Wednesday, March 9, 2016

Indian Biological Sciences and Research Institute global hits.

Friday, April 3, 2015

Now, a toll-free number to report medicine reactions

NEW DELHI: Now, consumers can call to directly report adverse reactions or their bad experiences from any medicine. The health ministry has launched a toll-free number where people can call and report the side-effects and problems faced by them along with details of the medicine, suspected to have caused the adverse reaction. 

The information received would be then screened and assessed by the Adverse Drug Reaction Monitoring Centers by using international parameters set by the World Health Organisation (WHO), a senior official said. Thereafter, the analyzed information would be forwarded to the national coordinating centre, which maintains a database for adverse drug reactions (ADRs). 

The health ministry has also set up a steering committee which will periodically review the data and suggest any intervention that may be required, the official said. 

The government would also share this database with international agencies including WHO, which manages the Global Pharmacovigilance Database. 

The ministry also plans to make it mandatory for pharmacists, hospitals and other independent clinics to display the toll free number - 18001803024 - in public interest. 

The idea is to empower consumers to report adverse reactions on their own. The move would also enable an environment that will allow reportage of adverse reactions from every nook and corner of the country. 

Surveillance of medicine, after it is approved for marketing, has been a major challenge for the government and the drug regulator. In the absence of enough field force and mechanism, the regulator often struggles to gather post marketing data on medicines. 

Since 2011, around 1,10,000 adverse drug reactions have been reported from across the country. However, this was after the government made it mandatory for hospitals to have a pharmacovigilance cell. Still, officials say, there are only few hospitals across the country operating with a proper cell. 

Currently, there are only 150 hospitals across the country which have pharmacovigilance cell, the official cell. However, the health ministry and the drug regulator are making efforts to ramp up such cells. 

Experts say lack of awareness has also been a major roadblock because those facing problems with a particular medicine would not know where exactly to report. 

"A toll free number would empower the consumer along with medical practitioners to directly report adverse reactions," the official said, adding the information provided by consumers or doctors would be handled in strict confidence.

Tuesday, November 18, 2014

Equip Yourself for the Post of Assistant Drugs Inspector (50 Vacancies) at Staff Selection Commission With Career- Oriented Courses @ IBRI

A good opportunity  for the Pharmacy Students to enter into Govt.Sector thus don’t miss the chance Enhance Your Skills with Regulatory Affairs and Pharmavcovigilance which includes topics required for the Post and you would able to Grab the Job and Get success at all levels of Screening and Exam.

Post: Assistant Drugs Inspector
Department: In Central Drugs Standard Control Organisation(Dte. of Health Services)
No.of post: 50 (UR-25 / OBC- 13 /SC – 08 / ST 04)
Pay Scale: Rs.9300-34800 with Grade Pay of Rs. 4200/- (General Central Service, Group 'B', Non-Gazetted, Non-Ministerial).
Age Limit: Not exceeding 30 years ( Relaxable by 05 years for Government servants and for SC/ST/OBC as per standing orders of Government of India)
Essential Qualification: Degree in Pharmacy/Pharmaceutical Sciences or Medicine with Specialization in Clinical Pharmacology or Microbiology from a recognised University or equivalent.
Initial Posting: CDSCO (HQ) and its Zonal, Sub-Zonal and Port Offices in different cities with AISL

 Job Requirements: 
1. To assist in evaluation of safety, efficacy and quality of Drugs as per requirement of Drugs and Cosmetics Act, 1940.

2. To carry out field duty in assisting superior/Drugs Inspectors in taking out samples, enforcement activities like raids/inspections and launching prosecution etc.

3. To assist CDSCO officers in the mater of monitoring documentation.

4. To carry out duties as may be assigned under the Drugs and Cosmetics Act and Rules framed there under.


Sunday, November 2, 2014

PGI Pharma centre to hold meet on July 2

CHANDIGARH: The pharmacovigilance centre and regional training and resource centre, PGI, would organizing Indian Pharmacopoeia Commission (IPC) and WHO meeting of coordinators on July 2 in Kasauli.

The fifth training programme would be held under the aegis of WHO, IPC and the ministry of health and family welfare, Central government.

The meeting would focus over various aspects of pharmacovigilance, including quality and completeness of reports, causality assessment. Drugs of current interest in pharmacovigilance would be emphasized over. Measures to be taken for increasing the reporting of adverse drug reactions would be discussed.

Further, the meeting would provide a platform to participants for exchanging their experiences and ideas for the success of the pharmacovigilance programme.


Tuesday, September 16, 2014


IBRI introduce new course in Food Regulatory Affairs 6[Months].Deatils are as below......

