Monday, 26 October 2015

Pharma academic research - Indian patent applications published on 23rd October 2015

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
A natural extract based polymeric prodrug for sustaining the release of a drug
3084/DEL/2015A
1) Gupta, Puneet
2) Singh, Neelam
3) Khosa, Ratan Lal
4) Annamalai Pandurangan
5) Kulkarni, Giriraj. T.
Amity Institute Of Pharmacy, Amity University, Noida, Uttar Pradesh.
An oro-dispersible tablet and a process for preparing the same
665/MUM/2014A
1) Mr. Prasant Dilipkumar Jadav
2) Mrs. Vishakha Samir Hastak
Not known

Friday, 23 October 2015

Mandatory code for pharma marketing on the anvil


Pharma companies may have to cough up huge penalties for unethical and illegal practices like offering freebies, gifts and foreign trips to doctors for pushing the sales of their products. 

The government is set to make mandatory the uniform code of conduct for pharmaceutical marketing practices, which have so far been voluntary. The department of pharmaceuticals (DoP) is working on a draft which will curb unethical marketing methods and ban specific practices such as giving gifts and sponsor vacations of doctors by drug manufacturers, an official source said. 

The draft mandatory code of conduct is expected to be finalized and put in public domain seeking stakeholder consultation by end of November, the official said. The draft is also likely to spell out the penalty and punishment for not complying with the prescribed code of conduct. 

The move has been triggered by insufficient compliance to the existing norms by pharmaceutical companies. "Pharma companies have not fully implemented the voluntary code of conduct till date. Since there is no penalty stipulated on the same, companies tend to take it lightly," the official said. 

In November 2014, the DoP had issued the 'Uniform Code of Pharmaceuticals Marketing Practices' for a period of six months starting from January 1, 2015. It was also suggested that it would be subject to review after six months on the basis of compliance and inputs received by the government. 

While the industry opposed mandatory norms for marketing, the government extended the deadline for the adoption of the voluntary norms by two months from July 1 to August 31, 2015. 

The latest draft will be based on its review of voluntary implementation of the earlier norms by the companies, the official said. 

If made mandatory, this will be for the first time that pharma companies will have to comply with such stringent norms. Though the government had in 2008-09 decided to put a similar ban on unethical marketing practices, it could not be implemented due to severe opposition from the pharma industry, which promised self-regulation. 


Source: http://timesofindia.indiatimes.com/india/Mandatory-code-for-pharma-marketing-on-the-anvil/articleshow/49499766.cms

Thursday, 22 October 2015

Job opening_Walk-in interview


The WhatsApp group of Pharma Literati has been turning out to be a helpful resource. We thank Mr. Arshad Khan for this post. 

To get added your number to the WhatsApp group of Pharma Literati, send a message to 09769059971.

Team Pharma Literati. 

Saturday, 17 October 2015

Pharma academic research - Indian patent applications published on 16th October 2015


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
Fast release taste masked dry powder for oral suspension
3782/MUM/2014 A
1) Mr. Umakant Verma
2) Mr. Gokul A. Khairnar
3) Dr. Vinod J. Mokale
4) Mr. Jayesh S. Patil
5) Dr. Jitendra B. Naik
North Maharashtra University

Friday, 16 October 2015

The other side of the coin_Online pharmacy portals

We recently published a post on the "Nationwide Chemist Strike on 14th Oct against online medicines". We thank Mr. Pankaj Gupta for his comments:

Please see http://pharmaliterati.blogspot.in/2015/10/nationwide-chemist-strike-on-14th-oct.html

We have received a response from one of the readers, which is worth sharing here:



"It`s unfortunate to see that Lakhs of chemists are making wrong decisions based on directives from few people in associations who have vested interests behind such strikes. We at Mera Medicare LLP (www.meramedicare.com) aspire to bring efficiency, transparency and innovation in the overall Healthcare sector but these kinds of strikes and blind following is truly regressive for the society. 

