KCCI concerned over negative publicity of pharmas

Karachi Chamber of Commerce & Industry (KCCI) has expressed concern over what it called an “undue victimization” of pharmaceuticalindustries in the wake of tragic incidents of deaths at Punjab Institute of Cardiology in Lahore. In a statement issued, KCCI President Mian Abrar Ahmad said that the negative publicity was affecting the image of the country’s entire pharmaceutical industry, which is the fourth largest revenue contributor to the national exchequer. He articulated that such incidents had happened in the developed countries. Recently, in France a drug killed around 1300 people. Such an accidental incident happened in neighbouring country also and the Chernobyl tragedy claimed lives in thousands.

Mian Abrar was of the view that tragic incidents happen around the globe and inquires and investigations are made to find out the real cause of happenings. However, nowhere in the world the industries are penalized or compelled to shutdown or sealed. He criticized the registration of FIR under section 302 against accused factory owners and asked for its withdrawal.

He also urged to stop harassment and provide fair chance to the owners of alleged pharma company to clarify their position and allow them a fair opportunity to carry out company’s internal audit and investigation in this regard. He urged all the concerned to stop negative publicity as it was harming the reputation of Pakistan’s vibrant pharma industry of around 400 manufacturing units catering to 70% of the country’s demand of finishedmedicines and providing employment to over 4 million people particularly to women.

The national pharma industry has shown a progressive growth over the years, particularly over the last one decade. The victimization of pharmaindustries will have damaging affect on the entire pharmaceutical industry, pharma exports and shake the confidence of citizens as well, he added.

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Budget 2012: Incentive needed for enhancing spending on R&D in pharma sector

The pharmaceutical industry has asked the Centre to incentivise the sector to promote higher spending in research and development and bring down taxes and duties on life saving drugs and active pharmaceutical ingredients (API) to provide a fillip to its growth.

Besides, the wish-list of the industry for th upcoming Union Budget also figured in enhancing export incentive on drug shipments in order to compete with China.

With research driven business becoming the business model for the industry, pharma companies strongly pitched for Centre adopting incentive driven approach to enhance spending in R&D activities.

"Centre must announce some sort of incentives in the upcoming Union budget to encourage more spending by SMEs on R&D," Ind Swift Laboratories, Vice Chairman and Managing Director, N R Munjal said here.

"The government's focus must be on how spending on research can be increased in the country because country's average expenditure on R&D is just 2 per cent which can be scaled up to 4-6 per cent with some support (incentive)," he said.

The industry has also sought that the Centre should exempt expenditure on import of all capital goods, raw material and consumable to be used for R&D purposes from custom duty, besides making Cenvat credit available on capital goods used for R&D to reduce research cost.
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Currently, Indian Pharma industry's annual market size including export is Rs 1 lakh crore with over 8,000 SME units engaging in this sector, said Munjal who is also past President of Indian Drug Manufacturers' Association.

Another major demand of the industry was to exempt all life saving drugs from custom duty which is at 5 per cent at present and rationalize the duty on formulations by reducing it from 10 to 5 per cent.

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BioSante Pharmaceuticals Reports Positive LibiGel Safety Data Review for Phase III Program

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), announced today that the independent Data Monitoring Committee (DMC) has completed the eighth unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of subjects. The independent DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications. LibiGel (testosterone gel) is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women.BioSante reported that with 3,656 women enrolled and over 5,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 31 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.53 percent. In the same population of subjects, there have been 19 breast cancers reported, a rate of approximately 0.33 percent, which is in line with the ages of the subjects enrolled in the study."The DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification, as there were no general or specific safety issues based on their unblinded review of adverse events. We are pleased with the low number of CV events to date and we believe it is consistent with the safety of testosterone in this population," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante.Subjects have been enrolled in this study for an average of 19.3 months. More than 2,500 subjects have been enrolled in the study for more than a year and over 830 subjects have been enrolled for more than two years. The periodic reviews by the DMC are based on their mandate in accordance with FDA agreement on protocol-defined study oversight."BioSante's LibiGel Phase III safety study continues," said Stephen M. Simes, BioSante president & chief executive officer. "We plan to meet with the FDA to determine the best path forward for the program, and will make a decision as to the conduct of the LibiGel safety study during the second quarter of this year. We have instituted appropriate cost savings in order to minimize the continuing cost of the safety study. Although LibiGel did not meet the co-primary or secondary endpoints in two Phase III efficacy studies, BioSante continues to investigate alternative strategies to utilize the continuing LibiGel cardiovascular event and breast cancer safety study."About the LibiGel® Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 subjects. The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including, for example, hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.

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3 spurious medicine sellers arrested in city, Cuttack

Continuing their offensive against vendors of toxic alcohol, police on Sunday arrested three more persons for selling "dubious" medicine brands that have so far claimed 35 lives in Cuttack and Bhubaneswar. The accused were owners of three medicine stores in the twin cities.

While two of them were from Bhingarpur area, the worst-hit region near Bhubaneswar, the third accused hailed from Kantapada area in Cuttack district, sources said. Police and excise officials have so far arrested more than 20 people, including six employees of the controversialEastern Indian Pharmaceutical Laboratory in the wake of the toxic alcohol tragedy. The laboratory was sealed for allegedly manufacturing the toxic medicines. Also on Sunday, police brought two employees of Eastern India Pharmaceutical Laboratory on four-day remand for interrogation. The accused, Bhagirathi Mishra and Biswanath Mallick alias Sania, were arrested on Friday.
While Mishra, a sales agent of the company, was accused of hiding the toxic medicine brands --Epecarm and Cinnamon --in a warehouse at Baramunda, driver Mallick was in the eye of storm for allegedly playing a key role in supplying the spurious medicines to unauthorized chemist stores and liquor joints. "We hope to gather vital leads during interrogation," a senior police officer said. Twin city police officials on Sunday also met in Bhubaneswar to chalk out strategies to fight the scourge of spurious medicines.

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Hikal's API manufacturing plant to be ready by June 2012

Hikal Ltd, the outsourcing partner for pharmaceuticals, biotech, agrochemicals and speciality chemicals industries announced that the company's multipurpose facility to manufacture active pharmaceutical ingredients (APIs) will be operational by June 2012.The company also informed that it will supply a wide range of APIs from its Bangalore facility to its customers in markets like the US, Europe, South East Asia, Latin America, Canada and Japan. This was the company's third site approval as a result of the US FDA audit at the facility located at Jigani near Bangalore.Hikal is building a new multipurpose API facility at this site would meet additional demands from its US, European and Japanese customers. The plant will be operational by June 2012 and can accommodate 32 reactors with capacities ranging from 6 m3 to 10 m3.This will result in a total reactor volume of approximately 300m3.The company has appointed Peter Nightingale as the president of its 100 per cent contract research subsidiary, Acoris Research Ltd, Pune, India. Nightingale is a PhD in chemistry from the University of Manchester, United Kingdom and is a process development chemist with over three decades of experience in the pharmaceutical, agrochemical and fine chemical sectors."We are pleased to announce the appointment of Dr Nightingale as the president of Acoris Research Ltd. Dr. Nightingale’s extensive experience in the adaptation of new technologies in chemistry and as a veteran process development chemist will be a great asset to Acoris Research," said Jai Hiremath, vice chairman and managing director, Hikal.

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