Tuesday, 28 June 2016

Brexit Will Be Bad For Pharma

In this nice piece of article on Forbes, http://www.forbes.com/sites/stephenbrozak/2016/06/25/brexit-will-be-bad-for-pharma/#398890a57ab3 the author highlights the impact of Britain's potential exit from the European Union on the pharmaceutical industry.

1. Big Pharma’s balance sheets just took a hit:
Between the UK and the EU, most large pharmaceuticals have more than 20% of their sales in the region; as a result, these companies will be working the numbers this weekend to see how their performance will be affected by Brexit and the ensuing financial chaos.

2. The healthcare capital markets have now come to a screeching halt:
With a decompensating banking system, the UK’s financial chaos will certainly have a domino effect across the rest of the continent. Management teams will be distracted, layoffs will certainly ensue and, once that happens, meaningful R&D will slow down as workers begin to worry about their jobs.

3. Even the EMA is a question mark:
The European Medicines Agency (EMA) is the pharmaceutical regulatory agency for Europe. Right now, the word is: “Don’t panic. No changes soon.” Nice to know, since EMA headquarters is Canary Wharf, London.

4. The downsides of inversions:
As EU cohesion and European financial instability become issues, tax laws as well as trading relationships are in play.

Remember: Pharmaceutical and medical device companies aren’t just service providers. They are among the largest industries in the world. They require stability. And suddenly, we don’t have it.

National Seminar on Advances in Technology, Regulatory and Clinical Aspects ts in Controlled Drug Delivery system

Delhi Pharmaceutical Sciences and Research University (DPSRU) and Controlled Release Society - Indian Local Chapter, better known as CRS-IC are organizing National Seminar on Advances in Technology, Regulatory and Clinical Aspects ts in Controlled Drug Delivery system.

The details for the same are as follows:

Date:                 July 15, 2016.
Theme:             Affordable Medical Services via Pharmaceutical Research

Poster Session:
Young scientists will have an opportunity to present a concise overview of their research study. The posters will provide a platform for discussion, a forum to exchange ideas and ample opportunity for networking.

Abstract submission:
The research abstract should be appropriately structured and complete with the subheadings – Title, Authors, Address, Email id, Objective, Methods, Result and Conclusion. The title should be written in capitals. Name of authors should start with surname, followed by initials of rst and middle name. Underline the name of presenting author. The main body of abstract should not exceed 250 words. Type in single space with font times new roman and letter size 12 in the abstract. Research work based abstracts/presentations will be given priority. The abstract can be submitted by email to: dpsrucrs2016@gmail.com
Last date for abstract submission: 5th July, 2016.

Poster Guidelines:
Participants are requested to present posters of size 1.0 X 1.2 m. The content should be visible from a distance of atleast 1.5 m.

Friday, 24 June 2016

Blood transfusion and its risk assessment: are we safe?

This post originally appeared on our partner blog Pharma Sastra at http://pharmasastra.blogspot.in/2016/06/blood-transfusion-and-its-risk.html

14th June, WORLD BLOOD DONOR DAY, a campaign marked by WHO (World Health Organization), established in 2004 in order to raise awareness of the need for safe blood and blood products, and to thank blood donors for their voluntary, life-saving gifts of blood.

World Blood Donor Day celebration brings a precious opportunity to all donors for celebrating it on national and global level as to commemorate the birthday anniversary of KARL LANDSTEINER (a great scientist who won the Nobel Prize for his great discovery of the ABO blood group system).

This year the theme of the day was “Blood connects us all”. And we should not forget that blood can also connect to us via a disease as well.

This week itself, lots of blood donation program has been conducted by various organizations. But very less such organization take care about the risk of disease transmission via such large mass blood donation program. Here we tried to elaborate some risk which can occur via blood donation programs. Being a health professional its our duty to present a real picture and risk of blood transfusion.

