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Bio Saga

Monday, January 29, 2018

USFDA delivers strong message to pharma companies on quality culture & data integrity

USFDA delivers strong message to pharma companies on quality culture & data integrity:

The US Food and Drug Administration (USFDA) seems to have sent out a strong message to pharmaceutical companies in India on the need to adhere to a quality culture and on matters relating to data integrity. This was as part of 'Advanced GMP (good Manufacturing Practices' workshops that the US and European regulators conducted across four city of India between November 6th and 17th. Various presentations were made during these but one that needs particular mention is the USFDA paper titled: "Current Trends in Quality and Data Integrity Trends - Is it a Myth or tip of the iceberg?"

As is apparent from the paper, now posted on the website of the Indian Pharmaceutical Alliance, the number of warning letters issued by the Office of Manufacturing Quality of the USFDA to pharmaceutical companies has shot up and this is mainly on account of increase international warning letters (that is those outside of the US). And, in the international warning letters, India and China are two leading countries.

These warning letters used to average around 20 in a year in the calendar years 2013, 2014 and 2015. But these shot up to 43 in calendar year 2016. And so far 2017, seems to be no better, since already 35 warning letters have been issued.

Going by the numbers from this presentation, in 2017, out of about 45 warning letters in all, some 35 were international. In 2015, India accounted for the maximum number of warning letter. There was an improvement for India in 2016 and that year, China and others (those other than US, China and India) accounted for the maximum. However , in 2017, India and China are more or less on par in terms of warning letters received.

The key point therefore is that international account for a significant proportion of all the warning letters issued and while India was less than China in 2016, it is more or less equal in 2017.

What may be disturbing for pharma companies is the summary of the findings that the agency has arrived at based on the recent warning letters. For instance, it points out:

1, Releasing failing product as if it had passed.
2, Testing into compliance (in other words read: you keep on testing till you get a positive result
3, Not saving electronic or hard copy data that would confirm the failing results (which in a sense implies fabrication)
4, Disabled audit trail feature.
5, Inadequate out of specification investigation.
6, Inadequate CAPAs (Corrective and Preventive Action).
7, Root cause lacking scientific evidence.

As is apparent, the points one to four seem the findings but the rest from points 5 to 7 seem like analysis and remedial action. Next, the most cited observations are also listed with the section numbers also and here, Take two observations for example:
1, section 211.22(d): The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed;
2, section 211.160 (b): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures.

But it is really the pointers on why it feels these happen that need mention. Of the six pointers, two have been highlighted as these attribute the reasons to
1, immature quality culture.
2, Investigation focused on giving any explanation that may work, and not on what caused the problem in order to prevent recurrence and predict outcome.

Last but not the least, there is mention of symptoms and foundation problems. The symptom is that companies may be driven by production goals. One of the foundational problems cited is: 'lacking understanding of science.' Bad behaviour in terms of poor culture quality has also been pointed.

Ask Indian companies on what they think of these and while no one is willing to comment or get quoted, some felt that these are what the USFDA is finding world wide and not just in India.

Others felt these need to be perhaps seen as a warning letters issued based on the conclusions that these might have happened and that it is now for the companies to prove that it has not happened. While some others felt, these are concerns which may not necessarily mean all have them. All were however agreed that these are the expectations of the regulator and companies have no option but to satisfy them and therefore move in the direction of what is expected. Also, some felt it also goes to show that it is not as if US companies are doing any better because the points listed out are for all the warning letters issued by the US regulator.

But at the end of it all, the key point remains that it is important for the US regulator and especially in India. Take one statistic that does the round in the pharma circles is that typically of the total number of ANDA applications that the USFDA receives in a month, about 50 per cent would be from India. In this respect, India is ahead of China, the other important hub for pharmaceuticals.
But that is not to say, it is the only reason. As the presentation pointed out, the big worry is that the cases of non-adherence to some of the quality norms have also increased. There are some recurring citations and there are newer challenges too that need to be kept in mind.

In all, the workshops attracted some 400 odd participants all across four cities - Chandigarh, Ahmedabad, Goa and Hyderabad and these numbers also included some 100 odd domestic regulators, who also took part in these workshops. The goal of the meetings, organized by the Indian Pharmaceutical Alliance, but open to all pharma companies and not just its own members, was to educate people directly involved in various companies in India on issues around gaps in meeting global quality and monitoring requirements.

