FDA Approves Vaccines for 2009 H1N1 Influenza Virus

The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

“Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This vaccine will help protect individuals from serious illness and death from influenza.”

The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.

”The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” said Jesse Goodman, M.D., FDA acting chief scientist.

Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.

Clinical studies under way will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.

As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.

People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.

For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and -- in children 2 to 6 years old -- fever.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is working closely with governmental and nongovernmental organizations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention.

Analytical positions at Natco Pharma Limited

Natco Pharma Limited
Natco House, Road No 2, Banjara Hills
Hyderabad 500033

Sr Faculty for Analytical
The applicant should have MSc (Analytical Chemistry / M Pharmacy (Analysis) with 5-10 years of teaching experience.
People with Industrial Experience will be given preference.

Jr Faculty
The applicant should have MSc (Analytical Chemistry / Organic Chemistry / M Pharmacy (Analysis) with 2-3 years of teaching experience.
Applicants would need to furnish: 1) Copies of all relevant certificates and other documents. 2) A hand-written (by self) resume and 3) Two recent passport size photographs. Applications can be send to the above mentioned address within a week to the above mentioned address.

Salary revision for Pharmacy teachers in Kerala

THIRUVANANTHAPURAM: The Cabinet gave its clearance for revision of salaries of teachers of government medical, dental, nursing and pharmacy colleges in the State on Wednesday evening.

Briefing the media, Chief Minister V.S. Achuthanandan said the non-practising allowance of medical college teachers too would be revised along with pay and allowances. Private practice by medical college teachers would not be allowed.

An official spokesman of the Health Department said the non-practising allowance of medical college teachers would go up by about 25 per cent and patient care allowance by 15 per cent. A medical college professor would now get salary exceeding Rs.85,000 while associate professors would earn more than Rs.77,000 a month. The salary of assistant professors would exceed Rs.50,000.

The ban on private practice would come into effect from September 15. The revised scales of pay would have retrospective effect from January 1, 2006. The arrears of pay up to August this year would be merged with the provident fund. The total outgo from the exchequer for it would be of about Rs.100 crore a year.

Dental surgeons under the Kerala Health Services and lecturers in dental colleges would be exempted from appearing in the entrance examinations for admissions to post-graduate courses under service quota.

Conference on Recent Advances in Pharmaceutical Research

G.Pulla Reddy College of Pharmacy, Hyderabad is organising a conference on Recent Advances in Pharmaceutical Research on 9th and 10th October, 2009.

This seminar is designed for the teachers and post graduate students of Pharmacy.

Abstract submission Guidelines:

• Original Research work should be sent for the presentation
• The presenting author name should be underlined and he/she should be registered participant of the seminar
• Abstract shall be not more than 250 words, covering title, objective, methods, results & discussion
• Mention whether oral or poster presentation in the abstract
• Poster size 3ft X 3ft
• Oral presentation duration is 8 minutes

Abstracts shall be submitted online at gprcphyd@gmail.com or by post in CD.

Important dates:

Last date for receipt of registration forms with DD/cash by post/person: 30 Sept, 2009

Submit abstract not later than: 20th September 2009
Acceptance/Rejection of abstract is intimated on or before: 25th September 2009

Growth in China’s CRO industry

Read this and thought someone will be interested to know.

Masood Tayebi, Executive Chairman and Co-founder of BioDuro, a CRO headquartered in San Diego, broke down the growth in China’s CRO industry in distinct phases at the ChinaBio® Workshop “Leveraging China to Build a Global Biotech.”

• 2000-2004 – most of the work was low-cost outsourcing; the industry provided largely crank-turning commodity services;

• 2004-2007 – higher quality work, more protein drugs, DMPK, ADMET, basic pharmacology; influenced in part by growing numbers of returnees;

• Since 2007 – collaboration grows between client and CRO as risk sharing increases to modest levels; CROs contribute their innovative skills; and

• Future – CROs providing scientific breakthroughs for their clients.

Ethics in Indian Clinical Trials

Happened to read an interesting article that discussed on the ethical aspects of clinical trials that are being conducted in India.

Not a new topic for the media to criticize but this was one was worth a read.

Excerpts from the article:

....In Gujarat, unemployed diamond workers and migrants from Uttar Pradesh and Bihar get paid between INR 5000 and INR 20,000 to take part in bioequivalence trials – sums large enough for them to put money over personal safety. Indeed, trial participants may be both financially and socially vulnerable. It is reported that Surender, who died in the Hyderabad felodipine trial, was one of a number of Dalit students being recruited for clinical trials in that city. Likewise, some years ago, a 22-year-old Adivasi youth died in a bioequivalence trial of the antidepressant citalopram by the Sun Pharma Advanced Research Centre in Vadodara...

