Workshop on Good Clinical Laboratory Practices (GCLP)

YRG Care is organising a Workshop on Good Clinical Laboratory Practices (GCLP) at Chennai on 12 – 14th March 2015.

GCLP out line 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.
The faculties are from National and International Institutions / Universities. For more details about GCLP workshop, log on to www.yrgcare.org/GCLP

Program details are given below

Date 12 – 14 the March 2015
Venue TICEL Bio Park Ltd
CSIR Road, Taramani
Chennai – 600 113
Registration 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)
Registration fee includes Registration, Workshop materials, refreshments, breakfast and lunch provided during the workshop
No. of seats Restricted to 60 and participants will be registered on “first come- first served basis”.
Registration form along with payment to be sent to GCLP Work shop Coordinator
YRG CARE, Voluntary Health Services ( VHS)
Taramani , Chennai – 600113
Cancellation Policy No refund will be given, but the registration can be transferred to substitute participants without penalty

Click here for the GCLP workshop brochure Kindly ensure early registration.

Draft Minimum Standards for Various Categories of Clinical Establishments

The Clinical Establishments (Registration and Regulation) Act, 2010 has been enacted by the Central Government to provide for registration and regulation of all clinical establishments in the country with a view to prescribing the minimum standards of facilities and services provided by them. The act has already taken effect in 4 States and all Union Territories since 1st March 2012 vide Gazette Notification dated 28th February 2012.

Keeping in view to implement the act across the country the National Council for Clinical Establishments under the Chairmanship of Director General of Health Services, Government of India in consultation with various stakeholders has prepared draft minimum standards for various categories of Clinical Establishments for implementation of the Clinical Establishments Act.

The comments, suggestions, objections, including deletions /additions if required in the draft documents are invited from public at large, including the stakeholders like hospitals and other clinical establishments, consumer groups etc.

The draft standards for various categories of clinical establishments is available and can be downloaded from the link below

http://clinicalestablishments.nic.in/En/1070-draft-minimum-standards.aspx

 

The comments may kindly be sent to Dr. Anil Kumar, CMO(AK) Room No.506 ‘D’ Wing, 5th Floor, Nirman Bhawan, New Delhi-110018 at his email- id dr.anilkumar@nic.in with in one month of publication of this Notice on the website. A copy of the same may also be endorsed to nsdharmshaktu@yahoo.com

The last date for sending the comments is 20/04/2014.

Delays in clinical trials will deter innovation: Biocon’s Shaw

October 4, 2013 by · Leave a Comment
Filed under: Clinical Trials, Healthcare 

Source : October 2, 2013:  - THE HINDU BUSINESS LINE

The recent ruling by the Supreme Court halting clinical trials on new drugs until the Health Ministry is able to monitor the process will deter innovation, says Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon.

“This may have an irretrievable impact on India’s ability to partake in new drug development and will lead to an exodus of innovators from India.”

Biocon has two novel molecules under development in India. One is a new oral insulin drug, which the company believes will transform treatment for diabetes.

The development trials on this molecule have been delayed as the company awaits regulatory clearance to conduct additional tests.

The earlier trials faced a setback, says the company. Trial results were impacted by selection of patients and drug administration not being ‘optimal’.

In order to validate the efficacy of the drug, the company has been hoping to conduct another set of trails but clearances have not been forthcoming. “It is quite frustrating that despite the drug proving safety and efficacy, the approval for conducting additional trials has been held up for months now,” says Shaw.

The ruling by the apex court, however, may not result in a big adverse impact for Biocon.

The revenue contribution from Clinigene, the clinical-trial arm of Biocon, is not very significant to the company’s overall business. Further, the high growth potential in its research subsidiary Syngene may more than compensate for Clinigene’s revenue loss.

Syngene, which focuses on discovery and development research, enjoys gross profit margins as high as 30 per cent. Instead of providing mere fee-based research services to clients, the company has diversified into offering an end-to-end solution, which has helped margins.

Syngene has around six molecules in phase II and III of development, of which three are already in the final phase.

