Cancer has been steadily increasing within the Indian population in the last decade. With a personal experience of my mother suffering from Ovarian cancer and battling the disease with multiple recurrences in the last seven years, this journey is sometimes delirious and at times rewarding.

This blog is dedicated to my mother for being an inspiration by battling Ovarian cancer with multiple recurrences. She is still living her life with a positive attitude and it is for her that we as a family are trying all our best to arrange this life-saving drug through the United Kingdom.

I am writing this blog so as to make it easier for others to import life-saving drugs in India for free if medication needs are unmet in our country. We have to be a proud nation as systems are in place to achieve these drugs through managed access programmes for compassionate use and further reading would provide the details.

This blog is a personal experience of our journey while achieving the goal of Life-saving drug for free in India for Ovarian Cancer through import from AstraZeneca Pharmaceutical in the United Kingdom. There are different procedures in different states of India however this blog would provide you with a base towards set procedures for importing these drugs.

These steps have been followed to achieve life-saving drug for Ovarian cancer in Mumbai, Maharashtra, India.

Step 1: Open Conversation with your Doctor

Speak with your Oncologist about the availability of treatments and if there is any life-saving medication which can assist the patient for achieving remission or stabilising the disease.

It is important for patients and their family members to keep an update on the latest treatment available within India and outside of India. My personal suggestion would be to look at the Ovarian Cancer Research Fund Alliance Support Group which is based in the USA. (https://www.inspire.com/groups/ovarian-cancer/).

Also, you can take a second opinion from world-renowned institutes in London or the USA to see if there are any drugs that may help or are in clinical trials.

Step 2: Eligibility for Life-saving drug (LSD)

 Patient information about these drugs and their eligibility are extremely important before you apply for the same. Speak to your oncologist and whether you are able to fit into criteria to achieve these medications.

Step 3: Investigations required for achieving LSD

 It is imperative post-diagnosis of Ovarian cancer that we should check for genetic and different tumour receptors. We managed to do our BRAC 1 and BRAC 2 genetic mutation testing in India. Our life-saving drug is based on these genetic testing as it would provide information about whether your drug is dependent on it. Also, you can test the tumour for Oestrogen sensitivity or PD-L1 pathways. It is important to know the latest trends for treatment and investigations. Foundation Medicine has their representative in India who can be contacted for Molecular testing of the tumour.

Stage 4: Link to Organisation for managed access program

 Speak to your oncologist if there is any availability of clinical trials or managed access programs of pharmaceuticals for provision of free LSD.  Our oncologist provided the link to the managed access program for AstraZeneca, India.

We got in touch through an email with a single point of contact at the customer services of Clinigen group India who were managing the access program for further information about the processes.

Note: There would be different organisations like Clinigen which may be providing the medications hence procedure may differ at times.

 

Step 5: Complete requirement from an Organisation

We were sent requirements of

  • Clinical Registration Form
  • New account form
  • License for your hospital/Institute clearly showing the address.
  • The license of your current Doctor/ Oncologist is essential who is connected with the institute.

Complete these requirements and send it back to them through email.

Providing license of your doctor would help in Cliniport registration under his name as the license of an institute may be in different names.

Note: Make sure you are filling in the latest registration form as we had filled in an old form which led to delay.

Also always keep a print copy of the original and completed forms.

We were in touch through email with Clinigen group, the United Kingdom for further correspondence to complete requirements.

 

Step 6: Access and Order by Cliniport User

  • Cliniport Users would receive their Login details separately through their email. They did not copy those correspondences with us as these users would be your Oncologist.
  • Please make sure to be in touch with your clinician about the same.
  • Cliniport registration will give access to the physician involved with the password for them to order. They will Need to Place Order on it
  • Take prescription of the same order on letterhead.

 

Step 7:  Requirement and application of Import License

  •  The current government has made an amendment to an act which allows Life-saving drugs to be imported if medical needs are unmet in India.
  • Please visit this site for detailed information about the application of important license http://www.cdsco.nic.in/forms/list.aspx?lid=2068&Id=30
  • Apply for FORM 12 A which is an application form for getting import license FORM 12 B
  • A prescription from a Registered Medical Practitioner (RMP) in respect of the drug requirements for the purpose of patient use required to be attached. Prescription shall bear Medical Council of India (MCI) Registration No. of the Physician.
  • Fill and sign the application in Form 12A along with the Prescription and submit to ADC(I)/TO/DI of the respective port offices of Central Drugs Standard Control Organization (CDSCO). The list of such offices is at Annexure A
  • No fee is required under the Rule for said purpose. The name of the drug, quantity of the drug and duration of medication shall be clearly mentioned in the Prescription.
  • Permission in FORM 12 B shall be issued to the applicant on a priority basis preferably in a day or two.

Note: Make sure you provide all details accurately on the FORM 12A. Also, make sure the country from where the medication is to be shipped is in place. We got delayed due to placing the wrong country of shipping.

Also, you can get in touch with any freight forwarding company who may be able to assist.

Correspond to Clinigen or respective Organisation if any queries about the FORM.

Step 8: Completion of Import License

  • We got our FORM 12 B in 3-day time from the time of application of FORM 12 A.
  • We forwarded this FORM 12B to corresponding address for Clinigen U.K
  • Forward the contact details of ourselves along with FORM 12 B
  • Clinigen U.K had sent these details to their warehouse in the U.K along with the additional contact details for the courier/local office.
  • Informed us that Courier company (DHL, DPD et al)  in India would get in touch for verification documents

Step 9: Documentation requirements for Organisation in India or Courier company

The list of documents for customs clearance and format for some of them was included.

