Naglazyme

Naglazyme Warnings and Precautions

• Serious infusion reactions: Anaphylaxis, shock, hypotension, bronchospasm, and respiratory failure can occur during or up to 24 hours after infusion. The infusion should be stopped immediately if a severe reaction occurs.
• Airway complication risk: Patients with acute febrile or respiratory illness at the time of infusion should be assessed for the risks and benefits of delaying treatment.
• Pretreatment recommended: Antihistamines, with or without antipyretics, are recommended before each infusion to reduce reaction risk.
• Spinal/cervical cord compression: Patients with MPS VI are at risk for spinal cord compression; clinical monitoring is recommended.

How to Access Naglazyme in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant, cold-chain conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation & Availability

What documents are required to import Naglazyme to India?

Naglazyme (galsulfase) injection may be imported in the patient's name only, by patients or government hospitals, in line with India's import regulations for unapproved medicines. The following documentation is required:

• A valid prescription from a qualified metabolic specialist
• The patient's diagnostic reports confirming Mucopolysaccharidosis VI (MPS VI)
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription from the doctor and, if applicable, an import permit.

Is Naglazyme available in India?

Naglazyme (galsulfase injection) is a prescription medicine that legally requires a doctor's prescription to be dispensed. As of current publicly available information, Naglazyme is not commercially marketed in India.

However, patients in India can legally access Naglazyme through the Named Patient Program (NPP) — an import provision that allows patients to receive medicines approved in other countries but not yet marketed in India, under a doctor's prescription and proper regulatory documentation.

Naglazyme received US FDA approval in 2005 for the treatment of MPS VI, ensuring full transparency throughout the process.

Naglazyme can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others.

Sourcing & Delivery of Naglazyme

Naglazyme is sourced directly from authorized channels in the country of origin and shipped to India under GDP-compliant, cold-chain logistics to preserve product integrity from dispatch to delivery.

• Cold-chain shipping maintained at 2°C to 8°C throughout transit
• Real-time shipment tracking and delivery updates
• Delivery coordinated directly with the patient, family, or treating hospital

Availability of Naglazyme Across Major Cities in India

Named Patient Program supports access to Naglazyme for patients with MPS VI across major cities in India, coordinating documentation, sourcing, and delivery with treating metabolic specialists.

Mumbai

Patients in Mumbai can access Naglazyme through NPP with support from treating metabolic specialists at the city's leading centers.

Delhi

In Delhi, NPP coordinates with hospitals and specialty metabolic disorder clinics to facilitate timely access to Naglazyme.

Bangalore

Bangalore's genetics and metabolic disorder centers work with NPP to support patients requiring Naglazyme.

Chennai

Patients in Chennai can access Naglazyme through NPP, with coordination between treating doctors and the program's regulatory and logistics team.

Hyderabad

Hyderabad's metabolic and genetic testing centers support diagnosis and access coordination for Naglazyme through NPP.

Kolkata

NPP facilitates access to Naglazyme for patients in Kolkata under the guidance of treating specialists.

Pune

Patients in Pune can access Naglazyme through NPP with prescription-based coordination and cold-chain delivery support.

Ahmedabad

NPP supports access to Naglazyme for patients in Ahmedabad, working directly with treating specialists.

Kochi

Patients in Kochi and across Kerala can access Naglazyme through NPP's regulated import pathway.

Chandigarh

NPP coordinates access to Naglazyme for patients in Chandigarh and the surrounding region.

Jaipur

Patients in Jaipur can access Naglazyme through NPP with support from treating specialists.

Lucknow

NPP facilitates access to Naglazyme for patients in Lucknow and across Uttar Pradesh.

Bhubaneswar

Patients in Bhubaneswar can access Naglazyme through NPP's coordinated import and delivery process.

Guwahati

NPP supports access to Naglazyme for patients in Guwahati and across the Northeast region.

NPP also supports access for patients in other Indian cities not listed above — contact the team to check availability and timelines for your location.