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

Sunday, May 16, 2010

Analyst (Life Science) Post unfilled at SMART ANALYST (Gurgaon) | Life Science Candidates can apply Online

At Smart Analyst, We empower clients in Life Science and Consumer Healthcare to make successful business decisions by providing best of class customized analyses and superior strategic insights.

Position: Sr Analyst/ Analyst Life Sciences

Qualification: PhD (Life Sciences) or Post Graduate (Life Sciences) and MBA


location: Gurgaon

Desirable

* Analytical thinking: Accuracy and attention to detail, Strong ability to analyze and interpret data, and Creative problem-solving skills
* Good Commercial and Market sense
* Understanding of Therapeutic areas preferably CV/ neurology/ neurosciences/ autoimmune/ Infectious diseases
* Good spoken and written communication skills
* Strong ppt skills; Proficiency in excel will be an added advantage

Job Description

* Report Execution
* Implementation of work processes, protocols and Quality parameters

Friday, May 14, 2010

IMS forecasts Global Pharma Market growth of 5-8% annually through 2014

IMS Health has reported that the size of the global market for pharmaceuticals is expected to grow nearly US$300 billion over the next five years, reaching US$1.1 trillion in 2014. The 5 - 8 % compound annual growth rate during this period reflects the impact of leading products losing patent protection in developed markets, as well as strong overall growth in the world’s emerging countries.

Global pharmaceutical sales growth of 4 - 6 % is expected this year, consistent with IMS’s prior forecast. In 2009, the market grew 7.0% to $837 billion, compared with a 4.8% growth rate in 2008.

“Patient demand for pharmaceuticals will remain robust, despite the ongoing effects of the economic downturn being felt in many parts of the world,” said IMS’s Murray Aitken, senior vice president, Healthcare Insight. “In developed markets with publicly funded healthcare plans, pressure by payers to curb drug spending growth will only intensify, but that will be more than offset by the ongoing, rapid expansion of demand in the pharmerging markets. Net growth over the next five years is expected to be strong — even as the industry faces the peak years of patent expiries for innovative drugs introduced 10 - 15 years ago and subsequent entry of lower-cost generic alternatives.”

In its latest analysis, IMS identifies the following key market dynamics:

Geographic balance of the pharmaceutical market continues to shift towards pharmerging countries
Pharmerging markets are expected to grow at a 14 - 17% pace through 2014, while major developed markets will grow 3 - 6%. As a result, the aggregate growth through 2014 from pharmerging markets will be similar to the growth experienced in developed markets — about US$120 - US$140 billion. This compares to aggregate growth over the past five years of US$69 billion in pharmerging markets and US$126 billion in developed markets. The U.S. will remain the single largest market, with 3 - 6 percent growth expected annually in the next five years and reaching US$360 - $390 billion in 2014, up from US$300 billion in 2009.

Therapy area growth dynamics driven by innovation cycle and areas of unmet need
As the pharmaceutical industry’s research and development programs adjust to the broad availability of low-cost generic options in many chronic therapy areas, higher growth will occur in those therapy areas where there is significant unmet clinical need, high-cost burden of disease, and innovative science that can bring new treatment options to patients. In the areas of oncology, diabetes, multiple sclerosis and HIV, annual growth is expected to exceed 10% through 2014 as new drugs are brought to market, patient access is expanded and funding is redirected from other areas where lower-cost generics will be available.

Broad cuts in spending applied by public payers to reduce growth in drug budgets
Publicly funded health systems are under increased pressure to reduce growth in drug budgets following the global economic downturn. Countries including Turkey, Spain, Germany and France already have announced plans to apply across-the-board restrictions on access or reductions in reimbursements to reduce drug spending growth. Governments in other countries seeking to restore fiscal balance may take similar actions, or shift more costs to patients.

Thursday, May 13, 2010

Clinical Trials: A Medical Research Perspective

Clinical trial data is complex and has huge volumes. Inconsistency of data between multiple systems results in data conflicts and efforts, problems in compliance, validation requirements, polices and procedures. Clinical trials industry globally faces similar issues. Expert researchers from pharma and biotech sectors alongwith the experts in regulatory issues should come together to develop a national consensus and initiate policy decisions to develop standards, policies and procedures.

     Clinical trials are the links between advances in drug discovery and improved healthcare. The ever lasting conquest for prevention of disease requires rich and authentic information about disease incidence in the population, probable causes and results of drug trials conducted.

     Over the last couple of decades, there has been exponential growth in the number of clinical trials conducted worldwide. India has seen sizable growth of Clinical trials industry in last decade and holds the promise to continue the same in future. Any such dramatic growth always faces challenges. The challenges are many. Inspite of the weaknesses like lack of strict regulatory regime, governance, management of data and records, the industry in India has not only survived but proliferated aggressively.

     Clinical research organizations (CRO) have been instrumental in strengthening India’s growth story. India is one of the preferred destinations for clinical trials. Growth in numbers of clinical trials conducted has led to increased competition among sponsor companies and CROs to find clinical sites and to recruit clinical investigators and treatment-naïve patient populations.

The need for clinical trials:
Medical research has progressed studying medial records over years. Review of studies and publications are very important in medical research. Data obtained on human subjects is of utmost importance for further research.

     A clinical trial is a systematic study of pharmaceutical products in human subjects, in order to discover or verify the clinical, pharmacological and adverse effects for determining the safety and efficacy.

     Clinical trials are defined as Pre-planned studies of the safety, efficacy, or optimum dosage schedule of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavourable effects.

     Scientific research has developed well-established, well documented and validated methods for the design, conduct and analysis of clinical trials over years. The entire drug discovery process is very lengthy and complex spanning over 10 to 15 years making it very expensive. Clinical trials, being the tail-end and most important of the entire process, demand critical attention. The outcome of clinical trials has major impact on the manufacturer’s interests and efforts and also on prognosis of disease. Although drugs hold a hope for certain critical medical conditions, they require very careful analysis of desired outcomes and side effects in human subjects. The failure of desired outcome can make a drug company run into losses of millions of dollars. It is thus important to have a stringent control on clinical trials. The trials involve human subjects, making it a very sensitive issue. Accordingly legal implications involved in clinical research are complex.