Local chemists don`t really understand who`s their competitor and who`s their partner and that`s why they are falling into this 'Bhed-chaal'. Hyperlocal Marketplace such as Mera Medicare is a true partner of these local chemists while chain pharmacies such as Religare, Apollo, Medplus are the real threats to the local chemists. Mera Medicare neither has any inventory nor plans to have one in the future. We can only do business in conjunction with local chemists. They are our life blood to be successful in this sector. On the other hand, Chain Pharmacies want to wipe out all the local chemists and grab 100% market share through their Inventory+ E-commerce model.

From our discussions with the pharmacies, we understand that they are only going on strike because of immense pressure from the association. Ironically, almost 20 pharmacies approached to us on 14th Oct to partner with us. 

We truly believe that chemists will take a wise decision and won`t be trapped into vested interests of associations. That`s the reason, we are pretty optimistic about our business model. We have already expanded to 8 cities of India and will quickly expand to total 25 cities in 2015. We are seeing 50%+ month-over-month growth in the orders, which explains that Indian youth is embracing us with open arms."

Thursday, 15 October 2015

Eli Lilly collaborates with 10 leading academic institutions to create graduate level course on drug development


Graduate students across the country, with an interest in health care and medical research, will soon have the opportunity to learn about a lesser-known area of patient care - the drug discovery and development process. Eli Lilly and Company has collaborated with 10 leaders from academic institutions to create an elective graduate level course, "Making Medicines: The Process of Drug Development." Lilly will formally unveil the eLearning course at the American Osteopathic Association scientific conference in Orlando, Florida, October 17-21, and launch its pilot programme with academic partners beginning in 2016.

The online drug development course provides an interactive platform for students to explore the fundamental principles of drug development, learn about the regulatory environment that govern the biopharmaceutical industry, and identify the roles of key stakeholders, including physicians, who develop, investigate, and regulate biopharmaceutical products. The course includes seven chapters that contain various elements, such as expert videos from the perspective of the FDA and NIH, knowledge checks, case studies and competency tests.

"We identified a knowledge gap surrounding the biopharmaceutical industry and its drug discovery and development process," said Yolanda Johnson-Moton, Director, External Relations Medical Affairs, Lilly USA, "and set out to find a solution that would further education and awareness. Our unified focus is on creating better patient outcomes, and the healthcare providers of tomorrow are an integral part of the process."

"The 'Making Medicines: The Process of Drug Development' course allows students to engage in a self-directed learning process to become familiar with drug discovery and development," said Dr. Marc Kahn, Senior Associate Dean, Tulane University School of Medicine. "Students will obtain useful knowledge in a self-paced setting and will apply that knowledge in a series of assessment exercises.  I plan to use this course as an elective for senior medical students who want to learn more about drug development, the FDA and the biopharmaceutical industry."

The launch of the course comes shortly after the introduction of Lilly's Medical Student Rotation Program, a four-week experiential learning program at their Indianapolis headquarters, where third- and fourth-year medical students familiarize themselves with the biopharmaceutical industry and its role in the practice of medicine through real-world projects and workshops. Future healthcare providers, who will be dependent on new medicines for their patients, will benefit from learning about the discovery and approval process.

"These student programmes offer Lilly the opportunity to bring forth its longstanding focus on education and build collaborative relationships," said Johnson-Moton. "The Making Medicines: The Process of Drug Development" course provides flexibility to fit within existing academic programs. Our goal is reach more students with an interest in medical research and help provide a balanced perspective on the process and rigor behind drug development."

India risks missing boat as biosimilars shake up drug industry


The country, which has dominated the generic drugs industry for decades, is falling behind in the race to make copies of complex biotech drugs, which are expected to generate tens of billions of dollars in sales in the coming years.

While domestic firms have launched a few such products on the domestic market, where regulatory barriers are relatively low, they are being overtaken by European, American and South Korean firms in the race to supply lucrative Western markets.

