Pharmabiolien Consulting

Pharmabiolien Consulting We are Research Consulting operating in verticals of Drug Development,Preclinical Research,Clinical Studies,CMC Manufacturing Support among other services

We are a research consulting/service provider incorporated with headquarters based in Hyderabad, India operating in the verticals of Drug Development, Preclinical research, Clinical studies, CMC-Manufacturing Support, Regulatory Assistance/ Liasoning for various types of submission dossiers, post marketing studies etc. We primarily have no vested interests with any of the pharma and biotech companies, thereby retaining our independency.

15/06/2023
Gujarat FDCA clarifies misconceptions over quality issues at a meet with western mediaSuja Nair ShirodkarSaturday, Septe...
13/09/2015

Gujarat FDCA clarifies misconceptions over quality issues at a meet with western media

Suja Nair Shirodkar
Saturday, September 12, 2015, 08:00 Hrs [IST]
In a move to clear doubts over the efficacy of drugs manufactured in India, especially in the state, the Gujarat FDCA recently had an interactive meeting with the German and French media to strongly project the facts and clarify the misconceptions over the same. The meeting was primarily focused on assuaging the fear and confusion emanating from the European nations over the quality of the drugs that are manufactured in the country after the GVK fiasco.

The EDQM last month had suspended the use of about 700 medicines, including different APIs, formulations and dosage strengths, made by numerous drug makers. This move was prompted in the wake of reports and recommendations over the veracity of studies conducted by Hyderabad based GVK Biosciences, about the reliability of several studies conducted on behalf of several drug makers by GVK between 2008 and 2014.

The suspension will last upto two years, although individual drugs may not be suspended if a member nation determines these are critical medicines, reports suggest. This decision by the EU has come as a huge set back for India as it will seriously impact not only the reputation of the industry but also the export margin as well.

Dr Hemant G Koshia, commissioner of Gujarat FDCA stressed that it was imperative on their part as drug regulators to ensure that the western media was duly appraised about the ground realities so that the effectiveness of the drug regulatory body in the country was not maligned or questioned in the process. “We wanted to send a clear message to them that the Indian regulators are doing their job well in safeguarding the interest of the patients while conducting all the drug regulatory process like following stringent rules before granting any license as per the standards accepted and followed globally. Thus it is important to make a clear stand that there is no need to ensure a blanket ban on the drugs that are manufactured from India based on allegations without having clear proof over the matter.”

He further informed that during this meet the foreign media was given an overview of the over all Indian drug regulatory requirements and how they are at par with that of other global counterparts. Detailed and strategic tour was also given on various measures taken by the regulators to keep a tab on the stakeholders’ activities and the drugs running in the market.

Gujarat is major pharma hub with key focus on exports to European countries. Thus, this meeting was strategically called to restore the trust in Indian manufactured products among the western counterparts and to boost the confidence of the stakeholders.

Gujarat FDCA clarifies misconceptions over quality issues at a meet with western media

Elder Pharma in deep neck problem on both financial terms and the recent regulatory FDA audits...
13/09/2015

Elder Pharma in deep neck problem on both financial terms and the recent regulatory FDA audits...

Elder Pharma today said it is in the process of restructuring as a whole and is in an advanced stage of discussions with prospective lenders.

With clinical trial approvals in India on a steady decline, pharmaceutical companies are shutting their indigenous drug ...
06/09/2014

With clinical trial approvals in India on a steady decline, pharmaceutical companies are shutting their indigenous drug discovery operations in the country.

Last week, Piramal Life Sciences announced that it is shutting down its drug discovery and research unit in Goregaon, Mumbai. This has left close to 400 employees in the categories of band one and two, research fellows on government-funded projects and apprentices in a lurch.

While the pharma company has offered its scientists an option to either opt for voluntarily retirement from their posts or seek a relocation to other units in Hyderabad, Pithampore, Indore, Chennai or Ahmedabad, the latter choice looked bleak.

Close to 90% of the 200 scientists in the company have opted for Early Separation Scheme (ESS), said a senior scientist on condition of anonymity. Also, whether the applications made by the employees for ESS have been accepted or rejected by the management will be conveyed to them by September 9, states the letter dated August 27, circulated by Piramal Life Sciences to their employees, of which dna has a copy.

A scientist working in the drug discovery unit of New Chemical Entities (NCE) research since the last seven years told dna, “The option of relocation is a very diplomatic mention. We have to intimate the company by September 2, whether we want to opt for Early Separation Scheme. Meanwhile, there is no clarity on where could we be possibly relocated or what our future job role in the company will be, if we are retained.”

In the letter, the company mentions that investments in NCE research are no longer viable and needs to be cut down. “We have been reviewing our pipeline of drugs under development along with our advisors, and based on future investments and time required to take them to fruition, we have determined that the risk reward ratio is no longer favourable,” says the letter.

Some scientists, sources say, had joined barely two weeks ago from other drug companies and have been asked to retire voluntarily, which is a huge setback for them. “Some more who were joining in another week, had already left their previous jobs and were in transit from Gujarat and Bangalore," said another scientist.

However the company maintains that change in regulatory environments has necessitated shifting clinical trials out of India, resulting in higher costs for conducting research in the country.

“Of hundred odd drug compounds which are tested over a span of years, hardly one compound is successful. Each compound to reach a stage of clinical trials from drug discovery requires an investment of close to $4 billion. We cannot afford such high investments and thus have little option but to shut drug discovery units,” said Dr Swati Piramal, vice chairperson, Piramal Industries Limited.

Employees in the drug discovery unit ranging from junior research associates to higher managerial levels get paid between Rs three lakh to Rs forty lakh per annum.

“With no clarity on where will we be posted if we do not opt for ESS, as also a slump in the job market with no clinical trials happening in India, we are stuck between the devil and the deep blue sea,” added the scientist.

The drug discovery and research unit has been running into losses since the past two years. Since the past 17 years, the company has invested over Rs 2,000 crore in research and development of NCEs in the fields of infectious diseases, inflammatory disorders, neurosciences, cardiology, oncology and metabolic disorders including diabetes.

NCEs are new single or combination drugs which provide important new therapies to patients which have not been previously approved by drug regulators like the US- Food and Drug Administration (FDA).

In India, Piramal Healthcare invests between Rs 100-200 crore every year on each of its facilities The pharma company has a total employee strength of 6,000, with eleven manufacturing and R&D units in India and abroad.

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