The Curious Case of Banning 344 Drugs, Oops! 349 Drugs, Oh Sorry! 328 Banned – OMG its confusing! Let’s understand what has actually happened.

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Banned compressed

Download Complete List here: LIST OF BANNED DRUGS

What is FDC (Fixed Drugs Combination)?

An FDC drug contains two or more active ingredients in a fixed dosage ratio.

The Timelines through which the Battle between Health Ministry & Pharma Companies has come to an End!

10th March, 2016 – Ban of Manufacturing, Sales & Distribution of 344 FDCs & later 5 more FDCs added to the list = Total 349 FDCs Banned under Section 26A of the Drugs and Cosmetics Act, 1940.

Post Ban – Manufacturers of these drugs contested the ban in various High Courts & Supreme Court.

15th Dec, 2017, As per Supreme court orders, the matter was examined by Drugs Technical Advisory Board (DTAB) constituted under section 5 of the Drugs and Cosmetics Act, 1940.

Drugs Technical Advisory Board (DTAB) report comes around in the middle of year 2018 which recommends BAN on FDCs under consideration.

DTAB conclusion is based on the logic that these 328 FDCs have:

1. No therapeutic Benefit but

2. These can be a risky to the health of people.

12 Sept, 2018 – 328 FDCs Banned

CDSCO Letter for 328 Drugs Ban

Ban on 328 drugs

6 FDCs are under restricted use & manufacture based on therapeutic Justification

15 Drugs could not be banned reason being manufactured in India before 1988. However, the further investigation can be carried out to take final call on these also.

So, finally fate of 328+6+15 = 349 FDCs Decided!

One of the Petitioner in Supreme Court– All India Drug Action Network (AIDAN)

Read Twitter Trends on Drug Ban.

https://twitter.com/search?q=328+drugs+ban&ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Esearch

The Impact of this FDCs Ban on Pharma Industry:

Market Value loss of Business to Pharma Companies – Rs. 1500 Crores to 2000 Crores out of total Indian Pharma Market size Rs.1.18 Lakh Crores

Estimated Value of Unsafe FDCs in Indian Pharma Market – Rs. 1.3 Trillion. It can further lead to actions on other FDCs.

Pharma companies are cutting down their portfolio of FDCs since the ban announced for the first time on 10th March 2016.

In August, 2018 FDC Market Growth/FDCs Market Growth – 2.2%/8.9%

 

For any Feedback or suggestion mail at: info@pharmastate.com

 

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