Saturday, February 28, 2009

Workshop on Pharmacovigilance

Department of Pharmacology, KLE University’s J N Medical College, Nehru Nagar, Belgaum and Indian Pharmacological Society, Belgaum Branch has jointly organized an Workshop On PHARMACOVIGILANCE on 14th March 2009

PARTICIPANTS/ ELIGIBILITY:
The workshop is open for 50 participants. Faculty / Postgraduates on first come first serve basis will be registered.

Last date – 7th March 2009

RESOURCE PERSONS:
Highly experienced faculty members from academia and industry.

REGISTRATION:
Registration fee of Rs 200/-
(Two hundred only) should be sent by DD drawn in favor of – Secretary, IPS Belgaum Branch.

ORGANIZING SECRETARIES:

Dr. Aruna.Bhushan - 09480538661
arunamarina@yahoo.co.in

Dr. Nayana Hashilkar - 09986710438
drnayana@rediffmail.com

Tuesday, February 24, 2009

Good News Indian Pharma

A couple of news bits that gives the Indian Pharma folks a reason to be happy.

- GSK is increasing its field force by about 200.

- Merck to increase its head count here by 300.

- When the country expects a single digit hike this year, Pharma professionals can see a 13% hike this year

Advanced Certificate Course in Clinical Trial Management

Advanced Certificate Course in Clinical Trial Management (ACC-CTM) - The clinical trial course jointly conducted by Anna University, Chennai, and Apollo Hospitals Educational and Research Foundation (AHERF)

(I still wonder if I wrote that correctly in one of my previous blogs, I remember it to be called as "Post Graduate Certificate Programme in Clinical Trials Management (PGC-CTM)" then.. whatever it is a certificate program and saw an article today in The Hindu. (advertisement infact. I come across several such "adverticles" these days...he.. he ...he ... coined a new name here for these articles that are nothing but advertisements)

Wednesday, February 18, 2009

M Pharm students face disqualification by PCI due to illegal admission

An excerpt from the article in Pharmabiz...

Thousands of M Pharm students, studying in various deemed university colleges including NIPER, Hyderabad, may face disqualification by the Pharmacy Council of India (PCI) as these colleges have given admission to 200 to 600 students against the approval of only 18 students per batch.

As per the norms set by the AICTE, the pharmacy colleges can give admission to a maximum of 18 students, that too with proper faculty, with the ratio of one teacher for every three students. But, throwing all the norms to the winds, these colleges have been giving admission to as many students as possible and charging more than Rs 3 lakh per student, sources said.

Sources also said that thousands of these students, who have been given admission without AICTE permission, are heading for huge trouble as the matter has caught the attention of the PCI. It is learnt that the PCI may disqualify these students which means these students cannot join the colleges as teachers and cannot take up any other job in the absence of PCI's approval, which is mandatory to get jobs.

The norms about the faculty are mostly met by these colleges in its violation rather than its compliance. Several of the colleges are running without proper faculty and other infrastructure necessary to conduct the PG Course. In some of these colleges there are only very few teachers, while they have given admission to hundreds of students, sources said.

One of the major reasons for the situation like this is the dual regulation of pharmacy education in the country. Though AICTE is the regulator of higher pharmacy education in the country, it does not have the infrastructure to verify the compliance of its rules by the colleges.

Wednesday, February 11, 2009

Diploma Course in Pharmacovigilance & Clinical research

IIHMR Delhi is starting a Diploma Course in Pharmacovigilance & Clinical research from 22nd March 2009 in technical collaboration with Uppsala Monitoring center, Sweden,
Rapid Pharmacovigilance Program and Empower Manpower Solutions

This 11-month course runs every Sunday 9.30 am to 6.00 pm, from 1st Mar'09 to Jan'10.

View the course brochure here.

(Am loosing the count of such institutes in India..)

Diploma Course in Pharmacovigilance & Clinical research

Yet another course on clinical research.

IIHMR Delhi is starting a Diploma Course in Pharmacovigilance & Clinical research from 22nd march 2009 in technical collaboration with Uppsala Monitoring center, Sweden,
Rapid Pharmacovigilance Program and Empower Manpower Solutions

This 11-month course will run every Sunday 9.30 am to 6.00 pm, from 1st Mar'09 to Jan'10.

View the course brochure here.

(Am loosing the count of such institutes in India..)

Tuesday, February 10, 2009

Ties between Doctors and Pharmaceutical Companies

Dr. Daniel Carlat knows all too well how easy it is for doctors to be seduced by drug industry money.
In 2002, he earned $30,000 in speaking fees to promote Wyeth's antidepressant Effexor XR to fellow doctors.
"I quit doing it because I felt I was beginning to push some ethical boundaries in terms of what I was saying and what I was not saying," said Carlat, a psychiatry professor at Tufts University in Boston who believes doctors need to cut their financial ties with drug companies.
"My own story was really nothing special," he said in a telephone interview. "I made $30,000 for the year, which is less than some of these doctors make in a weekend."
..."It is self-evidently absurd to look to a company for information about a product it makes," Dr. Marcia Angell of Harvard Medical School and former editor of the New England Journal of Medicine, said in a telephone interview.
"Why can't doctors, who are among the most privileged members of society, pay for their own continuing medical education?" Angell said. "Why have they abdicated that responsibility to the companies who make drugs?"...


