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Generic Harvoni in India

Hi Everybody ! I need help to get any related information about generic version harvoni and sovaldi. I have found today the pre-order offer for generic harvoni from India. I have been informed from indian newspapers that generic version become available soon within 2-3 months on Indian market . Does anyone know something else about this? Any ideas? My Mom is suffering from fibrosis stage 3 , and now i'm feel that here is only one way to cure hepatitis C using the harvoni. But our insurance would not cover branded version!!! Does anyone waiting the generic version like me?

And finally, it will be accessible for patients from abroad?

Any recommendations, please .

Thanks and regards,

Alex
780 Responses
Avatar universal
Is hepcinat lp available in Nepal right now?
Why not go there for it?
Avatar universal
Yes can or to Bangladesh
Avatar universal
The companies fell short of Diwali bribes but the market of Nepal is not enough for Natco or others. Worst comes to worst they will only export Harvoni to other countries and not sell it in India
Avatar universal
Ahh India....
Avatar universal
Hi Narou,

Cipla distributor in India (Delhi) 9999990100
Avatar universal
and what to with this distributor ? There is no generic harvoni in India , he will try to sell him twinvir from Bangladesh at 3 times the normal price.
Avatar universal
I think I can't wait for general harvoni India, I want to buy harvoni in Nepal, it only need $2100 a course!
Avatar universal
Where in Nepal can I get hepcinat lp?
Avatar universal
I come from China, some act as purchasing agency can get hepcinat - lp from Nepal. Just need to around $2100, but I think it's a bit expensive
Avatar universal
I think the Indian general harvoni then price will be cheaper
Avatar universal
No Bangladesh is the cheapest if you go there to buy.
Avatar universal
Indian Harvoni will be $ 1200 if bought yourself from India for a 12 week treatment if and when it comes
Avatar universal
Thank you for your advice, I'm not very rich for family, so I want to  wait general harvoni on sale in India and i think Indian harvoni quality is better!
and Twinvir sells for $1380 in our country
Avatar universal
I preffer indian generic harvoni due to compact pack, easy for custom. But the quality is the same.
Avatar universal
yes the quality is same anywhere. Costs is different due to many factors. Indian product will be a bit more expensive than Bangladesh because the Indian pharma has to pay the BIG pharma ( Gilead)
Avatar universal
Of course, but I have been waiting  from April , I don't want to in the critical moment to give up india general harvoni
Avatar universal
yes it is worth waiting at max December.

Avatar universal
If it don't released in December, I will consider harvoni of Nepal
Avatar universal
yes
Avatar universal
and latest they say is 1st week December But that only God knows.
Avatar universal
1st week is the launch date or it is the time when it will be actually available in the market.  Becoz there remains a gap of around one week between the launch date and the actual availability in the market.  
Is there any info who is going to launch first : Natco or Mylan or Copla ??
Avatar universal
Yes, I'm from Nepal and had just bought it 1 week back. The medicine is highly controlled in Nepal.
Avatar universal
actually available in the market but I am never sure when it comes to india
Avatar universal
How u purchased it ??.. is it available at the normal drug stores ?? a prescription from a doctor abroad works or it should be prescribed by a Nepalese doctor only ??
1 Comments
No it is not available at any drug store (There is just one store where we can find it). And a prescription from abroad should work, if not then you can get it made for USD 5 within 1 hour.
Avatar universal
How u bought it ?? Is it available on the normal drug stores ???  A prescription from a doctor abroad will work or we should have a prescription from a Nepalese doctor only ??
Avatar universal
Hi,
I am living in Riga, which you mentioned . I have hepatite C for more than 15 years. I went through Interferon/ribavirin course. Terrrrible experience, severe side effects. I also would be happy to get Twinvir or other generic analogue of Harvoni. Unfortunately I have no idea what to do first – whom approach to, where to go in India or Bangladesh or so... May be there could be any option to order/pay and receive medicine by mail? Viesturs
Avatar universal
Viesturs1 If you decide to go to get Twinvir - go straight from the airport to the company. Incepta Pharma in Dhaka Bangladesh has been very helpful. Their general manager for marketing is Dr. E H Arefin Ahmed  His assistants are: Asif Mostafa , and Alimul Razi . They informed me that they; 1- accept photocopies of doctors prescription in English. 2- accept a doctor's letter stating that the bearer has chronic hep c (for example from places where doctors are unwilling to write a presription. 3- they will accept orders via couriers under 100 boxes (there are 6 tablets per box). Bangladesh customs won't question such small orders. 4- I brought out 28 boxes. The price I paid last week for Twinvir was 862 Taka per tablet (with the airport exchange rate at USD 1 = 78.5 Taka) it cost me slightly less than $11 USD. 5- I purchased my 24 weeks worth of generic harvoni within 2 hours of landing at the airport in Dhaka. I spent the night there, and was back home (Southeast Asia) the next day - 2-days round trip. Warm regards, palviet
Avatar universal
everything written above is true. I did exactly the same thing...
Help is there (in terms of meds/scrips/courier... if you want it, you just have to go get it.
Avatar universal
Hallo,
please if you haven´t started trinking Twinvir and if you have the treatment of 12 Weeks can you please sell it to me?
i am in Germany
tnks Galant
Avatar universal
just contact Incepta and see if they can send you the medicine

