Bioinformatics Institute of India: Pharma Department

Health ministry to withdraw ban on ads on morning after pills

2011-10-18T23:45:00.000-07:00

The Union health ministry will soon withdraw its ban on advertisements on emergency contraceptive pills like Unwanted-72, Option-72 and I-Pill. The ministry had imposed the ban in January last year after experts raised concern that these advertisements may promote the misuse of the pill by the young generation.

According to sources, the Drugs Technical Advisory Board (DTAB) of the union health ministry in its meeting held on October 10 has decided to allow the advertisements on emergency contraceptive pills with some riders. As per the new DTAB guidelines, a committee consisting of the principal of a reputed girls college, representatives from civil society groups and the advertising council should screen the ads and the scripts before they are on air.

Ever since the drug companies launched advertisements on emergency contraceptive pills like Unwanted-72, Option-72 and I-Pill, experts and public interest groups in the country have been raising concern that these advertisements may promote the misuse of the pill by the young generation who have started looking at the pills as a regular contraceptive method as the advertisements are said to have failed to drive home the message clearly that these pills are emergency contraceptives.

Apart from the civil society organisations, gynaecologists in the country have also been expressing concern on the misuse of the pill by the young generation. It triggered a debate in sexually conservative India with critics arguing that the easy availability of such pills would encourage promiscuity among the millions of young people. There was also criticism that the easy availability of these drugs will also promote unsafe sex among younger generation and may result in promotion of diseases like HIV/AIDS in the country.

When the public criticism reached its crescendo after the companies started airing competitive ads on these pills, the Drugs Controller General of India (DCGI) banned the advertisements on these emergency pills and left the matter to the DTAB, which is the highest authority of health experts on technical matters under the union health ministry.

Now that the DTAB has taken a final decision in favour of the pharma companies, they can start advertisements on these pills.

Source: Pharmabiz

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DCGI asks State DCs not to issue fresh licenses for FDCs with paracetamol above 325 mg

11:13 pm in DRUGS CONTROL, pharmacist by admin

The Drug Controller General of India (DCGI) has asked the state licensing authorities not to grant fresh licenses or renewals of the combination products of paracetamol, containing more than 325 mg per tablet or capsule.

The DCGI, in a notice to the zonal and sub-zonal officers of Central Drugs Standard Control Organisation (CDSCO), asked them to covey it to the respective State authorities. “The manufacturers marketing combination products having more than 325 mg of paracetamol should be asked to limit the paracetamol contents to 325 mg only in a period of three years,” it said.

The manufacturers of paracetamol combination products may also be asked to provide box warning on the label of such FDCs indicating that ‘taking more than daily dose may cause serious liver damage or allergic reactions such as swelling of the face, mouth and throat, difficulty in breathing, itching or rash,’ according to the order.

The order was issued based on the decision of the Drug Technical Advisory Board (DTAB) which agreed that as the paracetamol is known to have liver toxicity in the light of the decision taken by the US FDA, India also should limit the content of paracetamol to not more than 325 mg per tablet or capsule in the combination products in a phased manner in three years.

The proposal of limiting acetaminophen (paracetamol) was considered by the DTAB in the wake of US FDA issuing a note in January last year. The US agency asked the manufacturers of prescription combination products in USA to limit the amount of acetaminophen to 325 mg per table, citing the toxicity complications and with a view to ensuring patients safety.

The US FDA had also mentioned in the note that there was no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by the healthcare providers. “The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4000 mg within 24 hours. The elimination of higher dose prescription combination acetaminophen products will be phased out in three years and would not create shortage of pain medication,” according to the US FDA note.

Source: Pharmabiz

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Delhi Pharmaceutical Trust calls for reviewing D&C Act

3:10 pm in pharmacist by admin

Drugs and Cosmetics Act & Rules need to be modified and there is also a need to review the Schedule H drug List. The Drug Act and Rules also need to outline a clear Over- the- Counter (OTC) drug policy and also notify a ‘Pharmacist dispensing list of drugs’ and ‘Pharmacist to refer to Doctors list of diseases and medicines. These are the recommendations of the second national survey conducted by the Delhi Pharmaceutical Trust (DPT) to ascertain the ‘Professional Aspects of Pharmaceutical Service by Pharmacist.’

In reality, such a move could have a number of benefits including improving access to medicines, reducing healthcare costs, stated Dr DBA Narayana, Managing Trustee, Delhi Pharmaceutical Trust (DPT).

Healthcare delivery model needs to be reviewed at the national level to involve pharmacists fully and major reforms in the same need to be thought of. Preparation of a list of common and minor diseases and drugs for treating such conditions need to be prepared. These were the recommendations based on the national survey conducted by DPT.

The All India Quantitative Study of Consumer Perceptions, availability, role, services provided and expectations of pharmacists in India revealed that there was a definite trend in the consumers recognizing the importance of pharmacists’ role in healthcare and the trust factor has gone up from what it was a decade ago. Consumers are also getting useful information from the pharmacists about disease and drugs. Although more details on drugs from all pharmacists are insisted, consumers are clear that they do not have to pay more for such information or for the counselling provided.

