Analysis On The Issues Raised By The Regulatory Authorities On Indian Pharma Companies And Inputs Provided By Them
Pharma Bio World|September 2018

Pharmaceutical industry across the globe bench marks the standard of regulatory processes carried out by Food and Drug Administration of USA (USFDA). India which has th e highest number of USFDA approved plants outside of USA itself, has been confronted with slew of warning letters and import alerts from the said regulatory authority, which especially were accentuated during last six years i.e. from FY13-FY18. The current article delineates upon analysis on classification of violations cited by FDA for Indian Pharma cos, inputs provided by them while concluding with solutions to overcome majority of the regulatory observations.

D Naveen Kumar & Vidhyasagar L
Analysis On The Issues Raised By The Regulatory Authorities On Indian Pharma Companies And Inputs Provided By Them

With market size of around $ 35 bn in FY2018, Indian pharmaceutical industry is ranked third globally in terms of volume and thirteenth in terms of value. Indian pharmaceutical companies, over decades of arduous efforts, have gradually developed the necessary technology, capacities and capabilities to meet the demand and to explore the opportunities provided by global regulated markets; and currently, United States of America (USA) contributes about one third of the total Indian pharmaceutical exports. Furthermore, Indian pharmaceutical manufacturing companies accounted for 36% of the total Abbreviated New Drug Application (ANDA) approvals by USA in 2017 as compared with 34% in 2016; the total number of ANDA approvals has increased from 201 to 304 during the same period. India has second highest number of USFDA (United States Food and Drug Administration) approved manufacturing plants, ie, about 700 units with over 5000 ANDA approved drug products during last decade i.e. 2008-2017.

With all the aforesaid accolades, however, lately, it has been noted that there has been a spurt in the issuance of the import alerts and warning letters for domestic manufacturing facilities significantly over the past years following USFDA’s increasing focus on compliance of guidelines of cGMP. This restricts the manufacturing units to supply drugs to the US market from that facility resulting in the decline of revenue for the companies particularly to US market and also from other markets subsequently if the issues are not closed out to the earliest.

Sequence observed by USFDA in regulatory enforcement:

Diese Geschichte stammt aus der September 2018-Ausgabe von Pharma Bio World.

Starten Sie Ihre 7-tägige kostenlose Testversion von Magzter GOLD, um auf Tausende kuratierte Premium-Storys sowie über 8.000 Zeitschriften und Zeitungen zuzugreifen.

Diese Geschichte stammt aus der September 2018-Ausgabe von Pharma Bio World.

Starten Sie Ihre 7-tägige kostenlose Testversion von Magzter GOLD, um auf Tausende kuratierte Premium-Storys sowie über 8.000 Zeitschriften und Zeitungen zuzugreifen.

WEITERE ARTIKEL AUS PHARMA BIO WORLDAlle anzeigen
B&R Expands Gilgenberg Site
Pharma Bio World

B&R Expands Gilgenberg Site

Automation specialist invests in production, office space and logisticsB&R is investing in its Gilgenberg site, located a few kilometers from the B&R headquarters in Eggelsberg. The expansion adds new offices, training rooms and production space. A new logistics hall has also been opened at the site.

time-read
1 min  |
March 2018
Creating An Annual Event Of The Biopharma Industry By Focusing On Frontiers, & Promoting Leading Enterprises To Collaborate
Pharma Bio World

Creating An Annual Event Of The Biopharma Industry By Focusing On Frontiers, & Promoting Leading Enterprises To Collaborate

The Union Budget 2018 was presented on February 1, 2018.

time-read
3 Minuten  |
March 2018
Pain Point To Gaining Brownie Points: Technology Is A Game Changer For Indian Pharma Sector
Pharma Bio World

Pain Point To Gaining Brownie Points: Technology Is A Game Changer For Indian Pharma Sector

The Indian pharmaceutical industry has come a long way from traditional home-made herbal medicines to being the manufacturer of world class life-saving drugs. However, at the helm of game-changing innovations steering this industry to a whole new level is the implementation of technology.

time-read
3 Minuten  |
Pharma Bio World MAY 2018
Data Acquisition, Evaluation And Transmission To The Cloud
Pharma Bio World

Data Acquisition, Evaluation And Transmission To The Cloud

A single device to acquire data, evaluate it and send it to the cloud – that’s now possible with B&R’s Edge Controller. The powerful industrial PC can even be used for big data analysis and machine learning, while at the same time serving as a full-fledged industrial controller.

time-read
1 min  |
Pharma Bio World MAY 2018
Pharma Bio World

Just The Right Dose Of Intelligence

Nothing herein shall constitute an offer to sell, or a solicitation of an offer to buy. The ACOPO Strak product is not available for sale into the United States of America until September 2018.

time-read
1 min  |
Pharma Bio World MAY 2018
Considerations For Extraction, Stabilization And Quantification By PCR For Sensitive Sample Such As RNA
Pharma Bio World

Considerations For Extraction, Stabilization And Quantification By PCR For Sensitive Sample Such As RNA

This article talks about careful selection of an extraction system that helps stabilize and protect targets, especially RNA, or which allows for immediate analysis.

time-read
6 Minuten  |
August 2018
Novel Research In Pharmaceuticals And Bio-Pharmaceuticals
Pharma Bio World

Novel Research In Pharmaceuticals And Bio-Pharmaceuticals

This article covers entire spectra of pharmaceutical research and as well as those related to synthesis and processing of pharmaceuticals.

time-read
5 Minuten  |
June 2017
Boost Productivity With Anti-sloshing
Pharma Bio World

Boost Productivity With Anti-sloshing

Transport liquids faster without spills With B&R’s industrial transport system, it is now possible to transport liquids quickly with no spills. SuperTrak is the only system on the market to offer anti-sloshing technology. This technology suppresses the format ion of oscillations on free surfaces to prevent liquids from spilling over container edges during transport .

time-read
1 min  |
June 2017
Rational Use Of Drugs And Irrational Drug Combinations
Pharma Bio World

Rational Use Of Drugs And Irrational Drug Combinations

Irrational use of medicines is a global phenomenon. Rational use of drugs may be defined as: Patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and the lowest cost to them and their community. Overuse, polypharmacy and incorrect use of drugs are the most common problems of drug use today. Irrational use of drugs may result due to various reasons at various levels including the prescribing errors and over the counter drugs. Irrational use of medicines may lead to serious negative health and economic consequences. Many irrational drug combinations are available in the Indian market. Proper implementation of rational use of drugs will improve the quality of life and result in better community healthcare.

time-read
6 Minuten  |
February 2019
Cold Chain Management For Sensitive Goods
Pharma Bio World

Cold Chain Management For Sensitive Goods

Packaging, route planning and risk analysis ensure safe conditions during transportation of delicate drugs. Drugs are sensitive goods to transport, which can be subject to irreversible damage if they are stored or transported at temperatures outside the tolerated range. If the temperature falls below or rises above the specified range the quality of drugs requiring refrigeration can be seriously affected and they may cease to be effective. This article therefore describes how transport conditions during the transportation of drugs can be optimised through suitable packaging, individualised process design, the analysis and assessment of potential risks and close collaboration between the sender and the freight carrier.

time-read
7 Minuten  |
February 2019