     Thus clinical trials are not only important to a drug company and patients but also to government, regulators, media, different advocacy groups, ethical police, media, and the general public.

     There has been as a steady increase in the drugs in the development pipeline with advancement of genomics, bioinformatics, high throughput analysis etc, making the efficient use of resources very important. Drug companies, pharmaceuticals and medical-device manufacturers who would conduct trials on their own, have gradually realized the benefits of outsourcing clinical research. The concept of CRO is now well established and the budgets used for CRO contracts are on the rise all over the world.

Clinical Research Organizations:
Clinical trials are heavily regulated, which in part is a reason for drug companies to start outsourcing services, resulting in the growth of clinical trials industry. Over the years, CROs have proved as the trusted service providers for pharmaceuticals and bio-medical organizations. CROs offer a range of expertise, such that along with conducting actual clinical trials, even pre-clinical management is taken care of. However, their core competencies are still in managing human trials.

     The unprecedented growth in Clinical research industry is estimated to be worth over USD 52 billion and has employed more than 2,00,000 people in USA alone.

     The salaries too are very attractive and have attracted attention of many students, especially medicos. They perceive it as lucrative career with good employment opportunity.

     India has become a strategic centre to conduct clinical trials. Today's CROs operate on an international scale, conducting trials in multiple countries concurrently under the supervision of multiple regulatory bodies.

     This industry is evolving toward a full-service model. Smaller CROs with niche provisions are merging into or being acquired by organizations that are more focused on offering a complete range of services.

     This has resulted in CROs providing services from early drug-safety trials (Phase I), through regulatory approval (Phase IV) with research efforts required alongside.

     It is estimated that currently, more than 50 per cent of the clinical trials are handled by CROs, with value added services. The success of CROs to conduct more and more complicated trials is now proven. Since the requirement of this industry is very crucial, CROs have a steep performance curve. There is greater competition as well, resulting in substantial growth.

     Many major pharmaceutical industry players are conducting trials in India with the help of either their in-country partners, or have on-the-ground presence. India has witnessed growth in pharmaceutical business also resulting in increase in outsourcing to India.

     It is forecasted that, by 2012, India will be conducting 5- 15 per cent of total global clinical trials.

Advantage India:
India is emerging as a fast growing economy. As regards clinical trials, there are many factors that are in favour of India as a preferred destination. According to McKinsey and Co., by 2010 global pharma majors would be spending up to $1.5 billion for clinical trials in India.

     The prime most factor is that medical knowledge available here is well respected. This has also given rise to medical tourism as another booming industry in India. India offers specialty hospitals with state of the art facilities even in smaller cities. India also offers very good educational support resulting into thousands of medical graduates. The Medical Council of India currently recognizes 273 Indian medical colleges, with a total capacity to train 31,298 Indian medical students.

     There are also a large number of students graduating in different fields of life sciences and information technology every year creating a large brain pool of qualified and efficient professionals. The proficiency in English is an added advantage to make India a preferred clinical trial hub.

     India has workforce that can easily be trained into the pattern that suits USA/Europe work practice. Many satisfied pharma clients are proof of meticulous and scientific professionalism of Indian CRO workforce. E.g., Quintiles has sailed through all five audits of its clinical work by the FDA. Many drugs have been approved in Europe and the U.S. with significant data from India.

     Since an ideal study design should have sufficient sample size and statistical power and proper control of bias to allow a meaningful and statistically significant interpretation of the results, countries like India and China are growing rapidly in this sector. India has a large and ethnically diverse population, resulting in great variety of medical conditions. Patients are easier to recruit as compared to western countries. India has among the largest pool of patients suffering from different ailments such as, cancer, diabetes, hypertension, asthma, tropical infections and degenerative diseases.

India's patient population estimates:
● 40 million asthmatic patients
● 34 million diabetic patients
● 8-10 million people HIV positive
● 8 million epileptic patients
● 3 million cancer patients
● 2 million cardiac related deaths
● 1.5 million patients with Alzheimer's disease
● 15% of population is hypertensive
● 1% of population suffer from schizophrenia

     Another important advantage India has is that, drug trials can be carried out in India at extremely competitive costs. Both facilities and Staffing costs are economically attractive in India.

     Initiatives like, increasingly compliant regulatory affairs and Intellectual property protection by strong government support will be a positive measure for CROs. Additional support in terms of infrastructure improvement will contribute further to growth of clinical research industry.

     An indicator of India’s stronger presence in clinical research for the pharmaceutical sector is the recent opening of US FDA office in New Delhi.

Briefly, the advantages India enjoys are:
● Huge patient base with diversity of diseases
● Heterogeneous population
● High enrollment
● High patient compliance / retention
● State-of-the-art hospital facilities
● Reliable, well-trained investigators
● English-speaking workforce
● High ICH GCP quality standards
● Cost effectivity
● Good IT infrastructure
● Increasingly compliant regulations

Clinical trial research: Challenges
Clinical research, is a highly regulated industry and hence there are many crucial components to running a CRO.

     Apart from need for medical treatment, patients opt to participate in clinical research for many other reasons as well. Some may desire early access to new, still experimental medications or even try to reach to highly sought after physicians or specialists. Others could opt to obtain medical care not covered by their insurance plans. Even to reach out to other patients suffering the same ailment could be a reason too. Opportunity to remain under vigilance for their conditions is also motivating. Patients may also be paid for their participation in studies. This however may contribute to the hidden costs, as most of India’s population does not have health insurance. Those costs have to be covered by the sponsors.