Transfusion-Transmitted Infection (TTI):
Blood transfusion has been and continues to be a possible source of disease transmission. A myriad of agents can potentially be transmitted through blood transfusions, including bacteria, viruses and parasites. Of these, bacteria are the most commonly transmitted. Some of the enlisted exogenous substances which may come during blood transfusion and infect the healthy human:
·        Prions : These can cause Creutzfeldt-Jakob disease, are also transmissible through transfusion; they cannot be destroyed using current techniques for inactivating pathogens in the blood supply.
·       Viral: Nowadays viral transmission is a greatest chanllenge for the health professionals. Dieases like hepatitis C and HIV has high risk of transmission by blood transfusion. Some other like, cytomegalovirus (CMV), Human T-cell lymphotrophic viruses (HTLVs), West Nile Virus 9 (WNV).
·         Parasites: Some parasites like malaria also transmit via blood transfusion.
·         Bacteria:- Some of the bacterias like Pseudomonas, Staphylococci, Treponema Pallidum, a spirochete bacterium(Syphilis).

Any infective agent that potentially evades the sterility of the transfusion loop can come from the donor's blood or skin or from a contaminated environment. It has been proposed that the higher incidence of bacterial transmission via platelets is due to the difference in storage temperatures. Also important is the duration of storage, which has a direct correlation with the likelihood of bacterial contamination. An important concept in the evaluation of data regarding transfusion-transmitted bacterial infections (TTBIs) is the definition of a case.

Such infected blood transfusion can cause mild to serious damage till death. So to prevent such ill effect any organization can take various measures which are enlisted below:
*Donor selection
*Processing, Quality control
*Screening Tests
*Storage , Pathogen inactivation
*Better blood transfusion
*Tracing surveillance

We recommend any organization to follow following measures or visit red cross for the proper guidance and training.
·     Assure the donor safe from any diseases by taking his/her history.
·     Repeat the type and cross-match, and also collect blood for a Coombs test and bacterial culture from the recipient
·     In order to prevent an infective incident, strict sterile precautions and donor screening are required 
·     Donors who are febrile and likely infected should be deferred
·     Chlorhexidine or iodine should be used to properly disinfect the venipuncture site.
·     The initial aliquot of donor blood should be discarded to prevent contamination with the skin flora.
·     Identify bacterial contamination by laboratory methods
·     Bactericidally treat the donated blood

Despite the potential for disease transmission through transfused blood, the safety of the blood supply should be continued to improve blood donation and transfusion.

Ms. Sandhaya D.

Wednesday, 22 June 2016

OPPI hails new FDI norms for pharmaceutical sector

The Organisation of Pharmaceutical Producers of India (OPPI) today welcomed the Centres decision to allow up to 74 per cent Foreign Direct Investment (FDI) in pharmaceutical sector under the automatic route.

With the objective of promoting the development of this sector, it has been decided to permit up to 74 per cent FDI under automatic route in brownfield pharmaceuticals and government approval route beyond 74 per cent will continue.

"We welcome (the) governments decision to make changes to the FDI policy. We believe that this will provide an impetus to employment and job creation in the country," OPPI Director General Kanchana TK told PTI.

"The decision...will augur well with our members who are constantly exploring ways of ensuring new drugs and medicines are made available to Indian patients," Kanchana added.

Under the existing policy in the sector, 100 per cent FDI is allowed under automatic route in greenfield pharma and up to 100 per cent under government approval in brownfield pharma.

The new norms will enable enhanced investments (in the form of M&A activity) from the MNC companies, which believe in the growth potential of the domestic industry.

Source: http://indiatoday.intoday.in/story/oppi-hails-new-fdi-norms-for-pharmaceutical-sector/1/696879.html

Pharma biggies among 200 under lens for poor drugs

The Drug Controller General of India has launched inspections against 200 drug makers, including leading firms like Cipla and Pfizer, for allegedly selling poor quality medicines and non-compliance to manufacturing norms.

"We have already inspected 36 drug manufacturing plants over last three months. In the second phase, starting from Monday, we will conduct inspections in 20 more facilities, “an official in the health ministry told TOI.

According to a source, notices have been issued recently to Cipla and Pfizer informing them of the upcoming inspection as well as violations found in their products. Cipla maintained it has not received any intimation so far. Pfizer did not comment.

This is for the first time inspections on this scale have been undertaken by the domestic regulator. The move also assumes significance as it comes in the wake of the recent regulatory ban on 344 fixed dose combination drugs.

The 200 companies, where "risk-based inspections" are being carried out, have been listed based on three criterion. "We have analysed regulatory data for last five years and listed companies where violations were reported regularly. Besides, complaints from international agencies and importers of medicines from Indian plants have been considered," the official said.

