PCI warns pharmacy colleges planning to launch 2nd shift for B. Pharm

The Pharmacy Council of India (PCI), the statutory body governing the pharmacy education in the country, has warned against the move by some of the institutes to start a second shift for pharmacy courses. PCI said that it would not approve such courses or students taking such courses as per the Pharmacy Act, 1948.

The council has notified its decision to all the concerned educational institutions through a notice, of late. The PCI has come across the information that some of the pharmacy institutions has started a move to commence a second shift of courses in order to accommodate more student batches, according to PCI sources.

"It is brought to the notice of all concerned that the Pharmacy Council of India has not approved conduct of pharmacy courses in the second shift," said the PCI notice.

"The pharmacy institutions intending to run pharmacy course in second shift and students intending to enroll in such courses are hereby informed that such pharmacy course will not be approved u/s 12 of the Pharmacy Act, 1948 and students shall not be eligible for registration as a pharmacist under the said Act which is mandatory to practice the pharmacy profession in the country," informed the council officials.

Further, it warned that the entire consequence for running unapproved pharmacy courses would rest on the institution as well as the students enrolling in such institutions and the PCI, in no way, shall be responsible for such courses.

The PCI, constituted under section three of the Act, is entitled to prescribe minimum standard of education and to approve courses of study and examinations for the purpose of qualifying for registration as a pharmacist under section 10 and 12 of the Act. At the present, the eligible qualifications include D Pharm, B Pharm and Pharm D along with Pharm D (Post Baccalaureate) from approved pharmacy institutions.

The council, working under the Union Ministry of Health and Family Welfare, has the onus to keep close vigil on the infrastructure and teaching and training quality of approved pharmacy institutions and monitors the functions of such institutions. It also has the responsibility to update the government about the status and courses of the pharmacy institutions.

Contract manufacturing of drugs to grow by 10-15%

Contract manufacturing in pharmaceutical industry is set to grow by 10% to 15% in the near term and is expected to double in the next five years after the approval of US healthcare bill as the bill has opened up opportunities for the use of more generic drugs in the US market.

US healthcare bill, approved by the US Congress recently, aims to bring an additional 32 million people under the insurance net and also plans to reduce the healthcare bill of the state. Moreover, the bill prohibits insurance companies from excluding people with pre-existing medical conditions and dropping policy holders on account of coverage limits.

“The demand for generic drugs will increase in the US market as this bill aims to reduce the healthcare spending of the state. As India is a prime destination for manufacturing generic drugs due to its low manufacturing cost and the availability of good facilities, contract manufacturing industry will definitely see a rise,” Goutam Das, chief operating officer of Syngene International Ltd, a wholly-owned subsidiary of Biocon said.

The contract manufacturing industry will see a 10-15 per cent rise in the near term as many global generic drug companies will place manufacturing orders to feed this new demand, he said.

The domestic Indian drug industry, pegged at Rs 40,000 crore by 2009 end, will get support as many drugs will go off patent by 2013, throwing opportunities for generic drug makers.

“Many global drug makers like Pfizer, GlaxoSmithKline, Aspen among others have entered into manufacturing agreements with Indian companies and these deals are expected to grow in future,” Das said.

The last two years have witnessed many such deals being struck between global and domestic pharma companies. In March 2009, Pfizer and Aurobindo had entered into an agreement for the manufacture of 60 products for the regulated market in the latter’s facility in India. Pfizer also has similar arrangements with Claris Lifesciences. Moreover, Biocon and Mylan Labs have an arrangement to develop and manufacture monoclonal anti-bodies in Biocon’s facility. Recently, Aspen entered into a drug supply pact with Indoco.

“India, which has over 95 facilities approved by the US heathcare regulator, is expected to contribute 3-4% of the market share in the manufacturing space in near future,” Sanjay Singh, Associate Director, KPMG said.

While 70 per cent is contributed by generics in pharma drug industry, their contribution in value terms is around 15 per cent, which is set to improve, he added.

Not only is the cost factor driving more outsourcing deals for India, factors like scarce pipeline of new molecules will also contribute to it.“Global pharma companies don’t have a sound pipeline of new molecules as of now. So, pharma companies have to opt for generics to protect their topline,” R D Joshi, Senior Consultant of a pharma consultancy firm-Interlink Marketing said.

