History of pharmacovigilance in India

The origin of pharmacovigilance in India goes back to 1986, when a formal adverse drug reaction (ADR) monitoring system consisting of 12 regional centers, each covering a population of 50 million, was proposed for India. However, nothing much happened until a decade later when in 1997, India joined the WHO Adverse Drug Reaction Monitoring Program me based in Uppsala, Sweden. This attempt was unsuccessful and hence, from 1January 2005, the WHO-sponsored and World Bank-funded National Pharmacovigilance Program for India was made operational. 
The National Pharmacovigilance Program established in January 2005, was to be overseen by the National Pharmacovigilance Advisory Committee based in the Central Drugs Standard Control Organization (CDSCO), New Delhi. Two zonal centers-the South-West zonal center (located in the Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai) and the North-East zonal center (located in the Department of Pharmacology, AIIMS, New Delhi), were to collate information from all over the country and send it to the Committee as well as to the Uppsala monitoring center in Sweden. Three regional centers would report to the Mumbai center and two to the New Delhi one. Each regional center in turn would have several peripheral centers reporting to it. Presently there are 26 peripheral centers. The program has three broad objectives: the short-term objective is to foster a reporting culture, the intermediate objective is to involve a large number of healthcare professionals in the system in information dissemination and the long-term objective is for the program to be a benchmark for global drug monitoring.

Given this background on pharmacovigilance in India to date, things have definitely changed for the better but at a very slow pace. The Regulatory Authority for India should be commended for introducing and implementing the Schedule Y and for reporting of all serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARS) from clinical trials. However, there is a need of spontaneous adverse event reporting from post-marketed medicines to the zonal centers and in turn to the National Pharmacovigilance Centers to the WHO Uppsala Monitoring Center, which at the moment is woefully lacking. Therefore, in these circumstances, the questions that arise are whether the strategy should be changed and if so, how?

Ethical issue in Clinical Research

History of Clinical Research

PLACEMENT TALK

Mr. Prashanth Krishna, Head Healthcare - IDS Infotech and Mr. Ravinder, Manager IDS- ARGUS were here to discuss career opportunities with our students............ the session was very informative & students had a chance to get the queries resolved ..... got some clicks from the event...........we are grateful to IDS for their time and knowledge they shared with us.

Indian researcher bags award for Alzheimer’s drug

London: London-based Indian researcher Mahaveer Golechha has been selected for an award for his work on a drug to cure Alzheimer’s. 
    The 27-year-old will be travelling to San Francisco to receive the Alzheimer’s Drug Discovery Foundation’s ‘Young Investigator Scholarship Award’ at the 7th Annual Drug Discovery for Neurodegeneration Conference to be held next month. 
    “I feel very proud that I have proved world class research in the area of medicine can be done in India,” Dr Golechha said on Thursday. 
    He has been recognized for his outstanding research on ‘naringin’, a bioflavonoid found in grape fruits and citrus fruits. In his study, he found that naringin possesses significant “anti-Alzheimer activity” and will form the basis of further research to develop as a cure for the degenerative disease in old age, which worsens as it progresses. 
    “Alzheimer’s disease is a neurodegenerative disorder that generally affects the elderly population. Till date the treatment was symptomatic but naringin will act at pathological level and have lesser side effects,” he said. 
    “I hope this award creates further avenues for budding scientists in my country to be recognized for their work and facilitated to follow their dreams,” said Golechha, who completed his Master’s and PhD from the All India Institute of Medical Sciences in New Delhi, where he was involved in research on Alzheimer’s and epilepsy. 
    His work on naringin has also been included for a poster presentation at the San Francisco conference. PTI

India to inspect drug firms in China: DCGI Inspection Office To Open In Beijing By Mar 1 Kounteya Sinha TNN

New Delhi: Increasing the heat on Chinese drug firms exporting medicines to India, the Drug Controller General of India (DCGI) is all set to open its first foreign drug inspection office in Beijing by March 1. 
    Around four Indian drug inspectors will be posted in China to inspect manufacturing sites and check whether good manufacturing practices (GMP) are being complied with. DCGI Dr G N Singh told TOI that the commerce ministry has cleared the proposal. 
    Health minister Ghulam Nabi Azad recently said that in the last two years, 10 Chinese bulk drug manufacturing firms were inspected and the registration certificate of one firm and 16 import licences were cancelled. 
    Ministry sources said the decision to audit Chinese drug manufacturing units was taken after several import licences of local agents were cancelled due to poor drug quality and their failure to comply with GMP. 
    “We will post Indian drug inspectors in China to send a clear message that Chinese drug firms are under watch. Gradually, China will be asked to only allow drugs exports from manufacturing sites that have been inspected by Indian drug inspectors. We want to ensure safety, efficacy and quality of Chinese drugs,” said Dr Singh. 
    “GMP of Chinese drug firms has to be certified by our regulators. This is a practice followed in most countries, including the FDA in the US. To protect the interest of Indians, we have to go international,” he added. 
    Now, more than 45% of bulk drug exporters registered in India are from China. The number of registered Chinese bulk drug manufacturers in India is around 280, and altogether 417 different drugs from the Asian giant are registered. 
    A ministry official said, “We had earlier written to Chinese Food and Drug Authority (FDA) regarding complaints that some Chinese drug firms which export bulk drugs to India might not be holding proper GMP certificates. The Chinese FDA too confirmed our apprehensions and asked us to carry out our own inspections.” On the basis of complaints and doubts on authenticity of GMP certificate, India has already cancelled 10 registration certificates and related import licences. These certificates were from Zhejinag, Jingsu, Henan province and Chongquing. 
    A DCGI note said, “Similarly, several cases of imported kits of HIV were declared to be not of standard quality by the government laboratory, which are originating from Zhejiang and Fujian provinces. These issues further support this office which stands to carry out foreign site inspections in line with other regulatory agencies of the world.”

