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Sun Pharma Q4 net up by 82%

Sun Pharmaceutical Industries Ltd has posted a net profit after tax and minority interest of Rs. 8202.10 mn for the quarter ended March 31, 2012 where as the same was at Rs.4427.50 mn for the quarter ended March 31, 2011.

Total Income is Rs. 25480.50 mn for the quarter ended March 31, 2012 where as the same was at Rs. 15950.80 mn for the quarter ended March 31, 2011.

The Group has posted a net profit after tax and minority interest of Rs. 25872.50 mn for the year ended March 31, 2012 where as the same was at Rs. 18160.60 mn for the year endedMarch 31, 2011.

 Total Income is Rs. 84296.90 mn for the year ended March 31, 2012 where as the same was at Rs. 60857.50 mn for the year ended March 31, 2011.

Mr.Makov is the Chairman of  Sun Pharma Industries Ltd

Sun Pharmaceutical Industries Ltd has announced that the Board of Directors of the Company at its meeting held on May 29, 2012, has appointed Israel Makov. a resident ofIsrael, as an additional Director on the Board of Directors of the Company.

Further the Company has informed that, Dilip Shanghvi has stepped down from the Chairmanship of the Company while continuing to remain the Managing Director of the Company and Israel Makov has been appointed as the Chairman of the Company at meeting of the Board of Directors of the Company held on May 29, 2012

 Speaking on the induction, Dilip Shanghvi, Managing Director of Sun Pharma said “I welcome Makov on behalf of the entire Board and the larger Sun Pharma team.  He is an exceptional leader with deep knowledge and experience in globalizing businesses successfully.  As Sun Pharma continues to rapidly expand its presence worldwide, I am sure that we will benefit immensely from his experience.”

On his appointment, Makov said, “I am happy to accept the position of Chairman of the Board.  Sun Pharma is an exciting company poised for substantial global expansion and I look forward to working together with Dilip and his team in realizing their visionary goals.”  

GVK EMRI 108 Neonatal Ambulances in Madhya Pradesh

Government of Madhya Pradesh and GVK Emergency Management and Research Institute (GVK EMRI) started the new service of Neonatal Ambulances in Madhya Pradesh. Neonatal Ambulances will provide extra care to the new born babies and the infection prone patients.

 In Neonatal Ambulance, the neonate’s cabin is specially created to make it sterile. It also has collapsible bed, attendant sheet, medical storage cabinet, and central oxygen line system. The ambulance is also equipped with the following:-

Incubator Unit

Pulse Oxy meter with neonatal probe.

UPS- for incubator running

Separate oxygen support system

Baby Resuscitation Kit - Ambu Bag Case

Overhead Ceiling Radiant Warmer

And other equipments

The launch of the neonatal ambulances was done on 29th May, 2012. The chief guest for the occasion was  Dr. Narottam Mishra, Honorable Minister Public Health and Family Welfare, Govt of Madhya Pradesh. The launch function was held at the GVK EMRI 108 office at Idgah Hills.

 Speaking on this occasion Dr, Narottam Mishra, Health Minister, said, “I congratulate GVK EMRI on behalf of  department. This is one more addition in the services being provided by the organization. This service will provide the transportation service to the infants which otherwise was quite difficult.”

 Dr. Pankaj Shukla , CHMO  , Bhopal  said, “GVK EMRI is already providing emergency services to the victims, we are offering them all help we can from available resources with us. And we hope they will provide these services to the kids and the patients in the future as well.”

 Subodh Satyawadi , CEO,  GVK EMRI, said “Neonatal ambulance is the demand of the time. Transportation of sick newborn babies to higher facilities would increase their survival chances. This is a new initiative from our side for the new born.” 

 The launch function was attended by the team of GVK EMRI and the people from the health and family welfare department. All of them were very glad as now they have one more feather in their cap.        

USFDA rules on sterility testing of biologics takes effect on June 4, 2012

  The US Food and Drug Administration (US FDA) has issued a final rule on sterility testing on May 3, 2012, that amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Indian biotechnology companies along with others globally will have to implement the changes as the rule takes effect June 4, 2012.

The rule is in response to President Obama’s Executive Order 13563 which called for improving regulation and regulatory review.