He also said India had a definite edge over countries like China, Vietnam and Ireland because of its manpower, good quality facilities and cost effectiveness.

However, some companies are of the opinion that it is too early to gauge the impact of the US healthcare bill.“We have to wait and watch for the possible opportunities thrown after passing of this bill rather than jumping into conclusion,” Abhaya Kanoria, chairman and managing director of Anglo French Drugs and Industries Ltd, said.

Drug suppliers for CGHS dispensaries asked to put special Barcode to check pilferage

The health ministry has asked the drug manufacturers, supplying medicines and medical devices to the Central government health scheme (CGHS), to stamp special tag and put barcode to check the instances of pilferage of medicines and equipments.

The authorities have asked the manufacturers to stamp 'CGHS supply not for sale’ with indelible ink and place special barcode on the drugs and medical devices supplied to the schemes and dispensaries. The government has also set up a task force to check further pilferage of medicines and equipments. Senior officials have been instructed to hold regular inspection of dispensaries to monitor procurement, distribution and storage of drugs.

These measures were taken in the wake of some recent instances of pilfering of medicines and equipments meant for CGHS dispensaries and selling them in the open market in Delhi.

One case of pilferage was reported from CGHS wellness Centre, Vivek Vihar, Delhi. SIT Crime Branch, Delhi arrested Revti Prasad Sharma, store keeper, Vivek Vihar and Mithun Tyagi, computer operator at CGHS Wellness Centre Yamuna Vihar, in December last in this connection. The store keeper had been suspended while the other person had been terminated.

Besides, the instance has prompted the authorities to launch more preventive measures as such cases are believed to be happening in many parts of the country. The CGHS authorities have directed for surprise checks and inspection by additional directors. The CMOs and other medical officers were also asked to conduct random inspections.

The scams involving the CGHS drugs are worth several hundred crore of rupees in all parts, as per reports. Crime Branch some time back arrested owner of two medical stores at Bhagirath place in Delhi in connection with one of such scam to the tune of Rs 8 crore.

Good future for Indian pharma

The future looks somewhat bright for the Indian pharmaceutical industry which is wholly into generics.

It expects to get a push from the new US legislation bringing into the health-care fold 32 million or 10 per cent of the country's population which is currently uninsured.

As the US administration has also projected a reduction in the fiscal deficit of $143 billion by cutting the cost of public health-care delivery over a 10-year period, there is a strong business opportunity for the suppliers of cheap medicines, that is, generics.

The best placed to exploit this opportunity are the Indian and Chinese pharmaceutical industries and between them it is the Indians who have the lead with their substantial, in-place capacity to produce quality drugs at 175 plants (the largest outside the US) approved by the US regulator.

The Indian domestic scenario is also bright with growing incomes giving a boost to private health-care expenditure as also a rising public health-care bill. In 2009, the domestic market grew 17 per cent.

Thus, the volume scenario is bright but margin prospects are another matter. Generics (drugs off patent) are a commoditised business marked by high volumes, low costs and low margins. And things on the margins front are likely to, if anything, get tougher.

On the export front, as far as the regulated markets are concerned, the drug majors that have so far relied on their patented blockbusters are rapidly changing their business model in several ways.

They are acquiring capacities and forging partnerships with some of the best Indian names to get a foothold in the generics space.

By riding on their marketing and distribution networks, Indian suppliers will be able to clear larger volumes. But their margins in this segment will be lower than what they would have been if they were on their own.

The drug majors are also thinking up new and ingenious ways to extend the life of patents and thus hang on to their blockbusters for as long as they can. This prevents the generics space form growing to its full potential.

The domestic market has always been very highly competitive, not allowing high margins. The only bright spot is the unregulated market like Russia, Africa and Southeast Asia where the reputation of leading Indian brands give them an edge.

In this scenario, there are two ways to improve margins. One, keep pecking away at the long-term goal of discovering new molecules that will command a premium under patent protection.

Two, in the medium term, those with well-developed R&D facilities, should go in more for custom development of new entities on behalf of drug majors.

By doing this kind of high-value work, Indian pharma companies will be doing exactly what the product development and engineering services firms are doing in software. There is also the lucrative allied business of conducting clinical research to test new drugs belonging to others.

The hope is that in this way, by developing and testing others' blockbusters, Indian firms will develop enough expertise to one day produce blockbusters of their own.

