Monday, 29 February 2016

National seminar on "Innovative concepts and methodologies in Pharmaceutical research

Source: http://www.hrpatelpharmacy.co.in/asojpharmvention/ICMPR-Details.php


Pharma academic research - Indian patent applications published on 26th February 2016


Every week of thousands of patent applications are published in India. The patent applications filed by the pharma academic research institutes in India go un-noticed.

We publish a list of Indian applications published related to pharma academics. This would provide us an idea about the kind of academic research being carried out in these institutes. For details of these patents, please write back to us at pharmaliterati@gmail.com

Invention
Application No
Inventors
Institute
Development of potent poly-phyto capsules for dyslipidemia management using smart ideal antihyperlipdemic tree concept
2397/DEL/2014A
1) Dr. N. V. Satheesh Madhav
2) Kumud Upadhyaya
3) Asha Bisht
Director, DIT-Faculty of Pharmacy Dehradun, Uttarakhand.
Formulation process for a bionano gel loaded with chlorpromazine for brain targetting via trans nasal route
2373/DEL/2014 A
1) Dr. N. V. Satheesh Madhav
2) Deepika Raina
Director, DIT-Faculty of Pharmacy Dehradun, Uttarakhand.

Wednesday, 24 February 2016

Dabur to make Ayurvedic drugs for diabetes, malaria


With the Ayurveda sector in the country heating up with new entrants such as Ramdev's Patanjali and HUL's Ayush, homegrown FMCG major Dabur has decided to strengthen its portfolio by inking a licence agreement with the Government of India to produce two Ayurvedic drugs -one for management of diabetes and another for treatment of malaria -to begin with.

The company is preparing to bring these Ayurvedic medicines, which will be available in various formats, to the market within the next six months. While Ayush-64, for malaria, can be used to both prevent the ailment and treat it, Ayush-82 can be used primarily to mana ge diabetes.

“Around 50% of the count ry's population lives in mala ria-infested areas. This can prove to be a very cost effective solution,“ said Dr JLN Sastry head of healthcare research at Dabur India.

“Both medicines are not over-the-counter drugs and ne ed to be prescribed by a doctor The ingredients used in the medicines are very simple too -karela, jamun, mango seeds and Himalayan herbs such as kutki and chirayita.“

The Ayurvedic formulations for both these medicines were developed by Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, an autonomous organization under the Ministry of AYUSH (Ayurveda, Yoga, Unani, Siddha and Homeopathy), Government of India. While a number of Indian firms were said to be in race for commercialization of these Ayurvedic drugs, Dabur managed to clinch the deal thanks to its greenhouses in the Himalayas where it grows the rare herbs that are used for producing these medicines. 

Source: http://timesofindia.indiatimes.com/business/india-business/Dabur-to-make-Ayurvedic-drugs-for-diabetes-malaria/articleshow/51115325.cms

Seminar on "Strategies for Empowerment of Women Associated with the Healthcare Profession"


Allana College of Pharmacy, Pune and Women’s Forum, APTI jointly organize one day seminar on "Strategies for Empowerment of Women Associated with the Healthcare Profession".

The details are as follows:
Theme:      One day seminar on "Strategies for Empowerment of Women Associated with the Healthcare Profession".
          
Dates:                   8th March 2016.

Organized by:        Allana College of Pharmacy, Pune

Location:               Pune.



NIPER Ahmedabad to set up centre of excellence to boost skill development in devices sector


The government of India has mandated National Institute for Pharmaceutical Education and Research (NIPER) Ahmedabad to initiate a National Centre for Medical Devices (NCMD) for development of skilled manpower in the medical device industry. This would involve collaborative inputs from the industry to help build innovation ecosystem and develop human resources for the industry along with a testing infrastructure at NIPER. This would also complement the first upcoming medical device testing lab of the country at Vadodara in Gujarat by the end of this year.

The department of pharmaceuticals (DoP) for the last one year has actively engaged both the NIPERs and the pharma industry to build partnership in areas of education, research and development.

Says Dr Kiran Kalia, director, NIPER, Ahmedabad, “As a part of the government initiative to develop an ecosystem for development of medical devices sector in the country, NIPER Ahmedabad has recently signed two MoUs with leading medical devices manufacturers at Rashtrapati Bhavan in Delhi. This would go a long way to further collaborate with the industry.”

