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

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

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

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

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

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

Future strategies for pharmaceutical education

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

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

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

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

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

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

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

Health Ministry asks State govts to adopt Clinical Establishment Bill

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

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

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

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

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

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

One Day Seminar on GLP on 4th Sept. 2010

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Growing generic opportunities of Indian Pharmaceutical Industry

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Clinical Establishment Bill passed in the Lok Sabha

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

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

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

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

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

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

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

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

SMS based IT solution to track expired drugs

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The 62nd Indian Pharmaceutical Congress will be held in Manipal

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

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

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

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

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

Important Dates

Online Submission Starting from: 1st August 2010

Last Date for Online Submission: 30th September 2010

Announcement of Acceptance: 15th October 2010

Pharma Export Council to open offices abroad

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

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

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

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

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

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

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

Tighter norms for Clinical Research

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

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

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

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

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

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

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

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

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

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

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

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

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

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

IDMA urges govt to include Pharmacovigilance in Medical and Pharmacy syllabus

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

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

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

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

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

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

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

Indian Pharmacopoeia 2010 to be released soon

Indian Pharmacopoeia Commission (IPC) is going to release the Indian Pharmacopoeia (IP) 2010 - Sixth Edition, which is in print, in few months. IPC, under the Union Ministry of Health has now started working on the Addendum to IP 2010, as decided in its Scientific Body’s meeting held in May.

At present the Indian Pharmacopoeia does not have much provisions relating to excipients and IPC has recognised the need, which has triggered this move. “One of the important areas that IPC has decided to work on is to strengthen the quality standards for excipients. “The IP 2010 edition thus will have twenty one new monographs on excipients and the addendum is going to focus further on this critical area,” informed Dr D B A Narayana, member of the Scientific Body, Indian Pharmacopoeia Commission.

In a meeting held in Delhi on May 1 it was decided by the IPC to address this in the addendum. Speaking about this Dr Narayana, said that work on the addendum has already begun. He averred, “It is important to focus on excipients and its quality since any compromise on the same can adversely impact the stability of the drugs.”

In India excipients are largely imported and some of the excipients are manufactured within India. The excipients that are imported are tested according to the pharmacopoeia of the country manufacturing it. At present, the Indian Pharmacopoeia does not specifically address this segment fully, thus the pharmacopoeia commission felt the need to review and prepare new monographs and add it accordingly.

According to Dr Narayana, once the addendum work starts, the excipients that are imported in large quantities need to be looked into. Similarly, those excipients that are known to be more critical for quality will also need to be assessed. He said, “The pharma companies are required to inform the pharmacopoeia commission about the excipients manufactured in India, and about those that have no IP monograph.” The pharmacopoeia wants the stake holders to work with the commission so that they can keep a better tab on the quality of the drug.

The Indian Pharmacopoeia is the official book of standards and medicines produced in India, and the companies must comply with the specified quality standards. Pharmacopoeial standards and acceptance criteria are set with the intention that they be used only as compliance requirements and not as requirements to guarantee total quality assurance. The main aim is to promote public health in India by bringing out authoritative and officially accepted standards for quality of drugs including active pharmaceutical ingredients, excipients and dosage forms, used by health professionals, patients and consumers. The Indian Pharmacopoeia Commission (IPC) has been formed as an autonomous institution under the Ministry of Health and Family Welfare’s on 2008. It is dedicated for setting of standards for drugs, pharmaceuticals and health care devices/technologies etc besides providing reference substances and training.

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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.

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.

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.

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 24^th & 25^th 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