City jobs outlook in Healthcare and Pharma Sectors rises by 16 index points

The employment outlook for the city has registered an increase of 16 index points during the April-June period on the back of robust growth in the healthcare and pharma sectors, a report by TeamLease Services has indicated.

Nationally, while Bangalore has recorded the maximum increase of the 23 points in the employment outlook index followed by Ahmedabad at 17 points.

In Kolkata, the healthcare and pharma sector has been marked as the largest contributor (22 points) to the employment outlook for the period under consideration, followed by the information technology sector. Last quarter, the infrastructure sector had been pegged as the backbone for job growth in the city by the same report.

“Typically, the traditional sector of healthcare and pharma is been seen as a big contributor and they have seen robust growth, in terms of percentage increase. This goes to show that job growth in Kolkata is not just based on the IT and ITes sector,” TeamLease Services vice president Rajesh AR said.

According to the report, the first quarter of 2010-11 is expected to witness a gradual return of aggressive hiring. As a result, the employment outlook countrywide for the quarter has jumped by 11 per cent to 58 per cent.

Among the sectors covered, there is an increase in index points in all sectors except infrastructure and telecom. Healthcare and pharma, with 72 points, has the highest index points followed by IT with 69 points) as the overall trend for the cities. Interestingly, the marketing and customer services segment has recorded the least hirings.

On the attrition front, during the last quarter Hyderabad, Delhi, Bangalore, Chennai and Kolkata saw the highest attrition rates, even as Ahmedabad witnessed the lowest attrition levels.

Additionally, barring the entry level, the intention to hire has increased, especially across the middle tier.

IIFT to host a seminar to boost export potential of Ayush products

The Indian Institute of Foreign Trade (IIFT), a deemed university under the Ministry of Commerce, as part of its research study on ‘India’s Export Potential of Ayush Products with SAARC and ASEAN Countries’, is holding a seminar of exporters of Ayush products in Chennai.

The meeting will be held at the Seminar Hall of IMPCOPS at Thiruvanmiyur in the afternoon. IIFT has been commissioned to carry out the research study by the Department of Ayush.

Dr. T Thirunarayanan, Secretary of Centre for Traditional Medicines and Research, Chennai, who organizes the seminar on behalf of IIFT, said the research study of IIFT is mainly aimed at looking into the prospect of India’s export potential of Ayush products in SAARC and ASEAN countries in terms of the market size, trade channels, and regulation requirements for boosting the potential of export business.

He said the objective to conduct a meeting in Chennai is to explore the current export potential of Siddha, Ayurveda and Unani drugs from Tamil Nadu to these countries and to discuss government initiatives in promoting export awareness in the industry and understanding regulatory requirements of the targeted countries.

Dr. Vijaya Katti, professor & chairperson (Research) of Indian Institute of Foreign Trade has informed CTMR that IIFT has already started with the data collection from different database for the study and is in the process of organizing overseas survey. The team member of the Research Project, Dr Jaydeep Mukherjee, will attend the seminar for data collection here.

The meeting would help IIFT in getting an overview on the market size of Traditional Medicine in SAARC and ASEAN countries, their purchasing capacity and the percentage of people from those countries consuming traditional medicines, CTMR sources said. Besides, it can assess the government initiatives to promote export awareness of Traditional Medicines in India.

According to Thirunarayanan, 15 major manufacturers of ISM from Tamil Nadu and 8 Ayush experts will attend the seminar as resource persons. The experts are selected from the areas of Drug Development, Regulation and Quality Assurance.

DCGI asks State Drug Controllers to collect data on impact of revised Schedule M norms on Small Scale Industries

The Drugs Controller General (India) has asked all State drug controllers to collect the information on the closure of small scale pharma units following the amendment of the Drugs and Cosmetics Act enforcing the revised Schedule M guidelines in the country from July, 2005.

The DCGI has called for the information including the names of units along with their addresses closed since July 2005 due to non-compliance of Schedule M requirements after the Ministry of Micro, Small and Medium Enterprises (MSME) made a request in this regard in view of the proposed detailed survey to ascertain the extent of the impact of Schedule M.

MSME, the agency entrusted to conduct the survey as recommended by the Rajya Sabha committee on subordinate legislation, had informed the DCGI office that it did not have sufficient infrastructure and manpower to conduct the survey and had requested the assistance. Hence the DCGI, after taking up the matter with the DTAB, has instructed the State drug controllers to collect the data as they are the licensing authorities to enforce the Schedule M, sources said.

