Last updated: 5 September 2026
Lotuspharm Manufacturing Private Limited (“Lotuspharm”), in connection with its responsibilities for the safety and pharmacovigilance of medicinal products, collects and processes information about suspected adverse reactions, other safety issues and product-quality complaints in order to fulfil applicable pharmacovigilance obligations.
Privacy contact: info@lotuspharm.pro
Pharmacovigilance contact: pv@lotuspharm.pro
1. Data we may process
- Reporter data: name, surname or initials, role/profession, email, telephone number, country and follow-up communications.
- Patient data: initials or another limited identifier, age or date of birth, sex, weight, country/city, medical history, concomitant conditions, allergies, test results and other relevant health information.
- Medicinal-product data: INN/product name, strength, dosage form, dose, frequency, route, indication, treatment dates, batch/lot number, expiry date and other relevant details.
- Safety-event data: description and timing of the reaction, seriousness criteria, outcome, pregnancy/breastfeeding, overdose, medication error, misuse, off-label use, lack of efficacy, interaction, occupational exposure, suspected falsification or quality defect and other medically relevant circumstances.
- Attachments: relevant medical documents, laboratory results, packaging photographs or other files voluntarily provided.
Please do not submit passport numbers, national identification numbers, full medical-record numbers or other excessive identifiers unless specifically required for a legitimate pharmacovigilance purpose.
2. Why we process the data
- to receive, validate and register safety reports;
- to assess completeness, seriousness, causality and medical significance;
- to contact the reporter for follow-up where necessary;
- to identify and assess safety signals;
- to evaluate the benefit–risk profile of medicinal products;
- to prepare and submit legally required safety reports;
- to respond to competent authorities;
- to maintain traceability, quality control, audit trails and inspection readiness;
- to investigate product-quality complaints where relevant to patient safety.
3. Legal basis
Pharmacovigilance processing is carried out primarily because Lotuspharm is required to comply with medicinal-product safety and regulatory obligations. Where an additional legal basis is required under applicable data-protection law, Lotuspharm relies on the basis permitted for regulatory obligations, public-health or medicinal-product safety functions, substantial public interest, legal claims, or another applicable statutory basis.
The acknowledgement shown next to the online reporting form confirms that the reporter has been informed about the processing. It should not be presented as a mechanism allowing mandatory pharmacovigilance records to be withdrawn or erased where applicable law requires continued processing.
4. Sources
Information may be obtained directly from the reporter or patient, from a healthcare professional, distributor, business partner, regulatory authority, literature source, contractual pharmacovigilance partner or another legitimate safety-information source.
5. Recipients
Where necessary for pharmacovigilance, information may be shared with competent health and medicines authorities; authorised Lotuspharm personnel; pharmacovigilance service providers, medical reviewers and database operators; contractual partners or other marketing authorisation holders where safety responsibilities are allocated by agreement; auditors and inspectors; and other recipients where disclosure is required by law.
Lotuspharm limits the use and disclosure of direct identifiers and applies coding or pseudonymisation where appropriate and practicable.
6. Hosting, email and international transfers
Reports submitted through the website are processed using website infrastructure hosted by Beget in the Russian Federation. Pharmacovigilance email communications sent to or from pv@lotuspharm.pro are also processed using Beget mail infrastructure in Russia.
Pharmacovigilance activities may require transfer to India, Belarus, other EAEU member states and other countries in which competent authorities, authorised service providers or contractual partners are located. Lotuspharm applies the legal bases and organisational, contractual and technical safeguards required under the data-protection law applicable to the relevant transfer.
7. Retention
Pharmacovigilance information is retained for the periods required by applicable medicinal-product legislation. For medicinal products registered in the Eurasian Economic Union, pharmacovigilance data and documents are retained by the marketing authorisation holder for at least 10 years after expiry of the relevant registration certificate, unless a longer period is required by applicable law.
8. Your rights
Depending on applicable law, data subjects may have rights to obtain information, request access, correction or restriction, and exercise other statutory rights. Rights such as erasure or objection may be limited where continued processing or retention is required for pharmacovigilance, regulatory compliance, auditability or legal claims.
9. Confidentiality and security
Lotuspharm uses organisational and technical measures designed to protect pharmacovigilance information from unauthorised access, disclosure, alteration, loss or destruction. Access is limited to persons and service providers who require it for approved pharmacovigilance functions.
10. No marketing use based on a safety report
Personal data submitted in connection with a pharmacovigilance report is not used for direct marketing merely because a person submitted a medicinal-product safety report.
11. Contact
For privacy questions: info@lotuspharm.pro.
For safety reporting and pharmacovigilance: pv@lotuspharm.pro.