     What has been discussed earlier as an advantage however could be a challenge when the same patient registers for different trials. Multiple enrollments are a problem faced by the CROs. Such cases, even if less frequent, could be a problem as drug interactions may give altered results. Retaining patients for post-trial assessment is another challenge. Long term analysis is a major problem in many trials. Another issue that many face is when trials are not done at site but drugs are given and patients are supposed to do regular follow-ups. Both, certainty of proper dosage and regular follow-up, could get affected.

     These trials are the scientific studies of medication use in people to assess the specificity, efficacy and safety of new drugs. It is because of these volunteers that improved drugs can be found. All these factors call for a strict regulatory compliance. However, it also raises many issues that pose as a hurdle, such as regulatory uncertainties about time for approval, involvement of multiple agencies for approval and for processing import/export licenses. Several other factors also delay the trial resulting in losses. Regulatory approvals in India can take three months or more, compared to 30 days in the US.

     Data exclusivity is a prerequisite for the protection of research efforts. India is yet to comply fully with the TRIPs requirement of providing data exclusivity. A much tighter IPR environment is the need of the time in the highly confidential industry of clinical research.

     Experts in industry opine that one concern about confidentiality protection is that the needs of clinical research are not often explicitly addressed.

Clinical research: Medical perspective
Registration of clinical trials is now taken seriously and The Clinical Trials Registry- India (CTRI) has been set up by the ICMR's National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR). It also receives financial and technical support through the WHO, WHO-SEARO, and the WHO India Country office.

     This will safeguard patient interests and ensure greater transparency, accountability and accessibility of clinical trials.

     Another fallout of lack of regulations is that, majority of investigators lack knowledge of regulations, ethics and GCP (good clinical practices) and skills for clinical trial management. Sudden rise is clinical research has led to mushrooming of clinical trials education institutes, many of which are offering substandard education, concepts and knowledge. Large number of graduates being churned out by these institutes lack a formal course in management of clinical research. The first generation of researchers in clinical trials industry have acquired their knowledge either through mentor or by first hand experience, however, there is shortage of trained manpower. There is inadequate industry-academia collaboration for students to obtain proper training. If the projections made for the industry in 2010 are considered, there would be heavy shortage of trained investigators.

     It is a trend in clinical trials industry to adopt a complete electronic information environment, gathering and reporting data through secure online channels. This has advantage of reducing errors and enhanced speed. The prerequisite will be high quality specific training. Lack of industry standards leading to inability to leverage global standards, such as Clinical Data Interchange Standards Consortium (CDISC) is often noticed.

     Inconsistency of data between multiple systems results in data conflicts and errors, problems in compliance, validation requirements, policies and procedures. Clinical trial data is complex and has huge volume, which makes it increasingly difficult to analyze and process if it’s coming from multiple sources.

     Clinical trials industry globally faces similar issues. The entire industry has a heterogeneous landscape owing to its sensitive nature. There are number of dimensions which differ from country to country resulting in most countries having their own sovereign view to these aspects.

     Hence there is great variation in clinical trial approval procedures, in terms of documents required, time frame of getting them done etc. The countries need to come together to have consensus in reaching harmonious procedure. A tough task, as it is, would require contributions from experts with minimal interference from Pharma industry. Since the daily expenditure on clinical trials is huge, the companies are very sensitive too about the issue.

Conclusion:
India has made considerable progress in clinical research during last few decades. It has the potential to be a key player in this highly remunerative and fast growing industry. With the global pharmaceutical company’s preference for outsourcing to reduce costs and retain competitiveness, India is considered as a preferred destination for contract research in the pharma sector.

     Medically there is a great opportunity of conducting multiple studies in disease segments for new biomarkers and novel drugs – both yielding high value intellectual property.

     India with its strength, can easily grab this opportunity, provided faster solutions are obtained by reaching consensus on the challenges faced by the industry. Academia-industry collaboration, stringent regulations and their strict compliance, friendly for intellectual property protection provisions are some of the steps needed to tackle challenges faced by medical community in conducting clinical trials. The issues outlined here are genuinely difficult and no easy and quick answers are possible. In fact many of the challenges outlined here, are in various stages of formulation and implementation both in India and worldwide since concern about these issues is widespread. Professional institutions like ICMR are addressing these issues in India. There is a need for better and proactive interaction among policy makers, health-care professionals and researchers.

     This is a complex but workable process. A clear understanding and a dialogue at all levels such as, scientists, clinical professionals, population scientists, ethical committees, advocacy groups, the FDA, the NIH and all local country specific governing bodies is needed.

Tuesday, May 11, 2010

Vaccine Clinical Trials Regulations in India

       A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed. It is always better to prevent a disease than to treat it. Vaccines prevent diseases in people who receive them and protect those who come into contact with unvaccinated individuals. It is only due to vaccination against infectious diseases, millions of people do not succumb to morbidity and mortality from viral and bacterial infections in the modern world.

      Vaccination is generally considered to be the most effective and cost-effective method of preventing infectious diseases. The material administered can either be live but weakened forms of pathogens (bacteria or viruses), killed or inactivated forms of these pathogens, or purified material such as proteins. Live vaccine has the characteristics to replicate in the host and attenuated in pathogenicity. Killed vaccines are unable to replicate in the host and gets inactivated by either radiation, heating & formalin. Vaccine-preventable diseases have a costly impact, resulting in doctor's visits, hospitalizations, and premature deaths. Sick children can also cause parents to lose time from work.

      The advantages of live vaccines include relative ease of production, very small amount of immunogens required; only single inoculation is needed in most cases, and induction of appropriate immune response. However, the drawbacks are potential for reversion to virulence, limited shelf life, and potential interference by co-infection with a naturally occurring wild type virus.

      On the contrary, the killed vaccine has an advantage of non-infectivity of the immunogen & relative product stability. The drawbacks are that it requires large quantities of immunogen, need for complete inactivation, needs high purity of final product, needs multiple vaccinations and potentially limited immune response. The characteristics of vaccine (live or killed) have high impact on the process of Regulatory approval in India.

