Knowledge Sharing Initiative of Value Added Corporate Services P Ltd, Chennai, India http://www.valueadded.in
CDSCO team recommends health ministry to cancel registration of one unit in China
June 26, 2012, 0800 IST – Source : Pharmabiz News
The three-member team of the Central Drugs Standard Control Organization (CDSCO), which had audited four manufacturing units in China in February this year, had recommended to the union health ministry to cancel the registration of at least one of these units as it was not found in proper condition.
The three-member delegation, consisting of Dr S Eshwar Reddy, assistant drug controller, CDSCO New Delhi; B Kumar, assistant drugs controller, CDSCO sub-zonal office (Chandigarh) and Dr C Sokhey, senior scientist at National Institute of Biologicals (Noida), inspected a total of four manufacturing units in China, during their visit to China from February 11 to 22 this year. They had inspected three API units and one diagnostics unit.
According to sources, the CDSCO team has submitted its detailed report to the health ministry in which it has recommended to cancel one unit as they have found several anomalies in the unit. However, the official refused to reveal further details.
This is the second time that the Union health ministry has sent its team to China for auditing and inspection of manufacturing units there. As part of its efforts to ensure that only quality products are sourced by Indian companies from abroad, the health ministry had earlier last year started the process of auditing and inspection of manufacturing plants outside India. The first delegation was sent to China in May last year in which the delegation had inspected five manufacturing units there. Though the delegation was to inspect six units, one unit did not allow the delegation to inspect their unit.
The introduction of auditing and inspection of foreign manufacturing facilities by the Indian drug regulators was a long awaited practice, especially in the wake of the fact that even though the government had made registration of imports of drugs and pharmaceuticals into India made mandatory way back in 2003, it failed to bring the desired results as the inflow of inferior raw materials into the country refused to subside.
It was under this background that the ministry earlier last year decided to introduce the practice of inspection of foreign manufacturing facilities.
During the second delegation, the inspections were carried out in China only and the plans to inspect manufacturing plants in Italy has again been deferred. Earlier, the ministry had elaborate plans to start the new practice with one country each in Europe and Asia — Italy in Europe and China in Asia.
Parliamentary panel to meet stakeholders on National Commission for Human Resources for Health Bill
June 26, 2012, 0800 IST – Source : Pharmabiz News
The Parliamentary Standing Committee on Health and Family Welfare, currently examining the National Commission for Human Resources for Health Bill (NCHRH Bill), is planning to meet different stakeholders for wider consultations. The Committee is planning to finalise the recommendations soon and to submit them before the House during the next Session.
The Parliamentary panel had received inputs from different sections and was examining them before scheduling meetings with the stakeholders for extensive and ‘in-depth’ consultations before finalizing the recommendations to be submitted to the Parliament. Once fixed, the schedule of the meetings will be intimated to the stakeholders, sources said.
The NCHRH Bill, 2011 seeks to consolidate the law in certain disciplines of health sector and promote human resources in health sector and provide for mechanism for the determination, maintenance, co-ordination and regulation of standards of health education throughout the country to ensure adequate availability of human resources in all the States.
The Bill was introduced in Rajya Sabha on December 2011 and was referred to the Department-related standing committee headed by Brajesh Pathak for examination and report. The panel had invited suggestions and comments from the interested groups and individuals on the Bill. It got several representations already, sources said.
It also seeks to establish the NCHRH and to supervise and regulate professional Councils in various disciplines of health sector and for matters connected therewith or incidental thereto.
“The Commission will carry out studies and collect data required to assess the needs and requirements of human resources for health in different States and Union territories; assess the requirement (including the number, type and geographical location) of health training facilities for education and training in medical and allied discipline; formulate action plans for development of human resources for health in accordance with the policy and priorities laid down by the Central Government from time to time; formulate a plan for financial and other resources required for creation of human resources; make recommendations on the measures to strengthen the healthcare delivery, operational efficiency and healthcare infrastructure; coordinate existing healthcare infrastructure in Central and State Government for effective utilisation thereof; and regulate, in accordance with the law, for the time being in force, the entry and operation of foreign health educational institutions if permitted under the law for the time being in force in consultation with the Board or such other authority as may be specified by the Central Government,” according to the Bill.
