FDA approves Adcetris to treat two types of lymphoma

The U.S. Food and Drug Administration has approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).

Lymphomas are cancers of the lymphatic system. Adcetris is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30.

Adcetris is to be used in patients with HL whose disease has progressed after autologous stem cell transplant or after two prior chemotherapy treatments for those who cannot receive a transplant. Autologous stem cell transplant is a procedure using a patient’s own bone marrow that is designed to repair damaged bone marrow after the use of high chemotherapy doses. Adcetris may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment.

Adcetris is the first new FDA-approved treatment for HL since 1977 and the first specifically indicated to treat ALCL.

For more information, please visit: Adcetris

Amgen Highlights Data to Be Presented at American Society for Bone and Mineral Research Meeting

Amgen today announced that it will present data from several Prolia® (denosumab) studies, including eight year efficacy and safety data from a Phase 2 extension study in women with postmenopausal osteoporosis with low bone mineral density (BMD), at the 2011 American Society for Bone and Mineral Research (ASBMR) Annual Meeting in San Diego, Calif. from Sept. 16-20, 2011.

"The breadth of data being presented at this year's Annual Meeting demonstrates Amgen's continued commitment to advancing the scientific understanding of bone biology," said Catherine Stehman-Breen, M.D., vice president of Global Development at Amgen. "Importantly, the eight year data from our Phase 2 extension study supports the long-term efficacy and safety profile of Prolia for women with postmenopausal osteoporosis at increased risk of fractures."

ASBMR abstracts are available and can be viewed online at www.asbmr.org. Identified below are selected abstracts of interest on Amgen research.

Oral Presentations

Effects of Denosumab on Bone Mineral Density and Biochemical Markers of Bone Turnover: 8 Year Results of a Phase 2 Clinical Trial
Lead Author: Michael R. McClung M.D. FACP FACE, Oregon Osteoporosis Center
Abstract No. 1061, Oral Presentation
(Saturday, Sept. 17, 2:15 p.m. – 2:30 p.m. PT)

Effects of Denosumab on Radius BMD, Strength, and Wrist Fractures: Results From the Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) Study
Lead Author: James Simon M.D., George Washington University
Abstract No. 1062, Oral Presentation
(Saturday, Sept. 17, 2:30 p.m. – 2:45 p.m. PT)

Efficacy of Five Years of Denosumab: A Novel "Virtual Twins" Method for Minimizing Bias in Extensions of Trials
Lead Author: Steven R. Cummings M.D., University of California, San Francisco
Abstract No. 1063, Oral Presentation
(Saturday, Sept. 17, 2:45 p.m. – 3:00 p.m. PT)

The Transitory Increase in PTH Following Denosumab Administration is Associated with Reduced Intracortical Porosity: a Distinctive Attribute of Denosumab Therapy
Lead Author: Prof. Ego Seeman, Austin Health, University of Melbourne
Abstract No. 1064, Oral Presentation
(Saturday, Sept. 17, 3:00 p.m. – 3:15 p.m. PT)

Safety Observations From Denosumab Long-term Extension and Cross-over Studies in Postmenopausal Women With Osteoporosis
Lead Author: Henry G. Bone M.D., Michigan Bone and Mineral Clinic
Abstract No. 1065, Oral Presentation
(Saturday, Sept. 17, 3:15 p.m. – 3:30 p.m. PT)

Poster Presentations

Rates of Diagnosis and Treatment of Osteoporosis in Males Before and After Hip, Vertebral, and Non-Hip/Non-Vertebral (NHNV) Fractures
Lead Author: Susan K. Brenneman, PT Ph.D., Innovus
Abstract No. SA0445, Poster Presentation
(Saturday, Sept. 17, 11:00 a.m. – 1:00 p.m. PT)

Medication Adherence in Patients on Osteoporosis Therapy: Physician Perceptions Versus Patient Behavior
Lead Author: Cai Q, HealthCore
Abstract No. SU0443, Poster Presentation
(Sunday, Sept. 18, 11:00 a.m. – 1:00 p.m. PT)

Discontinuation of Denosumab and Associated Fracture Incidence: Analysis From the FREEDOM Trial
Lead Author: Jacques P. Brown M.D., CHUQ-CHUL Research Centre
Abstract No. SA0446, Plenary Poster Presentation
(Saturday, Sept. 17, 11:00 a.m. – 1:00 p.m. PT)

The Effect of Denosumab on the Bone Matrix Mineralization in Mice
Lead Author: Barbara M. Misof, Ph.D., Ludwig Boltzmann Institute of Osteology at Hanusch Hospital
Abstract No. SA0058, Plenary Poster Presentation
(Saturday, Sept. 17, 11:00 a.m. – 1:00 p.m. PT)

Adherence to Osteoporosis Medications in Men: A Systematic Review of the Literature
Lead Author: Robyn VonMaltzahn, HERON Evidence Development Ltd.
Abstract No. SU0442, Poster Presentation
(Sunday, Sept. 18, 11:00 a.m. – 1:00 p.m. PT)

Development of a Comorbidity Index Using the FREEDOM Trial in Women with Postmenopausal Osteoporosis
Lead Author: Neil S. Silverman M.D., Cedar-Sinai Medical Center
Abstract No. SU0455, Poster Presentation
(Sunday, Sept. 18, 11:00 a.m. – 1:00 p.m. PT)

Psychometric Properties of the Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS) in Postmenopausal Women With Osteoporosis (OP) Treated with Bisphosphonates (BP)
Lead Author: Kristi Reynolds, Ph.D., MPH, Kaiser Permanente Southern California
Abstract No. SU0439, Poster Presentation
(Sunday, Sept. 18, 11:00 a.m. – 1:00 p.m. PT)

Persistence, Gaps in Therapy, and Re-initiation of Osteoporosis (OP) Therapy Among Women in a Commercially Insured US Population
Lead Author: Akhila Balasubramanian, Ph.D., Amgen Inc.
Abstract No. MO0435, Poster Presentation
(Monday, Sept. 19, 11:30 a.m. – 1:30 p.m. PT)

Healthcare Costs for Males After Closed Fracture in Commercially Insured and Medicare Advantage Populations From a National Health Plan
Lead Author: Susan K. Brenneman, PT Ph.D., Innovus
Abstract No. MO0441, Poster Presentation
(Monday, Sept. 19, 11:30 a.m. – 1:30 p.m. PT)

Associations Between Osteoporosis (OP) Treatment Change, Adherence, and Incident Fractures Among Members in a Medicare Advantage Prescription Drug (MAPD) Plan
Lead Author: Yihua Xu, Ph.D., Competitive Health Analytics, Inc.
Abstract No. MO0429, Poster Presentation
(Monday, Sept. 19, 11:30 a.m. – 1:30 p.m. PT)

A Phase 3 Study of the Efficacy and Safety of Denosumab in Men with Low Bone Mineral Density: Design of the ADAMO Trial
Lead Author: Eric Orwoll M.D., Oregon Health and Science University
Abstract No. MO0442, Poster Presentation
(Monday, Sept. 19, 11:30 a.m. – 1:30 p.m. PT)

Osteoporosis: Impact and Prevalence

Referred to as a "silent epidemic" by the International Osteoporosis Foundation (IOF), osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. The World Health Organization has officially declared osteoporosis a public health crisis, and the IOF is urging governments worldwide to make osteoporosis a healthcare priority.

Osteoporosis-associated fractures are a significant cause of mortality and morbidity. In 2000, the number of osteoporotic fractures in Europe was estimated at 3.79 million, of which 890,000 were hip fractures.(i) Since 2001, the incidence of hip fractures in European countries has risen significantly.(ii) In the United States (U.S.), the number of fractures due to osteoporosis is expected to rise to more than three million by 2025. (iii)

The direct medical cost of osteoporotic fractures in Europe is expected to rise from euro 31.7 billion in 2000 to euro 76.7 billion in 2050.(iv) In 2005, osteoporosis-related fractures were responsible for an estimated $19 billion in cost in the U.S., and this cost is expected to rise to approximately $25 billion by 2025. (v)

About Prolia

Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).