The study has also proved that consumers demands are increasing to expand the services provided by the pharmacists. Further, it was also ascertained that consumers had drawn up on what they considered as common ailments which were not serious and visit pharmacists to get the medication which is being encouraged. The survey respondents accepted that many pharmacists refer the case to doctors and stay away from dispensing drugs for cases of severe chest infections, said Dr Narayana.

Nine categories which allowed DPT to comprehend the psyche of the consumers towards the pharmacy business covered asking for handling prescription, disease conditions where prescriptions are insisted on, patient counselling, usefulness of information given by chemists, willingness to pay more for getting professional information, offer brand substitution, instances of prescription being referred to the doctor by the chemist, issue of bill on purchase and confidence on pharmacist to prescribe.

The survey was conducted on 3086 respondents across the country. While Dr Narayana supervised the study, he was assisted by Kusum Devi, Nimisha Jain, T Naveen Babu and Uday Bhosale, department of marketing and management, Al Ameen College of Pharmacy in Bangalore and Asha AN. Co- investigators were Roop K Khar, department of pharmaceutical sciences, Jamia Hamdard, New Delhi, Moitreyee Manda, department of pharmacy JC Ghosh Polytechnic, Kolkata and Manjiree Gharat, KM Kundnani Pharmacy Polytechnic, Ulhasnagar, Maharashtra.

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Rajasthan govt to create 1400 posts of pharmacists in 3 months

6:56 pm in association, pharmacist by admin

Even as the Rajasthan government has launched its ambitious free medicine distribution scheme in the state, it has now decided to create 1400 permanent posts of pharmacists in the state. All these posts will be filled within three months.

According to sources, the Rajasthan government has launched the ‘Chief Minister’s Free Medicine Scheme’ under which it will distribute 400 medicines free of cost to all the patients who visit the government hospitals and medical colleges in the state. Chief Minister Asok Gehlot formally inaugurated the scheme on October 2.

Under this free medicine distribution scheme, the government has covered almost all the essential medicines, said Manoj Tongra, a legal expert and a drugs control officer in Rajasthan.

Meanwhile, Indian Pharmacist Association (IPA) has welcomed the creation of 1400 posts of pharmacists. “The state government has assured the creation and filling of 1400 permanent posts of pharmacist within three months. This is a historic event in the backdrop of the fact that there was no recruitment for the post of pharmacists in the last 25 odd years in Rajasthan,” said IPA general secretary Bhupendra Kumar.

He said that this has been possible due to the tireless and continuous efforts of IPA Rajasthan Branch. It would be a beginning of a new era for the pharmacists of Rajasthan. This decision of the state government will ultimately help in serving the most needy patients, he added.

According to Pharmacy Act 1948, no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner. Whoever contravenes these provisions shall be punishable with imprisonment for a term which may extend to six months, or with fine not exceeding one thousand rupees or with both.

At present work of a pharmacist in Rajasthan is done by nursing staff as there is no pharmacist recruited for dispensing of medicine. The dispensing of medicines by the professional pharmacists will further improve the overall health scenario in Rajasthan, Kumar said.

Source: Pharmabiz

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PCI to change syllabus for D. Pharm to make it healthcare oriented

11:57 pm in pharmacist, Pharmacy Council by admin

The Pharmacy Council of India (PCI), the statutory body formed to regulate the pharmacy education and practices in the country, has decided to change the syllabus for diploma in pharmacy course (D. Pharm) to make it healthcare oriented. The changed syllabus is expected to be introduced from next academic year.

Sources said that though a decision to this was taken in its Central Council Meeting held in February 2011, discussions are still on to prepare the nitty-gritties of the changes that have to be effected.

Experts said that the decision to make changes in the syllabus was taken as the PCI noticed that the syllabus, prepared way back in 1991, for the diploma course was vast, and the students were finding it difficulties to absorb the course. The changing scenario of pharmacy and current modern development makes it necessary to change the syllabus frequently.

The syllabus for each technical course needs to be updated to meet the current requirement of the country or to put new development in the new course, experts feel.

Dipankar Chakroborthy, vice president, PCI said, “We have not changed the syllabus for such a long period after it was set in 1991 and the expectation of the minimum registrable qualification of pharmacist may be changed from diploma to degree. But that decision of the central government is pending. Now it has been decided that PCI cannot wait for indefinite period for the decision of the Government to change the syllabus.”

The members of the Council has decided that the modification of the syllabus should be taken up on priority basis. While deliberating on the issue, members had pointed out that there is a need to look at the syllabus from the healthcare point of view, i.e. whether the students coming out of the institutions can act as a healthcare provider in the current healthcare set-up.

Chakroborthy informed that the present syllabus is not serving the current healthcare need. It was resolved that the diploma syllabus need to be thoroughly revised and should be made healthcare oriented.

PCI is responsible to provide a pharmacy education that focuses on the future requirements of pharmacists in the country, taking into consideration the demands of the healthcare landscape in the future. It is therefore important that the pharmacy education should be constantly revised and updated to meet the challenges.

PCI regulates the profession of pharmacy and frames education regulations prescribing the conditions to be fulfilled by the institutions seeking approval of the PCI for imparting education in pharmacy and to ensure uniform implementation of the educational standards throughout the country.