As per official sources, a total of 17 MoUs have been signed recently between seven NIPERs and pharma industry for academia industry linkages recently. Out of the total of 45 MoUs exchanged between central institutions, 17 are under pharmaceuticals sector alone. Academia-industry linkage is a significant development as one of the critical factors in building innovation ecosystem for medical devices industry.

High quality and skilled manpower is one of the critical requirements in the pharma sector today. This has gained further impetus as government of India is planning to expand NIPERs across the country to nurture manpower and hence boost domestic manufacturing of medical devices in the country. More than 70 per cent of medical devices are imported as of today which has impacted the development of the domestic industry.

Indian domestic pharma market is around Rs. 1 lakh crore and its analysis suggests that patent medicines constitute less than 1 per cent share illustrating poor accessibility and availability of latest innovative medicines in the face of growing non-communicable diseases like cancer because of affordability. This issue reiterates the urgency for India to have paradigm shift in its strategy to expand its leadership in drug discovery and innovation after post-WTO, TRIPS regime.

DoP has identified that academia-industry linkage as a basic requirement for translating research into development (commercialisation) and innovation; and also to fix accountability among the educational institutions. Further in India, the research and development in pharmaceuticals sector is spread across a number of ministries and departments viz., department of biotechnology, department of science and technology, department of scientific and industrial research, health systems research (ICMR) and department of pharmaceuticals.

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=93669&sid=1

Saturday, 20 February 2016

Pharma academic research - Indian patent applications published on 19th February 2016


Every week of thousands of patent applications are published in India. The patent applications filed by the pharma academic research institutes in India go un-noticed.

We publish a list of Indian applications published related to pharma academics. This would provide us an idea about the kind of academic research being carried out in these institutes. For details of these patents, please write back to us at pharmaliterati@gmail.com

Invention
Application no
Inventors
Institute
Urea complexes of chlorpyrifos, malathion, bifenthrin and cypermethrin for improving safe handling and other characteristics
201611002986A
1) Manish Dhall
2) A.K. Madan
Faculty of Pharmaceutical Sciences, Pt. B. D. Sharma University of Health Sciences, Rohtak, Haryana.
In-situ formation of lipidic nanoparticles
2307/DEL/2014A
1) Kaur, Indu Pal
2) Bhandari, Rohit
3) Singh, Mandeep
4) Kakkar, Shilpa
5) Taneja, Richi
University Institute of Pharmaceutical Sciences, Panjab University.
An ocular formulation and a method for its preparation
2339/DEL/2014A
1) Kaur Indu Pal
2) Yadav Monika
University Institute of Pharmaceutical Sciences, Panjab University.
Composition and method for rapid detection of fungal infections
3355/CHE/2014A
1) Chellan, Gopi
2) Rangaswamy, Jayakumar
3) Xavier, Wilbin
4) Nair, Shantikumar
Amrita Vishwa Vidyapeetham, Kochi, Kerala

Cipla doyen charts out vision for next ‘best’ phase


Battling monopoly and batting for the indigenous industry, YK Hamied scripts the drug-maker’s journey as challenges loom

The best is yet to come.” That was the message from Cipla doyen Yusuf K Hamied in his townhall address to employees across the world, to mark the company’s 80th anniversary.

Cipla has entered a dynamic phase in its growth, he said, outlining “six pillars” for the future — plants, products, partnerships, plans, passion and people. And this growth would also see the next generation of the Hamied family, with Samina Vaziralli (his niece) taking a hand to preserving the essence of the company.

For those following the company’s journey, Cipla’s “best” may have been in 2001, whenit rocked the pharma world by offering the HIV/AIDS three-in-one drug Triomune at less than a dollar a day, breaking the stranglehold of Big Pharma in South Africa. The combined international price of these drugs then was $12,000 per patient per year.

In fact, some health advocacy workers wonder if that assertive, even aggressive avatar of Cipla has given way to a more diplomatic company now.

Ask Hamied about the changing perception of the company his father KA Hamied started in pre-Independence India and why he feels the best is yet to come, he says the company is becoming more “global” these days.

Only this week, the ₹11,000-crore Cipla closed its acquisition of two US-based companies. And, it has been increasing its international footprint across Algeria, Brazil and Iran, he says.