Prolia is approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Prolia is approved in the European Union (EU) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

Prolia is approved in 20 European countries, the U.S., Canada and Australia. Applications in the rest of the world are pending.

Prolia is administered as a single subcutaneous injection of 60mg once every six months. For further information on Prolia, including prescribing information and medication guide, please visit: www.prolia.com.

IPC starts supply of IP reference substances to state, central drug testing labs

The Indian Pharmacopoeia Commission (IPC) for the first time provided around 50 IP reference substances to different state and central drug testing laboratories across the country. With this the Indian Pharmacopoeia started supplying India's own reference substances to the drug testing labs.

Dr G N Singh, secretary cum scientific director of IPC, informed, “By providing these references substances we would help in asserting the quality of the medicines that is moving in the market. We aim to bring in more IP reference substance for the industry in the coming four to five years.”

IPC supplied the reference substances to the drug laboratories late last month following the demands made by the government analysts from state and central drug testing laboratories. Apart from the demand for requisite IP reference substances the analysts also demanded for availability of hard copy of the IP 2010.

These demands where made by the government analysts during an interactive meeting that was organised by IPC in collaboration with WHO and CDSCO in Mumbai in May this year.

According to Dr Singh, “Through this meeting our main focus was to understand the challenges and issues faced by the drug analyst in the country. And the steps that we took by providing these IP reference substance to them is just a start on how we are trying to meet their demands.”

K Chandramouli, secretary Health & Family Welfare and chairman, IPC recently in his visit to the IPC ensured that he would expedite the process to ensure that the three main demands made by the commission to have adequate lab space, latest instruments and competent work force would soon be addressed.

Among the other major developments, IPC has put the National Formulary of India (NFI) in the CD format and is soon planning to put its contents in the mobile form as well for easy accessibility of the same to the doctors, chemists and nurses.

The selection of drugs for inclusion in the NFI has been made taking into consideration the relative advantages and disadvantages of the various drugs used, the extent of their use in current medical practice and their availability in the country.

It is a publication that contains guidelines on right dosage of medicines for drug prescriber's. NFI is essentially meant for the guidance of the members of the medical profession, medical students, nurses and pharmacists working in hospitals and in sales establishments.

TN govt allows state DCA to levy fee for issuing certificates outside purview of D&C Act

The Tamil Nadu government has accorded permission to the state drugs control administration to fix and collect fees towards the services rendered by the DCA for issuance of various certificates which are not covered under the Drugs and Cosmetics Act, 1940 (D&C Act). The state government has issued an order in this regard last week.

The amount thus collected will be utilized for the development of the department. The department will issue receipts for the collected amount, said M Rajendran, director of drugs control.

Majority of the certificates are useful for exporters and those who are participating in the tenders. So the new policy is applicable only to those units which are involved in exporting businesses. Tamil Nadu is the third state in the country to collect such fees from the exporters after Karnataka and Maharashtra, he said.

“Hitherto all the certificates were issued freely, now on more than 12 certificates will come under chargeable items. The request for collecting fees has been on the cards for the last five years and now the government has granted permission to collect it. The new policy has come into force from July 27 onwards,” the director told Pharmabiz.

As per the order, an exporting company has to pay Rs. 300 for getting Quality and Capacity certificate and Rs. 100 for Validity certificate. For GMP certificate and Marketing Standing Certificate, the exporter should remit Rs. 300 each.

Certificates for non conviction, manufacturing & marketing, performance and for COPP will be issued on remittance of Rs. 300 each. For free sale certificate, the manufacturing unit will have to pay only Rs. 100, but for Approval of technical staff or change of brand names, Rs. 500 should be remitted.

In the proposal given by the department to the government, the highest fee is fixed for issuance WHO GMP certificates for each product and the amount fixed is Rs. 1000.

DBT to provide assistance to UG colleges in North East to make them 'Star Colleges'

Under its 'Star College Scheme' for improving knowledge and skills of teachers in basic life sciences and specialized techniques in the undergraduate (UG) level colleges, the Department of Biotechnology (DBT) will soon provide financial assistance to the UG colleges in north eastern states like Arunachal Pradesh, Assam, Manipur, Meghalaya, Mizoram, Nagaland, Sikkim and Tripura.

Under the programme, the DBT will provide support to the UG colleges for improving knowledge and skills of teachers in basic life sciences and specialized technique, access to specialized infrastructure to students, assurance of consumables, reagents and chemicals for students, improved curriculum that enhances creativity in asking original questions and substantial hands-on experience in designing and conducting practicals by students, access to summer school for exposure to platform biotechnologies and critical thinking and access to knowledge banks with strong support of books and journals including e-journal facilities.

Committed to the values of pursuit of excellence, academic and intellectual freedom, creativity and innovation, the DBT launched the 'Star College Scheme' for improving critical thinking and 'hands on' experimental work in the cutting edge-technologies needed for modern biological studies at undergraduate (college) level in life sciences.

Major objectives of the scheme are to strengthen the academic and physical infrastructure for achieving excellence in teaching and training; to enhance the quality of the learning and teaching process to stimulate original thinking through ‘hands–on’ exposure to experimental work and participation in summer schools; to promote networking and strengthen ties with neighbouring institutions and other laboratories; to conduct specialized training programmes for faculty improvement for optimizing technical capabilities; to increase capabilities of core instrumentation resources by procuring new equipment and upgrading of existing facilities; to provide access and exposure to students to research laboratories and industries in the country; to help in devising standard curricula and Standard Operating Procedures (SOP’s)/kits for practicals; and to provide better library facility to students and teachers.

The colleges that successfully implement the strategy will be considered as life science 'Star Colleges'.

Under the scheme, DBT will provide one time non recurring grant up to a maximum of Rs.10 lakhs for each science department (botany, zoology, microbiology, biochemistry, physics, chemistry) and recurring grant of Rs.2 lakhs per year for consumables, Rs.1 lakh per year for contingency to cover expenses on visiting faculty, guest lectures, seminars etc. for each department will be provided initially for a period of 2 years. continuation of support for another 3 years will be based on evaluation of performance.

NPPA to launch SMS helpline to give options to consumers for buying cheaper brands

The Department of Pharmaceuticals (DoP) in collaboration with the National Pharmaceutical Pricing Authority (NPPA) will soon roll out an SMS-based helpline to help the consumers to choose the cheapest available drug.

The NPPA has launched the exercise for this ambitious programme, which has been mooted for long to make available the affordable drugs to the consumers and thereby indirectly influencing the market prices through transparent competition.

The NPPA has called for expression of interests from the interested agencies to set up and run the helpline. The consumer can send the brand name of a prescribed drug in text message and will get a list of brands of the same medicine along with their prices for choosing the cheapest brand.

The move is initiated after the NPPA had found that there were huge differences in the prices of different brands of the same medicines. In some cases, expensive brands are ten times higher than the cheapest available alternative brand of the same medicine. And the consumers do not have options, as they are not aware of the brands other than what is prescribed by the doctors. This SMS service is aimed at helping out the consumer on this count, sources said.

“In order to enable the consumers to know the latest market price of the medicines through SMS, NPPA intends to start all India SMS helpline service for consumers. Expression of Interest (EoI) is invited from eligible companies/firms/agencies having sufficient experience, infrastructure and access to MRP of all the medicines available and sold in various parts of India,” according to the notification by the NPPA.

