To empower the Professionals community with knowledge of Pharma as to provide the platform & opportunity to the young minds to enter the world of R&D sector of Pharma Industry.

Wednesday, January 12, 2011

Seminar on 'Common Technical Document' on Jan 21

Small and Medium Pharmaceutical Industry Centre (SMPIC) NIPER-SAS Nagar is organising a one-day interactive session for all manufacturers, regulators and suppliers of pharma industry on 'Common Technical Document' (CTD) on 21st January, 2011 at NIPER compound, Mohali, Chandigarh.

The main aim behind implementing a common format of submission is to make the reviewing of each application more easy and also to avoid omission of critical data or analyses. Omissions of such data can result in unnecessary delays in approvals. CTD not only help in raising the Indian standard but also will help to bring a proper structure to the whole process of filing an application.

The seminar will be attended by Dr Sanjay Jachak, associate professor, Department of Natural Products and in-charge, SMPIC, Dr D Roy, Deputy Drugs Controller, CDSCO (NZ), Ghaziabad, Dr A Panwar, Panacea Biotec, New Delhi, Aprajita Taklar, MD Lark Laboratories India Ltd, New Delhi, Dr Subhash Pande senior vice president, Glenmark Pharmaceutical Ltd., Mumbai and Dr Ajay Prakash, general manager (QA), Win Medicare.

International Conference on Harmonisation (ICH) has developed Common Technical Document (CTD) guidance's for Japan, European Union, and United States. Accordingly most of the countries have adopted CTD format. SMPIC wants to convey the benefits of CTD to all stakeholders for implementing it by sharing information between industries, government, academia and individuals.

Tuesday, January 11, 2011

BioAsia 2011: The Global Business forum to be held at Hyderabad from Feb 21-24

The Federation of Asian Biotech Associations (FABA) in association with the University of Hyderabad, Andhra Pradesh government and Pharmaceutical Export Promotion Council of India (Pharmexcil) will organize the BioAsia 2011: The Global Business Forum at Hyderabad from February 21 to 24, 2011.

The 8th edition of BioAsia, an annual event being held since 2004, will be inaugurated by Kapil Sibal, minister of Human Resources and Science and Technology and Kiran Kumar Reddy, chief minister of Government of Andhra Pradesh will preside over. The theme of the event is “Boosting Bioeconomy”.

The event, comprising conferences, trade shows and business to business platforms, is expected to create opportunities for academic and industrial collaborations and showcase latest trends and technology to a large gathering of biotech fraternity from across Asia and the world.

It will have three track conferences such as MediAsia, HealthAsia and AgriAsia. The MedAsia track will focus on oncology, diagnostics and medical devices, AgriAsia on latest developments in the world in Agribiotech and HealthAsia on pharmaceuticals with emphasis on biopharma and vaccines.

The event will also see the release of white papers by Grant Thorntom, knowledge partner of the event, on indigenous medical devices, merger and acquisitions in the pharma and biotech industry and learning’s from the evolution of agri sector globally.

Thursday, December 30, 2010

Changing Pharma Education in India: Join BII Pharma Programs for the New Paradigm of Pharmacy Profession in India

Due to the mushrooming of the pharmacy institutions, quality pharmacy education has faltered. As a result various institutions are finding it difficult to fill the approved quota of seats. Many institutions have a scant regard for maintaining education standards.

Pharmacy education in India had its beginning in mid of 19th century in Madras Medical College with introduction of pharmacy classes to impart pharmaceutical skills for the students qualifying for medical degrees or diploma or hospital assistance ship. Later it was helpful for the students who intended to qualify as chemist and druggists. Duration of study was increased to two years and entry qualification was made matriculation. The classes didn’t receive popularity and there were only a few students who used to opt for it. However, the course remained in operation and received Government sanction for its continuation. But the pharmacy education gained popularity only when Prof. M. L. Schroff with the consent of Madan Mohan Malviya introduced Pharmaceutical Chemistry and Pharmacognosy as one of the subjects for B.Sc. Degree in July 1937 in Banaras Hindu University. Then onwards there was no looking back. Pharmacy became a full pledged course with introduction of Diploma in Pharmacy and Bachelors of Pharmacy. Later Master of Pharmacy in various specializations was introduced. It is said that the first ever Pharmacy course was introduced along with the medical course in 1842 at the Old Portuguese school known as "Escola Medica de Goa" and later named as "Escola Medica Cirurgica de Goa". The Pharmacists (farmaceuticos) and Doctors (Medica Cirurgiao) were educated and trained in the same medical school and they had almost the same status in the Goan society.