      Vaccines are responsible for the control of many infectious diseases that were once common in India, including polio, measles, diphtheria, pertussis (whooping cough), rubella (German measles), mumps, tetanus, hepatitis, chickenpox and Haemophilus influenza type b (Hib).

      Early forms of vaccination were developed in ancient China as early as 200 B.C. Scholar Ole Lund comments: "The earliest documented examples of vaccination are from India and China in the 17th century, where vaccination with powdered scabs from people infected with smallpox was used to protect against the disease. Smallpox used to be a common disease throughout the world and 20% to 30% of infected persons died from the disease. Smallpox was responsible for 8% to 20% of all deaths in several European countries in the 18th century.

      Current guidelines concerning the development of new medicines and the conduct of clinical trials are based on more conventional, small molecule compounds. The results of the vaccine trials therefore raise the following question: are the current guidelines for pre-clinical testing appropriate and sufficiently rigorous for the new wave of biological medicines. The appropriateness of conventional clinical trials in the assessment of biological medicines should also be considered and, in particular, whether the present clinical trial guidelines are suitable for monoclonal antibodies and other biological medicines.

      Under the Drug and Cosmetics Act 1940, the regulation of manufacture, sale and distribution of drugs is primarily the concern of the state authorities while the central authorities are responsible for approval of new drugs, clinical trials in the country, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of state drug control organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the drugs and cosmetics act. Drugs Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccines and Sera.

      The manufacture and distribution of biological products for human use are regulated under the following two statutory authorities:
          ● Drugs Controller General of India (DCGI)
          ● Genetic Engineering Approval Committee (GEAC)

      Depending on the type of vaccine (live or killed) the approval or waiver from GEAC is sorted for all vaccine trials conducted in India. The ownership of a vaccine developed in India will be a crucial factor in having an affordable vaccine for public health use. The Department of Biotechnology (DBT) has been given the process for the development of a vaccine. PharmaLeaf has experience in garnering DCGI approval first, followed by GEAC waiver based on robust data and opinions from several participating countries.

      The guidelines for the vaccine clinical trial are as follows:
          ● Schedule – Y, Amendment version 2005, Drugs and Cosmetics Rules, 1945
          ● Biological guidelines
          ● GCP guidelines published by CDSCO, DGHS, Govt. of India.

      Ethical Guidelines for Biomedical Research on Human Subjects published by Indian Council of Medical Research, 2008 in New Delhi.

      The regulatory agency also takes the assistance of central institutions like Central Drug Laboratory, Kasauli, National Institute of Biologicals, Noida and Indian Veterinary Research Institute. Central Drug Laboratory at CRI Kasauli is a Central laboratory engaged in the testing of vaccines. It is a notified laboratory under the Drugs and Cosmetics Act, 1940 to function as Central drugs laboratory for testing of the following drugs or classes of drugs; Sera, Solution of serum proteins intended for injection, Vaccines, Toxins, Antigens, Anti-toxins, Sterilized surgical ligature and sterilized surgical suture, and Bacteriophages, including Oral Polio vaccine.

      The logistics for vaccine are vital since most of the biological product requires cold chain management in Immunization. However, potent a vaccine may be, if the cold chain is not maintained from the source of vaccine manufacture to the site of vaccine administration - the vaccine efficacy will grossly suffer. To maintain the potency of the vaccine a safe zone of temperature is mandatory.

      The logistics for vaccine are vital since most of the biological product requires cold chain management in Immunization. However, potent a vaccine may be, if the cold chain is not maintained from the source of vaccine manufacture to the site of vaccine administration -- the vaccine efficacy will grossly suffer. To maintain the potency of the vaccine a safe zone of temperature is mandatory.

      The cold chain system is a means for storing and transporting vaccines in a potent state from the manufacturer to the person being immunized. This is a very important component of an immunization programme, since all vaccines lose potency over time, especially if exposed to heat, and in addition, some also lose their potency when frozen. It is obviously pointless to immunize with an impotent vaccine, and efforts to reach extremely high levels of immunization coverage will be useless if the vaccine being administered has insufficient potency to give the necessary protection.

      Attention to maintaining correct temperatures during storage and transport of vaccine is thus a major task for health workers.

      The cold chain system comprises three major elements:
          ● Personnel, who use and maintain the equipment and provide the health service;
          ● Equipment for safe storage and transportation of vaccines; and
          ● Procedures to manage the programme and control distribution and use of the vaccines.

      Competent personnel and efficient procedures are a vitally important part of the cold chain system. Not all countries have an identical system, but the vaccine must always be maintained at a safe temperature throughout its entire journey.

      The safe zone for vaccine storage for short term i.e. 1 to 2 months is +2°C to +8°C. For long-term storage, -20°C as preferred only for BCG, OPV and Measles / MMR. This vaccine should not be freezed. Domestic refrigerators / Ice lined refrigerators (ILR) are used for short-term storage and deep freezer for long-term storage. Vaccine carriers are used for carrying the vaccine to an outreach centre which maintains the ideal temperature of 2°C to 8°C with the help of 4 fully frozen ice packs contained in them. Cold boxes are used in fixed centers as alternative vaccine storage equipment in the event of short duration of electricity failure.

      The storing of vaccines in a domestic refrigerator should be used only for vaccine storage. OPV in the freezer compartment and the rest of the vaccines in the non-freezing lower compartments. No vaccine should be stored in the tray or the door shelves. Repeated thawing of OPV should be avoided for all practical purposes. Never carry vaccines in a flask for an outreach place.

      In summary, multiple regulatory agencies are involved in India for managing, manufacture and conduct of clinical trials of biological samples in the well controlled environment. Pharmaceutical companies are seeking single window clearance system which will facilitate the approvals to conduct the vaccine clinical trials successfully in India. Pharma industry is working closely with both regulatory and central lab which is supportive in issuance of relevant licenses. These clinical trials with vaccines are useful to patients with poor immune responses for which the benefit far outweighs the risk. If vaccination is not done at the young age then chances of getting the disease per se is high in old age with high risk involvement. Hence vaccination plays a crucial role in children for preventing infectious diseases.