Cannot afford monopoly
“I cannot contribute in an area of monopoly,” says Hamied, explaining why Cipla has to focus outside India. In fact, he has been calling for a framework where drug-makers can partner with innovators to bring critical drugs to India, on payment of royalty to the innovator. This would help make these drugs less expensive.

“India cannot afford a monopoly in healthcare,” he says, adding that the prevailing environment ends up “pushing people like me to go overseas” where medicines get better prices.

India amended its patent regime in 2005 to honour product patents, following which generic companies were unable to make chemically-similar, or generic, versions of an innovative drug as long as it was patent protected.

For Hamied this is almost a déjà vu. His townhall speech recalled 1960, when he joined Cipla as an R&D officer. The “Made in India” label was not acceptable. “Every promising drug we wanted to manufacture in India was covered by patents, a monopoly granted to the innovator for a period of upto 20 years.”

This gave birth to the Indian Drug Manufacturers’ Association, the fight to change the patent law and the new Act that was passed in 1972, where product patents were abolished in three areas including health. Hamied says, the ensuing “golden era” for the indigenous industry allowed them to build manufacturing capabilities and become the pharmacy to the world.

Unfortunately in 2005, the amended Patents Act reintroduced product patents and backdated these to 1995, he says.

Patent issues
This change had health groups worried that medicines would get pricier. These fears also resonated beyond Indian shores, where India had supplied inexpensive medicines. In India, companies battled over patents and the nuances in enforcing a patent still stirs up much debate.

Recently, though, a truce seems to have been called. Hepatitis C drug Sofosbuvir saw innovator Gilead partnering with a clutch of Indian companies, including Cipla, to make the drug and at lower prices. But industry watchers caution that the going is still tough and drug-makers will look to bail out. Hamied too is “very worried” about the Indian landscape.

“I will do anything for India... But the government should realize that the foundation of healthcare in the country is the indigenous industry… and a step-motherly treatment should not be meted out to the industry who are your backbone,” he says.

As it navigates these challenges, Cipla has seen its share of speculation on its future. Hamied, though, has nixed talk of selling the company with his “not in my lifetime” response.

Last month, Cipla created a management council headed by Subhanu Saxena, Managing Director and Global Chief Executive Officer, and including Samina, to streamline operations and spearhead growth.

This, even as nephew Kamil quit the company last year. Of his own role, the scientist-Chairman says, “My head is clear, my mind is clear and I read a lot to keep abreast with science.”

Friday, 19 February 2016

Big pharma houses under the radar in Andhra/Telangana state


Prominent pharma manufacturing companies are under the Drugs Control Association (DCA) radar for production of poor quality anticancer drugs. The DCA received complaints that the anticancer drug ‘Vincristine’ imported from China is of poor quality and that some of important companies were using this as an Active Pharmaceutical Ingredients (API) in their units. Based on this information, checks were conducted on February 17 and 18 by 12 teams of regulators from DCA on prominent anti cancer manufacturing firms.

The firms under the radar are Hetero Labs Ltd. at Kazipally and Jadcherla, Dr Reddy Labs Ltd, FTO at Bolarum, Dr Reddy Labs Ltd, CTO at Bolarum, Natco Pharma Ltd at Kothur and Nagarjuna Sagar, MSN Labs Ltd at Shameerpet, Shilpa Medicare at Jadcherla, Laurus Labs Ltd at Shameerpet, Accura Labs at Shameerpet, Celon Labs, ALEAP at Gajularamaram and Therdose Formulations, ALEAP at Gajularamaram.

Five samples of the drug have been picked up and are being sent to the Central Drug Laboratory in Kolkata for analysis. The shortcomings noted are failure to stock bulk drugs as per label conditions, failure to conduct audit trials for HPLC (laboratory equipment),

Purchase of APIs from unapproved vendors, non maintancence of Analytical reports, stocking Anti Cancer drugs along with excipients instead of storing them separately, discrepancies regarding reconciliation of printed labels and no provision of biosafety cabin for testing cytotoxic APIs in laboratory.