Source: Pharmabiz

Become a Part of Clinical Research to get a Job

2011-09-06T04:00:00.000-07:00

Opportunities and challenges for clinical research in India
Clinical Research may be defined as organised research conducted on human beings, intended to provide adequate information on drug use as a therapeutic agent on its safety, efficacy and adverse effects. Globally, clinical research is becoming a thrust area, essential for development of new drugs, new formulations, drug delivery systems, dosage regimen, surgical and diagnostic techniques, devices and therapies. With the advent of high throughput screening, drug discovery programmes have expedited clinical evaluation. Globally, there is a paradigm shift in the pharmaceutical market, and nearly two thirds of R&D costs go into drug development. Of this, clinical research accounts for 70 percent of time and resources spent.
India: The clinical research hub
Indian pharmaceutical industry is one of the fastest growing sectors of the Indian economy and has made rapid strides over the years. From being import dependent in the 1950s, the industry has achieved self-sufficiency and gained global recognition as a producer of low cost, high quality bulk drugs and formulations. Having proved itself in the international market, India is ready to face the challenges of proving its efficiency as the preferred destination for global clinical trials.

Clinical research holds tremendous scope and opportunities not only for trained medical, pharmaceutical and paramedical professionals, but also for regulatory authorities, government and the society at large. A mechanism of knowledge transfer can be worked out which would lead to a definite improvement in hospital infrastructure. It will make the state-of-the-art therapy available for many deserving Indian patients who were hitherto deprived of such therapeutic advances. Consequently, the projected figures for the various aspects of clinical research (market value, revenue, staff requirement) for the next five years, promise a growth at a rate greater than 20 percent.
Lucrative job opportunities
It is certain that in future as the number of clinical projects expands, there will be demand for qualified personnel. According to a McKinsey report, the global clinical trial outsourcing opportunity in India in the pharmaceutical industry is estimated to be around $6 billion by 2015 and there will be requirement of one million clinical research professionals. Trained pharmacists and clinicians can plug this wide gap.
With this aim BII has initiated a 6 months regular /face to face mode program in Clinical TrialsThe course would equip the students with methodology employed in clinical trials. The course curriculum would provide the students an update knowledge in order to plan and design clinical trials along with the writing of protocols
Clinical trials Industry and Career ProspectsAccording to BioSpectrum “Trained clinical research professionals will also be in demand abroad. Today, there are more than 2,50,000 positions vacant worldwide. And salaries vary from a minimum of $40,000 per annum for a clinical research coordinator to almost $1,00,000 per annum for a business development manager”

For details visit www.bii.in or call 01204320801, 9818473366,9811420055 or mail at info@bii.in

Admission Notice

2011-01-20T23:19:00.001-08:00

Admission Notice for Advance Program in Clinical Trials Data Management
Bioinformatics Institute of India is happy to announce the admissions for its 4th Batch of 6 months weekend Advance Program in Clinical Trials Data Management. The main objective of the course is to provide students with a theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of clinical trials.

Program Methodology

Prospective participants may join the program by submitting the application form along with the necessary Fees and attachments.

Lecture classes for the program would be taken by expertise faculty

Guest faculty from industry and academia would also deliver the lecture

Students would be taken for Clinical site visits to various hospitals etc.

Along with the regular classes students would also be provided with the practical industry oriented knowledge of the subject .e.g. – Role of Computers in Clinical trial etc.

E-learning platform via Moodle would also be provided to students
Program Duration
The Program Duration is 6 months.

Program Eligibility
The eligibility for the training program is graduation in any discipline. Highly interested participants in final year can also apply.
The course is most suitable for Doctors, Medical professionals, pharmacist etc.
Program details are available at www.bii.in

Program Fees
The Program fees is Rs.45, 000/-.Payment in installments can also be made.

Career Prospects
Excellent career opportunities exist for students and professionals who are trained in these areas. Placement support is provided.

How to join: For a free copy of the prospectus email/write to the
Bioinformatics Institute of India
C-56 A/28, Sector 62
Noida
Tel: 0120-4320801, 802, 9810535368,9818473366
Email: info@bii.in,kumud@bii.in

Admission notice

2011-01-20T23:17:00.001-08:00

Seminar on 'Common Technical Document' on Jan 21

2011-01-12T02:25:00.000-08:00

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.

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

2011-01-11T02:45:00.000-08:00

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.

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

2010-12-30T02:04:00.000-08:00

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.

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

2010-09-03T22:58:00.000-07:00

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

Health Ministry asks State govts to adopt Clinical Establishment Bill

2010-09-02T22:01:00.000-07:00

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

2010-09-02T00:04:00.000-07:00

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.

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

2010-07-07T22:57:00.000-07:00

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.

Industry division of IPA plans to conduct a panel discussion on how to handle expired drugs

2010-07-07T04:13:00.000-07:00

In the wake of the present expired drugs scam that plagued the entire pharma industry in Tamil Nadu, the Industry Division of the Indian Pharmaceutical Association plans to conduct a Panel Discussion on ‘How to Handle the Expired Drugs’. The programme will be conducted in Chennai.

Apart from experts in the industry, the discussion will be attended by senior officials from the departments of drugs control and pollution control board from southern states of the country, said J Jayaseelan, secretary of the Industrial Division, IPA.

Jayaseelan was elected to the post of Secretary to Industry Division in the national executive. Dr Kaushik Desai is the new president of the Division.

