Friday, 31 March 2017

Pharma Innovation Yatra_March 2017

Pharma Innovation Yatra was launched in the month of January 2017. This March the Yatra was at SIES Institute of Management in Navi Mumbai. The speaker interacted with the students doing their MBA in Pharmaceutical Management and Biotechnology management.

The events were conducted with presentations on creative thinking, innovation and role of patents in the pharmaceutical industry.

1. Vivekanand Education Society’s College of Pharmacy.
Website:
University:
University of Mumbai.
Location:
Mumbai, Maharashtra.

2. M. C. E. Society’s Allana College of Pharmacy.
Website:
University:
Savitribai Phule Pune University.
Location:
Pune, Maharashtra.

3. SVKM’s Dr. Bhanuben Nanavati College of Pharmacy.
Website:
University:
University of Mumbai.
Location:
Mumbai, Maharashtra.

4. Maharashtra College of Pharmacy.
Website:
University:
Swami Ramanand Teerth Marathwada University, Nanded.
Location:
Nilanga, Maharashtra.

5. NCRD’s Sterling Institute of Pharmacy.
Website:
http://www.ncrdsip.com/
University:
University of Mumbai.
Location:
Navi Mumbai, Maharashtra.

6. Oriental College of Pharmacy.
Website:
http://ocp.edu.in/site/
University:
University of Mumbai.
Location:
Navi Mumbai, Maharashtra.

7. Rajarambapu College of Pharmacy.
Website:
http://www.kespharmacy.com/
University:
Shivaji University, Kolhapur.
Location:
Kasegaon, Dist. Sangali, Maharashtra.

8. Ashokrao Mane College of Pharmacy.
Website:
http://www.amcoph.org/
University:
Shivaji University, Kolhapur.
Location:
Peth Vadgaon, Dist. Kolhapur, Maharashtra.

9. SIES College of Management studies.
Website:
University:
Mumbai University
Location:
Navi Mumbai, Maharahtra.

Please get in touch with us at pharmaliterati@gmail.com to know more or arrange the workshop at your institute. 

There is no specific fee for the workshop and the institute needs to decide about the arrangement for the same. 

Monday, 27 March 2017

Patent filing feasibility study for M. Pharma students_Free of cost by Pharma Literati

As a commitment to the profession, we at pharma literati are offering free patentability analysis for the thesis of M. Pharma students. This is for the limited period till 30th April 2017.

In this, a group of experts at pharma literati would assess the patentability of your M. Pharma thesis free of cost. 

Eligibility:
1. M. Pharma students passing out in 2017;
2. The thesis has not been yet published as a research paper or presented in any conference;
3. Any students who passed out in 2016 are also eligible provided the institute allows them.
4. Anyone registered for Phd in pharmaceutical sciences in India and not yet submitted the thesis for the same. 

Process:
1. With prior permission of the institute or University, the students need to make use of the service by pharma literati;
2. The students would discuss the thesis or the novel aspect of the thesis with our experts;
3. If required, a confidentiality disclosure agreement is signed between the institute and the experts;
4. The experts would provide patentability analysis within a time frame of 10 days to the institute or students, which report would be confidential. This would be free of cost. 
5. This does not involve any activity related to patent drafting or filing. The students, faculty members and institutes can file their patents independently based on the discretion of the report with any expert or agent. 

The students, faculty members and institutes can get in touch with us to know more. Send an email to pharmaliterati@gmail.com for the same. 

Wednesday, 22 March 2017

Internship opportunities at Pharma Literati

Pharma Literati is pleased to announce the internship opportunities for undergraduate/ post-graduate students in pharmacy/ life sciences domain. 

Looking for passionate, career-focused, highly motivated individuals who wish to join the dynamic team of Pharma Literati. 


  • Profile: The students would work on a collaborative project along with an industry expert for the purpose of original research work or review or literature survey or market research; Also, the students would work as bloggers for this tenure. 
  • Location: Work from home;
  • Tenure: 2-3 months during summer vacation;
  • Joining date: Flexible, after the examinations;
  • Requirements: Internet connection and laptop/desktop at home;
  • Stipend: No stipend in the form of cash; However, expenses if any, during the internship would be reimbursed; Also, few opportunities available to get benefited via different platforms; 
  • Eligibility: B. Pharm/ M. Pharm students with basic understanding of internet and Microsoft Office;
  • Certificate: To be provided to the intern on successful completion of internship;
  • Project: The students can publish the work during the internship in co-authorship with their mentor who would be assigned to them during the internship. 
Send your CVs to pharmaliterati@gmail.com before 10th April, 2017. Only 2-3 positions available. 