“To provide instant information through SMS (in 160 characters) reply on the latest market price of various generic and branded medicines of the same salt available in the area of the queerest on receipt of SMS query from the consumers. If the query is for the price of a specific brand the SMS reply be for the latest MRP of the said brand in that area. In case the query is for the cheapest medicines without specifying any name subject to space availability the service provider will provide at least five cheapest prices of generic medicines and five cheapest prices of branded medicines,” according to the scope of work specified in the notice.

The company/firm/agency should have three years experience of providing this type of services. The company/firm/agency should have access to latest market price of all the generic and branded medicines available and sold in various parts of the country including in the remote areas. The company/firm/agency should have the ability to track and update the new generic and branded medicines prices at least on quarterly basis to give the most relevant SMS reply considering the latest updated MRP prevailing in the area of the queerest, it said.

Bombay Hospital successfully completes surgery on patient weighing 198 kg

Bombay Hospital's bariatric surgery department has successfully treated a 32-year-old women with asthmatic attack by making her lose around 10 kg. The patient who weighed around 200 kg was brought to a stable state and made to lose around 10 kg - a precondition to operate upon her under general anaesthesia.

Since the patient weighed around 200 kg, she may not have survived another similar asthmatic attack. After repeated discussions within the bariatric (weight loss) team and her family, it was decided that the best opportunity lies in a definite procedure to get her weight down.

This patient underwent Sleeve Gastrectomy surgery in which two-thirds of the stomach is removed resulting in a banana shaped stomach. This reduces hunger and gives a feeling of fullness with small meals. This surgery is expected to bring her weight down by around 100 kg within a year.

Dr Ramen Goel, Bariatric and Weight Loss surgeon at Bombay Hospital said, “This patient was a challenge not only because she survived a life threatening episode and surgery, but also because she is mentally challenged. This has tested the effort of Bombay Hospital’s robust and proven infrastructure and team of doctors and she will continue to require our and the family’s support for long term results.”

He further added, “The safety of surgery lies in patient preparation, adequate infrastructure and experience of the entire team. Fortunately at Bombay Hospital, we have the country’s most experienced physicians, anaesthetists, dieticians, physiotherapists and other reputed doctors.”

Bombay Hospital is the first major hospital in Mumbai to start a dedicated bariatric (treatment of obesity) surgery department over nine years back under one of the most experienced bariatric surgeon. The expert multi–specialty bariatric team has been able to successfully prepare and operate many other similar patients in the past too.

UTILITY MODEL PATENTS

India’s commerce ministry is reported to be considering a proposal to introduce a Utility Model for patents in the country as a new tool for granting intellectual property rights. The Utility Model is a framework for providing limited protection to those innovations which may not meet the standards of the Patents Act but are still commercially exploitable and socially relevant. The Department of Industrial Policy & Promotion under the commerce ministry floated a discussion paper on the utility model of IP protection in India a few weeks ago. The requirements for obtaining a utility model protection for a product are less stringent than what is required for a patent with the test of inventive step being absent. And the applications for the utility model of patents need not necessarily be accompanied with substantive examination. It seems that the MNC lobby is behind this new initiative by the government so as to dilute the effectiveness of the revised Patent Act. The Section 3(d) of the Indian Patent Act, amended six years ago, has already prohibited patenting of insignificant or minor improvements of known compounds. The Section has also given opportunity to anyone to object a patent before and after it is granted. It is this crucial section of the amended Patent Act that has prevented pharmaceutical companies from obtaining patents in India for pharmaceutical substances that are not actual inventions such as combinations or minor modifications of formulations of known compounds.

Frivolous patent filings are done by the companies to prevent and delay generic competition that could lead to lower prices and thus greater access to essential medicines. There is no doubt that granting patent protection for pharmaceutical substances involving only incremental innovation is against the public interest as such research does not involve any huge expenditure or time line unlike in the case of a new molecule. A 20 years market exclusivity for any incremental innovation cannot be justified as powerful pharma companies charge any price for such products by strongly promoting them at the cost of patients. Currently, there is no price control on patented products world over. Take the case of Glivec, the high priced anti cancer drug of Novartis. Dispute on its patentability is on for the last more than five years. Although it is a clear case of incremental innovation, Novartis is not willing to give up its claim for patent and now it has approached Supreme Court. Since the amended Patent Act was notified in 2005, there are several where patent applications are being opposed by generic companies on patentability. Considering these facts, any move by the MNC lobby to influence the commerce ministry to circumvent the Section 3(d) has to be resisted. Doha declaration on TRIPS agreement and public health had confirmed the flexibilities allowed to WTO members to define patentability in the national laws.

Middle East to be the Future in Clincial Trials

Global pharmaceutical companies are currently seeking emerging markets to conduct clinical trials due to the increase in drug development costs and the demand to advance drugs faster.

The Middle East is forecasted to be one of the fastest growing markets for clinical research outsourcing based on availability of the required infrastructure, access to necessary patients, faster timelines and lower costs compared to other markets.

Clinical Trials Partnership Middle East Summit will assemble all stakeholders from leading research sites, clinical research organisations, regulators, government organisations and pharmaceutical companies to provide strategies and knowledge on critical issues such as regulatory compliance, optimising clinical trials, overcoming clinical trials challenges and identifying business opportunities in the Middle East region.

Taking place between 28^th & 30^th November 2011 in Dubai, this three day summit is a must for all executives, senior level directors or directors from the pharmaceutical, biotech, clinical research organisations and clinical investigators who are looking to discuss the advances of the regions clinical trials market.

Clinical Trails Partnership Middle East Summit kicks off with an essential interactive workshop on day one, looking at a comprehensive overview of 'Good Clinical Practice' in relation to the regional and international guidelines for conducting clinical trials.

The next two days are packed full of exciting and innovative discussions, crucial networking opportunities and exciting round table discussions where delegates will be able to share their views and knowledge on subjects such as 'Improving the quality of clinical trials by using standardised performance metrics'.

Event Director for Clinical Trails Partnership Middle East Summit, DoaaSaid, described the conference as'A vital event for the increasing success and on-going improvement and competitiveness of the regions clinical trials market.'

Delegates in the field will come away from the summit with all the tools needed to better their practices, making them more competitive and efficient. They will also have the chance to make vital relationships and connections in the scheduled networking periods.

Registration for this event is now open on the website http://www.clinicaltrialsmena.com. Delegates booking before 19th September 2011 will receive a discount of up to $450.

For more information about the Clinical Trails Partnership Middle East Summit please contact Jihan Mohammed,

Marketing Manager,

IQPC Middle East,

Email enquiry@iqpc.ae

call +971-364-2975

FICCI organised first road show of PHARMAceutical EXPO 2011 in Bangalore

Karnataka’s pharma sector, already one of the fastest growing sectors of the state, is set to get a major boost thanks to Bengaluru being the host city for this year’s PHARMAceutical EXPO. Held concurrently with the 63rd Indian Pharmaceutical Congress (IPC), the Expo is scheduled for December 16- 18 at Bangalore International Exhibition Centre, Tumkur Road, Bangalore. The Expo is set to showcase the strengths of the sector and the potential of the industry. The PHARMAceutical EXPO 2011 has received tremendous response, with around 122 companies already confirming participation at the show, revealed FICCI, the organisers of the Expo, at a recently organised road show in Bengaluru. The road show was well attended by representatives from pharma companies as well as allied industries.

The Expo organisers also announced that they are in the process of signing an agreement with Pharmexcil in order to arrange buyer seller meets at the Expo. This will be the first time in the history of IPC that exhibitors will get an open platform to take enquiries to the next logical level. The organisers have also fixed student visiting hours from 1-3 pm each day.

PHARMAceutical EXPO 2011 will provide excellent business opportunities to all participating organisations to enable them explore new business avenues and opportunities. The event is supported by the Karnataka Drugs and Pharmaceuticals Manufacturers Association (KDPMA), the nodal association of pharma drugs manufacturers in Karnataka. While all major pharma machinery companies are participating in this show, Cadmach Machinery is the co-sponsor with IKA and Fluid Pack as associate sponsors. Express Pharma remains the official media partner for the event this year as well.