The regulator has also drawn drug samples from the market through surveys and gathered inputs from state authorities to identify the firms.

The 36 plants already inspected are based in Tamil Nadu, Uttarakhand, Maharashtra and Himachal Pradesh. The health ministry had also organised special training programmes for drug inspectors to ensure objectivity and transparency.

Indian pharmaceutical manufacturing plants have been on the radar of international agencies. Ranbaxy Laboratories, now part of Sun Pharma, had to stop supplies after the US FDA pointed out major violations. Pharmaceutical exports are expected to cross $20 billion by 2020 from $14 billion in 2016.

Source: http://timesofindia.indiatimes.com/india/Pharma-biggies-among-200-under-lens-for-poor-drugs/articleshow/52842920.cms

Higher cap in pharma sector raises questions

In 2010, alarm bells went off when the government found that the pharmaceutical industry had witnessed about six local acquisitions by foreign drug makers in just five years.

Ministries like Commerce and Health started wondering aloud if investment caps were required in a sector that was integral to keeping the “health security” of the country.

In fact, multiple departments evaluated these concerns, including the DIPP (Department of Industrial Policy and Promotion), the Arun Maira committee and a Parliamentary Committee on Foreign Direct Investment (FDI) in the pharmaceutical sector. The resounding view was that new or greenfield projects could attract 100 per cent FDI, while brownfield investments (into existing operations) would go through a gate-keeper, a task bestowed on the FIPB (Foreign Investment Promotion Board), again after much discussion.

This being the backdrop, the Centre’s latest move to relax foreign investments in domestic pharmaceutical operations up to 74 per cent has raised the question as to what gave confidence for such a decision, and whether concerns raised by several agencies in the past have been allayed. The move would have met with greater approval if the Centre was transparent with the rationale behind the decision.

Stable policies
But not everyone is worried that a domestic sell-out is imminent. Hitesh Sharma, EY’s Partner and National Head (Life Sciences), observes the move may not be a “game-changer”, though it does reduce the uncertainty and waiting period of three-six months that every deal took while being reviewed by the FIPB.

Beyond the 74 per cent cut-off, a buy-out deal will be put through checks on its overall size and the impact on market share, etc, he points out, referring to concerns on whether the latest move would change the ability of local drug makers to make medicines.

In fact, he adds, the FDI breather, in isolation, would not see foreign drug makers line-up to buy operations in India, until greater stability comes into the local environment in terms of clinical trial norms, intellectual property protection, and medicine price control. Indian Pharmaceutical Alliance’s DG Shah feels the “acid test” for the government is in how the pharmaceutical landscape fares over the next three years. It will show up whether investments come into small drug companies making generic medicines, or into those making specialty products like injectables, vaccines, and biotech products, he says.

A similar concern had been raised in the Parliamentary committee report on the subject that found FDI went largely into brownfield projects.
The concern of “family silver” leaving the country had reached a shrill pitch when big-guns in the industry like Ranbaxy sold out to Daiichi Sankyo and Piramal Healthcare sold domestic operations to Abbott.

The Parliamentary report also stated that investments needed to go into segments like Active Pharmaceutical Ingredients (bulk drugs), etc.

Source: http://www.thehindubusinessline.com/economy/higher-cap-in-pharma-sector-raises-questions/article8756737.ece

Tuesday, 21 June 2016

FDI in pharma to boost mergers and acquisitions, say experts

Govt’s decision to increase FDI to 74% in existing pharma companies is expected to boost mergers and acquisitions and private equity investments in the sector.

The government’s decision to increase foreign direct investment (FDI) to 74% in existing pharmaceutical companies through the automatic route is expected to boost mergers and acquisitions (M&As) and private equity investments in the sector in future, said experts.

Allowing FDI beyond 74% will continue through the government approval route. Earlier, 100% FDI was permitted through the government approval route. The government has also allowed 100% FDI under the automatic route in greenfield pharma.

India’s pharmaceutical market may reach $20 billion this year and about $55 billion by 2020 from about $18 billion as of 2014, clocking a compounded annual growth rate (CAGR) of over 22%, according to a joint study by the Associated Chambers of Commerce & Industry of India (ASSOCHAM)-TechSci Research released in June.