Lost interest in Fixed dose combinations

In spite of favourable court verdicts, top pharmaceutical companies are losing enthusiasm for fixed dose combination medicines.

Early this year, the Indian arm of Pfizer decided to discontinue the manufacture and sale of Corex cough syrup, the crown jewel in its domestic portfolio. Corex was its biggest revenue generator and among the country’s top five drug brands. What made the decision more surprising was that Pfizer had fought a legal battle against a March 2016 Central government ban on sale of this fixed dose combination, or FDC, medicine, along with 333 others, and won. The decision to discontinue the syrup came a month after the court ruling. The government had banned these FDC drugs in March 2016 after a committee of experts found that they were likely to pose a risk to patients and safer alternatives were available. An FDC drug includes two or more active pharmaceutical ingredients combined in a single dosage form.

Pfizer says the decision was based on a review of "respiratory offerings" that happened independent of the legal issues. "We decided to discontinue the manufacture of the erstwhile Corex cough syrup. At the same time, we decided to launch a series of line extensions of the Corex brand that will address specific sub-therapeutic areas under the broad respiratory segment," says a Pfizer spokesperson.

Perhaps, that was not the only reason. By winning the case, Pfizer proved its argument that there was no legal basis for banning Corex (a combination of chlorpheniramine maleate, codeine phosphate and some colorants). At the same time, the decision to discontinue the sale of the specific FDC drug made a bigger point - that Pfizer was not opposing the spirit behind the government decision, which was to stop the sale of 'irrational' and 'unapproved' FDC drugs. An FDC is called 'irrational' when there is no scientific rationale for combining two or more individual drugs in a particular combination.

Pfizer is not alone. In spite of the court staying the ban just a few days after it was imposed, the share of FDC drugs in total sales has been going down. One reason could be the uncertainty about the final court verdict and government policy. The other could be pharmaceutical companies, too, being alive to the safety concerns around some of these drugs.

For instance, Pfizer, in response to queries from BT, said while it welcomed the high court order that allowed the company to continue the manufacture and sale of Corex, it is also "fully supportive of any process that is aimed at weeding out medicines that are irrational or not duly approved by the central and state regulators".

Market research firm AIOCD-AWACS has estimated that the market of all these FDC drugs, at the time of the ban, was worth `4,000 crore or about 4 per cent of the Indian pharmaceutical market. Early estimates by AWACS put Pfizer's potential loss at 12 per cent of revenues. Abbott, affected the most, was staring at a potential 15 per cent revenue loss, it said.

THE ISSUES
India has been battling the problem of unapproved and irrational FDCs for two decades. While FDCs account for a small percentage of new drugs approved globally, in India, almost every second medicine that gets marketing approval is a combination drug. The combination of two or more medicines is not a problem in itself. It is, in fact, preferred for several conditions such as HIV-AIDS and diabetes that are lifelong or life threatening, as fewer drugs means lower cost and better patient compliance. However, the presence of hundreds of drug combinations with untested efficacy/safety was an India-specific problem that the government had no option but to sort out.

What is worse is that India's regulatory system was indirectly contributing to the mess till 2002. The companies were, until then, exploiting the ambiguity over the powers of state drug regulatory authorities and the central drug regulator, the Drugs Controller General of India or DCGI. This allowed them to launch FDC drugs after state regulators' approval, though laws (clarified again in 2002) stipulated that all new drugs, including new combinations of approved medicines, could be approved only by the central regulator. By 2007, the DCGI had identified 294 unapproved FDC drugs and asked state drug authorities to ban these. The decision was not implemented due to a Madras High Court stay order. The matter is still sub judice.

The second move to weed out irrational drug combinations came in 2012, when the Parliamentary Standing Committee on Health came out with startling revelations about unapproved and FDC drugs. The committee called for a transparent policy for approving FDC drugs based on scientific principles. As a result, in 2013, the DCGI asked drug manufacturers for proof of safety and efficacy of medicines that had only "state approval". In the next 18 months, it got 6,300 applications. An expert committee scrutinised these and recommended ban on 344 FDC drugs. It was government action on this recommendation that was challenged by companies such as Pfizer in the Delhi High Court, which quashed it on December 1, 2016. Since all 454 petitioners, including Pfizer, had anyways got a stay on the order immediately after it was notified in March 2016, the companies were free to sell these medicines.