Source: http://www.thehansindia.com/posts/index/Hans/2016-02-19/Big-pharma-houses-under-the-radar/208246

Free course on "FDA overview of Biosimilars"

USFDA is offering a web-based free course on biosimilars. The course provides an understanding of biological products and biosimilar products and a description of FDA’s general approach to the development and approval of biosimilar products. The target audience for this course is healthcare professionals, including physicians, physician assistants, nurses, nurse practitioners, and pharmacists.

The course comprises eight different modules:
Module
Title
1
Introduction
2
Biologics Price Competition and Innovation (BPCI) Act of 2009
3
What is a biological product?
4
Complexity of Biological Product Manufacturing
5
What is a similar Product?
6
Abbreviated Approval Pathway for Biosimilar Products
7
Standards for Approval
8
Conclusion






National seminar on "Recent trends in prevention, treatment and awareness of cancer, diabetes and cardiovascular disorders"




Pioglitazone may prevent recurring stroke, heart attack


Pioglitazone, a drug used for type 2 diabetes, may prevent recurrent stroke and heart attacks in people with insulin resistance but without diabetes. The results of the Insulin Resistance Intervention after Stroke (IRIS) trial, presented at the International Stroke Conference 2016 in Los Angeles and published in the New England Journal of Medicine, suggest a potential new method to prevent stroke and heart attack in high-risk patients who have already had one stroke or transient ischemic attack. This large, international study was supported by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (NINDS).

The IRIS trial is the first study to provide evidence that a drug targeting cell metabolism may prevent secondary strokes and heart attacks even before diabetes develops. Insulin regulates metabolism and keeps blood sugar levels from getting too high, along with many other processes, in the body. Insulin resistance is a condition in which the body produces insulin but does not use it effectively.

“This study represents a novel approach to prevent recurrent vascular events by reversing a specific metabolic abnormality thought to increase the risk for future heart attack or stroke,” said Walter J. Koroshetz, M.D., director of the NINDS.

“The IRIS trial supports the value of more research to test the vascular benefits of other interventions such as exercise, diet and medications that have similar effects on metabolism as pioglitazone,” said Walter N. Kernan, M.D. professor of general medicine at Yale University School of Medicine, New Haven, Connecticut, and lead author of the study.

More than 3000 patients from seven countries who had experienced an ischemic stroke or transient ischemic attack within the previous six months were randomized to receive pioglitazone or placebo for up to five years in addition to standard care. Ischemic stroke and transient ischemic attacks can occur when a cerebral blood vessel becomes blocked, cutting off the delivery of oxygen and nutrients to brain tissue.

In this study, stroke or heart attack occurred in 9 per cent of participants taking pioglitazone and 11.8 per cent of patients on placebo, which was a relative decrease of 24 per cent. The results suggest that 28 strokes or heart attacks may be prevented for every 1000 patients who take pioglitazone for up to five years.

Insulin resistance is a hallmark of type 2 diabetes but also occurs in more than 50 per cent of people with ischemic stroke who do not have diabetes. People with diabetes are known to have increased risk of stroke. Previous research suggested that insulin resistance increases risk for stroke, but the IRIS trial was the first to treat it and suggested that the therapy reduced the risk of recurrent stroke and heart attacks. However, pioglitazone is not FDA-approved for the uses studied in the IRIS trial.

In this study, pioglitazone also reduced the risk of diabetes by 52 percent in the study participants. The study evidenced an additional known side effect of the drug, which is an increased risk of bone fractures.  To help doctors and patients choose the best strategy for preventing recurring strokes, future studies will attempt to identify a person’s risk of bone fractures due to pioglitazone. As approved for use in medical practice, the drug also carries additional side effects.

“More research is needed to determine the mechanisms by which pioglitazone decreases risk for stroke and heart attack and increases bone fracture risk, with the hope of developing strategies that maximize benefit and minimize serious side effects in our patients,” said Dr. Kernan.

This work was supported by the NINDS, the nation’s leading funder of research on the brain and nervous system.

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=93543&sid=2

Thursday, 18 February 2016

Univ of Findlay partners with pharmacy colleges to promote e-prescription records & widen job scope for Pharm D


University of Findlay, Ohio has now collaborated with pharmacy colleges in India to widen the scope of pharmaceutical care in the country. At the Manipal University and St. Peter's Institute of Pharmaceutical Sciences, Warangal, University of Findlay’s College of Pharmacy has initiated global expert lectures and student exchange programmes where candidates get the required exposure about the advanced pharmacy practices in US. These include creation and maintenance of electronic prescription dispensing records and monitoring Narrow Therapeutic Index Drugs across patient population that can be replicated back home.