Monday, May 10, 2010

Indian Clinical Trials Industry takes rapid strides

The Indian clinical research industry, valued at Rs. 8,000 crore ending fiscal 2010-2011, is making rapid strides in the global arena leaving even China way behind in conducting clinical trials according to experts. The industry which was valued at Rs. 1,200 crore in 2006 has grown to Rs. 6,500 crore in 2009-10.

The key growth factors driving the sector are the sound medical expertise, English speaking work force, capability in information technology, large patient pool and modern hospital infrastructure. Supporting these capabilities are quick turnaround time and the data management skills.

The global economic slowdown which has seriously impacted western world has benefited the Indian clinical research industry. Scores of assignments are pouring in to conduct clinical trials, pharmacovigilance studies and data management works.

The India clinical trials industry has around 40 major players. Of these the leading names are global players like Quintile, Pharma Net, Pharma Olam and Clin Tech International to name a few. The well-known Indian names include Ecron AcuNova, Lotus Labs, Clingene, part of Biocon Ltd, Omnicare, ICON, Vaatsalya, St. John’s Medical College Clinical Trial Centre, Triesta Life Sciences part of Health Care Global Enterprises Ltd, Siro, Synchron, D2L, SMO India and Infinitus.

According to Dr Saral Thangam, Technical Director, Lotus Clinical Research Academy, the main attraction of India is the availability and confidence in the qualified trained personnel comprising pharmacy graduates and doctors who are sound in spoken and written English.

In fact, the global recession has led companies in the West to largely look at low cost markets which include India and China. However, India is preferred to China in the area of clinical record documentation because of the better standards in English, she added.

According to Ashis Mukherjee, senior director, Hospitals & Oncology BU and Corporate Hospitals, Sanofi Aventis, India’s sound knowledge in information technology has been a key growth driver of the clinical research industry. Although the clinical research industry started off in India in 1992, it gained momentum only from 2004 and the last three years have seen an exponential growth. An important factor for such fast paced activity in the sector is the sound IT and English skills supported by qualified doctors, trained medical personnel including investigators, research-hospital infrastructure, economies-of-scale and access to recruiting large number of patients. There is a huge disease burden in the country from cancer, diabetes, tropical fevers to genetic disorders.

The installation of electronic medical records (EMRs) by hospitals in the country have also proved as a major attraction for international clinical research organizations (CROs) and multinational companies to offload human studies to India, he added.

There is a growing global demand for clinical trial management which provides opportunities in IT specific to clinical trial industry. These include data management and medical writing which have widened the scope for outsourcing clinical research business to India.

India is now at the helm of clinical research and speed is the essence of this sector. Pharma companies are looking to hasten the drug development process and CROs are scrambling to access right talent. Clinical research training centres are working to groom candidates as industry ready professionals at a faster pace, said Dr Ramananda S Nadig, dean and chief operating officer, Clinical Research Education Management Academy.

The hospital infrastructure and medical expertise have facilitated smooth conduct of phase-III and phase-IV human studies. However, India needs to look at conducting phase-I trials immediately. The expertise in phase-III and phase-IV have given the country much of the recognition to become a hub in clinical research. In order to grow the clinical research industry here, phase-I needs to be taken on. The country has been a hub for human studies cardiology, oncology, diabetes, thrombosis, central nervous system disorders and tropical diseases.

Global companies are eager to set up pharmacovigilance centres 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 back end services. IT majors like Accenture, TCS and Infosys are particularly focusing on pharmacovigilance, according to Sudhir Pai, Managing Director, Lotus Clinical Research Academy.

Clinical research education Along with the worldwide growth in clinical trials, enforcement of regulation has also become stringent. In India Schedule Y is considerably regulating the industry. According to Dr Arun Bhatt, president, Indian Society for Clinical Research and president, ClinInvent Research India Pvt Ltd, the Government of India should notify amendment to Schedule Y-1 without delay so as to make registration of clinical research organizations mandatory in the country. In this regard, the Indian Society of Clinical Research had worked on the revised guidelines and made a submission to the Drugs Controller General of India (DCGI) in September 2009. Only a speedy tabulation of the guidelines could provide the industry the much needed fillip, he added.

Supporting this strict adherence and creating an awareness on the need to ensure right conduct of human studies, several clinical research education centres have sprung up. Some of the leading names are Institute of Clinical Research India (ICRI), CREMA and Lotus Clinical Research Academy.

The estimated shortage in the Indian clinical research industry is at 65,000, of which 15,000 are for pharmacovigilance jobs alone. “Global demand is annually around 2.50 lakh trained professionals of which only four per cent of the requirements is met,” said Vijay Moza, chairman, CREMA.

According to Pai, managing director, Lotus Clinical Research Academy, there are bright career opportunities in this industry in India for professionals like doctors, pharmacy, IT and science graduates and post graduates.

The transfer of jobs from global locations to India will give an opportunity to Ecron Acunova to scale up operations and improve processes, said DA Prasanna, founder, Ecron Acunova.

There is also an expansion of facilities by CROs. GVK Biosciences has commissioned its new clinical pharmacology unit (CPU) in Ahmedabad. The DCGI-audited facility is the second centre after its Hyderabad unit which has added 110 beds to the company's existing capacity of 144 beds and will aid faster recruitment solutions to our global customers, said Manni Kantipudi, president, GVK Biosciences.

Challenges
The challenges of this industry in India is that the knowledge of product patent is low. There has been no focus on drug development till 2005. Despite the presence of large and young team of clinical research professionals, they lack training on Good Clinical Practices (GCP) and Good Lab Practices (GLP). Other issues are that medical education curriculum in India does not have a component on research methodologies and there is no standardized training on clinical research. In addition, there is also a need for accreditation of hospitals on similar lines of NABH for sites selected to carry out human studies, opines Mukherjee.