....Another concern about trials in government hospitals is that they are conducted on poor people who may have no access to the drugs tested on them after the trial is over. In August 2008, the media reported that 49 children died in 42 clinical trials that were conducted over two and a half years in the Department of Paediatrics at the All India Institute of Medical Sciences (AIIMS) in Delhi. An investigation ordered by the National Human Rights Commission concluded that the trials were conducted properly: the children in the trials were seriously ill, and all the deaths occurred because of the serious illnesses, not the treatments. However, the committee’s report left many questions unanswered. What, for instance, was the purpose of these trials? Would they help other poor children in India?...

Ethicist Amar Jesani points out that ethics committees have a lot of power, as the DCGI requires that all trials be passed by such an appointed group. In fact, the DCGI only requires approval by an ethics committee, since it does not monitor the actual conduct of the trial – it does not check that informed consent is taken, that the investigators do their job correctly, that subjects are not harmed, and so on. Thus, says Jesani, it is the ethics committee, not the DCGI, that is the real regulator of clinical trials.

....Now, the FDA’s decision to do away with the Declaration of Helsinki will create a dilemma for the DCGI. If CROs in India are to follow the FDA requirements – such as using a placebo even when it is not absolutely necessary, and when it might put subjects at risk – they will be violating Indian regulations, which require that the Declaration of Helsinki be followed. The latest revision of the Declaration is quite clear that the placebo may be used in very few circumstances. At the moment, however, the DCGI’s record – permitting a number of unethical trials – suggests that his office places greater value on the potential financial returns of clinical trial outsourcing than on protecting the people who take part in drug trials in India...

Pharmacy Council of India (PCI) constituted Woking Group suggest ways to take pharma education to international standards

Pharmacy Council of India (PCI) has constituted a Woking Group comprising of experts in pharma education to suggest ways and means to improve the educational system in India. The step is expected to help it become part of the Global Framework of Pharma Education of the International Pharmaceutical Federation (FIP), a 120-member global body of national associations of pharmacists and pharmaceutical scientists.

Once India becomes part of FIP's global framework, it will be a big boost to the pharma education in the country as the students passing out of the Indian pharma educational institutions will get equal status in all the member countries of the FIP. The educational qualifications of Indian institutions will be recognised in all the member countries of the FIP. There will be huge increase in the job opportunities for the pharma students in the country.
PCI vice-president PP Sharma is heading the Working Group. Other members of the Group are Dr SY Gave, Dr Parthasarathy, Dr Ravi and M Venkat Reddy. The Group will submit its findings to the PCI within two to three months, sources said.

Recognising the need to support and strengthen pharmacy education worldwide, FIP, along with WHO and UNESCO, formed the Pharmacy Education Taskforce. The Taskforce is a coordinating body of organisations, agencies, institutions, and individuals with the shared goal of catalysing actions to develop pharmacy education in the world.

The purpose of the Taskforce is to oversee the implementation of the Pharmacy Education Taskforce Action Plan 2008-2010. The Action Plan aims to enable the sustainability of a pharmacy workforce that is relevant to local needs. The Action Plan is dedicated to three domains of action: quality assurance, academic and institutional capacity, and competency and vision for pharmacy education.

For becoming part of the FIP global framework, Indian pharma education should be of international standard. The newly formed Working Group will find ways and means in this regard.

FIP's priorities have expanded both literally and figuratively to meet the needs and expectations of the profession in expanding healthcare services and integrating emerging scientific developments. Changes in pharmacy and the emergence of Pharmacy Practice as a cornerstone of the profession have led FIP to become globally visible for its advocacy on behalf of the role of the pharmacist in providing healthcare, while still maintaining its grounding in the pharmaceutical sciences.

Through the work of various individuals, working groups and taskforces, FIP initiates and implements numerous projects and programmes that are making a significant impact within global pharmacy practice, pharmaceutical sciences and community health.

Source: Pharmabiz

Excerpts from the interview with Kiran Mazumdar Shaw, chairman and managing director of BIOCON

Biocon’s chairman and managing director Kiran Mazumdar Shaw is betting big on the oral insulin drug that the company is scheduled to unveil next March. Now that the markets are picking up, she also said the firm would look at listing its research division Syngene. Dr Shaw spoke to ET NOW on the sidelines of a seminar organised by the Great Lakes Institute of Management, where she shared her experiences in setting up and growing Biocon with the B-school.

