DCGI Gazette Notification 13-Feb-14 GSR 89 (E)

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GSR 13-Feb-14

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Crocin headache for GSK Healthcare

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Mumbai, March 17:

GlaxoSmithKline Consumer Healthcare has run into trouble with the drug regulator in Maharashtra over the company’s popular fever and pain medicine Crocin.

The medicine has not been available at local chemists after the Maharashtra Food and Drug Administration (FDA) sent GSK a notice for over-charging on the drug, and stopped supplies. Girish Vakharia, Assistant Commissioner (Bhiwandi), said the regulator has stopped supplies from the company’s main stockist for the State, located at Bhiwandi, on the outskirts of Mumbai.

The price of paracetamol is fixed under the Drug Price Control Order (2013), but GSK says its Crocin Advance is a locally-researched new drug, and, therefore, it is outside the ambit of price-control. The fixed price of paracetamol is 94 paise for a tablet (₹9.40 for a 10-tablet strip), Vakharia said, adding GSK sold Crocin Advance at ₹20 a strip.

Domino-effect?

The State regulator has written to the National Pharmaceutical Pricing Authority (NPPA) for clarity on whether the locally-innovated Crocin Advance should be exempted from price control. The authority’s clarification will be key to whether Crocin comes back on to chemist-shop shelves across Maharashtra.

However, if the NPPA agrees with the Maharashtra regulator’s view, it could result in a domino effect –other States may stop Crocin Advance at its present price.

Jayant Singh, GSK Executive Vice-President (Marketing), maintains that Crocin Advance (500 mg) was a local innovation that gave consumers faster relief than a regular paracetamol. The Drug Controller General of India had certified the product as a new drug, he said, adding locally-researched new drugs are exempt from price control. It has to do with interpretation, Singh said, with the company’s view being different from that of the Maharashtra regulator. The NPPA will give its ruling after discussions, he said, adding the company was also in discussions with various State authorities.

Media reports indicate that Kerala drug authorities, too, had stopped supplies of this drug for similar reasons late last year.

No shortages

Though the lower priced version of Crocin has been phased out, Maharashtra FDA’s Vakharia added that there was no shortage of paracetamol in the market, as several other brands were available at lower prices.

Source: Hindu Business Line

Hospital plans study on chocolate

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Boston scientists are launching a major study to finally answer the question on the lips of many chocoholics: Do components of dark chocolate protect the heart?

Brigham and Women’s Hospital researchers will announce Monday that they will lead a $20 million industry-funded clinical trial to test whether cocoa flavanols can reduce heart attacks, strokes, and heart disease deaths in 18,000 healthy people across the country.

The five-year study will also be the first to try to determine whether women who take a typical multivitamin — containing the daily recommended amounts of more than 20 vitamins and minerals — develop fewer cancers than those who take placebos.

The only previous large trial to test multivitamins for cancer prevention, also conducted at the Brigham, involved just men. This time, the researchers said two-thirds of the participants would be women, in an effort to help plug a gap in women’s health research highlighted earlier this month in a report released by the hospital.

Dr. JoAnn Manson, chief of the division of Preventive Medicine at Brigham, will lead the trial. She also led the landmark Women’s Health Initiative, which found that older women who took hormone replacement therapy had worse health outcomes than those who took placebos.

“We’ll be contacting women age 65 and older who participated in the Women’s Health Initiative trial,” Manson said.

Men age 60 and older will be recruited from a pool who volunteered for but were unable to join a trial of vitamin D and fish oil supplements, another study led by Manson that is underway.

Nutrition researchers not involved in the new trial reacted enthusiastically to the possibility of learning once and for all whether taking a daily multivitamin can help healthy people avoid cancer and whether cocoa flavanols would live up to the heart-protective promise seen in small clinical trials of short duration.

A 2012 analysis of 42 small clinical trials involving a total of nearly 1,300 patients found that eating cocoa flavanols in chocolate, cocoa, or supplements for a few weeks or months had beneficial effects on blood pressure, insulin, and cholesterol levels with no side effects.

“I’m 90 percent certain they’ll find something beneficial with cocoa flavanols,” said Eric Ding, a nutrition researcher at the Harvard School of Public Health. “For multivitamins, it’s really hard to say. I’m in the camp where I do think they have some benefit, but I’m not sure the study will be long enough to really see if cancers can be prevented.”

The earlier study of multivitamins in men found that those who took multivitamins for nearly 15 years had only a slightly lower risk of getting cancer compared with a placebo group. The benefits were larger for men over 70, who had an 18 percent lower risk of getting cancer, according to Manson, who helped conduct the research published two years ago in the Journal of the American Medical Association.

Based on that finding and a handful of smaller studies, a large government-sponsored task force concluded last month that there was insufficient evidence to recommend for or against taking multivitamins for cancer prevention. “I think it’s terrific and really exciting that this study will be done; it’s exactly the kind of research that we called for,” said Dr. Virginia Moyer, chairwoman of the group, which is called the US Preventive Services Task Force.

But some scientists expressed concern over the Brigham study’s funding source: mainly industry. Mars, Inc. will donate the cocoa extract capsules and funds to cover the researchers’ expenses, and a vitamin manufacturer, still to be determined, will donate the multivitamins.