For Indians to import from Bangladesh should not be difficult by courier.
You DOWNLOAD form 12 A from the CDSCO website, permission is granted in 2 days after submission of this form. Send by email a copy of this and Docs perscription to Incepta + payment and you should be able to import.
Avatar universal
Procedure for permission to Import Small Quantities of Drugs For Personal Use in India


NOTICE

In the medical practice, sometimes drugs which are not permitted to be imported or marketed in the country are required exclusively for the treatment of patients to save their lives. To facilitate import of such drugs in small quantities for personal use, it is provided under the Drugs and Cosmetics Rules, 1945, that a permit for import of small quantities of drugs for personal use in Form 12B could be obtained from the office of the Drugs Controller General (India), FDA Bhawan, Kotla Road, New Delhi or designated Port Offices of Central Drugs Standard Control Organization. The applicant is required to make an application in Form 12A, which could be downloaded from the website, along with the prescription of the Registered Medical Practitioner (RMP) indicating the quantity of drug required for the treatment of the patient. The prescription should indicate registration number of RMP. The permission in Form 12B is issued on priority basis within one or two days. Further the rules also permit import of small quantities of drugs for exclusive personal use of the passenger as part of his bona-fide baggage. The quantities of any single drug so important shall not exceed 100 average doses and shall be declared to the customs authorities, if so directed.

The Port offices of CDSCO from where permissions for import of small quantities of drugs for personal use could be obtained are situated at the Air ports of IGI Air Port, New Delhi, Air Cargo Complex, Chennai,  International Air Cargo Complex, Mumbai, New Integrated Cargo Terminal Building, Kolkata, RGI Airport, Hyderabad, Airfreight Terminal, Bengaluru, Aircargo Complex, Ahmedabad and Port offices at Custom House, Chennai, New Custom House, Mumbai, Nava Sheva Port, Navi Mumbai, Custom House, Kolkata. The details of the Form and addresses of the port offices along with the contact numbers are given as under:

PROCEDURES TO IMPORT SMALL QUANTITIES OF DRUGS FOR PERSONAL USE



PREAMBLE

To facilitate the availability of small quantity of drugs for personal use for the needy patients of India. The procedure has been simplified which as follows:

I.          PROVISIONS UNDER DRUGS & COSMETICS RULES

Rule 36 of Drugs & Cosmetics Rule provides Import of drugs for personal use. Small quantities of drugs, the import of which is otherwise prohibited under Section 10 of the Act, may be imported for personal use subject to the following conditions:

(i)            the drugs shall form part of a passenger’s bona fide baggage and shall be the property of, and be intended for, the exclusive personal use of the passenger;

(ii)          the drugs shall be declared to the Customs authorities if they so direct;

(iii)        the quantity of any single drug so imported shall not exceed one hundred average doses:

Provided that the licensing authority may in an exceptional case in any individual case sanctions the import of a large quantity:

Provided further that any drug, imported for personal use but not forming part of bona fide personal baggage, may be allowed to be imported subject to the following conditions, namely:

(i)           the licensing authority, on an application made to it in Form 12-A is satisfied that the drug is for bona fide personal use;

(ii)         the quantity to be imported is reasonable in the opinion of the licensing authority and is covered by prescription from a registered medical practitioner ; and

(iii)       the licensing authority grants a permit in respect of the said drug in Form 12-B.



II.       PROCEDURE TO OBTAIN PERMISSION:

1.         Download the application in FORM 12 A.

2.         Prescription from 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.

3.         Fill and sign the application in Form 12A alongwith 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

4.         No fee is required under the Rule for said purpose.

5.         The name of the drug, quantity of the drug and duration of medication shall be clearly mentioned in the Prescription.

6.         Permission in FORM 12 B shall be issued to applicant on priority basis preferably in a day or two.



III   In case of delay or further clarification, following officer are designated at the Secretariat of DCG (I), CDSCO (HQ), FDA Bhawan, Kotla Road, New Delhi. 110002

Contact Officers:

1.               Mr. Aseem Sahu, Deputy Drugs Controller (I)  

2.               Dr. V. Kasi Sankar, Drugs Inspector

Contact No.:

Ph. No.:  011-23236965;

Fax. No.: 011-23236973,

Email id : ***@****

Annexure- A



PORT OFFICES OF CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (CDSCO)



i.      IGI Air Port Office, Import 3 building, Room No. 4A 1st Floor, Air Cargo Unit, IGI Airport, New Delhi.

Phone: 011-25654408.