The Expo to be held concurrent with the 63rd IPC will discuss the challenges and opportunities in managing growth. It will also showcase new products and solutions for the sector. The Expo will have a range of products from lab equipment, pharma ingredients, machinery, packaging materials, water treatment and waste management, pharma software etc. The show is expected to attract representatives from the pharma industry, regulatory authorities, hospitals and other allied industries, besides the medical education field.

Health Min pushes further deadlines to make new AIIMS-like institutions operational

The Union health ministry has further pushed the deadline for making the proposed six AIIMS-like institutions fully operational. According to the new deadline, the medical colleges at six sites will be made functional from academic year 2012-13 and hospitals in the year 2013-14.

As per the earlier plans, these hospitals were to be functional by the end of this year as the project has been on for almost five years now. The Government had approved setting up of six AIIMS-like institutions in the states of Bihar (Patna), Chhattisgarh (Raipur), Madhya Pradesh (Bhopal), Orissa (Bhubaneswar), Rajasthan (Jodhpur) and Uttarakhand (Rishikesh) under the first phase of Pradhan Mantri Swasthya Suraksha Yojana (PMSSY).

“Construction of Medical Colleges and Hospital Complexes at all the six AIIMS-like institutions in first phase has started and is in full swing. Residential complexes at Jodhpur and Raipur have been completed and the work is in progress at remaining sites. An amount of Rs.847 crore has been released so far,” according to official sources.

“The sites for setting up AIIMS-like institutions have been identified on the basis of various socio-economic indicators like human development index, literacy rate, population living below poverty line, per capita income, and health indicators like population to bed ratio, prevalence rate of serious communicable diseases, infant mortality rate etc.,” Union health minister Ghulam Nabi Azad had stated in the Parliament recently.

To manage the running of the new institutions, the health ministry has also appointed mentor institutes. As per this, All India Institute of Medical Sciences (AIIMS) in Delhi will be the mentor institute for the two new institutions at Patna and Bhubaneswar. Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh will take care of the two institutions at Rishikesh and Jodhpur. Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER), Puducherry will run the affairs of the two new institutions at Bhopal and Raipur, sources said.

The new institutions were planned under the PMSSY with a view to ensure better and wider medical care in the tertiary healthcare sector. The Union Government approved the scheme in March 2006.

Industry bodies ask DoP to delete several clauses in Uniform Code of Marketing Practices

The pharma associations have asked the Department of Pharmaceuticals (DoP) to delete several clauses in the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) as they are unreasonable and difficult to implement. The department in the last week of May this year had issued the Marketing Code to arrest the unethical marketing practice of bribing of doctors by the pharma companies for prescribing their drugs.

After issuing the UCPMP, the DoP had asked the pharma associations and other stake-holders to send their feedback on the issue to incorporate relevant suggestions. In their suggestions, the associations have asked the DoP to delete several clauses in the Code.

The associations have asked the DoP to delete the clause on hospitality, sponsorship and meetings, which reads: Companies must not organise meetings to coincide with sporting, entertainment or other leisure events or activities. Venues that are renowned for their entertainment or leisure facilitates or are extravagant must not be used.

Arguing to delete this clause, the associations plead that it is difficult to keep tab on events other than medical which may be coinciding with the company's scheduling of the meetings. Most venues today indulge in leisure activities since this is the prime focus of the hospitality industry, hence specifically excluding such destinations would be unreasonable.

The associations also objected and asked the DoP to delete the clause -'Not include sponsoring securing, organising directly or indirectly any entertainment, sporting or leisure events'- on the plea that there is no justification in ensuring doctors do not enjoy privileges of normal working humans. Clubbing yoga, and de-stress sessions with medical meetings makes the learning more enjoyable and the doctor more receptive to modern trends and information imparted during the sessions.

Likewise, another important clause which the associations wanted to delete is on samples. As per the Code 'Sample packs shall be limited to prescribed dosages for three patients. Asking to delete the clause, the associations argue that sample packs are always distributed according to the needs of the product and doctor. Such cap on sampling is restrictive and may hinder the interested doctor getting adequate experience with the concerned product's safety and efficacy.

The UCPMP will initially be a voluntary code, and its implementation will be reviewed by the government after a period of six months from the date of its coming into force and if it is found that it has not been implemented effectively by the pharma associations and companies, the government would consider making it a statutory code.

Ozone to commence phase I trial of topical diabetic retinopathy medication

New Delhi - based pharmaceutical company Ozone Pharmaceuticals is developing a new molecule for diabetic retinopathy with the brand name 'OSIL'. Ozone Pharma has received a patent for th emolecule after animal testing and is now seeking an international tie up for a phase I clinical trial. The company is expecting to launch this product in late 2012.

This is a new invention by Ozone Pharma of a pharma composition for treatment of diabetic and non-diabetic ocular neovascular complications cataract and glaucoma. The composition of the new molecule comprises an active ingredient, selected from calcium benzene sulfonate salt compounds, and pharmaceutically acceptable excipients. Talking about the new innovation, SC Sehgal, Chairman and Managing Director said, “The need for a product which can prevent cataract as well as diabetes retinopathy is high because this has immense need worldwide. We had begun research and development of OSIL six to eight months back at AIIMS, New Delhi but the actual work was on for last four years.” The AIIMS study found administration of OSIL (Calcium dobesilate: one per cent w/v) as a topical medication in the form of eye drop to be an appropriate mode for long term administration for the slow processing disease like cataract. The study demonstrated that Calcium Dobesilate (CDO) in the form of topical administration is safe and expected to decrease systemic exposure.

He continued, “Now we are looking for alignment and seeking a approval from the regulatory body for phase I clinical trial. For phase I clinical trial we are looking for an agreement. The core reason behind international tie up is, to launch this product globally at an appropriate time.”

The company is diversifying into more specialised formulations like dentistry, neurology and gynaecology. Presently it has seven-eight new products at different stages of completion. Sehgal reveals the product launch details saying, “The products which we have planned to introduce in the Indian market are under evaluation and will take nearly 1.5 years for clinical trial. We plan to launch these products by end of next calender year.” The company plans to hire nearly 300-400 people adding to the existing headcount of 1200 by 2012. Sehgal said, “We are open to grow inorganically but predominately from organic way. We are also considering geographical expansion among SAARC nations.”

With a total turnover of Rs. 150 crore, it is targeting to take this figure to Rs. 1000 by 2016.

Orchid receives notice by TNPCB for its Chennai API facility

Chennai-based Orchid Chemicals and Pharmaceuticals announced that its Cephalosporin API manufacturing facility located in Alathur (Chennai) was issued a closure notice by the Tamilnadu Pollution Control Board (TNPCB) citing some non-compliance with regards to the disposal of solid waste.

The company is in active dialogue with the TNPCB officials and is confident of resolving the issues and bringing the plant to a fully operational stage at the earliest.

Lok Sabha takes up Transplantation of Human Organs Bill for discussion

The clearance of the much-awaited Transplantation of Human Organs (Amendment) Bill during this ongoing session of Parliament is almost certain now as the Bill has already been taken up in Lok Sabha for discussion.

The Bill, which is an amendment to the Transplantation of Human Organs Act, 1994, seeking to make the organs transplantation more transparent and patient friendly, and also for imposing stringent penalties on persons and hospitals violating the provisions of the Act, was taken up for discussion in Lok Sabha by Union health minister Ghulam Nabi Azad on August 11.

