond

  • Well before a medicine is approved by regulatory authorities and reaches patients, it is rigorously assessed through carefully designed clinical trials to better understand its benefits and risks.
  • However even after thorough research in clinical trials, Amazeal continues to carefully monitor for new safety findings, so safety evaluation does not stop when a medication reaches the market.
  • In fact, the monitoring increases – through collection of information from ongoing clinical studies spontaneous adverse event reports voluntarily reported directly by the physicians or the patients using the medication.
  • All Safety Information is continually assessed and we share new findings and emerging concerns openly with regulators and physicians to appropriately manage risks associated with the use of our medicines.
  • We also work diligently to combat drug counterfeiting, which poses serious health threats to patients.

The Drug Contoller General of India (DCGI) has established a national pharmacovigilance program to monitor safety information of all prescriptions medicines.

Please click here to know more

http://www.ipc.gov.in/PvPI/pv_home.html