Avatar universal
i THINK A SMALL QUANTITY THEY CAN EXPORT especially to neighbouring countries
Avatar universal
Hi All,

Greg have a new alternative for generic harvoni (not twinvir, not indian harvoni for the moment).

Just contact him and let him know you are a patient. He will explain to you the new alternative which a tested generic harvoni.
Avatar universal
The delay of indian generic harvoni is the result of Indian bureaucrats and maybe corrupted. But who cares about them. Its a big game and 150 000 000 people surely will win. Chinese APIs are proven to be highly effective even better than original Harvoni. Crystalline Form I versus Form II. To prepare this APIs is a very easy task. Compounding Chemists in Australia can make an Australian generic equivalent of Harvoni. I think that soon there will be more generic harvoni.
2 Comments
Gilead have given Licence they need to make money so do these Indian companies IT WILL BE OUT VERY SOON. They dont have a choice anymore.
I have writen earlier if you can wait like I can then wait, IF NOT then you have Greg Jefferys/ Dr Freeman or the 3 Bangladeshi firms.
Nepal seems all unclear to me.

Hepinat LP ( Nepal) or Twinvir is avaliable in India But it costs $ 2500 for 12 weeks so double the regular price.
Thanks I am actually trying to get twinvir
Avatar universal
Who has the  news  about India general harvoni in  this week? I hope this week is a new beginning !
2 Comments
lets see we hope
hope so
Avatar universal
Dear all Good day .
An update , 6 weeks of Lesovir-c from beximco pharma completed today ,6 more weeks to go ....

Am praying that all of you waiting for generic harvoni can get yours soon too and start treating ...

God bless and best wishes always ....
2 Comments
Great ! All the best.
Thanks my Friend :)
Avatar universal
I hope you can  cured successfully
1 Comments
Thank you for your good wishes ...
Avatar universal
Another Indian general harvoni  Be released
in Nepal,it  is from  hetero labs ltd

2 Comments
Great news
Where did you read this ?
Avatar universal
After 32 days of sof+dac from Mesochem. Not  detected alt and ast 10 and 16 . Now on week 8 . After many years of feeling tired all the time I am feeling fantastic now . I payed 1228 $ delivered by FedEx to my door. No need to go anywhere they send the mess.  
Avatar universal
The medicines .
Avatar universal
Are You said the  general india harvoni? it was named lisof

2 Comments
Lisof and Ledifos by Hetero.
Hepcinat- LP by Natco
Hepcvir-L by Cipla
But None of this is avaliable in India as yet.
Avatar universal
It was shipped by mesochem? It was in capsules?
Avatar universal
What is Lisof?
1 Comments
Generic harvoni by Hetero
Avatar universal
Why two types? Lisof and Ledifos
Avatar universal
What are the names of the 4 companies that are supposed to release the generic Harvoni in India? I only know Natco and i tried sending them an email regarding the release date, hopefully i'll hear something concrete from theme. (I'll update this community if i do). I plan to travel to India last week of December, so I'm really hoping it is out by then. Fingers crossed.

Meanwhile, stay healthy ya'll. If we are lucky, and are able to get the meds, we will all be able to toast a drink or two by March/April 2016. Till then, no alcohol!
2 Comments
Cipla, Hetero, Mylan and Natco
Natco will not give any answer as they cannot release info on what is speculation only as to when India will release generic Harvoni. Most dealers, local Pharmacy shops say 1st week December and I hope so too. But I expect it only in Jan 2016 as it takes 2 weeks to get the product in the market once the drug controller has approved. THERE IS NO APPROVAL AS YET.
The entire process has been slow and the Indian companies have failed to comply with the clinical trial as demanded and the end result is the patients are suffering and the companies are losing money. India is a bigger market than Nepal why release it there first ?? Same thing happened with sovaldi and now with Harvoni.
God bless !
Avatar universal
Thanks for the prompt reply darbara. I know all too well how the Indian govt./pharmaceuticals function (I'm Indian but don't live there anymore). Too many protocols and a 'please-all' attitude makes things move super slow. Add corruption on top of that and you know how crippled the system is. Oh well.

I'm guessing, Nepal there are less strict rules, and since it's a much much smaller country it's easier for them to pass a vote and begin distributing even.

We just need to be thankful that countries like India/Bangladesh/Nepal now have access to manufacture these drugs (or soon will have access) and ppl will at least have the option to buy from them in one way or another. Hope is on the way for us all, just a matter of a few weeks at most if all goes well.

Until then, just keep swimming, swimming, swimming....
Avatar universal
Hello there. It was shipped by Mesochem as powder. I encapsulated them my self. I got them in 5 days.  
Avatar universal
A doctor who is DCGI member disclosed me that they have approved Ladipasvir in India.

Only wait for final nod which is only possible by SOME GIFT to it's Members.
Avatar universal
We are launching Ladipasvir in First week of December month as per circulating news in India.
Avatar universal
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