Apart from the information on the closed units, the DCGI has also asked the State authorities to gather data on the cases in which licences have been surrendered by the manufacturers. “It is also requested to provide information on the cases in which licenses have been suspended or cancelled by the authorities due to the non-compliance to revised Schedule M. Please indicate separately the cases in which licences remained suspended or cancelled and those where licences have been reinstated after due compliance,” the DCGI letter said.

“Names of drugs and pharmaceutical units which are partly compliant to Schedule M in respect of specific sections while licence for other categories has been suspended, cancelled or surrendered specifically due to non-compliance of Schedule M also be forwarded,’’ the letter said.

The DCGI has asked the State licensing authorities to collect the data on top priority basis so that information could be forwarded to the Committee on Subordinate Legislation, sources said.

India in world's top 10 pharma hubs

India will join the league of top 10 global pharmaceuticals markets in terms of sales by 2020 with the total value reaching USD 50 billion by then, according to a report by Price waterhouse Coopers.

The country's population is growing rapidly, as is its economy - creating a large middle-class that can to afford western medicines, consultancy firm PwC's report said.

An ageing population together with increase in problems associated with cardio-vascular disorders and central nervous system will lead to higher demand for drugs, the report said.

Around USD 70 billion worth of drugs are expected to go off patent in the US over the next three years and India is capable of manufacturing a substantial share of the products.

India, which produces more than 20 per cent of the world's generics, is likely to become a competitor of global pharma in some key areas, and a potential partner in others.

It has a considerable contract manufacturing expertise, the report says.

"Global players in the pharmaceutical industry are seeing immense prospects in the Indian market due to its sheer demographic profile. India could be the most populous country in the world by 2050 and is now making its mark as a growing market," Sujay Shetty of PWC said.

Several Indian firms have already entered into research partnerships with multinationals--Dr Reddy's Laboratories Torrent have joined hands with Novartis while Ranbaxy has formed alliances with GSK and Schwarz Pharmaceuticals, the report added.

India has the world's second biggest pool of English speaking population and a strong system of higher education, so it should be well-positioned to serve as a source for talent for research professionals, the report said.

CLINICAL TRIAL MANAGEMENT: ENABLING OPERATIONAL EFFICIENCY

The way the biopharmaceutical industry conducts clinical trials is undergoing a remarkable transformation. Coupled with this much needed evolution are new challenges specific to the increasing role that information technology will play to enable the new clinical development landscape. Of the many challenges facing the biopharmaceutical industry today, the critical need for greater operational efficiency in clinical drug development is paramount. With flat and even declining productivity, rising research and development (R&D) costs, more complex preapproval trials and large post-approval studies driven by the shift toward biological agents, and increasing regulatory demands, it is essential that clinical trials are managed more effectively and efficiently. While progress has been made in addressing these challenges, companies are increasingly turning to clinical trial management systems (CTMS) to improve trial efficiencies, cut trial costs, and enhance the productivity of trial participants.