Just three groups - Biocon Ltd, Dr Reddy's Laboratories Ltd and Intas Pharmaceuticals Ltd - are working with partners on so-called biosimilars aimed at the United States and Europe.

Biotech drugs, which require genetic engineering, account for a growing share of new drugs and the future sales of copycat products will also switch to this category of pharmaceuticals from simple small-molecule pills like aspirin.

The global biosimilars market is predicted to have sales of $25 billion by 2020, according to a 2014 Thomson Reuters report.

"Biosimilars is a big opportunity," said Sujay Shetty, leader of the life sciences practice at PwC India. "But unlike generics, it is not yet an opportunity (for Indian companies) in the US."

Copying chemical-based drugs has long been the bedrock of India's $15 billion pharmaceuticals industry. Biotech drugs, however, are more difficult to make and cannot be replicated exactly, which is why regulators have come up with the notion of versions that are similar enough to do the job.

That also means regulators will be eagle-eyed on quality, posing a challenge to Indian companies, which have been distracted in recent years by manufacturing problems that have led to some drugs being barred from key overseas markets.

Many, including the country's biggest drugmaker Sun Pharmaceutical Industries Ltd, are still struggling to fix issues at their generic drug factories.

For details: http://health.economictimes.indiatimes.com/news/pharma/india-risks-missing-boat-as-biosimilars-shake-up-drug-industry/49369283

Private players in e-pharmacy space form association, IIPA


Amid a nationwide strike of chemists against "illegal" online sale of medicines, private players in the e-pharmacy space have come together to form an association.

"The Indian Internet Pharmacy Association (IIPA) officially formed with the mission to promote and protect the public health by ensuring that its members operate in accordance with the existing Drugs & Cosmetics Rules of Information Technology Act, 2008, and Pharmacy Practice Regulations, 2015," IIPA said in a statement.

With growing penetration and awareness of e-commerce companies enabling retailing of medicines and healthcare products, IIPA wants to make sure that its members adhere to the rules governing pharmacies and the dispensing of prescription medications.

IIPA will cater to public's demand for safe and easily accessible medicines at affordable prices. It also aims to be at the forefront to fulfil the Prime Minister's vision for a Digital India, it added.

The association claimed that it brings together some of the most credible and successful companies from both the pharma and e-commerce industry.

The current 11 member list includes Bookmeds, mChemist, Medidart, Medlife, Medstar, Netmeds, Pharmeasy, Zigy.com (PM Health & Life Care), SaveOnMedicals, Savemymeds and 1mg.com.

It would ensure that partners operate in the interests of the public, and would therefore, be extremely selective in its screening process and would only allow 'the best of the best' to earn the association's approval.

The main goal of this association is to ensure its members operate in harmony with the requirements of the consumers and the regulator, keep fly-by-night operators out of the business and to bring the 'best of the West', where online pharmacies are fairly mature, to India, IIPA president Prashant Tandon said.

"Our members are the industry's top players with credible experience. We are committed to working with the regulators to ensure that India has an exemplary model for e-pharmacy.

"We welcome and applaud the regulators' announcement that they are on a path to draft guidelines to regulate the new model," IIPA General Secretary Kiran Divakaran said.

Source: http://health.economictimes.indiatimes.com/news/pharma/india-risks-missing-boat-as-biosimilars-shake-up-drug-industry/49369283

Pharma companies take the lead as cross-border M&As rise


Cross-border merger and acquisition (M&A) deals rose 10% in terms of deal value in the July-September quarter this year compared with the same period last year, said law firm Baker and McKenzie’s quarterly cross-border M&A Index launched on Wednesday. The 1,230 deals in the quarter were worth $375 billion.

India ranks among the top 10 acquirers in the US market for 2015, with 16 transactions valued at $1.7 billion. The majority of those deals are in the life science sector, with six transactions totalling $1.5 billion, as Indian companies seek to increase their scale in the US generic drugs market, said Baker and McKenzie, a Chicago-based firm.