“Keeping the cost of production low in India and with high pricing in the US, the margins Indian generic firms make are very high. Even the branded generics market in India has high margins. I believe there is a lot of synergy in cross border deals and with this FDI proposal, it will increase the number and size of deals,” said Ameera Shah, managing director and chief executive officer, Metropolis Healthcare.

“This is a welcome change for global pharma players looking at establishing a presence in India but not looking for a 100% stake. Some foreign investors actually prefer having local partners, and this change will facilitate those deals,” said Sameer Sah, associate partner, Khaitan & Co.

“The new FDI norms are steps in the right direction. They will stimulate more M&A and investment in CRAMS (Contract Research And Manufacturing Services). We need to now streamline regulations, particularly Drug Price Control Orders (DPCO),” said Kewal Handa, industry expert and former managing director of Pfizer India.

Source: http://www.livemint.com/Companies/UuPjuc77Bqn4ZcxITQj4xK/FDI-in-pharma-to-boost-MAs-PE-investments-say-experts.html

Tuesday, 14 June 2016

Karl Landsteiner's birthday_The father of transfusion medicine

Today's Google doodle is about Karl Landsteiner.

Karl Landsteiner, (June 14, 1868 – June 26, 1943), was an Austrian and American biologist and physician. He is noted for having first distinguished the main blood groups in 1900, having developed the modern system of classification of blood groups from his identification of the presence of agglutinins in the blood, and having identified, with Alexander S. Wiener, the Rhesus factor, in 1937, thus enabling physicians to transfuse blood without endangering the patient′s life. With Constantin Levaditi and Erwin Popper, he discovered the polio virus in 1909.

In 1930 he received the Nobel Prize in Physiology or Medicine.

Monday, 13 June 2016

Telangana to set up ‘Pharma City’ near Hyderabad

The Telangana government on Friday ordered setting up of a "Pharma City" on 12,500 acres of land in Rangareddy and Mahbubnagar districts of the state.

Telangana State Industrial Infrastructure Corporation (TSIIC) shall send detailed project proposal (DPR) to the government on modalities for implementation and execution of project and also carry out all aspects related to the development of this park in a transparent manner duly following all relevant rules, a government order said.

"As Telangana has traditionally been the bulk drugs capital of the country with almost 1/3 of the total production in value terms, state government intends to keep not only the leader status in the sector but also facilitate setting up of the most modern facilities along with all necessary where withal in an integrated manner," it added.

The government has accordingly decided to set up a state-of-the-art pharmaceutical city, a one stop shop for pharmaceuticals manufacturing companies, biotech and life sciences companies along with all related activities, it said.

The proposed park will have components and other related activities with regard to antibiotics, fermentation products, synthetic drugs, large volume chemical synthesis, intermediaries, vitamins, vaccines, drug formulations, nutraceuticals, herbal medicinal products, specialty chemicals, cosmetics among others.

"Efforts will also be made to establish research & development incubation centre, central testing facilities facilitating clinical trials, testing and certification, contract research & custom synthesis," it order further said.

The actual location and exact extent of land will be firmed up based on the availability of government land and private land, it added.

Source: http://timesofindia.indiatimes.com/business/india-business/Telangana-to-set-up-Pharma-City-near-Hyderabad/articleshow/52694056.cms

Monday, 6 June 2016

Seminar on “Selection of excipients for oral solid dosage forms”

Small and medium pharmaceutical industry centre (SMPIC) and NIPER, Mohali are organizing one-day Seminar on “Selection of excipients for oral solid dosage forms”.

The details of the same are as follows:
Date:               Thursday, 30th June, 2016.
Venue:             NIPER, Mohali. 
Topic:              Seminar on “Selection of excipients for oral solid dosage forms”

1st Conference of the Indian Society for the Study of Xenobiotics (SSX®)

Details available at: http://www.issx.org/page/ssxmeeting

The Indian Society for Study of Xenobiotics (SSX®) is organizing its inaugural conference in Bangalore, September 1-3, 2016. The program will feature renowned speakers in drug metabolism, pharmacokinetics and toxicology, short courses, poster sessions, round-table discussions, mentoring sessions for students and young scientists, a vendor exhibition and numerous networking opportunities. SSX anticipates more than 200 attendees for this conference, with representation from academia, industry, CROs, government research institutes and vendors.