“We want to educate the public as well as the people in the industry and the trade. Even the manufacturers are not fully aware of the latest technology emerging in the industry. There are so many ways to handle the expired drugs. The recent issue has maligned the dignity of the industry and we are trying it not to recur. The manufacturers and the management of the industrial firms have to be trained and updated with the latest developments happening in the technology,” Jayaseelan said.

Prior to the experts’ discussion, there will be a symposium on the same subject where in representatives from Parma industries, wholesale distributors, retailers, faculties from pharmacy colleges and regulatory staffs will participate.

Since the subject has relevance at present, the participants can suggest ways and measures on how to handle the technology in the industry and how to recall the date expired drugs from circulation for destruction. Further to this, IPA will conduct training classes for people engaged in the drug business about the various methods of handling drugs and destruction of the date expired.

According to Jayaseelan, the secondary aim of conducting the symposium and the upcoming training classes is to educate the small and medium scale manufacturers.

In Tamil Nadu more than 400 SME units are functioning, but they are unable to train themselves or their staffs on the various methods of technology, not only for destruction purposes, but also for development of new drugs. So these initiatives of the IPA will help them attain knowledge based resources to benefit their business also. IPA will start such programs in other states too shortly, he said.

US FDA to set up the site inspections of clinical trials in the developing countries

2010-07-04T23:36:00.001-07:00

Under increased pressure from the Department of Health and Human Services, the US Food and Drug Administration (FDA) which has already set up representative offices in many countries including India, may soon step up the site inspections of clinical trials in the developing countries.

Based on a recent report on the oversight of foreign clinical trial data, the health department has already called upon the FDA to improve the inspections. Though India was not specifically mentioned as a key destination, being one of the most favourite sites for trials for the vast number of subjects and other factors, the drive may cover India largely also, according to the information reaching here.

The report had found flaws in FDA oversight of foreign clinical trials as the sponsors were found to be relying heavily on the data generated from abroad to support their marketing applications back home. While 80 per cent of drugs and biologics applications approved by the FDA in fiscal year 2008 contained clinical trial data from foreign sites, the agency inspected clinical trial investigators at only 0.7 per cent of foreign sites compared to 1.9 per cent of domestic of domestic clinical trial sites, revealed a report by the HHS’s Office of Inspector General.

Over the years, India has been emerging as a key destination for trials by the companies from the developed world. Though the exact number of trials by the US companies in India is not known, a search in the official Clinical Trial Registry of India (CTRI) has found that there are hundreds of trials going on in the country with the sponsors from the US. The FDA is likely to make use of its manpower at the two representative offices in Delhi and Mumbai for the purpose of on-site inspections of trials as it was one of the key agenda while setting up the offices here.

According to the HHS report based on the figures of 2008, Western Europe account for 58 per cent of subjects enrolled at foreign sites and 60 per cent of foreign sites. Central and South America also enrolled a significant number of subjects – around 26 per cent of all subjects at foreign sites – but the region accounted for only 7 per cent of total foreign sites. Peru, the report notes, had the fourth-largest subject enrolment, yet the FDA inspected no trials there. The report also lists several other countries with a large number of subject enrolments that were not inspected by the FDA for marketing applications approved in FY 2008. These include: Colombia, Chile, Panama, Venezuela, Nicaragua, the Dominican Republic, Denmark, Norway and Poland.

The domestic industry sources said India in fact gained more attention as a favourite destination in the recent years. Large number of trials by the US companies started here only after 2008 and hence India was not specifically mentioned in the report. The situation has changed a lot now and there could be added pressure on the investigators for the better, if the FDA steps up the inspections.

Growing generic opportunities of Indian Pharmaceutical Industry

2010-07-03T03:46:00.000-07:00

Indian Pharmaceutical industry ranks third worldwide by volume of production and 14th by value there by accounting 10% of world`s production by volume and 1.5% by value. The total turnover of Pharma industry was at Rs 1,0061.11 billion for the year ended September 2009, where domestic pharma market contributes about 58% or Rs 586.26 billion and exports contributes 42% or Rs 419.85 billion.

Pharmaceutical Industry in India is one of the largest and most advanced among the developing countries. Indian pharmaceutical industry has progressed tremendously on infrastructure, technology development and a wide range of products over past two decades. As Indian companies can deliver good quality of drug with lower cost, it now preferred destination for most of advanced countries. Most Indian companies maintain highest standards in purity, stability and international safety health and environmental protection in the production and supply bulk drugs to even innovator companies.

Broadly Indian Pharmaceuticals sector is classified into Bulk drugs, Formulation and Contract Research and Manufacturing Services (CRAMS). The drug and pharmaceuticals industry in India meets around 70% of the country`s demand for bulk drugs, drug intermediates and formulations. There are about 500 corporate players with more than 20000 players in general and thus fragmented Indian pharmaceutical industry. The bulk drugs and pharmaceuticals manufacturers produce complete range of pharmaceutical formulation and about 350 bulk drugs.