Excerpts from the Interview:

Biocon has aggressive plans in the monoclonal antibodies space through your recent partnerships with Mylan. What are the details of this partnership? Is it a profit sharing model? Will products be marketed under the Biocon brand?

The partnership envisages a profit-sharing business model for the markets of EU and US. And in the rest of the world, both the partners will be marketing their products through a co-marketing strategy. We will be marketing our own brands. Mylan has the sole responsibility of marketing these products in the Europe and US.

What are your plans for insulin? Are you taking it to the whole world by expanding marketing presence? There were talks of clinical trials in the EU and US?

Insulin and insulin analogues is a big play for us. And that’s certainly one of the big growth drivers that we have factored into our growth trajectory. We certainly want to expand our global footprint. We will do this through global partnerships as well as Biocon’s own presence in select markets such as Middle East and Germany. Apart from those and a few other markets, we would largely market through partnerships.

The NPPA recently brought your Basalog drug under price control. What are your views on this?

Basalog does not come under the purview of NPPA. It has been wrongly classified. There is a provision under the drug price control order, which actually talks about biotech drugs being exempt for five years, especially when they are developed and commercialized in India. So, I think it has been wrongly classified and NPPA needs to make that correction so we don’t come under NPPA.

There is a lot of talk about the bio-similar space. The guidelines are in place for EU, Japan and the process is underway in the US. Your marketing a biosimilar called Glargine in India. Will you take this global?

Absolutely. As I mentioned, insulin and insulin analogues, which includes Glargine would certainly be a global play for us.

What about analogues such as Lispro and Aspart? Is Biocon working on this too? Yes, we are looking at the whole analogue space. So, it won’t be just Glargine. We will be developing other analogues.

What about listing of your research division Syngene? You had plans for that a year back.

Yes, we are certainly looking at doing that. I think we are looking for the opportune moment.

Is Biocon focusing on bringing blockbuster innovative drugs to the market or will you focus on generics in the biological space?

I think we are one of the few companies that have advanced programs. The one that we are really betting on is oral insulin. We will be the world’s first developer of oral insulin, if it works. We are keeping our fingers crossed because by March we will know if we have made such a product. This is a very exciting program because it’s not about insulin in a tablet. Its about a new diabetic therapy because of the delivery profile that we have created in this molecule and it can be a game changer in diabetes management because early insulinization is a new, important concept backed by biologists.

Source: The Economic Times

Clinical Trial Outsourcing in India to Post Double Digit Growth by 2012

In the recent economic scenario, outsourcing business in life sciences, especially pharmaceuticals and biopharmaceutical business, has displayed an upward trend. This has been led by outsourcing of clinical trials which share a major part of drug development costs.

A research study “Booming Clinical Trials Market in India” conducted by RNCOS anticipates that clinical trial outsourced market in India is forecasted to grow at a CAGR of over 30% during 2010-2012 to around US$ 600 Million by 2012. With this anticipated growth, India will become one of highest growing clinical trial destinations in the world. An extensive research has been done on Indian clinical trial market in order to identify key trends across the market. The report highlights that all the major pharmaceutical/biotech players as well as major CROs are making India their base for conducting global clinical trials as finding patients, who can qualify for a clinical trial, is relatively much easier in India as compared to the Western countries.

Various other factors such as increasing prevalence of diseases and low cost of clinical trials are also promoting this market. We have observed that there is no dominance in terms of competitive landscape. There are more than 100 firms working in India in the clinical trial market, with Syngene and Quintiles right on top in terms of market share.

Apart from this, there are also some restraints, like weak IPR protection, lack of trained staff, etc., which are blocking the proper growth of the market. So, in order to ensure proper growth of the industry, these issues need to be addressed efficiently. Our study analyzes the key markets and segments of the concerned industry to project the future scenario of the industry. According to our industry experts, several steps need to be taken by the Indian government to ensure an easy approval system for promoting foreign investments. The report also studies various factors which are fuelling the growth of country’s clinical research market.

For FREE SAMPLE of this report visit: http://www.rncos.com/Report/IM564.htm

About RNCOS: RNCOS, incorporated in the year 2002, is an industry research firm. We are a team of industry experts who analyze data collected from credible sources. We provide industry insights and analysis that helps corporations to take timely and accurate business decision in today's globally competitive environment.