Specifically, the rule revises sterility requirements under Title 21 of the Code of Federal Regulations (CFR), sub chapter F, parts 600 through 680. It eliminates specified sterility test methods, culture media formulae or formulation, and culture media test requirements. It also does away with specified membrane filtration procedure requirements for certain products. There is no need for  specified sterility test requirements for most bulk material. It modifies the repeat sterility test requirements, so that repeat tests will occur only once for each lot.

It also replaces the storage and maintenance requirements for cultures of test organisms used to determine the ‘growth-promoting qualities’ of culture media with validation requirements specifying that any sterility test used is able to consistently detect the presence of viable contaminating micro-organisms, and with verification of ‘growth-promoting properties’ or micro-organism-detection capabilities of test and test components.

In addition, it also replaces the sample size or amount requirement with a requirement that the sample be appropriate to the material being tested. It substitutes the interpretation of test results section under 610.12(c) with a requirement that manufacturers establish, implement and follow written procedures for sterility testing that describe, at a minimum, the test method used, the method of sampling.

It identifies the Director of Centre for Drug Evaluation and Research (CDER) as one of the two Centre directors authorized to grant an exemption under the exception provision at 610.12(h)(2). In the proposed rule, the Centre for Devices and Radiological Health was erroneously identified in this exception, instead of the CDER.

It revises the definition of the term “sterility” under 600.3(q). It eliminates certain exceptions for allergenic products related to sterility testing under 680.3(c). The proposed rule received several comments from industry and the final rule includes the agency’s response to those recommendations.

Overall, FDA recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner. The agency’s efforts to review and update biologics regulations, to keep pace with technological developments helps to boost regulatory science, stated the guidance.

Indian Heart Watch reveals reasons for India’s growing cardiovascular disease

The Indian Heart Watch (IHW) study has revealed the truth behind the prevalence, awareness, treatment and control of key risk factors that are driving the country’s growing cardiovascular disease (CVD) epidemic, in a first-of-a-kind presentation of data at the World Congress of Cardiology .

The study assessed the prevalence of different “lifestyle” and biologicalCVD risk factors across the country – and results show that these risk factors are now at higher levels in 
India than in developed countries and regions such as the USA and Western Europe.

Seventy-nine per cent of men and 83 per cent of women were found to be physically inactive, while 51 per cent of men and 48 per cent of women were found to have high fat diets. Some 60 per cent of men and 57 per cent of women were found to have a low intake of fruit and vegetables, while 12 per cent of men and 0.5 per cent of women smoke.  

Moreover, the prevalence of biological and metabolic risk factors was also found to be high. Overweight and obesity was reported in 41 per cent of men and 45 per cent of women. High blood pressure was reported in 33 per cent of men and 30 per cent of women, while high cholesterol was found in one-quarter of all men and women. Diabetes (and or metabolic syndrome) was also reported in 34 per cent of men and 37 per cent of women.

India has the dubious distinction of being known as the coronary and diabetes capital of the world,” said Prof. Prakash Deedwania, Universityof California, San Francisco, USA. “These results show why - and must prompt the government to develop public health strategies that will change lifestyles, if these risk factors are to be controlled.”

According to the IHW, urban social development is also playing a role in the development of CVD risk factors. Risk factors such as smoking, high fat intake and low fruit/vegetable intake were shown to be more common in less developed cities, while physical inactivity was seen to be more prevalent in highly-developed cities. Accordingly, metabolic risk factors such as obesity, high blood pressure and high cholesterol were seen to be more prevalent in more highly developed cities. 

“These results show that improving urban planning and overall living conditions are critical to the curb the CVD epidemic in 
India,” said Dr. Rajeev Gupta, Fortis Escorts Hospital, Jaipur, India. “But, this can not be the extent of government efforts which have to include improvements in basic amenities, healthcare facilities and, perhaps most importantly, education that will enable people to take responsibility for their own actions.”

Indeed, the results of the IHW study showed that even among literate middle-class urban Indians there is a low awareness and control rates of these risk factors. Of the approximately one-third of study participants found to have hypertension, only about half (57 per cent) were aware of their high blood pressure, only 40 per cent were on treatment and only 25 per cent had adequate control. This is in contrast to more than 75 per cent awareness in most high and middle-income countries, where more than 50–60 per cent of people with high blood pressure are controlled.  

The study took place over a five-year period (2006–2010) and involved 6,000 men and women from 11 cities across various regions of India was conducted under the chairmanship of Professors Prakash Deedwania (University of California San Francisco, Fresno, USA) and Rajeev Gupta (Fortis Escorts Hospital, Jaipur, India).

 

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