Pharmaceuticals; Make in India

New Drug Approvals

Indian PM Narendra Modi: Understanding an enigma PM,  MODI
Brand India Pharma aims to make the most of a booming domestic pharma industry
India’s pharma exports stood at 90,000 crore rupees ($15 billion) for the year 2013-2014, and are set to cross the 1 lakh crore rupees ($16.4 billion) mark in the current financial year. The Brand India Pharma campaign aims to tap into this value proposition, under the guidance of the Indian Ministry of Commerce and Industry, aiming to showcase the strengths of the Indian pharma industry.

With more than 10,500 manufacturing units and more than 3,000 pharma companies, India is ranked among the top six producers of pharmaceuticals worldwide, and is well-positioned to take advantage of its place in a global landscape.

READ AT

http://www.thepharmaletter.com/article/brand-india-pharma-aims-to-make-the-most-of-a-booming-domestic-pharma-industry

List of WHO Approved Pharma Plant in India

http://pharmatips.doyouknow.in/Articles/Pharma-Companies/List-Of-WHO-Approved-Pharma-Plant-In-India.aspx

India’s spacecraft cost $74 million, a fraction of the $671 million spent by NASA’s MAVEN ……….SEPT 24 2014

Indian Pharma Sector

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WHO publishes New Version of the Draft on “Hold-Time” Studies

WHO publishes New Version of the Draft on “Hold-Time” Studies

http://www.gmp-compliance.org/enews_4483_WHO-publishes-New-Version-of-the-Draft-on-%22Hold-Time%22-Studies_8427,8526,9086,9087,Z-PEM_n.html

The 2nd revision for comment was published already in February this year (we reported). Now, a 3rd version is available – also for comment. The document describes the design of hold-time studies for the determination of time limits which have to be determined according to the generally applicable intermediate and bulk products. This should avoid that the storage of intermediate or bulk products from having any negative influence on their quality or the quality of a finished before processing to the next stage.

Chapter 2 which defines what intermediate and bulk products are has been added. It is now explicitly pointed out that hold-time investigations are part of the process validation. In turn, the reference to retrospective observation has been removed from the current version as well as – fortunately – the incomprehensible paragraph on the ‚most probable / worst case approach’.

Still, the different stages of production are explained with the example of solid forms. A flow chart for better understanding has been newly added.

The second part of the last chapter has been completely revised. In the second version, it contained proposals for hold-times of different process materials (in contradiction with the statement according to which data have to be collected for the determination). The quite vague information about cumulated hold-times has also been removed. Instead, the new version now contains a table with proposals of stages and respective tests that may be considered to certain study times.

Revision 3 of the draft can be found in the Members Area.

How to identify Out-of-Trend Results in Stability Studies?

 

How to identify Out-of-Trend Results in Stability Studies?
http://www.gmp-compliance.org/enews_4522_How-to-identify-Out-of-Trend-Results-in-Stability-Studies_8360,8348,8430,Z-QCM_n.html

An article in PharmTech from June 2013 (by Trajkovic-Jolevska et. al) deals with the methods to identify Out-of-Trend (OOT) results in ongoing stability studies.

With regard to stability studies, it is important to make the difference between Out-of-Specification (OOS) and Out-of-Trend (OOT). Both the pharmaceutical industry and authorities often misuse these two terms.

The article defines OOT results as those results which don’t follow the expected trend, either in comparison with other stability batches or compared to previous results collected during a stability study. OOT results aren’t necessarily OOS, but they don’t look like a typical data point.
Although OOT results are a serious problem, neither the scientific literature nor regulatory guidelines fully address them.

The aim of the study described in this Pharmtech article by Trajkovic-Jolevska et. al was to perform a statistical evaluation of the statistical methods used in the identification of OOS results.

The authors of this article present 4 statistical methods for the identification of OOT results:
•The regression control-chart-method
•The by-time-point method
•The slope-control-chart method
•The z-score method

The conclusion of this article is the statement that there is a tremendous need for a regulatory Guideline on OOT results in stability studies. This is exactly the next objective of ECA’s QC working group: an SOP on the handling of OOT results. On 22-23 October 2014, the OOT Forum in Prague will present the Draft of ECA’s SOP on OOT results.

The complete article can be found with the title “Methods for Identifying Out-of-Trend Results in Ongoing Stability Data”.

 

Australia: Orphan Drug Designation For Kalydeco + Lumacaftor For Cystic Fibrosis

Orphan Druganaut Blog

Australia’s Therapeutic Goods Administration (TGA) on September 22nd, designates Lumacaftor (VX-809) as an orphan drug in combination with Kalydeco (Ivacaftor), for the treatment of Cystic Fibrosis (CF) in patients who are homozygous for the F508del mutation in the CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) gene.

The combination of Lumacaftor + Kalydeco has the following Orphan Drug Designations:

•   FDA ODD in June 2014

•   EMA COMP recommendation in July 2014.

At the upcoming North American Cystic Fibrosis Conference (NACFC), October 9-11 in Atlanta, Vertex Pharmaceuticals will present the following Abstracts on the Phase III TRAFFIC and TRANSPORT studies of Lumacaftor in combination with Kalydeco (Ivacaftor), in CF patients with two copies of the F508del mutation:

•   “Effect of Lumacaftor in combination with Ivacaftor in patients with cystic fibrosis who are homozygous for F508del-CFTR: Phase 3 TRAFFIC & TRANSPORT studies.” An oral presentation of these data will be delivered as…

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