Almost every major player Business Today contacted either refused to comment or stood by the FDCs it was selling. "No comments," said a spokesperson for Sun Pharmaceuticals, India's biggest drug company. The India arm of US major Abbott, the most impacted, said the "judgment provides thousands of patients continued access to Abbott's doctor-prescribed products, which have the necessary regulatory approvals for manufacture, distribution and sale in India". Abbott's FDC drugs in question were mostly from Piramal Healthcare, whose formulations business it had acquired years ago.
THE FUTURE
The drugs controller, G.N. Singh, was on an official visit to Washington when the ban was notified. Among the visitors, immediately after the news about the ban spread, were some senior executives of Pfizer. "They met me there. I made it clear that we expected companies to be fair. They shouldn't go by the technicalities of approvals when their medicines are creating a public health issue. If people are getting addicted by your medicine, and if the government decides to ban the drug in public interest, there is no point in saying you have the approval," Singh recalls his message to the Pfizer team.

The problem with Corex and similar syrups was not whether they had all the approvals or whether the combinations were 'rational' or not. The issue was misuse. Codeine, its key ingredient, was a derivative of opium, and addictive. Singh, too, was referring to the alleged rampant misuse, which was the key reason for its inclusion among other 'irrational' and 'unapproved' FDC drugs.

Singh recalls that the executives of the global drug major assured to look into the 'ethics' of the problem. That perhaps explains the voluntary recall after the favourable court ruling.

Was Pfizer's response an exception? Not likely. Numbers suggest it has not been business-as-usual in the FDC segment ever since the ban order. Despite the high court stay on the ban, sale of FDCs, growing steadily before the ban, started falling. The fall has been severe in categories that most banned FDCs belonged to - respiratory, pain, anti-diabetic, dermatology and gastro-intestinal. AIOCD-AWACS data say the sale of FDC drugs fell 34.9 per cent in February 2017, when the overall domestic market grew7.1 per cent. In the preceding 12 months, the average fall in revenues was 22.3 per cent. The drugs controller says there has been a fall in the number of new FDC applications too. "Unfortunately, whenever there is confusion, the sentiment of manufacturers is hit. It will also impact development of FDC drugs. I hope the trend goes away," says Singh.

"The future (of FDCs in trouble) is doubtful. So, companies are not pushing such products. Not much brand building is happening. This is a short-term impact," says D.G. Shah, Secretary General of the Indian Pharmaceutical Alliance, which represents leading 20 drug makers that together account for 46 per cent domestic drug market.

While sales do indicate broad trends, they do not capture the complete reality of the market, served by close to 10,000 - majority of them tiny - pharmaceutical formulation manufacturing and marketing companies. While sales data tracked by market intelligence agencies capture the traditional wholesale and stockist channels, a big chunk of drugs, including FDCs approved by states, is marketed directly through medical practitioners, especially in rural markets. There are hundreds of companies that focus on these small pockets. The problem will end when one can ensure that even the smallest of such entities also stop making unethical and 'irrational' FDC drugs.

Unfortunately, the DCGI office has no database to track approvals given by state authorities on a real-time basis. Even past data are not fully available. One can only hope that state regulators are approving only those combinations that have undergone clinical trials as per the central protocol and received approval from the central regulator. "I don't think they will be giving fresh licences, as we have already informed them that these drugs are 'irrational' and that they should not clear FDC drugs that we have not approved. Since there is status quo, the companies that have old approvals from states continue to market these drugs but not the new ones," says Singh.

The irrationality of drugs approved by the central authority was also questioned by a parliamentary panel in 2013. The DCGI says it has since then set up 25 expert committees within the central drug administration to track medicines that may become 'irrational' on the basis of latest scientific developments. "We are making extra efforts. Our inspections are now meaningful as we are handholding state administrations. We are strengthening our surveillance systems so that no wrong-doer can get away. The WHO has declared us a stringent regulatory authority and we are in the same league as the US FDA and the UK's MHRA. We need to sustain that. The message is clear. Wrong-doers will be thrown out," says Singh.

Incidentally, over 40 per cent FDCs that were scrutinised by the expert committee were given a clean chit. The road ahead for irrational FDCs might be difficult but that might not be the case with rational combinations.

Hyderabad Univarsity inks MoU with Natco Pharma for research

University of Hyderabad (UoH) has signed an MoU with Natco Pharma for carrying out advance research in the areas of discovery of novel drugs and their delivery systems among others.

According to a release issued by the university today, the research includes nano formulations of new chemical entities and novel biotechnological processes for specific products with potential commercial importance.

Both the parties will promote cooperation in academic exchange, research and development collaborations, training and research in the areas of biotechnology, pharmacology, toxicology, pharmaceutical technology and organisation of national and international conferences, exhibition and similar events in areas of mutual interest, it said.

School of Life Sciences of UoH has been undertaking collaborative research in the areas of drug discovery for the past several years with Natco. The research has resulted in developing one of the molecules to Phase-II clinical trials for the treatment of chronic myeloid leukaemia, it added.