Dates:              September 1 - 3, 2016.

Venue:              JN Tata Auditorium, Indian Institute of Science (IISc) Bangalore, India 560012.

Themes:            Four main themes have been finalized:
  • Transporters
  • Drug induced liver injury/mechanisms of drug-induced toxicity
  • Pharmacokinetics/pharmacodynamics relationships, Modeling and Simulation
  • Drug-drug interactions/Personalized Medicine

Short Courses:
Two parallel short courses will be held:

·    Course 1 will cover basics and applications DMPK principles including biotransformation, transporters, clinical pharmacokinetics and biosimilars
·       Course 2 will be a whole day workshop by SIMCYP

Abstract Submission:
Abstracts for poster presentations are invited from diverse areas of drug metabolism and pharmacokinetics (DMPK) including in vitro/ in vivo/ in silico aspects of absorption, distribution, metabolism, excretion and toxicity (ADMET), drug-drug/drug-herb interactions, transporters, pharmacokinetics/pharmacodynamics and modelling, pharmacogenomics/personalized medicine, analytical methods in DMPK and regulatory aspects of DMPK. Best student abstract will be selected for oral presentations in the scientific sessions. Three posters will be selected for recognition in the Poster Award Competition.

Maximum Length and Format: 300 words with the subsections on title, affiliation, background and objectives, methods, results and discussion, conclusion. Abstracts due by July 15, 2016.

Mentorship Program:
SSX is committed to helping students and young scientists understand and explore research and career options that could help achieve their full potential by providing them mentorship opportunities from senior drug metabolism and pharmacokinetics (DMPK) scientists from academia and industry. Graduate students and young scientists will be paired with senior DMPK researchers so that they can get the opportunity to network, get research and career advice, and establish relationships that could help them in many aspects of their career. Participants in the mentorship program will be chosen on the basis of the submitted abstract and a short questionnaire.

Saturday, 4 June 2016

Pharma academic research - Indian patent applications published on 20th May 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

Application No
Institute/ University
A novel pH sensitive macromer based copolymer and a process for the preparation thereof
1) Suvarnapathaki Rupali Kedar
2) Kulkarni Mohan Gopalkrishna
Council of Scientific Industrial Research

INNOPHARM 2_International Conference on Bridging Innovations in Pharmaceutical, Medical and Bio Sciences

Paramita Health Care Society is organizing INNOPHARM 2, an International Conference on Bridging Innovations in Pharmaceutical, Medical and Bio Sciences in Bhopal, on 10 - 11 Feburary, 2017.

Conference Sessions:
Sessions in the conferences will be classified under following thrust subject areas
1.    Pharmaceutics, formulation development, NDDS, regulatory affairs and IPR
2.    Natural drug research, pharmacognosy, phytomedicine and biotechnology
3.    Pharmaceutical/Medical Chemistry, analysis, synthesis and molecular drug design
4.    Pharmacology, clinical research, pharmacy practice and pharmacovigilance
5.    Biochemistry, microbiology, cell biology and miscellaneous

Conference Scope:
Topics of interests include, but are not limited to:
·         Pharmaceutical technology, novel drug delivery system
·         Biopharmaceutics, pharmacokinetics and drug metabolism
·         Pharmacognosy, indigenous drugs, herbal formulations
·         Natural drug research and biological studies
·         Biotechnology and biotherapeutics
·         Biochemistry, microbiology, cell biology
·         Pharmacology, toxicology and preclinical research
·         Clinical research and pharmacovigilance
·         Medicinal chemistry, combinational chemistry
·         Pharmaceutical analysis and quality assurance
·         Drug regulatory affairs, patents, IPR
·         Pharmacoeconomics and pharmacoepidemiology
·         Polymer science, imaging and diagnostics

Conference venue:
M.P. Council of Science & Technology, Vigyan Bhawan, Nehru Nagar, Bhopal 462003 MP, India.
Important Dates:

 Abstract submission
 March 1, 2016
 July 30, 2016
 Notification of Acceptance
 By August 15, 2016
 Early Bird Registration
 March 1, 2016
 September 15, 2016
 Proceeding Submission
 December 1, 2016
 December 30, 2016