All documents need to be sent by the scan for verification to the courier company and then originals to be sent to Delhi.

FORM 12 B: Follow step 7 to obtain FORM 12B.

Original is required for customs clearance.

Customs Duty Exemption Certificate: CDEC certificate

Obtaining CDEC would be discussed in Step 10.

Original is required for custom clearance

ID Proof

Passport, Aadhar card or Pan card. Self attests the Photocopy. Do not send the original of Passport, Aadhar or Election card. The only photocopy is required which is self-attested.

Bank Authorised Dealer code (A D code):

 Speak to your Bank manager who would be able to provide with the 14-digit AD code. Take it on letterhead with stamp and signature of a manager.

Delivery Order Letter: Follow the format provided on –

Original is required on Rs 10 Bond paper or Rs 10 E-stamp duty paper with Notary.

We used the Rs 100 Bond paper.

Request letter to Custom ADC for NOC: Follow the format provided on –

Original is required on Rs 10 Bond paper or Rs 10 E-stamp duty paper with Notary.

We used the Rs 100 Bond paper.

Authority Letter by Customs Clearance: Format would be attached from them.

Original is required on A4 size paper with a sign as per ID proof.

GATT Declaration: Format would be attached to them.

Original is required on A4 size paper with date and sign as per ID proof.

GATT Import Declaration: Format would be attached to them.

Original is required on A4 size paper with the sign as per ID proof.

Step 10: Custom Duty Exemption Certificate: CDEC form

Application for CDEC was a bit difficult due to the unknown process in place. We were helped along by Clinigen and supportive staff of Arogya Bhavan, Mumbai.  Follow the steps to attain CDEC however these things keep changing hence talk to someone in Arogya Bhavan or Department of health as appropriate in your district.

  • Doctors prescription on a Letterhead:

Take the stamp, signature and date it. The prescription has to be the same as on the order form. I would be attaching examples of the forms in another section. You will need countersign by Civil surgeon or Chief medical officer or Superintendent of a district hospital.

  • Doctors certificate:

Print it on letterhead, stamp, sign and date it. You will need countersign by Civil surgeon or Chief medical officer or Superintendent of a district hospital. Make sure appropriate countersignatory is in place. In Mumbai- St George hospital, JJ hospital is allowed according to my knowledge. We got it done through St George and there was no issue.

  • Photocopy of a medical condition report

Either CT scan, PET report or MRI scan. Any other report which indicates analysis of disease.

  • ID proof for the patient and their relative

Who is going to the Department of health to get CDEC to form? Make sure to self attest the photocopies of the ID proof. Take originals with you but they only require photocopy.

  • Authority letter from the patient

To the person who is applying for CDEC on their behalf.

Make sure to print it with the date and signature of the patient.

  • Application form to Joint Health Director:

We got this form the Arogya Bhavan, Mumbai.

  • Utilization Certificate:

We got this form the Arogya Bhavan, Mumbai.

After completing these documents, we went back to Arogya Bhavan, Mumbai for application of CDEC. Staff was very helpful and they provided us with the relevant certificate within 3 hours.

Note: On doctor certificate, make sure exact days are mentioned as per the calculation of capsules or vials. E.g. We wanted to import 1792 capsules for 3 months with a dose of 16 tablets a day. It needed to be corrected to 3 months and 24 days instead of 3 months. Always keep bit more days for the consumption of medicine rather than less.

 

Step 11: Scan and Verify with Courier company and organisation

  • Scan all the relevant documents asked in Step 9 and wait for their verification
  • Once verified through a scan, then send the originals to address mentioned by your Organisation. For us too we had to send it to Delhi.
  • Make sure to send these documents with DHL with the highest security possible.

 

Step 12: Order confirmed and received

  • We received a phone call after 2 days of document verification about delivery of Life-saving drug to our hospital.
  • Make sure to let people at the Oncology department know about the possible parcel as they will have to provide a receipt to the courier.
  • All these medicines would always go to a registered hospital/institute provided in your initial forms.
  • Thanks to efforts of everyone involved we were able to get this drug within 45 days of inception.

As I have mentioned before, these steps will vary accordingly to where you live and which drug you want to access.

We were very confused about the procedures when we started hence this is a sincere effort to help others in a similar situation.

My sincere thanks to Dr Boman Dhabar and Mrs Pouru Dhabar as well as their BND oncology team for supporting us through this journey. I would like to extend my sincere thanks to Dr Rebecca Kristeleit, UCLH NHS Trust, U.K, Clinigen United Kingdom Team, AstraZeneca Team for helping us through the process and without them this would not be possible.

I would also like to extend my thanks to the staff at Government of India, Fortis Hospital, Arogya Bhavan, Superintendent of St George Hospital, Assistant Director of DMER and Director of Health, Maharashtra.

This medicine helped me with good quality of life for a year and a had year off chemotherapy and travelled London, Estonia, Malaysia, Singapore & Finland.

Many thanks

Alka

*** Note: This blog is a personal story and not indicative of current procedures. Please speak to your oncologist, pharma company or health ministry for due needs. This blog is just for information and every state will have different procedures.

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