Health Ministry revives steps to table pending bill on medical devices in monsoon session
June 27, 2012, 0800 IST – Source : Pharmabiz News
The Health Ministry has initiated steps to push the long pending bill on medical devices with the consent of the States and hopes to table it in the Parliament during the monsoon session. The Ministry held a meeting recently with stakeholder associations like FICCI and the Association of Indian Manufacturers of Medical Devices, apart from the senior officials from the Central Drugs Standard Control Organisation (CDSCO) to discuss the issue. In the face of continuing opposition from some States, the meeting decided to follow up the activities to secure the assent of all the States, sources said. Besides, the Ministry is also reportedly under pressure from Prime Minister’s Office to table the bill in the Parliament at the earliest so that the growing medical devices sector would get a much needed impetus in the form of regulatory mechanism. “The proposed amendment to the Drugs and Cosmetics Act (D&C Act) will lay down separate provisions for Medical Devices. The salient features of the bill would be to provide a separate definition of Medical Devices, their risk based classification for regulatory control, Clinical Trials on Medical Devices, Conformity Assessment Procedures, Penal provisions, etc.,” sources said. Currently, medical devices are treated as drugs. With only 14 notified devices regulated under the D&C Acts, thousands others remain unregulated in the country. The industry, which opposed the moves to increase the number of devices under regulation, wanted separate guidelines and definition for medical devices. Meanwhile, many States are still opposed to the bill but assent of all the States are required as health is under the concurrent list. The Ministry had circulated the draft among the States, after revising it on the basis of the recommendations by the Parliamentary Standing Committee attached to the Health Ministry. The bill has been pending now for over four years. Hoping that the bill will go to the Parliament during the monsoon session, the ministry had already sought Rs. 205 crore from the Planning Commission to set up regulatory mechanism for the sector during the next Five Year Plan period.
SEMINARS @ MEDICALL 2012
Medicall Seminars are a big hit with the medical fraternity. The topics are chosen with great care for their relevance to stakeholders of the healthcare industry.
“Chain Reaction” is the theme for Medicall 2012.
Healthcare delivery chains in ophthalmology, dentistry & diagnostic path labs have carved a niche for themselves and are growing at a healthy clip. It’s time to take stock of this growth, discuss about the problems therein and identify opportunities for future.
Medicall 2012 has invited eminent speakers, who have walked the talk of promoting healthcare chains. Entrepreneurs, professional experts representing engineering, design, supply chains, turnkey consultants, medical administrators & top notch surgeons will not only be sharing their experiences of setting up similar chains but they will also be elucidating the value proposition.
Two days of immersion seminars focused on the whole gamut of a healthcare delivery chain are waiting for you. Any doubts or questions relating to the setting up of a new business, to the scaling up existing ones, any grey areas to be sorted out when you plan to expand or strategize an acquisition will be addressed by professionals, who have been there and done that.
Nominate your best minds viz., the Hospital Manager,CEOs, the Medical Administrators, the Physicians and / or Surgeons who are keen to wear a grey coat in preference to a white coat. 3rd to 6th AUGUST 2012 CHENNAI TRADE CENTER, CHENNAI INDIA
| 3RD AUGUST 2012 | Topic | Duration Mints | Date | Time |
| IT for Chains | Health vault – Wealth in clinical data | 45:00:00 | Friday 3rd Aug | 10:15 to 11:00 |
| Supply Chain Management | JIT supplies for Just care | 45:00:00 | Friday 3rd Aug | 11:15 to 12:00 |
| Branding | Hospitals – A consumer brand? | 45:00:00 | Friday 3rd Aug | 12:15 to 1 pm |
| Lunch | ||||
| Remote Managing | Practice Acquisition – Pitfalls & Potential | 45:00:00 | Friday 3rd Aug | 2:15 pm to 3 pm |
| Eye care | Eye 20-20, Secret formula of success/Wal-Mart of Eye care | 45:00:00 | Friday 3rd Aug | 3:15 pm to 4 pm |
| Dental Care | teething problems while setting up a dental chain | 45:00:00 | Friday 3rd Aug | 4:15 pm to 5 pm |
| 4TH AUGUST 2012 | ||||
| Chain Reaction | ||||
| Oncology Care | Emperor of all maladies- we need a cancerous growth of cancer centers | 45:00:00 | Saturday 4th Aug | 10:15 to 11:00 |
| Pharmacy | How to maximize profits in a pharmacy | 45:00:00 | Saturday 4th Aug | 11:15 to 12:00 |
| Diagnostics | What is the Business? Diagnostics or Logistics? | 45:00:00 | Saturday 4th Aug | 12:15 to 1 pm |
| Lunch | ||||