“Indian companies (particularly in the pharmaceutical sector) have been on a acquisition spree and I think this trend will continue in the near term given the low valuation and the need for Indian companies to increase their scale to compete in the increasingly competitive generic markets, as well as to dip their toes into the innovator side of the business. Most of these acquisitions are funded internally as Indian companies are generally cash rich. On the other hand, we are also seeing an uptick in Indian pharmaceutical companies tapping into the debt market for acquisition funding, as money continues to be relatively cheap right now,” said Ashok Lalwani, global head of Baker and McKenzie’s India practice.

The Index, which analyses the number, size and complexity of cross border deals and includes six years of historical data, stands at 231 for period—down from a peak in April-June 2014 of 285, but well above the lowest quarterly figure of 119 for January-March 2010.

Overall deal activity in the year so far is already at $2.91 trillion, well ahead of last year’s pace. Cross-border transactions have so far totalled $1.05 trillion on course to match the 2014 figure of $1.42 trillion. The growth in total deal value is despite a 16% fall in transaction volume, reflecting a 10% increase in the value of mega deals worth more than $5 billion. Growth in cross-border transactions is also complemented by strong growth in domestic M&A deals, which have risen 40% in the year-to-date to $1.86 trillion and risen 35% in the September quarter to $680 billion.

The three largest cross-border deals in the quarter were Teva Pharmaceutical’s $40.5 billion acquisition of Allergan’s generics business, ACE Ltd’s $28.3 billion acquisition of The Chubb Corporation and Altice’s $16.6 billion deal for Cablevision Systems Corporation.

“Within pharmaceuticals globally, companies are looking to effectively manage portfolios and replace many products that have gone off-patent in recent years,” said Jane Hobson, global head of the Healthcare Practice Group at Baker and McKenzie. “We have also seen a great deal of activity in the generics space, an industry with business models different to innovators with more of a focus on managing margins at high volumes, in which creating critical mass through acquisitions has strategic appeal.”

Source: http://www.livemint.com/Industry/XEpwEXuEQuikbLRWfvna6L/Pharma-companies-take-the-lead-as-crossborder-MAs-rise.html

NIPER Ahmedabad develops new diabetes markers


Of India's 559,718 diabetics, at least a quarter or some 161,578 are in Gujarat. Retinopathy is one of the most serious microvascular complications of diabetes, resulting in blindness for over 50% patients across the country. In such a scenario, National Institute of Pharmaceutical Education and Research (Niper), Ahmedabad has not only developed new markers to predict such secondary complications but also modified an antidiabetic molecule to reduce the cost of drugs.

Present anti-diabetic drugs cost between Rs 100 to Rs 650 per mg. But the one developed by NIPER costs only Rs 20 per mg and will benefit millions of diabetes patients in the country. NIPER has also secured a patent for the invention which promises to be a revolution in the healthcare sector. Led by institute director Prof Kiran Kalia, the team has also created proteomic and genomic markers to predict onset of secondary complications in diabetics like retinopathy and nephropathy. "Presently, secondary complications are diagnosed at an advanced stage. But, we've developed bio markers that can predict such serious complications by urine and blood tests at an initial level," she said.

Senior diabetologist Dr Mayur Patel said: "Reducing the cost of therapy will be a boon. In India, nearly 60% of patients have to mortgage their property to keep their blood sugar under control. If we can predict future complications, it can reduce the financial burden on millions of patients."

He said: "When cost of therapy falls, physical and physiological suffering also reduces not of just the patient but the entire family."

Prof Kalia said: "With a rise in lifestyle diseases, an anti-diabetic molecule is one of the largest-selling formulations in the domestic pharma retail market. Thus, reducing its cost will be a boon for several patients. The new molecule is a new class of compound than drugs available in the market." She said: "The same product is being chemically synthesized and further modified to improve its efficacy."