In the last two years, the patent of drugs wroth of USD 40 billion has expired. The value is set to double (USD 83 billion) in the next three years. This gives ample opportunity to Indian companies. At the same, India is also become favorable destination for CRAMS business. India can develop a drug at half cost compared to advanced countries and can manufacturing drugs at 30-40% of production cost of advanced countries. M & A in Indian Pharmaceutical industry revived started with Japanese major Daichii Sankyo acquiring majority stake in India`s pharma leader Ranbaxy Laboratories, then followed by Sanofi-Aventis acquiring 80% stake in unlisted Shantha Biotechics and Hospira acquiring Orchid Chemicals & Pharmaceuticals` generic injectable business.

``Globally, pharmaceutical industry is witnessing M & A due to attractive valuation. But in the case of India, there are more buyers than seller, but the former feel that the current valuations are higher. As a result, frontline players are keener on acquiring brands rather than acquiring companies. On an overall basis, the growing global generic markets, increasing CRAMS opportunities and strong growth in domestic market are the key drivers of Indian Pharmaceutical industry. ``

FDA and NIH launched a new website for reporting pre- and post-marketing safety data

2010-07-01T23:49:00.000-07:00

The Food and Drug Administration and the National Institutes of Health on 24th Of May 2010 launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. Currently the Web site can be used to report safety problems related to foods, including animal feed, and animal drugs, as well as adverse events occurring on human gene transfer trials. Consumers can also use the site to report problems with pet foods and pet treats.

The new site, called the Safety Reporting Portal (SRP), provides greater and easier access to online reporting.

“The portal will be a key detection tool in improving the country’s nationwide surveillance system and will strengthen our ability to protect the nation’s health,” said Commissioner of Food and Drugs Margaret A. Hamburg. “We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public.”

The new Web portal includes different features for different types of reporting:

• Reportable Food Registry: Industry will have a more user-friendly electronic portal for submitting reportable food reports that are required by law. This electronic portal collects reports from the food industry and public health officials regarding problems with articles of food, including animal feed, that present a reasonable probability of causing serious adverse health consequences or death to humans or animals.

• Pets: Pet owners and veterinarians will be able to use the portal to report product problems with pet foods and pet treats.

• Animal drugs: Animal drug manufacturers can report adverse drug events associated with animal drugs.

• Clinical Trials: Biomedical researchers involved in human gene transfer clinical trials can report an adverse event, indicating whether it might be an unanticipated consequence of the product being tested. Trial sponsors can use the portal to prepare a report, print it and send it to the agency to satisfy reporting requirements for investigational new drugs.

In the future, the system will encompass other types of clinical trials and, eventually, safety problems arising from products regulated by a broad array of federal agencies. This is a first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event.

Just as important, the portal will ultimately enhance the government’s systematic analysis of safety information, which will benefit public health. In the meantime, the new portal redirects individuals who want to submit reports about other products regulated by FDA, the U.S. Department of Agriculture, Environmental Protection Agency or the Consumer Product Safety Commission to the appropriate contact.

Clinical Establishment Bill passed in the Lok Sabha

2010-06-25T22:59:00.000-07:00

With the passage of the much awaited Clinical Establishments Bill, 2010 in the Lok Sabha, it has become mandatory that all the clinical establishments in the country, big or small, should be duly registered as per the provisions of the Bill.

The Bill, which was pending for several years, aims to bring in uniformity in the healthcare delivery sector and prescribes enhanced penalty for the defaulters.

The proposed legislation is applicable to all the clinical establishments under all recognized systems of medicines or treatment such as Allopathy and Ayush. Another important aspect of the legislation is that it would apply to all the hospitals or clinics including single doctor establishments, with or without beds.

The legislation also makes it obligatory that any doctor in a registered clinic, hospital or other clinical establishment must provide treatment to anyone who is brought in an emergency medical condition. The patients cannot be sent back on excuses.

The Bill proposes a multi member National Council for clinical establishments to classify, determine and develop standards of clinical establishments and also to compile and publish national register of such establishments.

It also mandates that every State would set up a multi-member State Council of Clinical Establishments soon. In the states, the Registering Authority for Clinical Establishments would be a multi-member body at district level. The registration would be of two types, provisional and permanent. Permanent Registration would be provided after standards have been notified. There are different standards for different categories of clinical establishments.

The Bill says all the transactions under the proposed law would be transparent and in the public domain. The state register will help for the creation of a national database. Appeals against the orders of the Registering Authority shall lie to the State Council of Clinical Establishments.

The legislation would also empower the State Government or Registering Authority to direct any or all clinical establishments to furnish such returns/statistics or other information as may be required.

SMS based IT solution to track expired drugs

2010-06-25T02:13:00.000-07:00

A north based IT company, Pharma Secure has come out a high-end technology solution system to tackle the expired drugs concerns amongst the consumers. The solution provides the consumer with a short message on the mobile phones. The company claims that it is the first technology solutions to track the expired drugs.

The novel solution can track expired drugs with SMS and gives the consumer a short narrative about the status of the drug, whether it is time barred or spurious or sub-standard or banned one, along with a warning to the user to contact his/her chemist for more information.

The director-sales of Pharma Secure, Kishore Kar explained to the traders and manufacturers of Tamil Nadu pharmaceutical industry about the service and operation modes at the IPA sponsored symposium. Even though, the solution is mainly useful for the importers, the company was targeting all the stake holders of the industry including retailers and end users.

