Scribd
Upload
100 views1 page

Daily Dispatch

This letter is in response to a letter dated March 12th 2021 from the Drugs Controller General of India regarding the manufacturing and marketing of a fixed-dose combination multivitamin and multimineral capsule by Olive Healthcare Ltd. It informs that while the company holds a valid state license to produce the product until 2022, it does not have Form CT-23 or Form 46 permission from the central licensing authority. It details the company's application through the Sugam portal as directed, and requests that any action on the previous letter be held until the committee evaluates the case, as these are legacy products similar to other FDCs on the market.

Uploaded by

Hari Thekkethil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
100 views1 page

Daily Dispatch

This letter is in response to a letter dated March 12th 2021 from the Drugs Controller General of India regarding the manufacturing and marketing of a fixed-dose combination multivitamin and multimineral capsule by Olive Healthcare Ltd. It informs that while the company holds a valid state license to produce the product until 2022, it does not have Form CT-23 or Form 46 permission from the central licensing authority. It details the company's application through the Sugam portal as directed, and requests that any action on the previous letter be held until the committee evaluates the case, as these are legacy products similar to other FDCs on the market.

Uploaded by

Hari Thekkethil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 1

To,

Dr V.G Somani
The Drugs Controller General (India)
Directorate General of Health Services
FDA Bhawan, Kotla Road, New Delhi

Sub: Manufacturing & Marketing of FDC of Multivitamin, Multimineral capsules- reg


Ref: Your letter dated 12th March 2021; Vide File no. FDC/MA/21/000051

This is in connection to the above mentioned letter dated 12th March 2021 addressed to us(M/s
Olive healthcare Ltd) with a copy of letter information to Drugs Licensing Authority, Daman &
Deputy Drugs Controller (I) CDSCO west zone from your office.

In this regard, as directed by you, we are enclosing herewith the copy of SLA license valid till
2022. Further, this is to keep you informed that we do not hold Form CT- 23/Form 46 permission
from Central Licensing Authority. However, this is to bring to your notice that we have been
marketing this product since last few decades under valid SLA license.

As per the directions received from FDC division suggesting us to file the new FDC
application through sugam; File No. FDC/CT21/FF/2021/24213, we have complied with same
by applying through CT 21 for necessary permission was then met with the response to submit
the CLA and other licenses w.r.t this FDC product from your end (vide letter dated 12th Mar
2021). We are thankful that we were asked to present our case in SEC (Antimicrobial &
antiviral) scheduled on 24th March 2021 and the official Minutes of the said meeting is awaited.
As soon as the minutes are uploaded in the CDSCO website, we will respond to the observations
made by the committee through Sugam portal.

Meanwhile, we humbly request the Directorate to hold any action in regards to your
letter dated 12th March 2021 as we have already applied for the permission in CT 23 through
sugam portal as per your directions and we also request the Directorate to be kind enough to
evaluate/re-deliberate our case as these are legacy products in line with thousands of similar
FDCs available in the market.

Thanking you,

Authorised signatory

M/s Olive Healthcare Ltd

You might also like