More than 45% of bulk drug exporters registered in India are from China

Coffee Drinking May Halve Risk Of Mouth And Throat Cancer Featured Article Academic Journal Main Category: Cancer / Oncology Also Included In: Nutrition / Diet; Dentistry Article Date: 12 Dec 2012 - 3:00 PST

A new study from the US finds people who drink more than 4 cups of caffeinated coffee a day have half the risk of dying from oral/pharyngeal (mouth and throat) cancer as people who drink it either occasionally or not at all. However, the researchers say their findings need to be confirmed by more research, and for now should just be received as good news for coffee drinkers and not be used as a reason to recommend everyone should drink 4 cups of coffee a day.

Lead author Janet Hildebrand and colleagues from the American Cancer Society (ACS) in Atlanta, Georgia, write about their findings in a paper published online first on 9 December in the American Journal of Epidemiology.

Oral/Pharyngeal Cancer

Oral/pharyngeal or mouth and throat cancer is rarely diagnosed in the early stages because symptoms usually do not appear until the cancer is advanced. Also, the symptoms can be mistaken for something else, such as toothache.

The cancer can sometimes be spotted early during a routine exam by a doctor, dentist, or dental hygienist, and some dentists and doctors suggest you look at your mouth in a mirror at least once a month to check for symptoms.

The most common symptoms are a mouth sore that fails to heal, or a pain in the mouth that doesn't go away.

The biggest risks for developing oral/pharyngeal cancer are tobacco and alcohol use. Most people who have it are tobacco users.

Infection with the human papillomavirus (HPV) is also a risk factor, especially in people who do not use tobacco. The number of cases of oral/pharyngeal cancer tied to HPV has risen sharply in the last thirty years.

Researchers Examine Link with Coffee

Previous epidemiological studies have suggested coffee drinking is linked to a reduced risk for mouth and throat cancer.

It has also been suggested that it may not be the caffeine in coffee, but the fact it is rich in antioxidants, polyphenols, and other compounds, that help prevent or slow the development of cancer.

For their study, Hildebrand and colleagues used data from the Cancer Prevention Study II, a prospective US cohort study that the ACS started in 1982.

That study gathered a wealth of lifestyle and health information on 968,432 men and women, including their tea and coffee consumption. When they enrolled on the study, none of the participants had cancer, but over the 26 years of follow up, 868 died from oral/pharyngeal cancer.

When they analyzed the tea and coffee consumption in relation to deaths from oral/pharyngeal cancer, the researchers found those participants who reported drinking more than 4 cups of caffeinated coffee a day had a 49% lower risk of death from oral/pharyngeal cancer compared to those who reported not drinking coffee at all or only an occasional cup.

The link was not affected by gender, tobacco and alcohol use.

The researchers found an insignificant link with decaffeinated coffee, and none at all with tea.

Conclusion and Next Step

The researchers conclude:

"In this large prospective study, caffeinated coffee intake was inversely associated with oral/pharyngeal cancer mortality. Research is needed to elucidate biologic mechanisms whereby coffee might help to protect against these often fatal cancers."

Hildebrand says in a press statement:

"We are not recommending people all drink 4 cups of coffee a day. This is just a little bit of good news for those of us who enjoy coffee."

"There may be some other effects of coffee that may prevent people with certain conditions from drinking a lot of caffeine," she cautions, noting that:

"This study is about just one cancer site among many. There needs to be much more consistent research before we can support the conclusion that coffee should be consumed for cancer prevention."

The team is now planning to analyze links between coffee consumption and cancer in a more diverse population in the ACS's new Cancer Prevention Study - 3 (CPS-3).

The Society hopes to recruit at least 300,000 adults from a range of ethnic and racial backgrounds across the US to take part in CPS-3, which aims to increase knowledge of how to prevent cancer.

There has been a lot of debate recently about the benefits and harms of coffee drinking, with more recent news suggesting the benefits probably outweigh the harms.

But researchers spreading the good news are all saying the same thing, as Hildebrand and colleagues themselves point out in this latest study: while there appear to be some health perks from drinking coffee, there are also a few cautions, and the evidence is not solid enough to actively encourage people to go out and drink coffee.

Written by Catharine Paddock PhD 
Copyright: Medical News Today 
Not to be reproduced without permission of Medical News Today