Once these molecules make it to the market, the company may commence commercial supplies of these products, which will mean million-dollar opportunities for Syngene. The company targets growth in excess of 20 per cent.

Syngene received a fund infusion of Rs 125 crore from GE Capital, valuing the company at Rs 1,625 crore last year.

Biocon hopes to list this company once market conditions improve.

Source : http://www.thehindubusinessline.com/companies/delays-in-clinical-trials-will-deter-innovation-biocons-shaw/article5193538.ece

 

 

2050 deadline for Tuberculosis

August 26, 2013 by · Leave a Comment
Filed under: Clinical Trials, Healthcare 

It has been a challenge for the government of India to come up with a new drug to cure tuberculosis and scientists at IICT are keeping their fingers crossed as the new combination of PA824 moxifloxacin and pyrazinamide under the Open Source Drug Discovery has successfully entered phase-II of clinical trial.

The trials were conducted in South Africa and if approved, it will enter Phase-III — human trials — in India. The scientists are optimistic as the phase-II results have been encouraging.

Read more

Govt. bans painkiller

July 14, 2013 by · Leave a Comment
Filed under: Clinical Trials, Healthcare 

The government has banned the manufacture, sale and distribution of painkiller drug dextropropoxyphene, a drug that has been banned in various countries.

 

“…Central Government hereby suspends manufacture for sale, sale and distribution of the drug with immediate effect,” a government notification said.

 

Dextropropoxyphene, an opioid analgesic, was suspended under Section 26A of the Drugs and Cosmetic Act, 1940.

 

 

Source : The Hindu   dt June 13, 2013

 

 

Government approves  50 clinical trials

July 3, 2013 by · Leave a Comment
Filed under: Clinical Trials, Healthcare 

Six months after the Supreme Court banned clinical trials for new chemical entities (or molecules) unless these were personally vetted and cleared by the Union health secretary, on Tuesday, the health ministry’s apex committee on clinical trials approved 50 in a move that will bring some relief to an industry that is worth $500 million in revenue and employs around 15,000 people.

Some activists question whether the ministry had effected sufficient changes in its regulatory regime and monitoring process to clear such a large number of trials, but an expert said he expects that the ministry has “followed the apex court’s guidelines”.
“This is not simply about approving trials as the health secretary will be held responsible for monitoring all aspects,” said C.M. Gulati, editor of Monthly Index of Medical Specialities.
Read more

New treatment could cut down insulin injections for diabetics

June 29, 2013 by · Leave a Comment
Filed under: Clinical Trials, Healthcare 

Researchers have done path breaking research, which can help people suffering from diabetes to postpone or decrease their need for insulin injections.

 

Michel Pairet, head of pharmaceutical company Boehringer Ingelheim’s non-clinical research and development, said this treatment could be a cure if it is linked with early diagnosis and treatment.

 

Early trials have shown promising results in strengthening the beta cells in the pancreas, which secrete insulin to control high levels of glucose in the blood, the Daily Express reported.

 

Stem cells are used to protect and regenerate beta cells, which normally are damaged by high sugar diets in the process.

 

Pairet said that the next wave of innovation is to try to protect the beta cell in the pancreas and maybe to cure diabetes by inducing the regeneration of the beta cells.

 

He said that during diabetes, the beta cells disappear because of inflammatory mechanisms, however, not all mechanisms are known yet.

 

Pairet explained that you can protect the beta cells or you can identify factors for the regeneration of the cells based on progenitor cells and try to help these cells regenerate, meaning that the treatment could help stop or delay the disease and its complications.

 

 

Source : The Hindu   dt June 3, 2013

 

 

Indian doctors develop low-cost screening for cervical cancer

June 13, 2013 by · Leave a Comment
Filed under: Clinical Trials, Healthcare 

Tata Memorial Centre, a premier cancer treatment institute in the country, on Monday announced that its researchers have found an inexpensive way to screen for cervical cancer — the most common cancer among Indian women — which can prevent 72,600 deaths worldwide each year.