Source: http://health.economictimes.indiatimes.com/news/pharma/ahmedabad-institute-develops-new-diabetes-markers/49370848

Wednesday, 14 October 2015

The Journey of Pharma Literati

Pharma Literati started with a dream on 15th October 2014. A dream of connecting the pharmacy professionals across India from industry, academia and various domains under one umbrella. 

With globalization and changing dynamics of the industry, the pharmaceutical field is constantly changing. Be it community pharmacy, clinical pharmacy, drug regulations, research activities, manufacturing quality or patents, newer things are being introduced every day. In this era, what is required is the need of a mindset to get adapted to the changes, transform yourself according to the needs and be competitive. 

The first and foremost important thing required for a change is the knowledge of external environment viz. for a pharmacy student, faculty or industry resource, it is essential to know what all is happening in the filed surrounding them.  

When we started this concept with only two people involved, we believed the knowledge or the information is available but scattered. So, we decided to start this initiative which would connect all the stakeholders and the knowledge is shared freely. 

With a dedicated helpline for student queries, a Whats-App group, a blog, several partners and various bloggers, we have tried to achieve these goals and would be doing so in the coming years. 

We would require your support, blessings and involvement in the activities.   

Team pharma literati would like to thank all our mentors, partners, subscribers, bloggers and readers for their constant support and encouragement. The team likes to specailly thank Dr.S Vasudeva Murthy, Principal, Jayamukhi College of Pharmacy, Warangal for his valuable guidance. 

Happy reading. 

National Pharmacy Week_Competitions

We had posted about National Pharmacy Week - 2015 with the theme of "Responsible Use of Antibiotics Saves Lives" here: http://pharmaliterati.blogspot.in/2015/07/national-pharmacy-week-2015.html

IPA has announced competitions on the occasion of National Pharmacy Week, 2015. Please see: http://www.ipapharma.org/html/npw_2015.html



Tuesday, 13 October 2015

Dr. B. Suresh's message for pharmacists

We would like to thank Dr. Milind Umekar, President, APTI Maharashtra State and Principal, Smt. Kishoritai Bhoyar College of pharmacy, Nagpur for sending us this update.

Dear fellow pharmacists, 
There is a lot of wrong messages circulating on social media and emails that the pharmacists are empowered under Pharmacy practice Regulations 2015 to open clinics and practice medicine. This is false and there is no such provision.  Pharmacy practice regulations provide for practicing the pharmacy profession by providing pharmaceutical care to patients  which includes providing advise on medication, drug information, reporting adverse drug effects to the physician, and supporting the physician in medication management. This is provided in the interests of the patient with the idea of supporting the physician in health care delivery . Under no circumstances the pharmacist is empowered to practice medicine or open clinics to provide medical care. Please circulate this widely as it should not be misunderstood by our fellow health professionals. 

Dr. B Suresh,
President,
Pharmacy Council of India.

Monday, 12 October 2015

Pharma academic research - Indian patent applications published on 9th October 2015