The above is a little expert from an article that appeared in Reuters, today. This is not just in the U.S. This prevails in almost every part of the world and I have personally witnessed this is India. A well qualified doctor in his mid 40s, who runs a medium sized hospital (quite a big one infact) is the secretary of the Association of specialized doctors and he handed me a signed phamplet whose title read "You sponsor, we prescribe", a notice on behalf of the association seeking sponsorship from pharma companies for prescribing their products. That was the worst moment of my career as a Medical Representative. Many doctors would shamelessly ask me for compliments that comes from the company. Some placed orders for Medical journals and books, making me wonder what my job was. Am I a medical representative who carries the product information or a business executive who is trying to buy doctors for a pharmaceutical company. And most pharmaceutical companies sponsor doctors (will I be offensive if I use "Bribe" instead of "sponsor"). "Corporate doctors" get the gifts from pharma companies and prescribe their products happily and the ultimate looser is the poor patient who pays a high consulting fees and buys costly drug when cheaper/alternate options are available.

Only a very few doctors who I met during my short tenure of 5 months were really looking for scientific information from a medical representative. I really respect those doctors who really practice professional ethics and I wish all doctors be more responsible in their profession and do not become puppets in the hands of pharmaceutical companies. After all, they are professionals.

Monday, February 9, 2009

Advanced Diploma in Clinical Data Management

Sai’s BioSciences Research Institute, a Chennai-based institute focussing on bio-informatics and medical informatics has launched the second batch for its Advanced Diploma in Clinical Data Management Programme.

The programme is being run in association with ICON Clinical Research, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

The course is recognised by the University of Medicine and Dentistry of New Jersey (UMDNJ).

Upon successful completion of the programme, the University awards credit points to candidates, who will then be eligible for admission for higher studies at UMDNJ or placement in global clinical research organisations.

Eligible candidates should have completed a post graduation in science, life science, pharmacy or IT or hold an MCA, BE, B.Tech, MBBS, BDS or BPT degree.

The duration of the course is six months, with a two-month internship, during which students will be paid a stipend.

Revolt against the dual regulation of pharmacy education

After the Pharmacy Council of India, Private pharmacy colleges management association has raised banner against the dual regulation system existing for the approval of pharmacy colleges.

Presently, private pharmacy colleges are regulated by both the Pharmacy Council of India (PCI) and the All India Council for Technical Education (AICTE) and this causes a great deal of confusion in getting the approval.

It is said that there is no coordination between these two agencies and on several occasions, both the Councils work at cross purposes .

The PCI had taken up the issue with the union health ministry and had asked the ministry to bring in an Amendment to the Pharmacy Act to put an end to the dual regulation in pharmacy education. The matter is pending with the ministry. When there is specific body for other profession like Medicine, Dental, Nursing, Chartered Accountancy etc, I think regulation of pharmacy education and colleges should solely lie under the Pharmacy Council of India.

This issue is expected to be raised in the parilament and the main tussle is going to be between the Union Human Resources Development (HRD) Ministry and the Health Ministry. While the HRD Ministry is in favour retaining the regulatory powers with its arm (AICTE), the Health Ministry is learnt to be pushing for transferring the regulatory powers of pharmacy education from AICTE to PCI which is a statutory body exclusively constituted for the pharmacy education in the country.

Thursday, February 5, 2009

QUINTILES TO OPEN PHASE I UNIT IN INDIA

Quintiles is expanding its global Phase I capacity through partnership with Apollo Hospitals Group in India.

Quintiles Transnational Corp. recently announced a partnership with Apollo Hospitals Group to open a Phase I clinical trial unit in Hyderabad, India. This unit will allow customers additional options to complete integrated Phase I programs across multiple geographies at this pivotal stage in medical research.

This research unit is scheduled to open in the first quarter of 2010 and it will have approximately 50 beds, with plans to expand this number to 100 to meet predicted growth in demand. Hyderabad will be the fifth Quintiles Phase I facility, joining units in London, Kansas, Lulea and Uppsala.

Senior managers from Quintiles’ Phase I unit at Guys Hospital, London, unit will set up operations in Hyderabad and mentor the management team there. Quintiles’ London personnel also will help train staff for the India unit, which will be located in a building on Apollo’s Hyderabad hospital campus.

Hyderabad is the fifth Quintiles location in India. The company has offices in Mumbai, Ahmadabad, Bangalore and Delhi offering extensive clinical research, central laboratory, data management and ECG services.

Post Graduate Certificate Programme in Clinical Trials Management

Anna University and Apollo Health Education and Research Foundation in Chennai have joined together for a comprehensive one-year post graduate certificate programme in clinical trials management (PGC-CTM) from this academic year.

This will be full time course for one year with first four months of theory handled by the AU-KBC Research Centre of the University at its MIT campus at Chrompet and the next eight months will be onsite practical and internship programme conducted by AHERF at the premises of the Apollo Hospitals engaged in clinical trials. (Eight months of trial exposure!! sounds like a good selling point for the course.)

Graduates or post graduates in pharmacy, chemical or biological sciences, biotechnology, medicine, dental surgery, allied health sciences, Indian system of medicines and paramedical sciences can apply for the programme which commences from March 2009.