The specific course has been framed with a perspective to endow knowledge of Food Regulatory Affairs for individuals employed in the food sector or those who wish to develop their career in food industry. The course incorporates Food items regulations in different regions of the world along with in India, approvals, risk analysis, HACCP etc.
Course Objectives
·         Gain the essential knowledge and skills required to help companies navigate an increasingly complex regulatory environment in relation to food items etc.
·         Analyze how emerging developments and trends are reshaping food products regulations
Course- Structure
 Course-Paper-I: Introduction to the European Union and Food Regulatory Affairs
Course-Paper-II International Food Regulatory Affairs and Current issues
Course-Paper-III Food Regulatory Affairs in India (FSSAI, Approvals etc.)
Course-Paper-IV Risk Analysis, HACCP, and Health
Careers Opportunities
This qualification will lead to employment opportunities in government (EU and international) and non-government organizations, and in the European and international agri-food industry. The knowledge and understanding of legislative, policy and scientific aspects of food regulatory affairs will help to develop the intellectual and higher level skills of critical analysis, judgement and evaluation in addition to a range of transferable and communication skills
Course Fees: - Rs 10500/-(Student Participating from India) / 350 USD (Student Participating from Overseas)

Study Material for the course: - Complete study material will be provided by the institute in printed book form, PPT and Video Lectures.

Examination and Evaluation Process: - One time examination and mode of examination are
· Assignment Based Examination
· Examination Center based Examination
· Evaluation by experts from industry and academic team of institute.

How to join this course?
· Download Registration Form from website or from attachment in mail.
· Fill it completely and attach 10th, graduation and one photograph for ID card.
· Send it by Registered Post or Courier to institute address given below-
C 50, First Floor, Sector 2, Noida 201301 (UP) India
Phone: 01204122315, Mob: 9999509892

Posted by:Indian Biological Sciences and Research Institute, NOIDA

Friday, September 12, 2014

SC seeks records of cervical cancer vaccine's clinical trials

NEW DELHI: Taking serious note of alleged death of seven tribal girls in Andhra Pradesh, Telangana and Gujarat during clinical trials of a cervical cancer vaccine, the Supreme Court on Tuesday asked the central drug control authority and Indian Council for Medical Research to tell how permission for human trial of the drug was given. 

A bench of Justices Dipak Misra and V Gopala Gowda summoned the files relating to grant of permission for conducting clinical trial of a cervical cancer prevention vaccine in 2012. 

The bench also asked the Centre to produce all files relating to grant of licence for trial of the vaccine to prevent human papyloma virus (HPV) which causes cervical cancer. The drug is produced by pharma majors Glaxo Smithkline and Merck. The court asked relevant files to be produced on October 28. 

Dealing with a set of two PILs on clinical trials, the court wondered how a drug was licensed to be sold in India by the Drug Controller General of India (DCGI) and ICMR, even though it had allegedly caused death and severe ailments to tribal girls. 

It said, "We are concerned whether before drug was accepted to be used in India and whether DCGI and ICMR had followed procedure for its introduction." Counsel for petitioner, senior advocate Colin Gonsalves and Anand Grover, referred to an August 30, 2013 report by the parliamentary standing committee that painted a dismal picture of drug trials in India. 

The bench asked the Centre to detail an action taken report on the recommendations by the parliamentary standing committee. 

The bench also sought responses from Andhra Pradesh, Gujarat and Telangana, which had granted permission for the trial. 

It asked the states to explain why tribal areas were selected for trial and whether proper monitoring of the trial was done by following the laid down procedure. It also asked them to explain whether the procedure was followed in taking the consent of the girls, some of whom were minors, and what medical aid was given by the state to the affected girls.

Posted by:-Indian Biological Sciences and Research Institue, NOIDA

Monday, June 30, 2014

Worldwide Prescription Drug Sales is Expected to rise more than Trillion Dollars by 2020

   Evaluate Pharma reports that the market for prescription drugs, based on the consensus forecast for the leading 500 pharmaceutical and biotechnology companies, will grow by 5.1% per year (CAGR) to reach $1,017 bn. by 2020. Worldwide prescription growth was an uninspiring 0.3% in 2013, close to the 0.4% predicted in the previous edition of the World Preview report. This represents a return to modest growth versus the 1.6% contraction in 2012. The depreciation of the yen against the dollar has negatively impacted Japan's contribution to the worldwide market in 2013 by around $15bn. Sales at risk from patent expiries will average $3bn. per year to 2020; however, as an increasing proportion of sales are from biological products, the predicted erosion post-expiration is expected to be softer, thus protecting  industry growth.
Worldwide Prescription Drug Sales in 2020: Top 20 Companies
1 Novartis 2 Roche 3 Sanofi 4 Pfizer 5 GlaxoSmithKline 6 Merck & Co.
7 Johnson & Johnson   8 AstraZeneca 9 Novo Nordisk 10 Gilead Sciences
11 AbbVie   12 Bayer 13 Bristol-Myers Squibb 14 Amgen 15 Takeda
16 Eli Lilly 17 Boehringer Ingelheim 18 Teva Pharmaceutical Industries

19 Astellas Pharma 20 Biogen Idec