The Globalization of Clinical Trials

The global clinical trial, while not new to either sponsors or clinical research organizations (CROs), is becoming more prevalent, Clinical trials are increasing in size and complexity and more global trials are being conducted with sites across diverse geographical regions. The predicted trend is that there will be a significant shift from North America/Western Europe to the Asia-Pacific region (APAC). Between 2008 and 2010 the percentage of trials conducted in North America / Western Europe is expected to fall from 55 to 38%. Clinical trials conducted in APAC countries offer potential cost savings as well as large patient populations, particularly of treatment-naïve patients. This shift will also have certain implications. Sponsors and CROs will need to support all operational aspects of global trials: languages, logistics, access control, regional requirements, and region-specific business processes. Furthermore, it will be necessary to understand and need local regulatory requirements. To manage global trials more efficiency, many companies turn to commercial CTMS. These CTMS are typically implemented as enterprise applications. A fundamental value proposition of an enterprise CTMS is the provision of a centralized trial repository, which enables standard trial management processes across the enterprise and provides end-users, who increasingly are more geographically diverse, with real-time data visibility into study progress. However, this does not necessarily mean that everybody who is involved in a study should have access to all information about it. Organizations should balance the need to empower their employees with access to available information against keeping tight control over data access, allowing only those with proper authorization into the appropriate files. Fortunately, technology solutions exist that provide the access control necessary for the clinical trial industry, as well as tools that significantly reduce the administrative overhead. The globalization of clinical trials needs to be truly worldwide rather than just a process of more trials conducted in different locations. This will require global unified systems with built-in functionality that support specific regional needs. The current mindset, however, is still more or less focused toward the traditional North America/Western Europe requirements and supporting prevailing business needs. For a truly global system, this view needs to change to ensure individuals and departments have an understanding of where they fit into the business process. Regional units need to understand how their work affects others in the process so that effective collaboration can take place. It is also important to assess the impact or implication that local infrastructure and culture might have on conducting clinical trials in developing countries. Understanding the local environment and requirements often drives innovation that brings about substantial impact. Innovative solutions that are very site-focused, very pragmatic, and very specific to the local infrastructure may overcome barriers. For example, patient follow-up is a significant issue in China. A large Chinese CRO has proposed utilizing mobile technology, in the form of cell phones, as a component of its site management system. The proposed system would allow stakeholders to send the alerts or messages via SMS, or push reminders to patients regarding visits. This form of collaborative tool, along with better data visibility, will help clinical research associates (CRAs) better manage their sites and increase study compliance.

Adaptive Trials – A Reality of Clinical Trial Evolution

Adaptive trials will become a reality or even a necessity rather than just a concept. Regulatory agencies in the major markets have implemented evolving positions on adaptive clinical trial design, and information technology (IT) vendors are developing software to support adaptive designs. Adaptive design uses accumulating data to decide how to modify aspects of the study so that the right development questions can be answered more efficiently and accurately without undermining the validity and integrity of the trial. Adaptive design also provides patients participating in a trial with a greater probability of being allocated to treatment that works than in a traditionally designed trial. Much of the focus has been on statistical design of adaptive trials and impact on patient data capture, while very little has been done in terms of supporting adaptive trials from the trial management and operational perspectives. Traditionally, a study is set up when just about every step has been properly mapped out in as study protocol. Adaptive trials challenge the traditional model and call for greater flexibility on study set-up, site set-up, study design, and patient enrolment. Unfortunately, many current CTMS are built for the traditional clinical design, and only a very few CTMS vendors have started building functionalities that provide the flexibility for adaptive trial designs. One adaptive element that is not talked about in the context of adaptive trials is the ability to ‘Adapt’ and modify how trials should be ‘executed’ rather than ‘designed’ based on real-time information available on the study progress. Embedding analytics solutions in clinical applications transforms applications such as CTMS and clinical data management systems (CDMS) from being places where data are simply entered and stored to places where business intelligence is gained and actionable insights are generated by and for the end users. Embedded business intelligence will not only enhance the value of clinical systems, but also help drive end-user adoption.

GSK Issues Statement On FDA's Warning Against Rotavirus

Galaxo Smith Kline(GSK) has notified regulatory authorities of the presence of material from a virus called PCV-1 in its oral rotavirus vaccine, Roatrix. PCV-1 does not multiply in humans and is not known to cause illness in humans. It is found in everyday meat products and is frequently eaten with no resulting disease or illness.

The material was first detected following work done by a research team in the US using a novel technique for looking for viruses and then confirmed by additional tests conducted by GSK.

Having reviewed the information and data submitted by Glaxo Smith Kline, as well as information available regarding PCV-1 from the world's literature, the EMA and the WHO will also be issuing statements confirming the positive balance of benefits and risks of the vaccine despite the presence of the material from PCV-1 and have not recommended any change to the way that healthcare practioners in Europe and the dveloping world use Rotarix. The US FDA similarly has issued a statement confirming that there is no evidence that this finding poses a safety risk based on the exellent safety profile of Rotarix and evidences that PCV-1 is a known virus that does not multiply in humans and is and is not known to cause iullness in humans.

Roatarix has been produced according to US FDA standards reviewed and approved for US licensure in 2008. This notwithstanding, the US FDA is recommending that US clinicians and public health professionals temporarily suspended the use of Rotarix as a precautionary measure.