The company does not rule out the possibility of recycling expired drugs by some anti-social elements. Circulation of such drugs in the market not only harm the consumers, but also tarnish the image and long-term revenue potential of domestic pharma manufacturers. Often the drug regulators are unable to track all the sources of expired drugs, but a solution like SMS based tracking should help both the regulators and the customers.

“We are offering low cost, scalable and secure services for the manufacturers of and customers in Tamil Nadu and in other states. Our modules are the most targeted solutions for addressing the sale of expired drugs. The basis of these solutions lies in attributing a unique identifier code on drug packing, and associating these with authentic manufacture data, for instance expiry date”, he said.

Once a drug reaches the hands of the end user, the consumer can send one SMS indicating the code to Pharma Secure’s national authentication line, which promptly returns a valid, invalid or over-verified response. Authentication about expired drugs, validity of origin, product specific information and market data are given through this service. With its focus on the Indian Pharmaceutical sector, Pharma Secure is planning to partner with manufacturing companies shortly.

FOPE demands extension of two years before implementing the new Schedule L-1

2010-06-21T23:31:00.000-07:00

The Federation of Pharma Entrepreneurs (FOPE) has urged the central government to give an extension of two years before implementing the new Schedule L-I of Rules 74, 78 and 150 E. It stressed that since the small and medium enterprises (SMEs) are yet to come to terms with the concept, they should be given some time to accept the impending changes.

As per the union health ministry's notification, all the pharma companies in the country have to adhere to the new GLP regulations under Schedule L-I of Rules 74, 78 and 150 E under Drugs and Cosmetics Act by November 1, 2010. Under the new regulations, pharma companies will need to have the necessary requirement of premises and equipment along with upgradation of their systems.

FOPE pointed out that it is strongly felt in the SME segment that there is a lot of gap between current practice and newer GLP norms. Apart from that there is also shortage of trained QC and QA personal to handle the change.

This issue was discussed by FOPE at a one-day pharmaceutical convention organised by FOPE along with Himachal Drug Manufacturers Association (HDMA) recently at Solan district, Himachal Pradesh. The conference aimed to deliberate on various issues in the common interest of all manufacturers and was attended by almost 250 people from the industry.

It was decided that a committee shall be set up under Vinod Kalani, general secretary, FOPE; Jetendra Kumar, vice president, operation QA, Mankind Pharma; Arun Kumar, Medicamen Biotech and Rajeev Saxena who shall study the GLP document. Once they study it, they plan to discuss the fine points with other professional bodies like IDMA, IPA to identify the operational problems with the new GLP.

The occasion was also utilised to discuss other major issues of the pharma industry. FOPE raised the issue of exemption to SSI which was denied because many units could not file declaration of SSI status within 60 days of start of the production. S M Jharwal, chairman NPPA, assured that they would consider the matter. It was told that the price difference demands against the SME’s are negligible if compared to total demand pending against the industry.

The Health Minister of Himachal Pradesh Rajiv Bindal in his speech appreciated the efforts taken by technocrats to establish state of art facilities in the state of Himachal Pradesh and assured all help and support to units manufacturing good quality products.

B R Sikri, co-chairman, FOPE narrated the initiatives taken by FOPE for resolving various issues of industries based at Himachal Pradesh and Uttrakhand excise free zones specifically.

5th Amendment of D&C Rules 2010 for Ayush drugs

2010-06-21T05:09:00.000-07:00

Union Govt. has issued a draft copy of the Drugs and Cosmetics (Fifth Amendment) Rules 2010 for the Ayush industry seeking to introduce licensing for production of herbal formulations. The new rules would be issued under section 33 N of the Drugs and Cosmetics Act 1940.

The fresh rules are for Ayurveda, Unani and Siddha drug manufacturers under section 3 (A), ‘Balya, Poshak, Muqawi and Unavuporutkal’ which are positive health promoter formulations having ingredients mentioned in the books of the First Schedule of the D&C Act and recommended for promoting and preventive health. The formulations under Saundarya Prasadak and Azhagh-sadan having ingredients recommended for oral, skin, hair and body are also provided with a set of procedures for production.

In a communique from the Ministry of Health and Family Welfare, Department of Ayush, via GSR 377(E) No. K11020/02/2010 DCC Ayush, comments were sought from the industry on the draft before the end of June, 2010. The rules will be finalized then and will be approved for publication in the Gazette.

The new set of rules will be introduced after Rule 158(A) as 158(B) of the Drugs and Cosmetics Act 1940.

According to the draft, the drugs for Ayurveda, Unani and Siddha will not require data submission on safety study and evidence of effectiveness but the use of ingredients should be according to Indian system of medicine texts.

For the issue of licenses for patent and proprietary drugs, safety study report is not required but manufacturers will need to submit a pilot study according to the protocol of Ayurveda, Siddha and Unani drugs.

For the Medicines prepared using ingredients listed in Schedule E (1) of the Drugs and Cosmetics Act, 1940, companies will need to furnish the safety data and proof of effectiveness.

Govt. of India facilitating the export and import of drugs through Airports

2010-06-21T00:27:00.000-07:00

As part of the efforts to improve the situation in the airports to better handle the exports and imports of drugs, the facilities at some leading airports are being augmented, though the original plan to create special pharma zones is yet to be implemented formally.