In fact, the Bill was introduced in Lok Sabha way back on December 18, 2009 and it was referred to the Parliamentary standing committee attached to the Union health ministry for its scrutiny. After examining the Bill in detail, the standing committee laid the report on the Table of Lok Sabha on 4 August, 2010. For the tentative list of transaction of business for the ongoing session of Parliament, which started on August 1, the Bill was listed for 'consideration and passing'.

Since the Lok Sabha has already taken up the Bill for discussion, it is now certain that it may get the final Parliament nod. Once the Bill is passed in Parliament, it will be sent to the President for her consent. Once the President signs the Bill, it becomes an Act of Parliament and will come into effect in the country.

The government took the initiative to amend the law, which was originally framed around 16 years back, as there were repeated reports about a thriving human organ trade in the country and the consequential exploitation of economically weaker sections of the society. There was an increasing perception among the common people that while the Act has not been effective in curbing commercial transactions in organ transplant, it has thwarted genuine cases due to the complicated and long drawn process involving organ donation.

As the voice against the Act became louder, the central government held a national consultation on the need to have an effective regulation of organ transplantation in the country. State governments and various sections of civil society were also consulted during the process. Ultimately, a proposal to comprehensively amend the Transplantation of Human Organs Act, 1994, was submitted to the Union cabinet for its consideration.

Centre asks States to follow TN model for procuring drugs for public health programmes

The Union Health Ministry has asked the States to follow the model of Tamil Nadu for purchase of drugs for public health programmes, with a view to ensure transparency, availability, and distribution as the model has proved to be very effective.

“There is also great merit in making bulk purchase of drugs through a specialised agency. This not only ensures better quality but also reduces the prices. States may like to examine the Tamil Nadu Medical Services Corporation model set up by the Government of Tamil Nadu for the purchase of drugs for public health programmes,” the Health Ministry told the States, at a recent meeting of Health Secretaries here.

The Centre also wanted the States to set up special courts to tackle the spurious drugs cases. “It is also important that once the drug samples fail quality and safety standards, prosecutions are launched and culprits are booked quickly. There is need to set up Special Courts to try prosecution cases under the Drugs & Cosmetics Act 1940. Many have already designated Special Courts for such trails while others also should act on a priority basis,” the meeting was told.

“While promoting the generic drugs, it is important that a rational Fixed Dose Combinations (FDC) are weeded out from the market. This not only enhances the price of the drug but also leads to several other health consequences including drug resistance. While granting licenses for manufacture of FDCs, State Drug Regulators must be very careful regarding efficacy of such drugs,” the written brief by the Centre said.

Tamil Nadu Medical Services Corporation Ltd was set up with the primary objective of ensuring ready availability of all essential drugs and medicines in the Govt Medical Institutions throughout the State by adopting a streamlined procedure for their procurement, storage and distribution. TNMSC aim is to make the drugs and materials available to the poorest of the poor and “Service to the Public.”

It handles procurement, testing, storage and distribution of medicines, surgicals, kits and reagents to the Government Medical Institutions of the State. It finalises rate contract every two years for various frequently used surgical appliances, Instruments for direct procurement by the medical institutions in the State.

Recently, the public interest organisations have also called for adopting the time-tested TN model across the country. The Jan Arogya Abhiyaan (JAA), a network of NGOs working on health issues in Maharashtra, urged the State Government to implement it. Kerala has adopted it and other states like Rajasthan and Bihar are also in the process.

Source: Pharmabiz

BA/BE studies come to a standstill as DCGI stops clearance

The bioavailability and bioequivalance (BA/BE) studies have virtually come to a standstill in the country as the Drug Controller General of India (DCGI) has stopped giving clearance to these studies in the aftermath of the recent controversy surrounding the Hyderabad-based CRO, Axis Clinicals, in which the company is alleged to have conducted clinical trials of a breast cancer drug on nearly 30 illiterate agriculture labourers after luring them with Rs.10,000 each.

Sources in the industry said that for the last around two months since the untoward incident involving Axis Clinicals, not a single clearance has been given by the DCGI for conducting the BA/BE studies in the country. Even though several applications for conducting BA/BE studies by Clinical Research Organisations (CROs) across the country are pending with the DCGI office, not a single one has been approved as a fallout of the Axis Clinicals incident, sources said.

Industry leaders regretted that at a time when there is intense competition in the field, the non-clearance of these studies by the Indian regulators will adversely affect the Indian CROs. At a time the country, due to its several factors including cheap labour and skilled workforce, is becoming a hotspot for clinical research activities in the world, this kind of attitude by the Indian regulators will act against the overall interest of the CROs in the country, they said.

BA/BE studies, which take about three months time, are conducted for finding the bioavailability and bioequivalance of a drug, especially the generic drugs and the combination drugs which are already in the market. For getting the license for a new combination drug or generic drug, it is mandatory to submit the BA/BE study results to the DCGI office.

Meanwhile, the DCGI has started auditing of all the CROs in the country to ensure that the bio-availability and bio-equivalence (BA/BE) studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines in the country. His decision follows the findings in the investigations on Axis Clinicals which revealed that there were various irregularities in conduct of BA/BE studies with respect to subject recruitment process, informed consent process, independence of the Ethics Committee and its review and decision making process.

FGSCDA urges govt to amend D&C Act to disallow strip cutting

The chemists and the druggists in Gujarat have demanded to the government to make necessary amendments in Schedule P with regard to cut strips in the Drugs and Cosmetics (D&C) Act to ensure uniform strip size for all the drugs.

In a representation to the commissioner of Food and Drugs Control Administration (FDCA), the Federation of Gujarat State Chemist & Druggist Association (FGSCDA) urged the government to amend the Drugs and Cosmetics (D&C) Act and demanded that no strips size beyond ten, six, four or two should be permitted.

“There should not be more than 10 tablets or capsules per strip as the present strip size of 12 and above are either cumbersome to handle or they have to be cut to suite the budget of the patients,” reads the representation. Jashvant Patel, president, FGSCDA pointed out that this issue needs to be addressed urgently as cut strips is one of the causes for development of antimicrobial resistance as it leads to under dose of the antibiotics in patients.

Only about 1 per cent of the drugs in the market today are governed by mandatory pack size fixation. As of now D&C Act is silent on whether a strip can or should be cut or not which causes lot of confusion as different drug control authorities give different interpretations of this.

According to Patel, “We need more transparency in this matter as strip cutting is a serious problem which the lawmakers, FDA officials, pharma industry or the doctors cannot understand. It is finally the customers and the retail pharmacists who have to face the brunt of the losses and risk of consuming the wrong or expired medicines. Thus it is imperative that the government should take some steps to solve this problem so as to deal with the shortcomings of the present system of the pack sizes and problem of strip cuttings.”

For all the retail chemists, strip cutting is a huge problem that needs to be addressed urgently as it comes with heavy loss. Cut tablets are often difficult to be identified since the name of the drug may not appear on every part of the strip or foil and as embossing on the tablet is not always identifiable it is a potential loss to the chemist.

Patel further pointed out that adding to all these problems is the fact that cut strips which have expired are not settled by stockists and manufacturers thus putting the pharmacist at loss.

The association in its representation proposed certain suggestions to the government, which they expect to be amended in the Schedule P of the D&C Act. “Pro active steps should be initiated to ensure that strip cutting is disallowed completely as it will ensure that no physician samples or expired drugs with no batch number or expiry details are pushed forward to the patients,” he added.

India reiterates its political commitment to fight HIV and AIDS

The Prime Minister of India, Dr Manmohan Singh, recently inaugurated and presided over a two day national convention on HIV and AIDS at Vigyan Bhawan in New Delhi.

The convention brought together over 800 Zila Parishad chairpersons and mayors, parliamentarians and legislators across India. The purpose of the convention was to understand the impact of the HIV epidemic on health and other key sectors, and to emphasise the role of elected representatives in the national AIDS response.

