To

Central Drugs Standard Control Organization (CDSCO)

Hyderabad

Subject: Clarification Letter for Soniya Agarwal’s Medications

Dear Sir / Madam,

Soniya Agarwal is suffering from Rheumatoid Arthritis and on a long-term therapy for treatment
of her condition. Kindly note the following:

(1) Approval in India: All her medicines are approved in India

(2) Approval in other countries: They are also approved in the USA (prescription from her
doctor in the USA is also included)
(3) Cost: The cost for the import of these medicines for personal use will be borne by the
patient
(4) PatientMonitoring: The patient is already on a dose of these medications. In case of any
adverse reaction to the drugs, however, I will monitor the condition of the patient
(5) Necessity: Xeljanz is used in treatment of adult patients with moderately to serverly-
active RA and it is currently the only approved biologic treatment for RA available for
oral administration. It is currently not available in India. Another medication, Arava
helps to reduce the joint damage as well as pain and swelling to help the patient move
better. Other medications help her in maintaining and controlling swelling and pain.

Request you provide her a NOC to import a dosage for 30 days.

Best regards,