Clinical trials with industry sponsorship are “more likely to report favorable results,” said Dr. Beatrice Golomb, a professor of medicine at the University of California San Diego whose research has found an association between eating chocolate and lower body weight.

The National Institutes of Health is also expected to provide some of the funding, but that has not yet been secured, according to Howard Sesso, co-leader of the study at Brigham. “These types of trials can’t be done unless they have a collaboration with industry,” Sesso said, “since the cost of the pills and packaging can become quite prohibitive.”

He said that industry representatives will have no input on the study design and no involvement in the writing of the manuscript.

Golomb said it was “disappointing” that participants in the study would be given cocoa extract pills instead of actual chocolate. “I’m also generally an advocate of eating whole foods.”

Cocoa supplements were chosen over chocolate, Manson said, to prevent weight gain from excess calories.

Older people, in particular, may have a hard time absorbing adequate nutrients from their diet, so a daily multivitamin may prove useful to meet certain deficiencies. Still, she added, “a multivitamin should never be used as a substitute for a healthful and balanced diet” because whole grains, fruits, and vegetables contain nutrients beyond vitamins and minerals and probably play a far bigger role in cancer prevention.

Participants will be randomly chosen to be mailed either blister packs of cocoa extract and multivitamin pills or of placebos for one or both for at least four years. They will agree not to take multivitamins on their own and will grant the researchers access to their medical records; 1,500 participants will have blood samples taken and analyzed.

Deborah Kotz can be reached at dkotz@globe.com. Follow her on Twitter @debkotz2.

Source: Boston Globe

Doctors, pharmacists differ on their role in Pharmacovigilance Programme of India

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Government-of-IndiaWhen the debate over whether medical professionals or highly qualified pharmacists (Pharm D graduates) should conduct the Pharmacovigilance Programme of India (PvPI) is still continuing among doctors and pharmacists, different views and opinions are coming out from both the professionals and academicians in the fields.

Dr P S Bhagavan, former deputy director of pharmacy in the ministry of health in Karnataka government has observed that PvPI should be headed by a pharmacist, preferably a clinical pharmacist with Pharm D qualification. He said pharmacovigilance is an activity under pharmacy practice and not under medical practice.

According to him, the term pharmacovigilance has come from the concept of ‘pharmacy-vigilance’  and not from an idea of pharmacologists doing vigilance work. “If it were to be ‘pharmacologists do vigilance’, then what they were doing all these years confining to lab experiments” he asked.

Pharmacovigilance is both a monitoring of adverse reaction as well as an audit programme. It is a program based on documentation, he commented. According to him, the doctors should shun their idea and mindset that pharmacists should work under their control. It is this irrational mindset that leads to non-medical and non-pharmacy administrators to head the drug logistic in the government sector.

Whereas, Dr Binay Kumar, assistant professor, department of forensic medicine and toxicology, All India Institute of Medical Sciences, Patna observed that the Indian Pharm D graduates were  not capable of doing anything other than dispensing drugs prescribed by physicians.

“They are not even able to recognize signs and symptoms in patients. They should work under the supervision of physicians, pharmacologists etc. Many experienced MBBS doctors are very competent. So it is not correct that MBBS doctors should be debarred from prescribing new drugs as stated by Dr Atmaram Pawar”, he commented.

Dr M C Gupta, medical-lego consultant from New Delhi said ADR reporting is very important, but usually non-existent in Indian hospitals because of lack of knowledge, time and attitude on the part of doctors.

“When 150 PvPI centres are existing in India, they need to pool their data and views, and issue a consensus statement as to how ADR reporting should be strengthened and by whom. There is nothing basically wrong in Pharm D personnel helping in ADR”, Dr Gupta said.

Source: PharmaBiz

WCCT Global opens a newly Asian bridging clinical trials unit

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WCCT Global, a full service contract research organisation (CRO), has opened a new Asian Bridging clinical research site. This state of the art facility has been reconfigured to provide for 30 semi-private rooms to give each clinical trial volunteer a more comfortable experience for extended in-house stays.

This dedicated clinical pharmacology unit is located in Orange County, California which is a central location enabling access to the many Asian populations that reside in the surrounding communities. WCCT Global has been conducting Asian bridging clinical trials for over 10 years and has conducted the largest Asian bridging clinical trial ever done in the United States.

Over the past 5 years WCCT Global has conducted over 60 Asian Bridging studies and recruited over 1600 Asian volunteers during this 3-year period.  Interestingly, over 20 per cent of those trials have required extended overnight confinement (> 4 days) to the research centre.

Therefore, the availability of this “built-to-suit” extended stay facility will provide a more comfortable and attractive setting for research participants. WCCT Global reports that based upon volunteer exit survey results, safety and comfort are the two most important determinants for a volunteer’s decision to participate in ‘extended stay’ clinical trials. Therefore, WCCT Global has also designed this new facility to accommodate every aspect of a volunteer’s research experience, from the meals they are provided to the utilisation of their free-time in order to make the volunteers stay as enriched, safe and comfortable as possible.

WCCT Global’s chief operating officer, Jon Rojas, stated “We decided to reconfigure this research centre in response to our study participants’ survey responses.  I think that we have created an extended-stay research centre that will provide the safe and comfortable environment that our Asian bridging study volunteers have expressed the desire for. We wanted a unit that can make our volunteers as comfortable as possible while offering our clients the best ethno-bridging solution available.”

Source: PharmaBiz