The two day convention was organised by the Forum of Parliamentarians on HIV/AIDS (FPA), in partnership with Ministries of Health and Family Welfare and NACO, Ministry of Rural Development (Panchayati Raj), Ministry Urban Development, UNAIDS and AIILSG.

The inaugural session of the convention was graced by Prime Minister of India, Chairperson UPA, Union Ministers of Health, Rural Development and Urban development, senior political leaders from different political parties and Executive Director of UNAIDS. Subsequent to the inaugural session, various Chief Ministers made statements on the status of response to HIV epidemic in their respective states. Thereafter, the convention had four technical sessions and a zonal interactive and feedback parallel session to formulate future course of action. Speakers, Ministers of the state government in charge of health, Panchayati Raj and Urban Development also had a round table during the convention. Speaker of Lok Sabha, Leader of Opposition Lok Sabha, Leader of Opposition Rajya Sabha, Deputy Chairperson Rajya Sabha, Deputy Chairperson Planning Commission were the key speakers during the convention.

The convention aimed to strengthen local response and coordination to fight against HIV and AIDS, providing a common platform to parliamentarians, state legislators, zila parishad presidents and mayors for discussions on emerging HIV prevention and policy issues in both rural and urban India. The aim was to reach out to the masses through the Panchayat institutions in order to complement the national programme on HIV and AIDS.

HURDLES IN CDA FORMATION

The move to establish a centralized system of drug administration in the country by forming Central Drug Authority is being revived by the Union health ministry now after the proposal got shelved a few years ago. The plan was strongly opposed by the state governments and industry bodies from the very beginning. The health ministry had been wanting to centralize licensing for manufacture, sale, export and distribution of drugs in pursuance of the recommendations of the Mashelkar Committee. And the Drugs & Cosmetics (Amendment) Bill 2007 was drafted to set up the CDA. The Bill was introduced in the Rajya Sabha on August 21, 2007 and was thereafter referred to the Parliamentary Standing Committee of ministry of health. The Standing Committee had then submitted its recommendations to the government dropping the proposal for CDA and instead recommended setting up of a 'central drug administration' as an independent body with headquarters in Delhi and its zonal and sub-zonal offices at state-levels and by strengthening, modernising and restructuring the CDSCO. The health ministry seems to have taken expert opinion on the matter once again and the move now to set up CDA is on the basis of this new thinking.

Formation of CDA was contemplated by the government considering the fast pace of growth of Indian pharmaceutical industry over the years. Need for centralizing the drug control administration was felt on account of the urgency in bringing some uniformity in enforcement of various drug rules. Some of the key provisions of the D&C Act such as Schedule K, Schedule M, Schedule Y, etc. have been already amended and elaborated over the years considering the growth needs of this sector. As per the current system of drug administration, enforcement of all amended rules under the D&C Act is with the state health departments. But, most of the states have not been successful in implementing these amended regulations so far. This, in effect, has been making a mockery of the Act and rules in the pharmaceutical sector. Licensing of products has been one area where there was a lot of confusion prevailed in the country until 2008. A new drug is approved for marketing by CDSCO but issuing licences for its manufacture used to be done by various state drug administrations. Although states and Union territories are having drug control departments, most of them do not have officials with sufficient competence to evaluate an application before a manufacturing license is issued. The issues like these were under discussion by the office of the DCGI for some time but not in a comprehensive manner. All the state governments are still not in support of formation of CDA as that could take away a lot of powers from them. Now, without the support of the state governments and industry, it will be difficult for the health ministry to implement CDA even if the bill gets passed. Therefore, the health ministry needs to take the concurrence of most state governments and the industry again considering the sensitive features of the new system.

Eating Nuts Such as Peanuts Improves Diabetes Control Without Weight Gain

An important new study released in the August issue of Diabetes Care shows that replacing carbohydrates with two ounces of nuts, such as peanuts, everyday improves blood glucose control and blood lipids in people with type 2 diabetes.

David Jenkins, MD, PhD, DSc, Principal Investigator and a pioneer in the area of glycemic control for diabetics said, "Nuts, including peanuts, can make a valuable contribution to the diabetic diet by displacing high glycemic index carbohydrates and replacing them with vegetable fats and vegetable proteins which have been shown in the long term to be associated with better cardiovascular health and diabetes prevention."

Peanuts have more protein than any other nut and are a source of mono and polyunsaturated oils. The paper reports that, "increased proportions of fat and protein, especially of plant origin, may confer metabolic benefits and reduce the risk of developing coronary heart disease and diabetes."

The study, "Nuts as a Replacement for Carbohydrates in the Diabetic Diet", was conducted at the University of Toronto. During the study, 117 men and women with type 2 diabetes were randomized into three groups where they received either a full portion of mixed nuts including peanuts, a half portion of both nuts and muffins, or a full portion of muffins. The muffins were made of healthy whole wheat with protein from egg and skim milk powder. Participants' fasting blood glucose were tested every other week.

After three months, participants receiving the full portion of nuts showed the biggest decrease in glycated hemoglobin (HgA1c), a measure of blood glucose control. The difference was significantly more than the decrease shown in the participants receiving the half portion of nuts and muffins, and in those solely receiving muffins. Peanut and tree nut intake also decreased total cholesterol and bad LDL cholesterol in the blood compared to the other groups. It is notable that reductions in HgA1c and LDL cholesterol were achieved even though the majority of the subjects were already on antihyperglycemic medications and statins that lower cholesterol.

The authors conclude that nuts, such as peanuts, "may be used to increase vegetable oils and protein intake in the diets of type 2 diabetic patients as part of a strategy to improve diabetes control without weight gain."

The article says that weight maintenance could have occurred in nut eaters for a few reasons including increased resting metabolic rate, enhanced satiety resulting in decreased intake of other foods, or incomplete absorption of energy. Studies done specifically on peanut eaters have demonstrated each of these factors.

This new clinical trial is an important milestone demonstrating glycemic control and builds on an earlier population study published in JAMA in 2006. Researchers at the Harvard School of Public Health concluded, "Our findings suggest potential benefits of higher nut and peanut butter consumption in lowering the risk of type 2 diabetes in women."

Peanuts are the most commonly eaten nuts in America. Combined with peanut butter, peanuts comprise over two-thirds of U.S. nut consumption according to USDA data. Numerous studies have shown that consumption of peanuts and peanut butter is beneficial in keeping blood glucose stable, improving satiety and decreasing hunger, maintaining weight, and reducing risk of heart disease.

The 2010 U.S. Dietary Guidelines called for Americans to shift towards a more nutrient-dense, plant-based diet. Peanuts, peanut butter and nuts are foods to encourage daily. This may be particularly useful in preventing the onset of diabetes. Diabetes prevalence is growing at a dangerously rapid rate. Worldwide, the number of people with diabetes has increased over 40% since 1980.

The study was funded in part by The Peanut Institute, the International Nut Council, and the Canada Research Chairs Endowment Fund.

Source: PRNewswire

Sri Lanka assures better access to Indian pharmaceutical exporters

Sri Lankan health authorities have assured Indian pharma industry that the recent issues concerning the supply of sub-standard drugs would be settled amicably and the government will not resort to any harsh measures to ban the Indian companies.

This assurance was given by Sri Lankan Health Minister Maithripala Sirisena, while interacting with the select group of pharma companies here on Wednesday, under the aegis of the Pharmexcil. He was responding to the recent controversies regarding the suspension of tenders awarded to 10 Indian drug companies on the grounds of supplying substandard drugs, non-adherence to tender procedures and delaying deliveries.

The Sri Lankan Minister, while promising steps to ease the problems faced by the Indian exporters raised in the meeting, also sought help from the industry to strengthen the cooperation with his country. Indian industry urged the Minister not to target the entire industry in the name of a few companies which violated norms. Besides, issues concerning the exports were also raised in the meeting.