Dr. Baidyanath Mishra Senior Research Scientist-Agrotech(R&D)

Views For the Bioinformatics Institute of India.(A leading Institute of Distance learning Education) .

I have shared my experiences with my colleagues about BII that gained during my course-Regulatory Affairs continued (& still continues as result is not declared till date). Please have my views.

1. The questions papers as covered during the examinations on 24th & 25th April was really very good as compared with other organizations providing the same course.

2. The study material(s) was in receipt on right time.

3. The course materials are really well supportive for any beginners- simple, well explained, and elaborative till the basic knowledge is covered.

4. One of the most rewarding is the excellent job by support team, who replies to our queries instantly.

5. The most fascinating thing is the conduct of the examination schedule on time, as many institutes they skip from the date they initially declare during the admission/counseling.

In the meantime, my overall experience till now is very good. I can suggest more of my friends who are interested to continue any suitable that caters their career enhancement.

May I know when the result is going to be declared?

With good luck!

Regards

Dr. Baidyanath Mishra
Senior Research Scientist-Agrotech(R&D)
The Himalaya Drug Company
Makali, Bangalore 562 123, India
T +91 80 2371 4444 · F +91 80 2371 4471
dr.mishra@himalayahealthcare.com * www.himalayahealthcare.com

Dept. of Pharmaceuticals suggests PPP model for development, maintenance of new NIPERs

The Department of Pharmaceuticals (DoP) which took the initiative of the project of establishing six new National Institutes of Pharmaceutical Education and Research (NIPERs) has suggested in its detailed project report that development and maintenance of infrastructural facilities should be under the Public Private Partnership (PPP) model.

The new NIPERs, set up at Hajipur in Bihar, Rae Bareli in Uttar Pradesh, Ahmedabad in Gujrat, Hyderabad in Andhra Pradesh, Kolkata in West Bengal and Guahati in Assam, are currently run with the help of mentor institutes already existing in these places. Now the Government intends to set up these institutes independently on full scale basis with increased participation from the private sector, according to DoP officials.

A partnership model has been designed, wherein there would be four types of collaboration opportunities are available for the private partner under the header, Package A to D officials. The package A entitles the partner firm to have the oncus to design, build, finance, maintain and transfer the NIPER complex including land co-development for the activities related to pharmaceutical sciences and life sciences or academic activities.

The package B consists of responsibilities to design, build, finance, operate and transfer of certain facilities in NIPER campus by co-usage of facilities and creation of surplus capacity for commercial exploitation, even as the Package C offers the private partner to conduct operation and management of the academic and related functions of NIPER.

Package D would be for the partners who are looking for deals in any other manner in which they would be like to be associated with NIPERs under PPP. According to the detailed project report submitted by the consultant firm, Deloitte Touche Tohmatsu Pvt Ltd, the estimated cost on each NIPER is expected at approximately Rs 330 crore including PPP element.

Thursday, May 6, 2010

Drug regulatory agencies contemplating tightening of storage rules of trading outlets

The recent unearthing of expired drugs in Tamil Nadu has not only highlighted the necessity of a common incineration plant to destroy the drugs recalled from circulation, but also reinforced the need for proper storage facilities in pharmacies and in stockists' godowns as specified in the Schedule P of the D&C Act.

When the Tamil Nadu branch of the Indian Pharmaceutical Association has extended its support to the state government for establishing an incineration plant, the enforcement agencies of the government are serious on tightening regulations on the drug delivery system in the country with special focus on maintenance of storage conditions in pharmacies.

According to sources from the drugs control department, if a drug is to be sustained it should be stored in proper storage conditions. The department has strictly informed all the pharma wholesalers and retail outlets to maintain refrigerated godowns and air-conditioned rooms to keep the potency of the drugs.

In a recently held meeting of manufacturers organized by IPA in Chennai, the deputy director of Drugs Control MM Yousuf said the industry and the regulatory bodies are responsible to maintain the cold-chain management till the drug is reached the patients, the ultimate user. Good refrigerator, back-up generator / inverter and air-conditioner have to set up with the pharmacy stores in order to maintain the prescribed temperature always.

He said if the polio vaccine is not stored in a proper storage condition, it may give false hope to the people and children may develop polio in due course. So everyone involved in the business of drugs should give importance to storage maintenance because so as to give therapeutic efficacy to the drug. Like quality assurance, quality release of the medicine assumes vital role, whose responsibility is on the traders. According to him, vaccines are very sensitive drugs and if a small change in temperature occurs to them, the efficacy will be lost.

"Cold storage is an unnoted area, but plays a vital role in the efficacy of medicines. All the manufacturing units, retail shops and distributors' stores have to develop this facility. The need of the hour is to put up centralized AC in all the medical stores. All the government hospitals in Tamil Nadu, the pharmacies are following the rules," he said. The state health department ensures proper preservation of drugs as specified in the Act, he added.

It is learnt that the health department will shortly organize a meeting of office-bearers of the associations of manufacturers, distributors and retailers to discuss the issues and find solutions for the burning issues. The Tamil Nadu IPA has already approached the government with full support to establish a Common Expiry Processing Unit with men and machinery. If it is materialized, Tamil Nadu will be the model state to establish such a facility for a good purpose.

According to sources, there are 42500 pharmacies working in the state and 1000 manufacturing and marketing companies. For the smooth conduct of inspections, the government has recently appointed 25 drugs inspectors and process of filling up another 25 is on.

Centre to set up separate research council for Siddha systems of medicine

The Union Health and Family Welfare Ministry is planning to set up a separate research council for the Siddha System of Medicine bifurcating the existing Central Council for Research in Ayurveda and Siddha (CCRAS), the autonomous body under the Department of Ayush.

The proposal to set up the new council is being actively considered and it will be established in six month's time, according to a higher official from the Department of Ayush. The move aims to expand the research and development activities on Siddha medicine, a form of medical treatment of diseases using substances of all possible origins in a way that balances the possible harmful effect of each substance. The system is vastly prevailing in South India.