| Dialysis | Do Nephrology Departments leak profits? | 45:00:00 | Saturday 4th Aug | 2:15 pm to 3 pm |
| Finance for Chains | Hospitals in ICU! Help! We need Funds! | 45:00:00 | Saturday 4th Aug | 3:15 pm to 4 pm |
| Diabetes | Life style diseases & Chronic Care | 45:00:00 | Saturday 4th Aug | 4:15 pm to 5 pm |
| 5TH AUGUST 2012 | ||||
| Hospital Infrastructure | Sunday 5th Aug | |||
| Critical Care | Sunday 5th Aug | |||
| Hospital Property Mela | Healthcare real estate investment opportunity in India. | Sunday 5th Aug | 10:00 am to 5:00 pm | |
| How to identify the right healthcare property. | ||||
| In- and Out-sourcing Real Estate Functions: Case Studies from Healthcare Systems | ||||
| Medical mall – the need for hour | ||||
| Recent trends in healthcare infrastructure | ||||
| Technology Showcase | Sunday 5th Aug | |||
| Technology Showcase for Dealers & Distrbutors | ||||
FOR MORE DETAILS VISIT http://medicall.in/medicall/Conferences-%20at-%20MEDICALL-2012.php
WORKSHOP ON GOOD CLINICAL LABORATORY PRACTICES
Good Clinical Laboratory Practices (GCLP) outline the principles and procedures to be followed by medical laboratories involved in patient care and/or clinical research so as to provide consistent, reproducible, auditable, and reliable laboratory results; which contribute to good patient care and promote a positive attitude toward testing from a patient’s perspective. This workshop is designed to offer comprehensive guidance for those who are implementing GCLP in their laboratories.
WORKSHOP OBJECTIVE
Learn GCLP principles and their relation to patient care and/or clinical research.
Understand to develop quality system and implement GCLP in a laboratory.
Familiarize the requirements of standards of ISO 15189:2007.
WHO SHOULD PARTICIPATE
This workshop is designed for following professionals from:
Microbiology, Pathology, Biochemistry and Genetics.
Lab Directors, Lab Managers and Lab Technologists.
QA/QC personnel, Quality Officers and Quality Managers.
Investigators of research projects.
Professionals associated with clinical laboratory management and accreditation.
Only those who are currently engaged in the diagnostic lab or clinical research are encouraged to participate in this workshop and students are not eligible.
WORKSHOP CONTENT
The key contents of the workshop are:
Principles of quality essentials
QA/QC practices
Establishment and management of quality system
Documentation structure and system
Test facility operation
Continual improvement
Biosafety & Ergonomics
GCLP in clinical trials
Overview of NABL accreditation
Methodology of the workshop includes didactic lectures, interactive sessions, group exercise and case studies. The faculties are from national and international institutions /universities.
REGISTRATION DETAILS
Completed Registration form has to be forwarded to Workshop Coordinator along with prescribed Fee of Rs.3500 (Indian participants) in the form of DD / Cheque drawn in favor of “YRG CARE” payable at Chennai. (In case of outstation cheques, please include Rs.100 extra towards clearing charges). Fee for international participants would be USD 300 and can be paid via wire-transfer. The registration fee includes registration, workshop materials, refreshments, breakfast and lunch provided during the workshop. The seats are restricted to 60 and participants will be registered on “first come-first served basis”. The registration DOES NOT cover accommodation, however, assistance will be provided for arrangement of accommodation on request.
Cancellation policy: No refund will be given, but the registration can be transferred to substitute participants without penalty.
to download registration forms please click hereGCLP 2013-F
VENUE
TICEL Bio Park Ltd Taramani Road, Taramani Chennai – 600113, India
CONTACT DETAILS
Mr. J. Mohanakrishnan, MSc / Mr. P. Nandagopal, MSc
GCLP Workshop Coordinators
YRG CARE, Voluntary Health Services
Taramani, Chennai – 600113, India
Phone: 39106800 / 39106803
eMail: GCLP@yrgcare.org
State drug control officials not empowered to monitor clinical trials: Dr Jagashetty
June 12, 2012, 0800 IST – Source : Pharmabiz News
State drugs control departments have no powers to keep tabs on the clinical trials conducted in their states unless they are empowered as per the Drugs & Cosmetics Act & Rules, according to Dr BR Jagashetty, drugs controller, government of Karnataka.
The department’s team of inspectors has no authority to enter the premises of the clinical trial organizations, said Dr Jagashetty following the recent statement by the Drugs Controller General of India (DCGI), Dr G N Singh who said that the state DCs were required to keep a close vigil on the illegal human studies.
Without empowerment under the D&C Act & Rules, there is no question of inspection and even the clinical trial companies will not permit the inspectorate teams to enter the premises for the inspection, he added.
