MAKING PMS MANDATORY

The Union health ministry is considering to make it mandatory for the pharmceutical companies to have a Pharmacovigilance system within their organisation for the post marketing surveillance of new drugs launched in the market. The Drug Testing Advisory Board (DTAB) is working on a draft rule for the same so as to put in place a system of collecting, processing and forwarding the Adverse Drug Reactions report to the licensing authority by the companies. Pharmacy Council of India and Indian Council of Medical Research had suggested setting up of a pharmacovigilance department within each pharma company some time back as  most of them do not have such a system. The objective of the ministry is to make pharmacovigilance reporting mandatory on pharma companies in a bid to have detailed ADR data from the industry. In fact, the health ministry directed all the pharmaceutical companies last year to follow the practice of submission of Periodic Safety Update Reports (PSURs) of drugs on a regular basis but there has been no response from the industry so far.

In the absence of any cooperation from industry to generate detailed and reliable post marketing data of new drugs marketed in the country, the government itself took the initiative and established Pharmaco-vigilance Programme of India in 2010. The mission of PvPI is to safeguard the health of Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. ADRs are reported from different centres of the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute to the global ADRs data base. Drugs and pharmaceuticals are produced by pharmaceutical industry and approval for marketing the same is granted by the national regulatory authorities after duly verifying their efficacy and safety profile.  But even after three phase clinical trials, all approved medicines are not always found to be totally safe as trials are usually limited to a few thousands of patients. The need to have periodic safety assessment of any drug cannot be underestimated considering the fact that many drugs are getting withdrawn from the market even after their successful launches and remaining in the market for years. Apart from the safety of individual drugs, ADRs of thousands of combination drugs marketed especially in India are not all ascertained. This is a serious health issue neglected for so many years in India. It will be very difficult for the government's  pharmacovigilance machinery to collect such huge data of ADRs of all individual drugs and combinations from the market. Therefore, fixing that responsibility of collecting ADR data of drugs on the companies themselves is possibly the best option.

Care hospital performs first successful ‘Switch Liver’ transplant in Hyderabad

CARE hospitals, Hyderabad has successfully performed an unusual 'Switch Liver' transplant for the first time in India. This is the first such rare operation after the hospital opened its state-of-the-art liver surgery unit last year.

This landmark operation in Hyderabad suggests that we are now ready to do very complex liver surgery here within our city itself. Moreover this case proves that transplantation can be performed in these very sick patients with good results. Finally it shows that with good medical planning, even cases previously thought to be non-transplantable can be operated successfully, said prof. Tom Cherian, head of liver transplant surgery at CARE hospitals.

While explaining about the critical aspects of the surgery the professor explained that as the majority of the blood flow into the liver comes from the portal vein, a complete block of the portal and mesenteric vein inflow (called porto-mesenteric vein thrombosis) normally does not allow liver transplantation surgery.

However after careful examination and a high resolution CT Scan, the professor felt that the young age of the recipient plus his slender built would allow for completion of the surgery and respiratory wean. Finally the surgery was performed when a cadaveric organ became available. However at dissection a complete porto-mesenteric thrombosis was found despite recent imaging. Hence after discussion with experts from around the world Prof Cherian decided to perform a cavalswitch operation where instead of the portal vein, the cava was used to bring blood into the new liver. As this modification needed to be completed before the vulnerable liver graft died from prolonged lack of oxygen, there was additional stress on the team. The surgery lasted 13.5 hours and went well despite the blocked vessel, and the new liver started to work.

Zecotek receives patent for new advanced formulation of LFS scintillation crystals

Zecotek Photonics Inc., a developer of leading-edge photonics technologies for industrial, healthcare and scientific markets, has announced that its wholly owned division, Zecotek Imaging Systems Pte. Ltd., has been granted its first patent in a series of pending patents for its advanced formulation of its patented LFS scintillation crystals. The patent is for multi-doped lutetium oxide based scintillators having improved photonic properties.

“This patent protects our latest version of LFS scintillation crystals which are the fastest, brightest and most advanced scintillation crystals available to any OEM worldwide: the LFS-M,” said Dr. A.F. Zerrouk, chairman, president, and CEO of Zecotek Photonics Inc. “Most crystals for high resolution positron emission tomography (PET) imaging are based on stoichiometric formulations of lutetium oxide with silicate. While we also use lutetium oxide with silicate, our team of Russian scientists use an off-stoichiometric process which produces superior scintillators. No other company can produce crystal like ours, and no other crystal can compete with the LFS-M’s speed and brightness. We have filed similar patent applications in important jurisdictions around the world to re-enforce and strengthen the existing patent for our line of LFS scintillation crystals.”

The new patent protects Zecotek’s latest and most advanced formulations of “off-stoichiometric” multi-doped lutetium oxide based scintillation silicate crystals (LFS-M). Stoichiometric formulations are known to have matching number of reactants which produce full conversion of reactive groups into highly definable cross-linked products. However, intentional deviation from stoichiometric formulations, off-stoichiometric, enable the creation of products containing predictable amounts of other residual reactive groups which in turn enables the tuning of mechanical properties. By going off-stoichiometric, Zecotek’s scientific team has produced the fastest, brightest and most advanced LFS formulation available today.

Novartis ' PARADIGM-HF study shows Entrest reduces cardiovascular death/hospitalization for heart failure patients with reduced ejection fraction

Novartis announced new analyses of the data from PARADIGM-HF showing that Entresto (sacubitril/valsartan) consistently demonstrated benefit among heart failure patients with reduced ejection fraction (HFrEF), even when patients are considered clinically stable and regardless of background therapy.

An analysis of PARADIGM-HF patients found the following:

Even patients considered clinically stable - defined as patients with no history or a remote history of prior heart failure hospitalization - were still at risk for a serious clinical event.

In the analysis, over one third of patients were identified as clinically stable, and 20 per cent of those experienced a primary endpoint event (CV death or heart failure hospitalization). Among these patients, 51 per cent suffered CV death as their first event.

Further, the analysis determined that Entresto benefited patients considered clinically stable just as much as it did those who were least-stable (heart failure hospitalization within 3 months of baseline).

Among both groups, patients taking Entresto had a 20 per cent or greater reduction in CV death or heart failure hospitalization compared to those taking enalapril.