At present, the CCRAS is the apex body in India for the formulation, co-ordination, development and promotion of research on scientific lines in Ayurveda and Siddha systems of medicine. By setting up a separate council, the current research projects under the Siddha system of medicine will get a boost and more projects could be taken for research by replicating the working system in CCRAS, said the official.

The medicinal preparations under Siddha system are made primarily from the parts of the plants and trees such as leaves, bark, stem, root etc, but also from mineral and animal substances. According to reports from Department of Ayush, there are 2586 beds available for Siddha treatment in a total of 276 hospitals set up for the same and there are around 529 dispensaries with Siddha system of treatment available in the country, including the public and private healthcare establishments, till 2008. These healthcare centres are situated in five South Indian states, Karnataka, Kerala, Andaman & Nikobar Islands, Puducherry though a majority of the centres are in Tamil Nadu.

The use of metals like gold, silver and iron powders (Sanskrit bhasma) in some preparations, a special feature of Siddha medicine, has created confusion among the overseas regulators about the heavy metal content of such medicines, while the Siddha experts claims it can detoxify metals to enable them to be used for stubborn diseases.

The department, earlier in 1998, has also set up a National Institute of Siddha (NIS), at Chennai, with an aim to promote education, research and medical care through the particular system of medicine and to promote and propagate the science and technique of Siddha.

Monday, May 3, 2010

‘Jan Aushadhi Campaign’ quality medicines at affordable prices

Over the years, India has developed a strong capability in producing generic medicines in almost all the therapeutic categories. These medicines are being sold mostly as branded medicines which pushes up the retail price of these medicines. There is still a large population of poor people in the country which finds it difficult to afford these medicines. In fact access to quality health care is a challenge in a developing country like India. According to NSO estimates, upto 79% cost of health care in rural areas is due to cost of medicines. This problem gets further aggravated as upto 80% of expenditure on health care is out-of-pocket. With 65% of India’s population not having access to modern health care (WHO estimates 2008) the entire problem is compounded several times.

Unbranded Generic Medicines Vs Branded Medicines
Access to quality medicines at affordable prices is a key challenge for the Government. In this connection the prices of branded medicines are generally higher than generic medicines due to various reasons inter-alia including branded drugs having patent protection and a number of drugs having limited regulation through the Drug Prices Control Order, 1995 etc,. A sample comparison of some of the prices, shows the vast difference between the Generics Price and the Market price. Therefore, making available medicines at affordable prices has been taken up by the newly created Department of Pharmaceuticals.

Jan Aushadhi Campaign
For fulfilment of this goal, a campaign in the name of ‘Jan Aushadhi Campaign’ has been launched. The aim of this campaign is to make available quality medicines at affordable prices for all, especially the poor and the disadvantaged. Under this campaign, less priced quality unbranded generic medicines will be made available through Jan Aushadhi stores which inherently are less priced but are of same and equivalent quality, efficacy and safety as compared to branded generic medicines.

The generic medicines are being supplied in the first instance by the Central Pharma PSUs which will ensure both quality and timely supply. Medicines not available currently with the CPSUs will be sourced from quality SME units. This will also give support to the Pharma SME sectored as well as promote public-private partnership and avenues for achievement of corporate social responsibilities geared towards affordable Medicare for the masses. The Jan Aushadhi Campaign has now been formalized as Generic Drug Scheme with the approval of the Planning Scheme.

Under this Scheme, the State Government has to provide space in Government Hospital premises for the running of the outlets (JAS). Government hospitals, NGOs, Charitable Organisations and public societies like Red Cross Society, Rogi Kalyan Samiti typically constituted for the purpose can be operating agencies for the JAS. The operating agency for JAS is nominated on the basis of the recommendations of the State government. Operational expenditure is met from trade margins admissible for the medicines. The State Government has to ensure prescription of unbranded generic medicines by the Government doctors. The Jan Aushadhi Programme is accordingly a self sustaining business model not dependent on government subsidies or assistance. It is run on the principle of “Not for Profits but with Minimal Profits”. In order to encourage and provide the initial trigger for above, it is envisaged that the Central Government would provide only a one-time assistance of Rs. 2.00 lakhs as furnishing and establishment costs and further Rs. 50,000 as one time start up cost to NGO etc,. Setting up the Jan Aushadhi Outlet.

Jan Aushadhi stores
The Jan Aushadhi Campaign of the Government is expected to make a contribution by way of achieving the socio-economic goal of affordable health are through ensuring availability of quality drugs at affordable prices for all. At present, 231 medicines are being supplied in the 44 JAS opened in the states of Punjab, Haryana, Uttarakhand, Orissa, Rajasthan, Andhra Pradesh, Union Territories of Chandigarh and Delhi.

The scheme is also expected to lead to reduction of state health expenditure on branded medicines, more patient coverage, popularization of the use of unbranded generic medicines which will bring down the actual out-of-pocket costs of medicines for the common man due to wider availability (at present only 2% of the total medicines supplied in the market are unbranded medicines) and finally better and more affordable health care driven by the reduction in costs of medicines as the majority component of health care expenses.

People’s Participation
The assistance sought is for just one time facilitative incentive to the Jan Aushadhi outlet operating agency which would be an NGO/Charitable body/Cooperative body/health care driven societies like the Red Cross Society/Rogi Kalyan Samiti, etc., who would do the actual operation of the outlet on the principle of minimal profits obtained from the minimal margins included in the cost of the medicine itself. There is no subsidy or recurring assistance envisaged either by the State or the Central Government. Cooperation of the State Governments is essential for locating the outlets in the district hospital premises. The concern of the Members of Parliament regarding the issue of availability of medicines at affordable prices is being sought to be addressed under the Scheme. The Generic Drugs Scheme is an attempt in this direction based on a viable business model not requiring government subsidy. The programme does not envisage grant of any upfront subsidy other than the assistance indicated above to provide some support from the Government/BPPI to NGOs etc.