Implementation of WHO Certification Scheme by CDSCO

September 1, 2009

Letter from DCGI Office:

A considered view has been taken that Certificate of Pharmaceutical Products(COPP) and Certificate of GMP under WHO Certification shall be taken over by theNational Regulatory Authority ie DCG (I) office.

The WHO has time and againexpressed concerns on the implementation of WHO Certification Scheme on the Qualityof Pharmaceutical Products Moving in International Commerce.The matter was discussed in the 40th meeting of DCC held at New Delhi on 29-06-2009 and the States were informed that this activity would henceforth be taken overby CSDCO in a period of 3 months and WHO informed accordingly.

Now, the directorate has decided to implement WHO Certification Scheme byCDSCO from 1s' October 2009 and COPPs will be issued by Offices of CDSCO afterinspection of manufacturing facilities by CDSCO regulatory officials.

More swine flu deaths in Hyderabad

HYDERABAD: Two more persons succumbed to the H1N1 virus in the twin cities. Lakshmi Devi Lakka (30) from Kadapa and C. Roopa Devi (38) from Kavadiguda, died in the early hours of Saturday at Aware-Global, L. B. Nagar and Chest Hospital, respectively. Doctors said both were in a critical condition because of delayed diagnosis of swine flu.

Virus turns aggressive
With four swine flu deaths in six days and more likely in the coming days, health officials are now advocating the importance of adhering to the concept of ‘social distancing. Stress is also being given to improve medical infrastructure like more ventilators and manpower to treat critical cases in government hospitals. “The virus is gradually becoming aggressive. Within a short span of two weeks after contracting it, few patients have died.

It’s better to avoid public places for few months,” says Chest Hospital Superintendent Dr. S. V. Prasad. Doctors informed that Lakshmi Devi was admitted in a critical condition to Aware-Global Hospital, L. B. Nagar, on August 25 and was on ventilator since then.

The Chest Hospital doctors informed that Roopa Devi, admitted on August 29, was critical due to delayed diagnosis. “It’s always better to avoid public gathering spots. Yet, we have not reached a threshold to advise drastic measures like giving a blanket call to avoid public places. Those having flu like symptoms should be socially responsible enough to avoid public places,” says State coordinator for swine flu K. Subhakar.

Meanwhile, the authorities confirmed eight more swine flu cases in the twin cities, taking the total number of cases in the State to 215.

The Institute of Preventive Medicine (IPM) received 23 samples from the screening centres out of which they confirmed eight cases. The patients who tested positive are locals and do not have any travel history. All the eight swine flu positive patients are in a stable condition.

Source: The Hindu

Project vacancy at Banaras Hindu University (BHU)Varanasi

Department of Pharmaceutics, Institute of Technology, Banaras Hindu University (BHU)Varanasi

Project Fellow @ Rs 8,000 pm

UGC Project Under SAP

Qualification: M.Pharm

Apply within 15 days of this advertisement (Advertised date in BHU web site 01 Sep 2009)
Further Info about BHU MPharm Project Vacancy under UGC SAP Programme

State Bank of India (SBI) Pharmacist jobs

State Bank of India (SBI) Corporate Centre, Mumbai

State Bank of India (SBI) invites applications from Indian citizens for appointment in the Clerical Cadre posts of Pharmacists in State Bank Group.
Pharmacists : 35 posts
Age : 18-28 years
Pay Scale : Rs.4410-13210

Educational Qualification
Pass in SSC or its equivalent examination and minimum Diploma in Pharmacy (D.Pharma) from recognized University or Board.
Candidates with degree in Pharmacy will be preferred

Experience
The candidate must be a Registered Pharmacist under Pharmacist Act.. with State Pharmacy Council or similar recognized body constituted for the purpose. Minimum1 year experience as Pharmacist or Compounder. Ability to give first aid treatment independently in accident cases is essential. Job Profile All duties attached to Medical Clinic of the Bank as Pharmacist /Compounder, including assisting in clerical work, whenever necessary. Should be able to give first aid treatment independently in accident cases.

Application Fee : Rs.300/- (Rs.50/- for SC/ST/PH/Ex.SM) to be deposited in any CBS branch of SBI, pay through prescribed payment voucher in the A/c No.30838646685 and get cash receipt withunique deposit journal number, and Branch code No. which is to be submitted along with the application.