Pharmacy education played a very crucial role in the economic development of the country. Now Pharmaceutical Sector is considered to be one of the very important sectors which significantly contribute to country’s economy. Although the pharmacy education has its enormous contribution for the development of pharma industry, its contribution for the development of pharmacy practice was modest with just a Masters programme in Pharmacy Practice. Hence, it was decided that there is a need to start a full-pledged course which would impart sufficient knowledge to student to practice the profession of pharmacy. And then the birth of Pharm D in India took place with the untiring efforts of a few visionaries. Doctor of pharmacy is patient-oriented whereas, bachelors of pharmacy is industry — oriented. The students are shaping to enter with pride and knowledge to take up the challenges of patient care.

In general, there should be a re-look at the pharmacy courses. Diploma in Pharmacy course, as a prerequisite to run a pharmacy (medical shop), is said to be outdated and only a few students opt for the course. Bachelor in Pharmacy needs an update to adapt to the advanced technology at which pharmaceutical industry is operating. Although been criticized, there should be a second thought to be given to introduce specialization at bachelor’s level. There should be an amalgamation of a few specializations at post graduate level as there are various offshoot specializations, which have come up in recent past for just commercial purposes. Instead there should be an initiation of courses in Pharmaceutical Management, Intellectual Property Right, Regulatory Affairs, Pharmacoeconomics, Pharmacovigilance, Clinical trial data management and Nanopharmaceuticals.

There should be self-regulation by pharmacy teachers. Being in very pious profession, they should update themselves with recent happenings and maintain high professional standards. They should enthuse students to take up challenges of the industry and profession of pharmacy.

Future strategies for pharmaceutical education

Curriculum design and reorganisation of the degree programme requires a ‘visionary’ approach. We should try to imagine, what is most likely to be happening in about 10 to 15 years in the future at any point of time. It is necessary to prepare the student for tackling problems and situations of the future rather than for the current state. Present will be outdated very quickly. The state-of-the-art is not a static state but is very much dynamic. The concept of the state-of-the-art itself implies a parallel and constant change in our endeavour to keep pace with the rapid changes taking place in technology, basic sciences and information. A student needs the past and present states-of-art only as basis for his future states. Attempts to do this sublime approach of jumping to the future from the past without going through the present have not yielded satisfactory outcomes. Students and the educators tended to see the ‘present’ more clearly than visualise the future possibilities. Skepticism has always been responsible in delaying progress. We exist in a social and educational system that has limited vision and consequently limited goals of achievement. Our attention and focus have been distorted by the numbers of students involved rather than the quality of education. Every student has to necessarily learn many new concepts and skills just to be able to remain in the profession of the future. We should prepare students with the right skills to learn new states-of-the-art with less effort! Nobody can visualise the entire future and design a strategy suited for that. But we could concentrate on incorporating the mental skills in the educational activities that are more permanent and provide the student a capability for learning new concepts.

Strategy in education should shift to ‘concept’ approach from the present ‘content’ approach. All content should be chosen to demonstrate and strengthen a ‘concept’ with an objective that is basic to the topic. The approach should reflect in curriculum design, its implementation and evaluation areas of education. All evaluation methods like written, oral, practical, assignments, seminars, projects, discussions etc. should be concept oriented. A student will benefit most with orientation of educational process to such mental skills like observation, analysis, correlation, application, evaluation or judgement etc. Such a system will go a long way to lessen the effort required by the students to acquire such skills all by themselves.

Friday, September 3, 2010

Admission Open for Various Courses of PTU & JAMIA HAMDARD at BII

Admissions are open for various distance learning programs at Bioinformatics Institute of India, Noida.

P.T.U Programs:
M.Sc in Biotechnology & Bioinformatics
B.Sc in Biotechnology & Bioinformatics
PG Diploma in Biotechnology & Bioinformatics
Last date for Admission: 15th Sep. 2010

Jamia Hamdard Programs:
PG Diploma in Bioinformatics (PGDB)
PG Diploma in Chemoinformatics (PGDC)
PG Diploma in Pharmaceutical Regulatory Affairs (PGDPRA)
Last date for Admission: 30th Sep. 2010

For Details Contact 0120-4320801/802 or mail info@bii.in

Thursday, September 2, 2010

Health Ministry asks State govts to adopt Clinical Establishment Bill

The Union health ministry has asked the state governments to adopt the recently-passed Clinical Establishment Bill so that a comprehensive database of the health infrastructure could be made and the sector can be further streamlined.

Health Minister Ghulam Nabi Azad also asked the States to increase the allocation for the public health and take initiate stern steps to contain spurious drugs in the markets. He was addressing the 11thConference of Central Council of Health & Family Welfare, attended by his deputies and health ministers from all the States, here on Tuesday.

He called upon the State health ministers to strengthen the Public Health System for the prevention and control of infectious diseases like malaria, dengue, TB, H1N1 etc by improving laboratory practices, surveillance, outreach investigation and effective case management. He also advocated for the creation of a specialized public health cadre including a Directorate of Public Health in states to focus on prevention control of infectious diseases. The States were also requested to increase their Health Budgets to meet the growing demands of the health sector.