Benefits of the Scheme
The Jan Aushadhi Campaign will help:
· Improve access to healthcare in as much as cost of treatment would come down substantially. This would enable the Public Health System to increase the coverage.

· Secure a socio-economically viable mechanism/institutional arrangement for efficacious sales of Pharma CPSU products, thereby improving their viability.

· Promote & encourage private industry to sell their quality unbranded generic products through these retail outlets.

· Ensuring successful implementation of the Jan Aushadhi campaign would dispel the myth that quality of medicines is linked to price and demonstrate that quality medicines can be sold at substantially lower prices.

· Educate doctors that unbranded generic medicines provide a better option that branded products since quality of generic medicines can be equally efficacious and safe at much lower prices.

· Create consumer awareness by involving private, charitable bodies and NGOs by making them part of the campaign.

· Reduce promotional cost and profits for the benefit of patients.













Saturday, May 1, 2010

Industry may move court against DCGI's inclusion of old drugs in New Drugs List

Annoyed over the drug controller general of India (DCGI) Dr Surinder Singh's practice of including several old drugs in the List of New Drugs which prevents the manufacturers from getting licences from the state drug authorities, the industry is seriously contemplating to move court to get some solution on the issue.

Sources said that the industry, especially the small players are seriously contemplating to move court against the DCGI's new practice of including old drugs like Diclofenac+paracetamol combination in the List of New Drugs, despite several industry associations objecting to the practice. The industry is all the more annoyed over the fact that even though the industry had made representations to DCGI in this regard, there has been no response from the DCGI so far. “Unless relief is provided immediately, there will be no choice but to move court,” a senior industry leader said.

Several drugs being produced for decades including the time tested and commonly used Diclofenac + paracetamol tablet combination have been approved as 'new drug' by the DCGI for new symptoms. But they are uploaded on CDSCO website on the common list without specifying that they have been approved for new symptoms and SLAs may permit it for old symptoms with the result that many SLAs simply refuse to allow these drugs and SMEs feel deprived unnecessarily, sources said.

Industry sources said that the industry is both surprised and angered over the decision as the Diclofenac+paracetamol combination is one of the most commonly used medicines in the country and the drug has been in the market for more than 20 years. It is also one of the highest selling medicines. It is a non-steroid anti-inflammatory drug taken to reduce inflammation and as an analgesic reducing pain in conditions such as arthritis or acute injury. It can also be used to reduce menstrual pain dysmenorrhea, etc. It is an OTC drug.

There are several other drugs such as Terbutaline+ambroxol, Pregabalin Capsules, etc which the DCGI has put in the New Drugs List. The consequences of the DCGI's practice will be costly to the industry as once the DCGI includes a drug in the New Drugs List, the state licensing authorities (SLAs) will not provide license to that drug for four years. For getting license for this combination in the next four years, the drug companies have to approach the DCGI office in Delhi which attracts a lot of effort and money.

The DCGI periodically sends the List of New Drugs to the SLAs and they consider the list as ‘Bible’. Under no circumstances they will give license to the new drugs and they will direct the drug companies to approach DCGI office for licenses of these New Drugs.

Pharma firms see scope in US patent expiry

Fortune seekers in the Indian pharmaceutical space will find this irresistible. In less than 24 months, 26 blockbuster medicines, worth over $69 billion (about Rs 3,10,000 crore) — or thrice the size of the domestic industry — are going off-patent in the world’s largest drug market, the United States.

In other words, the increasing aggression shown by domestic pharmaceutical firms to penetrate the US market — despite severe setbacks faced by established players such as Ranbaxy and Sun Pharma in terms of regulatory hurdles posed by the United States Food and Drugs Administration (USFDA) — is driven by the huge market that remains open to them during 2010-12.

The potential business that can be looked at from the US patent expiry will, however, be a fraction of the current sales figures, as all these medicines undergo tremendous value erosion soon after it gets open to generic competition.

“It’s not just Pfizer’s cholesterol lowering medicine Lipitor (the largest-selling drug globally) that goes off-patent in 2011, but dozens of products marketed by companies such as Eli Lilly, Johnson & Johnson, Sanofi-Aventis, Astra Zeneca and Bristol Myers Squibb (BMS),” said HDFC Securities Vice-President (institutional research) Ranjit Kapadia.

A recent study carried out by HDFC Securities identifies 34 Indian companies as having positioned themselves to tap this emerging opportunity. While Dr Reddy’s, with its aggressive patent challenge strategies stands to gain most, Ranbaxy and Sun Pharma — despite their troubles with the US regulator — figure in the top 10 list. Even Cipla, the leading Indian company known for its risk-free US strategy, has applied for marketing generic or low-cost versions of medicines that enjoy a current market value of over $45 billion (over Rs 2 lakh crore).

The addressable market for most Indian companies are the same, as many of them have applied for marketing applications for the same medicine. For instance, at least 10 domestic firms have applied for marketing low-cost versions of Lipitor after its goes off-patent in the US market.

According to industry estimates, of the 15 medicines that go off-patent this year, Indian firms have filed marketing applications for 11. Merck’s diabetic medicine Cozaar and Astra Zeneca’s cancer medicine Arimidex are having most generic applicants from India. Similarly, Indian players are prepared to launch generic versions of 14 products out of the 16 that go off-patent in 2011. Apart from the three products, the US will have Indian penetration for all other 22 products whose patent expire in 2012.

“We are well-positioned to supply off-patent medicines to the US through our partners,” Amar Lulla, joint managing director of Cipla said. The company, known for its aggressive patent challenge strategy in the developing world, has opted for the partnership route to enter the US market.

With over 100 USFDA-approved manufacturing facilities in India, domestic drug makers are well prepared to avail of this ‘generic’ opportunity. Indian companies also account for more number of abbreviated new drug applications filed in the US.