BII EXAM NOTIFICATION

BII's Exams would be held on 24th & 25th April 2010 at the following cities Ahemdabad, Kottayam, Chennai, Hyderabad, Bangalore, Mumbai, Pune, Kolkata, Patna, Lucknow, Noida, Chandigarh.

India Opening up Power of PV – I

No drug is absolutely safe; all drugs have side effects. “Safe” here means that the benefits of the drug appear to outweigh the risks. Drug may contribute to 5-10 per cent of all hospital admissions; around 10-20 per cent of all inpatients may suffer a serious adverse drug reaction (ADR) in hospital. Some ADRs lead to death, and also may contribute 5-10 per cent of hospital costs. So the monitoring of the adverse effects of drugs becomes crucial for good medical practice. Therefore, the pharmaceutical industry has entered a new era of pharmacovigilance (PV).

Pharmacovigilance is relevant for everyone whose life is touched in any way by medical interventions. Pharmacovigilance provides comprehensive, risk-based, flexible solutions for the management of product safety, risk, and patient health during the entire life cycle of a medicinal product.

A series of high profile safety concerns, life withdrawal of certain drugs and the link between antidepressants and suicidal thoughts in children over the last three years, has made drug safety a major issue for governments, regulatory bodies and pharmaceutical companies.

Hence, pharmaceutical companies are highly emphasizing pharmacovigilance in the wake of product recalls, “black box” warnings, and litigation. An inventory of legislative requirements has been enforced during the last few years in the ICH regions. By now, pharmacovigilance planning has become a substantive issue for the long term success of any drug on the market, as malfunction of pharmacovigilance systems and communication channels may lead to license retraction. Recent instant communication channels rightly position manufacturers and marketers of medicinal drugs to report adverse drug reactions immediately to their competent authorities.

Present-day statute demands from the liable manufacturer to inform concerned authorities rapidly about serious adverse drug reactions (ADR) and other drug safety related events that are occurring during the developmental and marketing periods of a drug, such as Suspected Unexpected Serious Adverse Reaction (SUSAR) in clinical development or other immediately reporting events in later stages of a drug’s life-cycle.

Non-compliance with these requirements could make the difference between keeping your drug on the market and being forced to withdraw it. Therefore, early planning of your pharmacovigilance strategy is essential to the success of pharmaceutical products.

This may indicate areas of concern which may require closer attention by a potential sponsor. The pharmaceutical companies in Europe and US usually outsource a part or sometimes much of its pharmacovigilance system due to lack of experience and resource, especially with commercial pressures to get the product to market. Sometimes, all the necessary parts of the system cannot be implemented in time by a company as first-time marketing authorization holder. However, additional factors may drive outsourcing in India, such as neither a physical presence nor a cultural experience as well as reduced costs, so that even call centres acting for Western Europe may be placed in India. As regards development in general, it is hoped that the Indian research environment may help to solve enrolment challenges on large multinational phase III studies or indeed be a source of treatment-naïve patients for phase II or III.

A robust pharmacovigilance is critical to ensure quality and to protect the interests of patients whether this applies to investigational and marketed products. However, both the observational and interventional clinical researchers, are government by the internationally applicable Declaration of Helsinki. Similarly, if the results from Indian trials are to be used for regulatory submission in the West, then good clinical practices (GCP) compliance is essential.

Difficulty in operating PV in-house in cos

In fact, pharmacovigilance is an activity that has international significance. Pharmacovigilance involves proficient individuals, from registered nurses to specialist doctors who are performing relatively clerical functions, such as sifting through data and probing case reports; but despite the clerical natural of the work, it requires such a high level of competency that a company that a company must pay lavishly for it is the work is done domestically.

The requirements, and the stakes, of this kind of work continue to rise. Every new drug is put under dissection, wound up by negative media coverage. The volume of events to be reviewed and addressed is going up at an astounding rate, and so is the cost.

Cos reducing the cost of PV

The era of outsourcing has enabled pharmaceutical companies to hire third party vendors to perform non-core processes at lower cost and higher quality. Outsourcing of the pharmacovigilance process provides a cost effective solution, especially for small and medical sized pharmaceutical companies. This would avoid the high upfront investments and fixed over-head cost connected with setting up an in-house drug safety system. Along with meeting the regulatory requirements, outsourcing would allow immediate participation in the efficiencies provided through the looming implementation of electronic SAE (Serous Adverse Even) reporting. Even if a pharmaceutical company decides to develop their own drug safety group in-house over time, often there is need for external advice and possibly provisional coverage until the team gets up to speed.