 

The procedure, involving use of vinegar, curbed the deaths caused by the cancer by 31 percent in a group of 1.5 lakh women, it said.

 

Cancer of the uterine cervix is the most common cancer affecting Indian women with an estimated 142,000 new cases coming to light every year and 77,000 women dying of the disease, a TMC spokesperson said in Mumbai on Monday.

 

“India accounts for one-third of the global burden of cervical cancer. The disease is caused by infection with a virus called human papilloma virus (HPV) and is related to poor genital hygiene. The disease develops slowly and most women experience no symptoms until it reaches advanced stages when treatment is often unsuccessful. Cervical cancer is preventable if the disease is detected at early and treated in time. Cervical cancer incidence declined dramatically in high-income countries after introduction of organised population-based screening programmes using cervical cytology (Pap smear test),” he said.

 

“However, in India, a national population-based Pap smear screening programme is difficult to implement because of logistic problems related to need for laboratory facilities and expert cytologists.”

 

Visual inspection of the cervix after application of 4 per cent acetic acid (VIA) is a low-cost alternative, he said. However, efficacy of VIA test, conducted by trained health workers, was yet to be ascertained. So Tata Memorial Centre embarked on this research; funds were provided by National Cancer Institute, USA, supplemented by TMC and Women’s Cancer Initiative, Mumbai.

 

The study involved 150,000 women in the age group of 35—65, living in “relatively low socio—economic settings in 20 clusters in Mumbai suburbs”, TMC spokesperson said, adding that participation was entirely voluntary.

 

The researchers divided the participants into two groups: 75,000 women living in 10 clusters were allocated to the `screening group’ while another 75,000 women were allocated to the `control group’ Women in the `screening group’ were invited to a cancer education programme followed by VIA test.

 

This group received four rounds of screening and cancer education every two years. Women in the `control group’ did not receive the VIA test but were given cancer education. They were also asked to report to TMC in case they experienced any symptoms suggestive of cervical cancer.

 

According to TMC, results showed that VIA screening is safe, feasible and “acceptable to Indian women”, as there was an “overwhelming participation“.

 

“The study data recorded at the completion of 12 years show that cervical cancers were detected significantly early among the screening group….There was 31 per cent reduction in death-rate from cervical cancer in the screening group compared to the control group. Many more `pre-cancers’ were also detected in the screening group and were treated, indicating that these women are unlikely to get cervical cancer in future,” the spokesperson added.

 

VIA test can prevent 22,000 cervical cancer deaths in India and 72,600 deaths in “resource—poor” countries world—wide annually, TMC says.

 

The results of the study were announced at the annual meeting of American Society of Clinical Oncology, underway in Chicago.

 

 

Source : The Hindu   dt June 3, 2013

 

 

India unveils first indigenous rotavirus vaccine

May 17, 2013 by · Leave a Comment
Filed under: Clinical Trials, Healthcare 

The Phase-III clinical trial of low cost Indian-made rotavirus vaccine Rotavac has demonstrated strong efficacy and excellent safety profile and if approved by the Drugs Controller General of India, it would be available at Rs. 54 per dose.

 

This vaccine, developed under a public-private partnership, will be the third to hit the Indian market, but will be more affordable than the two vaccines now available costing more than Rs. 1,000 per dose.

 

The clinical study has demonstrated for the first time that Rotavac is efficacious in preventing severe rotavirus diarrhoea in low-resource settings in India, and developing countries in Asia and Africa. Strain diversity, too, has not apparently affected its efficacy.

 

Rotavirus is responsible for approximately 4,53,000 child deaths due to diarrhoea globally each year. It is particularly threatening in India where — according to a recent study — around 1,00,000 children die each year from severe diarrhoea and dehydration caused by rotavirus.

 

India accounts for 22 per cent of the estimated global deaths from diarrhoea-causing rotavirus.

 

Rotavac is an oral vaccine and is administered to infants in a three-dose course at the ages of 6, 10 and 14 weeks.

