Pharmacy Licensing & Regulatory Services
Explore drug licensing, hospital drug licences, licence amendments and renewals, and pharmacist compliance support. Avir HealthPac assists healthcare businesses with relevant licensing documentation and regulatory processes.
Regulatory Advisory Notice: Avir HealthPac provides professional documentation, advisory, and liaison assistance for regulatory filings. Approvals and licenses are granted solely at the discretion of the respective State and Central Licensing Authorities pursuant to statutory verification and inspection.
Category A: Drug Licenses
Statutory licensing solutions for new retail pharmacies, wholesale distribution networks, corporate entities, and medical device registrations.
New Drug License
Comprehensive guidance on end-to-end documentation, premise layout compliance, and application filing for establishing a new drug retail or distribution facility.
Drug License Retail (pharmacy / chemist)
Professional assistance in applying for retail drug sale licenses (Form 20/21) for standalone chemist shops, community pharmacies, and retail dispensing counters.
Drug License - Partnership firm
Tailored licensing and regulatory documentation support for registered partnership firms, including partnership deed verification, partner KYC, and premise compliance.
Drug License - Private Limited company
Complete statutory licensing assistance for private limited corporate entities, covering Board resolutions, Director KYC, authorized signatory filings, and corporate compliance.
Drug License - Wholesale
Advisory and documentation support for obtaining wholesale drug distribution licenses (Form 20-B/21-B), including storage area norms, cold chain verification, and competent person filings.
Drug Manufacturing License
Consulting and regulatory documentation services for formulation and manufacturing facilities, assisting with technical personnel filings, GMP alignment, and state FDA liaison.
Medical device Registration (Form MD-42)
Facilitation of Form MD-42 registration for wholesale distribution, sale, or stocking of medical devices under the Medical Device Rules with the State Licensing Authority.
RMI License
Regulatory documentation and application support for Recognized Medical Institution (RMI) licensing, enabling institutions to procure and possess essential narcotic drugs (ENDs) for palliative and clinical care.
Category B: Hospital Drug License
Dedicated pharmaceutical licensing, relocation, and bulk distribution compliance for in-house hospital pharmacies and healthcare facilities.
Change in premises - Hospital
End-to-end guidance for hospital pharmacies relocating within existing hospital premises or shifting to a newly constructed block or campus.
Drug License - Hospital Premises
Dedicated licensing assistance for internal hospital dispensing pharmacies, ICU drug storage units, and inpatient drug counters located within healthcare institutions.
Drug License - Hospital wholesale
Regulatory documentation support for multi-specialty and corporate hospital networks managing centralized procurement and bulk internal distribution.
Category C: License Change & Renewal
Administrative and legal compliance support for post-licensing modifications, location changes, ownership restructuring, and timely license renewals.
Change in constitution
Regulatory advisory and filing support for restructuring pharmacy ownership, including transitions between proprietorship, partnership, and private limited entities.
Change in Premises
Documentation and application management for shifting a licensed retail or wholesale pharmacy to a new commercial location with required site inspections.
Change in Premises + Constitution
Comprehensive handling of concurrent modifications involving both business restructuring and geographic relocation under drug control guidelines.
Competent person change
Regulatory documentation and endorsement filings for replacing, appointing, or updating approved technical staff or competent persons for wholesale operations.
Drug License Renewal
Timely retention fee submission, documentation audit, and renewal filing support to ensure uninterrupted validity of active retail and wholesale drug licenses.
Name change
Official endorsement and regulatory documentation services to update the trade name or corporate entity name on an active drug license certificate.
Category D: Pharmacist & Legal Compliance
Professional staffing endorsements, State Council certificate renewals, and expert legal response drafting for statutory drug control notices.
Pharmacist certificate Renewal
Guidance and renewal facilitation for registered pharmacists to maintain active registration and good standing with the respective State Pharmacy Council.
Registered pharmacist change
Endorsement filing support for updating, onboarding, or relieving approved registered pharmacists on retail and hospital pharmacy drug licenses.
SCN Reply (show cause notice)
Professional review, drafting, and regulatory guidance for preparing formal, compliant replies to Show Cause Notices issued by State Drug Control Authorities.
Need Personalized Regulatory Assistance?
Speak directly with our healthcare compliance consultants for customized licensing guidance, documentation review, and end-to-end liaison support.