The government is taking steps following the complaints from the industry that the quality of medicines transported through air routes is getting affected due to lack of proper storage system at airports. Efforts are on by some of the agencies running the airports to augment their facilities as the storage facilities are either maintained by the airport authorities or the airlines.

Mumbai International Airport Pvt Ltd (MIAL) has already created four new cold rooms for pharma products. The Delhi International Airport Limited (DIAL) has also planned to create 3700 square meters of additional cold room facilities for pharma products when the new cargo terminal becomes operational, sources said.

Drugs when not stored at recommended temperature whether transported through air route or any other mode of transport can deteriorate due to extreme temperatures, both high and low. Facilities for storage of drugs, including drugs requiring special storage conditions, are available at some of the airports. Where such facilities are not available because of space constraints or other reasons the consignments requiring special storage conditions are released on priority basis to avoid any deterioration in the quality, sources said.

The CDSCO had suggested creation of dedicated pharma zones at the airports and seaports in line with good manufacturing practices and good distribution practices to assure quality, safety and efficacy of drugs meant for export and import. However, it is yet to be officially launched.

As per the plan, pharma zones are to come up at the airports of Delhi, Hyderabad and Mumbai. Besides, another cargo zone will come up at Nhava Sheva port at Navi Mumbai. The DCGI office also had already initiated consultations with the airport developers and the civil aviation ministry in this regard.

The 62nd Indian Pharmaceutical Congress will be held in Manipal

2010-06-19T23:44:00.000-07:00

The 62nd Indian Pharmaceutical Congress (IPC), hosted by Indian Hospital Pharmacists’ Association (IHPA), will be held from December 17 to 19, 2010 in Manipal University.

It was at the 61st edition of the Indian Pharmaceutical Congress Association (IPCA) at Ahmedabad in December 2009 that the announcement was made. This event is taking place in Manipal for the third time.

The IPC is organized every year by IPCA, which is a federation of five professional bodies, viz., Indian Pharmaceutical Association (IPA), Indian Pharmaceutical Graduates’ Association (IPGA), Indian Hospital Pharmacists’ Association (IHPA), Association of Pharmaceutical Teachers’ of India (APTI) and All India Drugs Control Officers' Confederation (AIDCOC).

The 62nd Indian Pharmaceutical Congress will be held at Manipal in Karnataka. It will be held under the aegis of the Indian Hospital Pharmacists' Association (IHPA). As the president of the host association, I have great pleasure in inviting all pharmacists- regulatory, teachers, researchers and industrialists & students to the three-day event. One can look forward to this event in a rather serene atmosphere of Manipal, a small town known for high standards of professional education and human endeavour.

IHPA is a professional body of practicing pharmacists in the country. The practice of pharmacy has seen tremendous changes in the recent years. In the West the pharmacists play stellar roles along with doctors and nurses in health care delivery. The conditions in India up to now have not been satisfactory for the pharmacists. Except in rare instances, the pharmacists in India play only passive role in patient care. It is this lacuna that IHPA is trying to address. The IHPA aims to secure for them their rightful place through more active involvement in pharmaceutical care. They must strive for excellence and status in the society. Professional ethics must be maintained. For assuming the new responsibilities, they should gain more knowledge and develop skills.

Important Dates

Online Submission Starting from: 1st August 2010

Last Date for Online Submission: 30th September 2010

Announcement of Acceptance: 15th October 2010

Pharma Export Council to open offices abroad

2010-06-19T04:34:00.000-07:00

The Pharmaceutical Exports Promotion Council (Pharmexcil) will soon start offices and warehouses in the US, Europe, Latin America and Japan to help Indian drug exporters boost their business in markets abroad. Pharmexcil, under the Ministry of Commerce, is working out a detailed strategy paper in this regard, said Smitesh Shah, chairman.

“These four markets constitute a majority of exports by our members (over 1,500) and the move is to help in market development and to bring down export costs by using common warehousing facilities and office infrastructure, especially for companies entering into newer geographies,” he said.

Six-year-old Pharmexcil has regional offices in Mumbai, New Delhi and Ahmedabad, besides headquarters in Hyderabad.

Shah said though pharmaceutical exports were down in the April to October period of 2009, recent trends showed these had picked up. A temporary slowing was mainly due to the global slowdown in 2008-09 period, which resulted in less orders from overseas wholesalers to clear their inventories and less than expected orders from multinational companies for contract manufacturing.

The growth in drug exports from India decreased to about 10-12 per cent in the first three quarters of 2009-10, in comparison to Rs 39,537.7 crore of exports, with a 29 per cent growth, recorded in 2008-09, showed data from the Directorate General of Commercial Intelligence & Statistics (DGCI&S) and the Centre for Monitoring Indian Economy (CMIE). India’s drug exports grew at an average rate of 21 per cent in the past four years.

Shah said India’s drug exports were likely to show above 15 per cent growth for 2009-10. India’s $12-billion (Rs 53,500 crore) pharmaceutical industry earns 40 per cent of its revenue from exports of off-patent generic drugs.

A CII-KPMG report estimates total Indian pharma output (including that for export markets) would be growing at a compounded annual rate of 16 per cent over 2007-11. According to a Mckinsey report, the domestic pharmaceutical market is set to grow from $6.3 billion (Rs 28,000 crore) in 2005 to $20 billion (Rs 89,000 crore) by 2015, with a growth rate of 12.3 per cent.