Earlier, the visiting minister also called upon the Union Health Minister Ghulam Nabi Azad and took up different issues concerning the health ties between the two countries. Azad appreciated the progress made by Sri Lanka in Public Health and achieving reduction in IMR, MMR and Communicable Diseases burden. He mentioned the concrete steps being taken by India under the National Rural Health Mission (NRHM) to strengthen the health infrastructure in the rural areas, particularly in backward, inaccessible and remote districts and said that these investments have started showing results in the form of declining maternal and infant mortality rates now.

The recent cooperation in the health sector between India and Sri Lanka were noted and this co-operation would only be further strengthened by this bilateral meeting. Government of India has supplied medical equipment for Jaffna Teaching Hospital in January 2011. Government of India is also supplying medical equipment to two General Hospitals in Killinochchi and Mullaitivu and helping with construction of 150 bed base hospital at Dickoya which started in March 2011. Government of India has also announced a gift of Bhabha Radiotherapy Machine to Government of Sri Lanka. Government of India will set up a month long limb re-fitment camp (Jaipur foot) in Jaffna this year.

The Sri-Lankan side sought further help in training of medical and paramedical personnel (Short Term Skill Up-Gradation; Long Term Degree Courses); advice and guidance in procurement procedures of medical equipment, devices and medicines (mostly generic drugs for their public health program) as nearly 80 per cent of the supplies comes from Indian pharma companies. Azad has assured full assistance to Sri Lanka in all issues raised by them.

ACRO to launch campaign to allay negative public image about CROs

Enraged over the negative propaganda that the Indian subjects, especially the poor and the illiterate, are being used as guinea pigs by the Clinical Research Organizations (CROs), pharmaceutical companies and other organizations involved in the clinical trials and bioequivalence studies, the Association of Contract Research Organizations (ACRO) will soon launch a publicity blitzkrieg to allay the misconceptions about the CROs in the country.

During the last two months there has been misleading reports about the role and responsibility of the CROs and pharmaceutical companies involved in the clinical trials in India, an ACRO leader said.

ACRO, in the interest of the general public and the CRO industry would soon be coming up with the facts and figures for apprising all concerned on the objectives of the clinical research industry, the key role it plays in aiming at the general population health and in bringing the expensive drugs within the reach of the common man, the leader said.

Ever since the drug authorities raided and unearthed irregularities at Hyderabad-based CRO, Axis Clinicals, in which the company is alleged to have conducted clinical trials of a breast cancer drug on nearly 30 illiterate agriculture labourers after luring them with Rs.10,000 each, there has been a public criticism that the Indian subjects, especially the poor and the illiterate, are being used as guinea pigs by the CROs.

Under this background of growing public criticism against this dubious activities, the ACRO held an emergency meeting on July 29 in Mumbai which was attended by over over 35 CROs, pharmaceutical companies engaged in clinical research and representatives from Confederation of Indian Industries (CII).

Condemning the recent events which have been misrepresented without fully presenting all the facts, the ACRO decided to come out with a detailed information and a clarification regarding all the issues concerned. ACRO pledged its support to undertake initiatives that would create positive impression amongst participating volunteers and subjects in clinical research. “Clinical research is important for the development of drugs and it is our responsibility to build a strong scientific foundation in the interest of billion lives. Outcome of research should be used in positive and meaningful discussion for deriving better healthcare benefits to the nation,” an ACRO leader who actively participated in the meeting said.

He added that ACRO has pledged in supporting these initiatives and work closely with all stakeholders in ethical conduct of clinical research. All ACRO members conduct studies only after obtaining all the required approvals including from the DCGI and Independent Ethics Committees.

Source: Pharmabiz

Indian Govt. invites application for the post of DCGI

A day after the Madras High Court granting three-month extension to Dr Surinder Singh as the Drug Controller General of India (DCGI), the Health Ministry has stepped up the moves to find a replacement to Dr Singh within the period stipulated by the Court.

The advertisement by the Ministry hit the main newspapers today, inviting application for the post of Drug controller (India). The Ministry had already issued advertisement on June 14, with the same purpose.

The post will be filled by deputation (including short-term contract) from officers under the Central, State Governments, recognised research institutions, public sector undertakings, semi-government, autonomous and statutory organisations, according to the advertisement.

Sources in the ministry said, the government had decided to go for new DCGI many months back and the extension was an interim option till the new person was inducted. The files in this regard had been moved in time, even before the case came up in the courts, sources claimed.

While vacating the interim stay and allowing Dr Singh to continue for three months, the High Court had asked the Union Government to expedite the process of recruiting a new person for the post of DCGI within three months, as it specifically ordered that Dr Singh cannot continue beyond the said period.

The Additional Solicitor General of India Mohan Parasaran, appearing for the Government, had also given assurance in this regard to the Court. The Government on June 8, 2011 extended the appointment of Dr Singh till March 31, 2012, as his tenure was to expire on June 21. However, the public interest litigation was filed against this order and the Court passed an interim stay, before pronouncing the final order other day.

As per the advertisement, the applicant should be a “graduate degree in Pharmacy or Pharmaceutical chemistry or in Medicine with specialization in clinical Pharmacology or Microbiology from a recognized University established in India be law; postgraduate degree in Pharmacy/ Pharmaceutical chemistry/ Biochemistry/Chemistry/Microbiology/ Pharmacology from a recognized University or equivalent; and 15 years experience in manufacture or testing of drugs in a concern of repute or enforcement of the provisions of the Drugs and Cosmetics Act, 1940 and Rules.”

US FDA releases reports on pilot programmes on increasing international regulatory collaboration

The US Food and Drug Administration (FDA), together with its European and Australian counterparts, released two reports detailing the results of pilot programmes focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally.

The report on the Good Clinical Practice (GCP) initiative details the success of information-sharing and collaboration on inspections relating to clinical trials. Under the GCP pilot programme, the FDA and the European Medicines Agency (EMA) exchanged more than 250 documents relating to 54 different drug products and, in conjunction with the GCP inspectors of the EU member states, organized 13 collaborative inspections of clinical trials. This lays the foundation for a more efficient use of limited resources, improved inspectional coverage, and better understanding of each agency’s inspection procedures. It demonstrates how the agencies can work together to improve human subject protection and better ensure the integrity of data submitted as the basis for drug approvals.

The report on the Active Pharmaceutical Ingredients initiative details the success of information-sharing among the FDA, Australia’s Therapeutic Goods Administration and for Europe, the EMA, France, Germany, Ireland, Italy, the United Kingdom and European Directorate for the Quality of Medicines & Healthcare (EDQM). Over the course of the 24 month pilot phase, the participants shared their surveillance lists and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and in nine collaborative inspections.

The FDA used these reports to inform decisions, such as whether to postpone or expedite its own inspection. The FDA also prohibited imports into the US of a firm’s products based on the negative findings from a European inspection. The information-sharing and collaborative inspections were important milestones in establishing a sense of mutual trust and common purpose among the drug regulatory agencies involved.

“It is imperative that FDA work closely with its counterparts in order to ensure the safety and quality of products and the integrity of clinical trials. We cannot do it alone,” said Deborah M Autor, FDA deputy commissioner for Global Regulatory Operations and Policy. “We are grateful to our European and Australian colleagues for their willingness to partner with us in these pilot programs. The pilots are important stepping stones toward further global regulatory collaboration.”

These pilot programmes are part of the FDA’s global strategy to ensure the safety and quality of imported products. The new strategy builds on efforts that are currently underway at the FDA. The agency increased the number of foreign drug manufacturing inspections by 27 per cent between 2007 and 2009 and has opened several international offices in key locations such as China and India. The FDA has been an active contributor in the effort to harmonize certain aspects of drug regulation via the International Conference on Harmonization, and the agency recently joined the Pharmaceutical Inspection Cooperation/Scheme, an organization of drug manufacturing inspectorates from 39 countries.

