Safety Reporting

Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases. However, they may also carry risks, particularly Adverse Drug Reactions (ADRs), which can cause serious harm to patients.

Definition of ADR:

An ADR is โ€œan appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen or withdrawal of the product.โ€

ADRs are common, often preventable, and are a frequent cause of illness, disability, and even death.

ADR Monitoring

Thus, for safety of medication, ADR monitoring is required for each medicine throughout its life cycle i.e. during development of drug such as pre-marketing including early stages of drug design, clinical trials and post-marketing surveillance. Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human.

The adverse events reported by PV system will potentially benefit to the community due to their proximity to both the population and public health practitioners.

Therefore, with a goal to ensure benefits of use of medicine and to safeguard the health of the Indian population, we have decided to monitor ADRs in Indian population. All the regions across the country (India) where Medley Pharmaceuticals Pvt. Ltd. markets its medicines are involved in reporting ADR in the prescribed form (ADR form).

Reporting of ADR

If you are a healthcare professional/consumer and wish to report an adverse event which has occurred
by treating patient /using any of our products, you can opt any of the following procedure to report
an adverse event:


Send via any of the below mentioned method of communication.

  • Step 1: Download the Adverse Event Reporting Form.
  • Step 2: Fill in the required information.
  • Step 3: Submit the completed form via:
    • Email: Scan and email to pv@medleylab.com
    • Post: Send to the corporate office: Medley Pharmaceuticals Ltd. D-2, MIDC Area, Andheri (E), Mumbai-400 093
    • Authorized Company Representative: Submit the completed form through them
  • Contact via Phone Call +91-8104640495 between 9 AM to 5 PM on working days.
  • *Please note that, we are closed on Saturday, Sunday and Public Holidays.

Contact for More Information

For further details on Pharmacovigilance, write toย pv@medleylab.com

Company Identification Number
( CIN ) : U24230MH1975PLC018296

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Medley House, D2,
M.I.D.C. Area,
Andheri (East),
Mumbai-400 093, INDIA




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