Tighter norms for Clinical Research

2010-06-14T22:22:00.000-07:00

The government will soon make it mandatory for all firms involved in clinical research to maintain minimum quality standards and register themselves with the country’s drug regulator, a health ministry official said.

Once the law is implemented, the names of all the approved clinical research organisations (CROs) in the country will be uploaded on the website of Drug Controller General of India (DCGI). A violation of the norms could lead to the firm being barred from conducting clinical studies in India.

“It will weed out fly-by-night CROs,” said the official requesting anonymity. The health ministry will notify the amendment soon and the government inspectors then will start random audits to ensure the requisite standards are maintained, he said.

Several inspectors at the DCGI have been trained by the US Foods and Drug Administration to audit CROs.

The country’s highest technical body on medicines, Drug Technical Advisory Board, has approved an amendment to the Drugs and Cosmetics Act to make CRO registrations compulsory.

According to consultancy firm KPMG’s pharma analyst Hitesh Gajaria, the move is a step in the right direction but it must be effectively implemented. “This will regulate the entire clinical protocols, ethical norms and other practises,” he said. At present, there are 40-50 CROs in the country, a number that is increasing steadily.

CROs typically provide research services to drug companies in developing medicines, especially the clinical trials. They also liaison with hundreds of hospitals and clinics in the country who conduct clinical trials for Indian and global pharma companies.

India’s clinical research market is estimated at $300 million and growing at over 30% annually, thanks to the diversified gene pool and lower cost of clinical studies compared to developed markets. Although, Indian CROs are regarded highly in the global pharma industry, the local industry has remained largely unregulated.

Social groups have also occasionally raised concern about mandatory protocols not being followed during clinical trials and Indian patients being used as cheap targets.

The government’s move comes within weeks of Parliament passing the Clinical Establishments Bill, 2010 making registrations of all clinical establishments in the country, such as hospitals and clinics, mandatory.

Pharmacovigilance Programme to start on July 1st with 10 medical colleges in 1st phase

2010-06-14T02:08:00.000-07:00

The much awaited National Pharmacovigilance Programme, is expected to begin in 10 medical colleges across the country from July 1 this year. The first phase of the programme will be launched in 10 of the 300 medical colleges in the country and the DCGI plans to further extend it to 40 other colleges by next year and 60 the next. DCGI said that by 2014, all the 300 medical colleges will be participating in the National Pharmacovigilance Programme.

The national level Pharmacovigilance Programme will have a two pronged approach and will be targeted for five years initially. In the budgetary provisions the pharmacovigilance programme was granted with Rs 85 Lakh against the expectation of Rs 1.5 crore. This programme was supposed to be launched earlier in the month of April but it had repeatedly got delayed due to problems in the Union Health Ministry. The DCGI expressed that funding is the most important aspect right now for the success and development of this programme. Almost 50% of the allotted money will be used on HR to increase the manpower since it’s an issue that’s been haunting the DCGI’s office from the past several years.

The programme will be run in three units that comprises of the medical colleges, other institutes and CDSCO. AIIMS will act as the main centre for the National Pharmacovigilance Programme, whereas the CDSCO will be providing funds, manpower, training etc to the AIIMS and other institutes involved in this programme. This programme will be started in 10 medical colleges this year.

IDMA urges govt to include Pharmacovigilance in Medical and Pharmacy syllabus

2010-06-12T21:47:00.000-07:00

The Indian Drug Manufacturers' Association (IDMA) has urged the union health ministry to include pharmacovigilance as a topic in the subsection of pharmacology in the syllabus of medical and pharmacy students in the country.

In a White Paper recently submitted to Drug Controller General of India (DCGI) Dr Surinder Singh, the IDMA said that including pharmacovigilance in the syllabus will enable the medical and pharmacy students to understand issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug reactions (ADRs), the manner in which these are detected and monitored, and the related historic and legal frameworks etc.

Spontaneous reporting of ADRs is an important method for detecting new safety issues related to drugs and the best way to increase reporting is by way of educating students, the IDMA said and added that since pharmacovigilance is the best tool to indicate the safety of a drug, its awareness and understanding, must be ensured at all stages for all those associated with the drug industry.

There is an increasing need for well informed professionals to work in all areas related to the assessment of drug safety and risk-benefit of drug use. IDMA stressed on the need for implementing new rules so that it could strengthen the existing pharmacovigilane system in the country. Thus education on pharmacoviligance and importance of reporting should be extensively incorporated into medical and pharmacy training to address these issues.

The white paper also focussed on other issues pertaining to industry and laid down suggestions to the authority to ponder on. IDMA stressed that the pharma companies and CRO's must understand and support the need to have an adverse drug reaction registry database at CDSCO.

The white paper suggested that there should be a system devised of analysing ADR drug wise devised by the pharmacovigilance department of the CDSCO and the outcome should be published preferably bi-annually as report to the nation besides forwarding the same to the medical associations.

The paper calls upon practising medical professional to report ADRs and professional associations to be entrusted with task of taking suitable steps to ensure the same. It stresses that guidelines for reporting ADRs by the healthcare professionals should be accessible wherever reporting forms are available.