The Union Minister underlined the need for placing trained and motivated personnel to enhance the capacity of the health system to manage both communicable as well as non-communicable diseases. He requested the ministers to ensure that trained personnel are not frequently transferred so that their knowledge and skills are optimally utilized.

Expressing concern at the menace of spurious drugs and adulteration of food, the Union Minister called upon the State Health Ministers to enforce the provisions of the PFA Act strictly. He emphasized the need for strengthening the enforcement machinery by filling up the vacant posts of food and drug inspectors and by upgrading the laboratories with proper equipment and trained personnel.

The Union Minister emphasized the need for expanding the outreach of Medical Education in the unserved and underserved areas of the country. He highlighted the various path-breaking initiatives undertaken in the recent past to rationalize/liberalize the norms for setting up of the Medical Colleges. He particularly urged the State Government to rise the retirement age of the faculty to 65 years as has been a mended under the MCI regulations. He said that this lone step would enable state governments to overcome the shortage of faculty to some extent. The Minister also assured the Council that Ministry would engage in discussions with the Board of Governors, Medical Council of India to explore the possibility of further liberalization in the existing norms.

One Day Seminar on GLP on 4th Sept. 2010

Indian Pharmaceutical Association, Karnataka Branch & IPA Industrial Pharmacy Division in association with Karnataka Drugs & Pharmaceutical Manufacturers Association (KDPMA) & North Karnataka Drugs Manufacturers Association (NKDMA) is organizing a one-day seminar on Good Laboratory Practices. The event will be held on Saturday, September 4, 2010 at the Solitaire Hotel in Bangalore.

Karnataka chief secretary S V Ranganath is expected to inaugurate the seminar. Also present on the occasion would be State health and family welfare principal secretary Dr E V Ramana Reddy.

According to Premnath Shenoy, vice president, Indian Pharmaceutical Association, Karnataka Branch, there is a need to educate the industry on the GLP which will come into force from November 1, 2010. The pharma industry needs to be updated on the requirements.

Topics such as general laboratory requirements, instruments calibration, microbiological testing and internal audit will be covered during the day long deliberation. The seminar would provide an excellent opportunity to exchange ideas on topics of importance and also seek expert advice on current hot topics bothering the technical staff in day -today operations.

Experts from Regulatory Agencies and Industry including companies such as Apotex, AstraZeneca, Global Pharmatech would be participating in the deliberations.

The organizers recommend the seminar for persons working in pharmaceutical companies working in quality control, production, quality assurance, regulatory affairs. Members of Teaching staff from Pharmacy colleges and post graduate students of pharmacy would also benefit from the session.

Wednesday, July 7, 2010

DoP to organise a one-day 'National Convention on Biopharma' on July 12 in New Delhi

Considering the fact that India is a significant player in the global biopharmaceutical industry, the Department of Pharmaceuticals (DoP) is organizing a one-day 'National Convention on Biopharma' with participation from Department of Biotechnology (DBT) in partnership with Federation of Indian Chambers of Commerce and Industry (FICCI) with the support of Association of Biotechnology Led Enterprises (ABLE) on July 12, 2010, at FICCI House in New Delhi.

The objective of the convention is to bring stakeholders and the government together to discuss where industry needs facilitation and the support of the government to bridge the gaps for making the Indian biopharmaceutical industry live up to its identified and acknowledged potential of a leader. The convention will have speakers from academia, industry and government to share their experience and highlight issues.

The convention is significant as India is gaining momentum in positioning itself as significant player in the global biopharmaceutical industry. Presently, biotechnology drug candidates account for over 30 per cent of all pipeline research programmes. To achieve a leadership position in the global market, Indian biopharmaceutical industry and the government need to join hands to identify and address key issues and challenges. Despite the fact the Indian potential in biopharma has been well recognized across the world, the industry continues to struggle with issues like inadequate infrastructure and shortage of suitably trained and skilled manpower.

India is among the top 12 global biotech hot spots and the third largest in Asia Pacific (in terms of number of biotech companies). However the industry continues to struggle with issues like inadequate infrastructure and shortage of critical manpower.

This convention is to initiate a stakeholder consultation to discuss collaborative approach towards making the Indian biopharmaceutical industry globally competitive and sustainable and serving national need for quality healthcare for all.

Biopharmaceutical product development is characterized by high uncertainty of product outcome and a heavy reliance on R&D. Soaring time and cost of development is a serious challenge. Evolving technology requires regulations to be flexible and adaptive. All these issues along with a focus on infrastructure and HR gaps that need to be bridged for increasing the production in India will be discussed in the one-day convention.

This convention will also see a discussion on a biopharma strategy paper being prepared for DoP by ABLE and PwC.