In June, the FDA unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the “Pathway to Global Product Safety and Quality.” The FDA report calls for the agency to transform the way it conducts business, to build upon its ongoing collaborations with its regulatory partners around the world, and to act globally in order to promote and protect the health of US consumers. In the report, the FDA says that it will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality. FDA looks forward to working with its counterparts on this important effort.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA approves Scorpion Sting Antidote

Does the fear of a scorpion's sting take some of the fun out of camping and other outdoor activities? Now, you'll rest a bit better when you curl up in your sleeping bag at night.

The Food and Drug Administration has approved the first treatment in the U.S. especially for the sting of the Centruroides scorpion. Learn more at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm266515.htm

Pharma companies that used Cetero Research come under FDA Scanner

The FDA have notified pharmaceutical companies that bioanalytical studies conducted by Cetero Research between April 2005 and June 2010 in support of marketing applications may need to be repeated or confirmed. Cetero is a contract research organization (CRO) that performs bioequivalence and pharmacokinetic testing for a number of pharmaceutical companies.

The FDA is asking drug sponsors to identify those tests conducted by Cetero during the designated time frame that were used to support New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). Drug sponsors will need to determine whether any of the testing performed by Cetero should be re-done.

Also, the FDA will send letters to drug sponsors with pending applications, requesting that they either repeat the bioequivalence testing done by Cetero or retest drug samples using a different test laboratory or contractor.

It is unlikely that these concerns relating to data integrity affect the overall safety and efficacy of drugs already on the market and, at this time, there is no evidence of problems with the safety, quality, purity or potency of drugs already approved. However, as a precautionary measure the FDA is asking drug sponsors to review the testing in question conducted by Cetero to make sure that data are completely reliable.

FDA is taking this action as a result of two inspections of Cetero’s bioanalytical facility in Houston, Texas conducted in 2010, as well as the company’s own investigation and third party audit. The inspections and audit identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples.

The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame. FDA concurs with the assessment of Cetero’s independent auditor who stated, “This misconduct appears to be significant enough to cast doubt on the data generated…If the foundation of the laboratory is corrupt, then the data generated will be also.” As noted in a letter FDA sent to the company, Cetero also failed to conduct an adequate internal investigation to determine the extent and impact of the violations and failed to take sufficient measures to assure data integrity within the 5 year time frame.

As noted in the July 26 letter sent to Cetero, “FDA has reached this conclusion for three reasons:

(1) the widespread falsification of dates and times in laboratory records for subject sample extractions

(2) the apparent manipulation of equilibration or ‘prep’ run samples to meet pre-determined acceptance criteria

(3) lack of documentation regarding ‘prep’ runs that prevented you from conducting an adequate internal investigation to determine the extent and impact of these violations.”

Dr. Surinder Singh to continue as DCGI Until October

Much to the relief of many, the Madras High Court have granted a three month extenstion to Dr. Surinder Singh to continue as the Drugs Control General of India (DCGI) for three more months until October 31, 2011.

Earlier, the Government of India had on June 8, 2011 extended the appointment of Dr Surinder Singh as DCGI until 31. 3. 2012. The DCGI’s deputation tenure was to expire on June 21, this year.

A public interest litigation (WP 15607/2011) against the appointment of DCGI and the extension was filed by T K Ramalingasamy, a former regulatory officer of the Tamil Nadu Drugs Control Department. Advocate P T Asha from Sarvbhouman Associates, appeared on behalf of the petitioner. She quoted the reference of a government order (GO) passed by the central government that the period of deputation of a government servant should not exceed beyond five years. She said Dr Singh has already completed five years on deputation.

Additional Solicitor General of India, Mohan Parasaran, who appeared on behalf of the Government assured the court that Government would speed up the process of recruiting a new DCGI.

NPPA update on Overpricing

The outstanding arrears by pharmaceutical companies on the grounds of overcharging continued to increase steadily with Cipla remaining the leader of the pack, even as the recovery attempts by the National Pharmaceutical Pricing Agency (NPPA) did not improve in proportion to the rise in the arrears.

According to the latest list published by the NPPA, the agency sent out demand notices to the companies in 804 cases for a total recovery of Rs.2350.28 crore till May 31. The total recovered amount stood at Rs.210.20 crore, since the inception of the price monitoring agency.

Though all the major pharma companies find their way in the default roaster, Cipla Ltd continued to lead the tally with a total of nearly Rs.1400 crore, which accounted for more than 60 per cent of the total dues owed by the entire pharma industry of the country. Sources said most the cases with Cipla are in the courts still. Big companies figured in the list included Cadila, Ranbaxy, Dr Reddy’s Lab, Pfizer, GlaxoSmithKline and Merck.

During the last four months, the NPPA has sent notices in 18 cases, demanding over Rs.22 crore. The recovery during this period stood merely at Rs.2.14 crore. According to the previous compiled list as on January 31 this year, the total number of cases were 786 and the total arrears were Rs.2328.52 crore. The total amount recovered by the end of January was Rs.207.86 crore.

Till October 31, 2010, the total arrears were Rs.2208 crore, thus arrears grew by Rs.142 crore in the six months whereas the recovery was to the tune of Rs.8 crore during the same period. The NPPA has intensified efforts to recover the outstanding arrears in the recent years. As part of the measures, the NPPA has also started referring overcharging cases to district collectors of concerned States for revenue recovery.

Chaos in Clinical Research

The recent irregularities reported in conducting of clinical trials by Axis Clinicals, a Hyderabad based CRO, in Andhra Pradesh has once again brought to focus the questionable ways in which clinical trials are being done in India by the pharmaceutical companies and their agents. The report said that the CRO conducted bio-equivalence studies for an anti cancer drug on poor women early this year without securing their informed consent. The episode came to light only last month when some women belonging to this group complained of severe body ache, joint and chest pain and extreme weakness after taking the drug. A few of them even had difficulty in walking. The office of the DCGI raided the premises of the CRO after report came in the media and suspended its license. Axis also will be disallowed from conducting all bio-availability and bio-equivalence studies at their centre for some time now. Investigation carried out by the DCGI officials found irregularities in procedures such as recruitments of subjects and in taking their informed consents. The DCGI also found that the ethics committee at the centre was not functioning independently as required under the existing ICMR guidelines. Many such violations by CROs while conducting clinical trials in India were reported in the recent past and actions were taken against the offenders. But, these offences keep occurring in various parts of the country and very few of them get reported in the media.

After the action taken against the Hyderabad CRO, the office of the DCGI decided to audit all CROs in the country to ensure that the bio-availability and bio-equivalence studies are performed strictly in accordance with the regulatory provisions and prescribed guidelines. The DCGI office has already completed auditing of CROs in Andhra Pradesh and Mumbai. The basic problem with the clinical research in the country is that the sector is not at all effectively regulated. The health ministry has been working for last ten years to put in place a set of comprehensive rules to regulate clinical research with huge flow of contract research jobs into the country. But that has not happened yet. Ethics Committees at most of the trial sites are not active with no monitoring of the trials. What the country has a set of guidelines after amendment of the Schedule Y of Drugs & Cosmetics Act and it is not yet notified. That is what emboldens the MNCs and CROs to conduct trials as they do it now. Now in the case of CROs, a set of draft rules for their mandatory registration was issued by the DCGI some time in July 2009 after it was approved by the Drug Technical Advisory Board. But the registration process is still not in place. The move to make registration mandatory for CROs was taken after finding a spate of irregularities in conducting trials in the past. In short, the slow decision making process in the health ministry is the prime reason for the whole chaos in clinical research front. The matter has to be taken up by the health minister seriously and urgently if this critical sector of the pharmaceutical industry has to function with some order.

Source: Pharmabiz