Further state drugs control departments have no information on clinical trial or clinical research organizations. There is also no mention of human studies in the D&C Act. So far no state drugs control departments have been involved in conducting inspections on clinical trial companies.
A key focus of a clinical trial is to assess the safety of the drug and efficacy. There has been several initiatives to look at pharmacovigilance, a adverse drug monitoring activity, from the government side. “There is definitely need for an audit and a dedicated team of inspectors to be in place to carry out the inspections of all clinical trials,” said Karnataka drugs regulator, said Dr Jagashetty.
India has around 40 clinical research organizations (CROs) including domestic and multinational companies. Out of these, there are around 20 leading companies and Karnataka is home to at least 15 of these CROs. The notable names are Ecron Acunova, Clinigene which is part of Biocon Limited, Lotus Labs. Omnicare, Vaatsalya, Treista Life Sciences which is part of Health Care Global Enterprises (HCG), St. John’s Medical College Clinical Trial Centre, Synchron, D2L, SMO India and Infinitus which are the homegrown companies.
In addition the state also has a presence of global majors include Quintiles, PharmaNet, PharmaOlam and ClinTech International to name a few. Besides this, there are corporate and government hospitals engaged in clinical trials. These cover Manipal Hospital, Fortis, Columbia Asia, Ramaiah Memorial Hospital where international pharma majors identify a principal clinical investigator to carry out the human studies.
ABOUT MEDICALL
Medicall expo is a premier medical equipment fair organized by Medexpert Business Consultants Pvt Ltd, Chennai, India. The show was started 8 years back with the idea of bringing all the stake holders in the industry at one place. Indian Healthcare is growing at the rate of 15% pa, due to various factors like demand supply gap, increased affordable middle class population, growing healthcare tourism market and also due to the rise in life style disease like Diabetes, Heart disease etc.,
Medicall serves as the ideal platform for the companies to showcase their latest developments. All the previous 8 editions has been successful in attracting quality visitors, like hospital owners, specialists, hospital administrators, purchase managers and dealers and distributors of medical equipments.
The last edition at Chennai Trade Centre attracted more than 8250 hospital owners. Around 430 exhibitors, including international exhibitors from China, Taiwan, Germany & UK displayed various range of products.
Seminars on various interesting topics like Infection Control, CSSD Management, Materials Management, Hospital Construction, Patient Safety were organized during the previous year shows. International seminars in CAP Accreditation, Molecular Diagnostics & Australian Accreditation Standards attracted decision makers of the industry. Innovative Marketing campaigns, sector specific seminars has attracted quality crowd every year and made Medicall one of the premier medical expo in the country.
About Healthcare Innovation Awards
As a part of Medicall Expo, a Healthcare Innovation Awards was started during the last year to recognize, showcase and encourage innovation in the field of Healthcare. Last year the awards were classified in to 3 categories namely Innovation in Products, Concept & Process. There were 70 participants across the 3 categories last year.
This year to keep encouraging new innovations in Healthcare the awards have been instituted in 3 categories namely…….
HEALTHCARE DELIVERY – Innovation in healthcare delivery that makes healthcare delivery affordable, accessible & appropriate. Enhances the quality of service, Increases the Patient’s safety, Reduces Medical Errors, Shortens Turnaround time, Improves outcomes and Increases Customer Delight.
MEDICAL EQUIPMENT, DIAGNOSTICS, HEALTHCARE IT – Innovation in Medical Equipment, Medical Diagnostics, Information Technology product / services in the field of healthcare resulting in better, smarter, cheaper, safer, faster diagnosis & treatment
CSR INITIATIVES IN HEALTHCARE – Innovation in Corporate Social Responsibility initiatives of Healthcare organizations.
Seminars @ Medicall 2012
“Chain Reaction” is the theme for Medicall 2012
Healthcare delivery chains in ophthalmology, dentistry & diagnostic path labs have carved a niche for themselves and are growing at a healthy clip. It’s time to take stock of this growth, discuss about the problems therein and Identify opportunities for future.
Medicall 2012 has invited eminent speakers, who have walked the talk of promoting healthcare chains. Entrepreneurs, professional experts representing engineering, design, supply chains, turnkey consultants, medical administrators & top notch surgeons will not only be sharing their experiences of setting up similar chains but they will also be elucidating the value proposition.
Two days of immersion seminars focused on the whole gamut of a healthcare delivery chain are waiting for you. Any doubts or questions relating to the setting up of a new business, to the scaling up existing ones, any grey areas to be sorted out when you plan to expand or strategize an acquisition will be addressed by professionals, who have been there and done that.
For More Information please log on to http://medicall.in/medicall/index.php