The regulators present at these workshops were from the US Food and Drug Administration's (US FDA), the UK Medicines and Healthcare Products Regulatory Agency (UK MHRA), the European Medicines Agency (EMA) and off course the India's Central Drugs Standard Control Organization (CDSCO) and all seem focused on the need to adhere to better quality culture.

Friday, September 15, 2017

work on the NCBO technology

If you like to work on the NCBO technology with us, check this out ;)


The 3 French Labex NUMEVAGRO and CEMEB within the context of the AgroPortal project ( which builds an ontology repository for agronomy are offering a 1.5-year postdoc position starting early 2018 in Montpellier, to work on agronomical ontologies and their alignments as well as take part in the international GACS initiative (

Standards vocabularies and ontologies are key elements to achieve data interoperability. The AgroPortal project ( develops and supports a reference ontology repository for agronomy, plant sciences, biodiversity and nutrition. We have already designed and implemented an advanced prototype offering ontology-based services that hosts 64 ontologies or vocabularies including some reference resources in the domain: Agrovoc, NAL thesaurus, Crop Ontology, etc. One of the challenges when dealing with multiple ontologies is to determine their overlap and align them.
We are offering a postdoc position to investigate and develop ontology mapping capabilities for AgroPortal ontologies and participate into the international Global Agricultural Concept Scheme (GACS) project. With the experience and technology developed with the YAM++ application (LIRMM’s ontology alignment matcher -, we will make AgroPortal a state-of-the-art platform for mapping extraction, generation, validation, evaluation, storage and retrieval by adopting a complete semantic web and linked open data approach and engaging the community for curation. We will first focus on the ontologies of the Montpellier community (agronomy, food, biodiversity) and then join the GACS project(integration of Agrovoc, NAL Thesaurus & CAB Thesaurus) of the RDA AgriSemantics working group (

More detail here:

Tuesday, June 20, 2017

We are HIRING !! Do visit us at the corporate offices in Bangalore, for a dialogue with our HR specialist !!
We are HIRING !!  Do visit us at the corporate offices in Bangalore, for a dialogue with our HR specialist !!  

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Wednesday, June 14, 2017


The Genome Education (TGE) is a special initiative by Bionivid Technology Pvt. Ltd to develop, design and execute basic and advanced learning programs for Next Generation Sequencing data analysis. Through TGE we aim to enable students, research scholars, research faculties and clinicians to understand, learn and build expertise in handling Genomics “BIG DATA”. Under TGE initiative, Bionivid is proud to introduce Global Genome Informatics Certificate Program (GGI).
GGI is specifically designed for developing skills and enhancing career of students with Engineering / Post Graduate degree in the field of Biotechnology / LifeScience or other allied sciences. GGI is a combination of theory and technology aided practical platforms for hands-on learning experience. GGI is rigorous and challenging program where only 15 intensely dedicated and motivated participants will be selected on merit. GGI will cover indepth training and exposure to the aspects of basic and applied Genomics, Statistics, Data Mining, Data Visualization, Data Management, Data Analytics and Critical Thinking. In short, GGI will essentially provide technical perspective and advanced level training to manage and analyze Genomics “BIG DATA” and providing a very high profile and lucrative career of Genomics DATA SCIENTIST to the students. GGI will not just enhance your skills as Genomics DATA SCIENTIST but 100% guaranteed placement will ASSURE a great start to your CAREER

Tuesday, March 14, 2017

Research Associate Life Science

Research Associate Life Science

Eligibility : M Phil / Ph.D

Location : Shimla

Last Date : 24 Mar 2017

IHBT - Job DetailsDate of posting:14 Mar 17

Research Associate Life Science recruitment in CSIR – Institute of Himalayan Bio Resource Technology (IHBT), Palampur

Qualification : Ph.D. in Life Sciences with specialization in Microbiology/Microbial Technology/Microbial Biotechnology.

No. of Post : 01

Pay Scale : Rs.36000

Age : 35-40 Yrs

Hiring Process : Walk - In

Job Role: Research/JRF/SRF

Life Science and Informatics

What is this?
is this a new industry?
or a old wine in a new bottle?

Well Life Sciences and Informatics can be anything form computational biology, all omes and omics, core bioinformatics to curation and literature mining, database creation, in the area of biology, chemistry , bio-chem space.

There are number of companies in India and bangalore is the forefront as a major bio-cluster with 20 to 30 companies in this sphere.

now how good are these companies doing?
how good are they in terms of the international markets and how profitable is their business?
what do they do?
their clients?

These are some interesting things that could be discussed in this blog page...

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