How to Apply : Application alongwith cash receipt and desired enclosures should be sent in a cover super-scribed 'APPLICATION FOR THE POST OF __________________" to reach the following address on or before 30/09/2009 : Post Box No. 7698, Kandivali (West) Post Office, Mumbai - 400067

Cadila Pharmaceuticals Ltd - Walk in @ hyderabad

Cadila Pharmaceuticals Ltd (CPL) is one of India's most reputed, research based, tech-savvy pharmaceutical companies. Headquartered at Ahmedabad - Gujarat, CPL is an integrated health solutions provider with pharmaceutical product basket that caters to over 50 therapeutic areas. At Cadila Pharmaceuticals, Research and Development team of more than 350 scientists forms the core of all the initiatives in the realm of Biotechnology, APIs, Formulations, Plant Tissue Culture, Phytochemistry etc. This strong R&D team forms the backbone of state-of-the-art manufacturing facilities at Dholka, Ankleshwar, Kadi and Hirapur in Gujarat, Samba in Jammu & Kashmir, and Addis Ababa in Ethiopia.

CPL is all set to launch its biologics subsidiary (A joint venture with Novavax Inc, US), to carry out biotech research, manufacturing operations and contract research / manufacturing services. CPL is looking out for the best scientific talent available in the country in following areas:
Research Associates / Research Scientists - Analytical Development
Qualification: MSc / M Pharm (Experience: 2-5 years). Analytical Method Development, Method Validation and Routine Analysis in HPLC. Documentation as per regulatory guidelines. Candidate with experience in vaccine and other biologics will be preferred.

Executives / Asst Managers - Quality Control
Qualification: MSc (Biotech / Biochemistry / Microbiology / MTech / M Pharm). (Experience: 2-6 years). Candidate will be responsible for various QC activities related to Vaccine and other biologics. Must have an expertise in handling sophisticated instruments like Electrophoresis unit, Western Blot, Densito meter, FACS, Spectrophotometer, HPLC and Cell counter.

Executives / Asst Managers - Quality Assurance
Qualification: MSc (Biotech / Biochemistry / Microbiology) / MTech / MPharm. (Experience: 2-6 years). Candidate will be responsible for activities related to Qualification, Validation, IPQA and Documentation related to manufacturing of bulk/ finished products. (Vaccines and Other Biological Products).

Executives / Asst Managers / Dy Managers - Production
Qualification: B Pharm / M Pharm (Experience: 3-8 years). Candidate will be responsible for activities related to manufacturing of Sterile injectable products and documentation as per regulatory requirements.

Executives / Asst Manager / Dy Manager - Bulk Manufacturing
Qualification: MSc / M Pharm. (Experience: 2-6 years). Candidate will be responsible for Upstream, Filtration and Downstream processes related to manufacturing of Bulk (Vaccine / Biologics). Hands on experience in activities like Cell culture / Protein purification. Proficiency in operating reactors and fermentors along with ability to handle column chromatography.

Asst Managers / Dy Managers - Biochemical Engineering
Qualification: BE (Biochemical Engineering) from IIT or Equivalent Institute of International repute. (Experience: 2-5 years). Individual will be responsible for Yield improvement, Process Optimization and Cost reduction initiative of products. Hands on experience in designing of Fermentors/Reactors, Vessels, Mass Transfer and Heat Transfer. Individuals with Pharmaceutical Back ground will be preferred.

Research Associate / Research Scientist (R & D)
Qualification: MSc (Biotech / Microbiology / Biochemistry /) / MPharm (Biotechnology) (Experience: 2-5 years). Individual with research experience in vaccines / biologics with skills set like recombinant protein expression, purification, mammalian cell culture, fermentation, Virology, Immunology and process development would be preferred.

Candidates with expertise and exposure to various International Audits and cGMP/GLP standards will be preferred.

Interested candidates may walk-in with updated resume and copy of other credentials as per the details given below:
Venue: Hotel Hampshire Plaza, 6-1-79/80, Near HDFC Bank, Lakdi ka pul, Hyderabad 500004. Ph: 040 23335555.
Date: 5th (Saturday) & 6th (Sunday) September, 2009.
Time: 10:00 AM - 5:00 PM.
Candidates who are unable to attend the Walk-in may send resumes to dholka-hr@cadilaphamra.co.in Contact No: 09879287103.

The Drugs & Cosmetics (Amendment) Act, 2008

The Drugs & Cosmetics (Amendment) Act, 2008 has been released and came into force on August 10, 2009.

Click here to download.

Visitor Stat for August 2009