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
A process of isolation of immunostimulatory fraction containing flavonoids from andrographis echioides
3182/MUM/2014A
1) Dr. Ghule Balu Vinayak
2) Ms. Palve Sima Popatrao
3) Dr. Yeole Pramod Govindrao
IPER, Borgaon (Meghe), Wardha, Maharashtra.
A peptide based drug for the inhibition of angiogenesis
935/DEL/2014A
1) Koneriajapuram Natarajan Sulochana
2) Mohan Arun
3) Renganathan Bhuvanasundar
4) Karunakaran Coral
CSIR
A floating drug delivery system
2985/MUM/2013A
1) Dr. Gulkari Vijay Deorao
2) Dr. Kasliwal Rahul Harishchandra
3) Burpute Shashikant Sadashivrao
4) Dr. Gurav Shailendra Shivaji
5) Mrs. Gurav Nilambari Shailendra
6) Mrs. Wadetwar Rita Naresh
Priyadarshini J. L. College of Pharmacy
AN orally administrable gastro retentive drug delivery system
2986/MUM/2013A
1) Dr. Gulkari Vijay Deorao
2) Dr. Kasliwal Rahul Harishchandra
3) Burpute Shashikant Sadashivrao
4) Dr. Gurav Shailendra Shivaji
5) Mrs. Gurav Nilambari Shailendra
Priyadarshini J. L. College of Pharmacy
Newer fluoroquinolone derivatives as pharmacologically active agents
1834/CHE/2014A
1 )Dr. Kalam Sirisha
2) Ms. MD Munnisa Begum
3) Prof. Garlapati Achaiah
4) Dr. Chitra Chandrashekar
Vaagdevi College of Pharmacy, Warangal, Andhra Pradesh
Starch of musa paradisiaca as sustained release carrier in suspension for prolonged release of drug
1708/CHE/2014A
1) Dr.Karthikeyan Deivasigamani
2) Ch. Chandana
3) Dr.Sateesh Kumar
Srikrupa Institute of Pharmaceutical Sciences, Medak, Andhra Pradesh


Friday, 9 October 2015

Cost of patent filing in India

We recently received a query regarding cost of patent filing in India via email. For our reader's information, please find below the answer for same:

Patent filing involves various activities like patentability evaluation; patent draft preparation; official filing costs and handling or courier charges. 


Activity
Cost
Patentability evaluation
Depending upon invention varies from 6,000 Rs. to 25,000 Rs.
Patent drafting
Official filing fees
1800 Rs for natural persons
Handling/ courier charges
1000 Rs
Total
10000 to 30,000 Rs approximately

Any individual can file a patent with Indian patent office. However, preparing a patent draft requires techno-legal expertise and hence needs to be prepared by experts. The expert may be a lawyer or even a non-lawyer. 

For further details, please send an email to pharmaliterati@gmail.com

Thursday, 8 October 2015

Centre to establish three more AIIMS at Nagpur, Manglagiri & Kalyani at Rs.4949 crore


The Union Cabinet chaired by the Prime Minister Narendra Modi has given its approval for setting up of three new All India Institutes of Medical Sciences (AllMS) at Nagpur in Maharashtra, at Manglagiri in Andhra Pradesh and at Kalyani in West Bengal under Pradhan Mantri Swasthya Suraksha Yojna (PMSSY). This involves financial implication of Rs.4949 crore.

The new AIIMS will be established as institutes of national importance for providing quality medical education, nursing education and also to provide tertiary healthcare facilities to the people of these locations. The proposed institution shall have a hospital with capacity of 960 beds. In addition, there shall be a teaching block, administrative block, Ayush block, auditorium, nursing college, night shelter, hostel and residential facilities.

Of the total expenditure of Rs.4949 crore, the cost of the new AIIMS at Manglagiri in Andhra Pradesh will be to the tune of Rs.1618 crore, at Nagpur in Maharashtra of Rs.1577 crore and at Kalyani in West Bengal of Rs.1754 crore.

Setting up of these AIIMS will address regional imbalances in availability of affordable and reliable tertiary health care services in these regions. It will augment the facilities of quality medical education and would also address the shortfall of health care professionals in these regions.

The large populations of Andhra Pradesh, Maharashtra (Vidarbha) and West Bengal along with adjoining States and region will be beneficiary of this project.

Six new AIIMS under the Pradhan Mantri Swasthya Suraksha Yojna (PMSSY) have been made functional. Also construction of AIIMS, Rae Barely is under progress.

The approval for three more new AIIMS is in accordance with the announcement made by Union Finance Minister in his Budget Speech 2014-15 establishing new AIIMS at these places. This also fulfills the promise made under the Andhra Pradesh re-organization Act 2014 that provides for establishment of one AIIMS type institute in the successor State of Andhra Pradesh.

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=91002&sid=1