Benefits of outsourcing PV system

The use of an offsite pharmacovigilance system may be less expensive than in-house system. The most important benefits for an outsourcing solution are the ease of managing certain peaks and new demands, and the reduced cost for database infrastructure and license cost for software programmes. These key benefits allow a firm to keep the internal headcount low, as negligible corporate infrastructure is required. Outsourcing can provide an immediate, multi-location pharmacovigilance network with minimal IT investment.

Usually the pharmacovigilance provider lacks the specific product knowledge, and so an effective transfer of drug information data is necessary. This can be facilitated with liaising with a structurally competent partner who is able to assimilate the necessary product knowledge easily, for example, with a comprehensive training programme and regular interactions with the core product team of the pharmaceutical firm.

Guidelines On GFCP For Medicinal Plants Issued

The National Medicinal Plants Board (NMPB), Dept of Ayush, in collaboration with the WHO's country offices for India has issued a comprehensive guideline on Good Field Collection Practice (GFCP) for India.

The guidelines focus on packaging of medicinal plant storage and post-harvest management. There are also a set of rules for harvesting and post-harvest management for specific plant parts like roots, stem bark, select mature branches of a tree or shrub, leaves, fruits and seeds, gums & resins, galls and lac.

Importance is also given to training in plant collection building.

The demand and supply mismatch is the primary reason for unsustainable harvesting and quality degradation. Therefore, NMPB has called for a baseline assessment of availability of medicinal plant produce in the wild by adopting mathematical approaches using software. Once the baseline data is available, regular monitoring can be carried out as a part of routine management, according to the guidelines report.

The Board has insisted assessment for herbal plant species which are likely to be thretened. Wherever it is not possible to arrive at sustainable level of harvest, it can be carried out with reference to supply by setting up extraction quotas, stated the report.

For specific herbal plants like Shankhapushpi, Bhringaraj, Bhumyamlaki, etc, efforts should be made for 'compaction' using, manually/ mechanically operated compactors. This would help the communities in minimizing the storage area requirments and for primary transport purposes, said the report.

In the area of storage, guidelines call for proper labelling of the container of medicinal plant produce. The label should contain all the required information of medicinal plant produce.

The efforts to develop GFCP for Indian medicinal plants, which are mainly collected from the wild, is a praiseworthy. The guidelines would contribute to improve quality and sustainable management of plants resources, Dr. DBA Narayana, herbal scientist told Pharmabiz.

West Storms into India For Clinical Research, Pharmacovigilance Next Growth Path For CROs

India's clinical research organization (CROs) are set for exponential growth going by the number of assignments which are coming in here. The global economic slowdown which has seriously impacted wetern world has benefited the Indian clinical research industry. Scores of assignments are pouring into conduct clinical trials, pharmacovigilance studies and data management works.

The country is considered as a hub for clinical trials by pharma multinational companies (MNCs) primarily because of the diverse disease patient pool, scientific acumen, hospital infrastructure that help to provide the high quality and less expensive work. These aspects have made the recession hit international companies to off load assignments to India, said Dr. Ramananda S Nadig, dean and chief operating officer, Clinical Research Education and Management Academy(CREMA).

Pharma MNCs are also exploiting India's competencies in Information Technology and its strong low cost skill-set by setting up centers for their global clinical dwwata management function in India.

According to Dr. Saral Thangam, technical director, Lotus Clinical Research Academy, the key attraction towards India is the availability and confidence in the qualified trained personel comprising of pharmacy graduates and doctors who are sound in spoken and written English.

In fact, the global recession has led companies in the West lagely look at low cost markets which include India is preffered over China. However, India is preffered over China in the area of clinical record documentation only because of our English knowledge, she added.

Western companies are eager to set up phramacovigilance centers in India. The CROs here have demonstrated competence in quality deliverables in human studies and pharmacovigilance is an extension of this which covers reporting of adverse drug reaction (ADR) and post marketing surveillance. In fact, for CRO pharmacovigilance is a logical extension. Even Indian pharma companies have started pharmacovigilance as backened services. IT majors like Accenture, TCS and Infosys are particularly focusing on pharmacovigilance, said Sudhir Pai, managing director, Lotus Clinical Research Academy.