The objective of this initiative is to develop a pharmacy service platform to open up job opportunities where pharmacists could chip in their expertise to ensure safe medication practices. A lot needs to be done in India in pharmacy care. To begin with, the accessibility of electronic medical records across healthcare providers will be a big game changer in India’s medical practices.

In the current scenario, India faces an excess supply of Pharm D graduates over demand at hospitals. One way to ensure immediate employment opportunities is to set up Pharmacy Clinics manned by qualified Pharm D candidates. These could be set up in a small area within the existing pharmacy outlets, he added.

All that is needed is a computer, printer, along with blood pressure apparatus and blood test kits. The qualified pharmacist in-charge of this Pharmacy Clinic can ensure creation of prescription dispensing records of every order made at the chemist’s counter. Those patients on Schedule H and X drugs like anticoagulants, immunosuppressants and anti bacterials monitoring of Therapeutic Index will ensure if medication dose is effective, stall adverse events and improve treatment outcomes in India.

As part of the partnership with St Peter's Institute of Pharmaceutical Sciences, Warangal, a pharmacy faculty from the University of Findlay set up an anticoagulation clinic at a small hospital to ascertain the Warfarin drug residual content among patients to prevent adverse reaction.

It is reported that of the 36,000 articles on medication errors published globally, only 35 such instances are seen to be from India. This clearly indicates gross under-reporting of adverse drug reactions because no records are maintained, he said.

In the US, pharmacists maintaining electronic prescription records and measuring INR (international normalized ratio) for anti-coagulant therapy are in vogue. If India’s Pharma D teams establish Pharmacy Clinics, patient outcomes will see a remarkable improvement.

Bulk drug policy to be unveiled


The government wants to build an ecosystem to help pharma comapnies go up the value chain. Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers is expected to come out with a new bulk drug policy in less than a month with an objective to grow the Indian pharmaceuticals sector to a $200 billion industry by 2030. Under this policy, the government wants to build an ecosystem to help pharma companies to move up in the value chain and develop new molecules through innovations.

“We are coming out with a new policy. This policy should been announced six months back. Now it will be unveiled in less than a month,” said Dr V K Subburaj, Secretary, Department of Pharmaceutical, Ministry of Chemicals and Fertilizers said.

The industry which grew in the last 15 years has potential to be a $200 billion industry and can be the world’s largest if it scales up and moves up the value-chain. Until 1970 India was dependent on other countries for its pharmaceutical requirements and in 20 years’ time it became self sufficient to meet its own requirements, he said.

“India has now become a superpower as far as generic drugs are concerned. India can become a $300 billion industry including medical devices by 2030,” he said quoting a FICCI report. As per this report the country’s pharmaceutical industry has the potential to touch $200 billion by 2030 from the present $32 billion. And the medical devices segment can grow from $5 billion now to $100 billion. “This is a herculean task, but possible. We must get into development of new molecules and have new drug discovery which is currently lacking. We should reach this level,” he said. “If we concentrate on states where growth is less, we should be able to achieve the infrastructure requirements of the pharmaceutical industry,” he added.

The industry is growing at 8-9 per cent per annum at present, and even if we maintain the same growth rate, we can reach $110 billion by 2030, Subburaj said, adding that we need to overcome several challenges to achieve this herculean task. “To overcome the quality problems, we need to have our own APIs manufacturing capacities. The new bulk drug policy will help in increasing the domestic bulk drug production and reduce dependence on Chinese imports,” he said.

Union Minister Hansraj Ahir while speaking at this seminar said that the new policy is aiming at bringing down imports of bulk drugs and increasing the domestic output. Bulk Drugs otherwise called APIs are active raw materials that provide therapeutic effect to drugs. India is dependent on China for APIs and there is a concern on quality. Dilip Shanghvi, Managing Director, Sun Pharmaceuticals said industry must focus on innovation and adopt international practice.  “I see India as a potential pharmacy hub for the world,” he said, adding, “If we make a few changes in the way we do and manage business in India, we can accelerate that process.”

Source: http://www.thehindu.com/business/bulk-drug-policy-to-be-unveiled/article8249249.ece