 

It is given alongside routine immunisations in the Universal Immunisation Programme (UIP) vaccines recommended at these ages.

 

“Once sanitation and drinking water supply in the country improves, the efficacy of the vaccine is bound to go up. Rotavirus is also associated with gut infection and the vaccine is known to give ‘herd immunity.’ Even if 25 per cent infection is prevented, it will mean a substantial public health gain,” said M.K. Bhan, former Secretary, Department of Biotechnology.

 

“This is an important scientific breakthrough against rotavirus infections. Clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India,” K. Vijay Raghavan, Secretary, Department of Biotechnology, said.

 

The randomised, double-blind, placebo-controlled phase-III clinical trial enrolled 6,799 infants in India (aged six to seven weeks at the time of enrolment) at three sites — the Centre for Health Research and Development, Society for Applied Sciences, in New Delhi; Shirdi Sai Baba Rural Hospital, KEM Hospital Research centre in Vadu; and Christian Medical College in Vellore.

 

Infants received Rotavac and the UIP vaccines, including the oral polio vaccine (OPV).

 

Result showed that infants receiving OPV at the same time as Rotavac generated comparable immune responses to all three polio serotypes as the infants receiving OPV without Rotavac, supporting the concurrent administration of OPV and Rotavac.

 

Source : The Hindu   dt May 14, 2013

 

 

 

Clinical trials industry witnessing downtrend in India

May 6, 2013 by · Leave a Comment
Filed under: Clinical Trials, Healthcare 

The clinical trial industry in India is currently facing a challenging time and witnessing a downward trend as investors are looking to shift their focus to other liberal destinations like China, Turkey and Malaysia, says Dr C Raghu, director of Prime Hospitals in Hyderabad.

 

With the activism of media, judiciary and regulatory bodies, 90 per cent of clinical trial industry in India has slowed down. According to Dr C Raghu, chief cardiologists and director of Prime Hospitals, the clinical trial industry is witnessing a downtrend as investors are shifting their focus to other liberal destinations like China, Turkey and Malaysia.

 

At present, China is leading the clinical trial industry in the world followed by Turkey and Malaysia. These destinations are having liberal regulatory system and the government is also encouraging the pharmaceutical, biotechnology industries to invent and discover innovative drugs and procedures for treating patients suffering from deadly diseases like cancer and AIDS.

 

Until 2004, the entire world focused towards India for investments in clinical trials, as the country offered huge patient pool with different profiles of diseases. Moreover the cost of drug trials is also very less compared to the western countries. For instance, clinical trials for a standard drug in the United States can cost about $150 million. A similar drug could be tested in India at 60 per cent reduction of that whopping cost.

 

The officials from Indian drug industry opined that if liberal regulations were allowed the clinical trials industry would have cross more than $1 billion mark by 2015. At present, India is seeing a decline in the number of human trials because of time-consuming government approvals and rising allegations of unethical tests further hindering possibilities of gathering a large sample size of people. Out of 118,804 human clinical trials in 178 countries, less than 2000, or two per cent, are being done in India compared to 9352, or eight per cent, in neighbouring China.

 

According to a 2009 report by consultancy, Ernst and Young (E&Y) and Federation of Indian Chambers of Commerce and Industry (FICCI), India’s clinical trial market was valued at more than $300 million with a compounded annual growth rate of 30 per cent.

 

While India was seen among the fastest growing clinical research destinations in the world, human drug trials haven’t been monitored closely leading to several unethical practices, forcing the Indian government to strengthen regulations in this area. It can take drug makers several months in India to get a nod for conducting clinical trials.

 

Top pharmaceutical companies conducting clinical trials in India are Pfizer, GlaxoSmithKline, Aventis, Novartis, Novo Nordisk, Astra Zenica, Eli Lilly, Dr Reddy’s, Nicholas Piramal, Cipla and Lupin, according to ASSOCHAM.

 

Source : Pharmabiz News dt May 4, 2013, 0800 IST

 

 

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