The MoU, signed for a period of five years, will foster the academy industry interactions by utilisation of expertise of the faculty and infrastructural facilities for promoting anti-cancer drug discovery research and development at Natco, it said.



Monday, 13 March 2017

RGUHS mandates revision of theory question paper pattern for Pharmacy UG, PG & D Pharm courses from May

The Rajiv Gandhi University of Health Sciences, Karnataka has issued a draft notification for the revision of the theory question paper pattern in the Pharmacy of RS4 (regular and supplement) batch of undergraduate and post graduate courses. The notification will come into effect from May 2017.

At its 124th syndicate meeting, the RGHUS has now taken a decision to revise the theory questions paper by offering no choices. Under section 35(1) of the RGHUS Act 1994, the Syndicate vide ref. No. 03 approved the recommendations of the BOS (Board of Studies) vide reference No. 1 and faculty of pharmacy vide reference No 2 to revise the theory question paper.

For B Pharm, the revised question paper pattern will now mandate two long essays to be answered of 20 marks total. The candidate will also need to attempt all the 6 short essays of 5 marks taking the total to 30 marks. There will be 10 short answers of two marks each for a total of 20 marks.

Pharm D students will have a similar question paper format and the scoring pattern like that of the B Pharm. In the case of M Pharm, the candidates will now need to answer all the 10 questions of 10 marks each .

Education experts view the new format as transformational as it will enable the students to reshape how they learn and what they learn. The question paper pattern with no choice selection of questions will impact every aspect of classroom education from teacher training engagement to curriculum design and assessment.

According to Prof. Divakar Goli, Principal, Acharya & B M Reddy College of Pharmacy, this move is a positive step in the creation of high quality graduates and post graduates besides pharmacy diploma qualified candidates.

Previously there was a choice of questions in the examination. Now the choice is taken out. The other is the minimum marks to be scored in the examination. As per the new format, students need to score 40 per cent out of 70 marks in the University exams as against the earlier pattern of no minimum marks. So long students needed only 50 percent out of 100 to pass. The internal assessment comprised 30 marks and University exams 70 marks. In the former, most colleges gave full marks. This led to the student to score 30 out of 30. For the University exams, students needed only 20 out of 70 marks. We noticed that they lacked the subject knowledge, he added.

With the new format, students need a minimum of 50 marks out of 100 to pass the exam. They will need to score 40 per cent score out of 70 marks for the University exams. This change in question paper pattern was needed to improve the pharmacy education in the state across its 73 colleges. The move by the RGHUS is the best that could happen to improve the standard of education. There is no choice for the student in picking up chapters to study. Instead, they are expected to have adequate information on all the topics to be able to answer and succeed in the exam, noted Prof. Goli.



Pharma park on Jharkhand radar

If officials walk the talk, capital Ranchi could host Jharkhand's first ever pharma park, an idea promoted by the Union government on the lines of the present trend of earmarking geographical areas to develop specific industries like IT, pharma, auto etc.

Jharkhand Infrastructure Industrial Development Corporation (JIIDCO), an arm of the state industries department, today floated expression of interest in search of agencies to prepare a detailed project and feasibility report, attract investments and handle other allied work to set up a pharma park.

State industries director K. Ravikumar said the government had already earmarked around 50 acres at Itki and Sode areas near Ring Road on the outskirts of Ranchi.

"During our field visits, we realised that both places could be suitable for pharma parks. Once a DPR is prepared and a feasibility report comes in, we would take a call on where to go ahead," said Ravikumar, who is also MD of JIIDCO.

The total cost of the project, he added, would be known after the DPR was prepared.

In 2015, following the Union cabinet's decision to allow 100 per cent FDI in manufacturing of medical devices and allied products as a part of its responsible healthcare mission, the Centre began working on a scheme to establish pharma parks and clusters in various states to help bringing down production costs and also boost the domestic pharma sector.

Last year, a few states like Gujarat and Kerala showed interest to set up pharma parks.

Now, riding on the success of the recently concluded Global Investors' Summit, Jharkhand has set its sights on setting up at least one pharma park to begin with.

"About 10 days back, the Centre gave a formal go-ahead for setting up a pharma park in Jharkhand after which we started the ground work," Ravikumar said.

He added that the Centre would provide Rs 20 crore for the project.

Ravikumar said the proposed pharma park would be on lines of an IT or handloom park. "We will create necessary infrastructure like effluent treatment plant, drug testing lab and other requirements specific to this industry so that pharma companies can set up units," he explained.

Dr Barij N. Sinha, head of BIT-Mesra's department of pharmaceutical sciences & technology, who is also honorary secretary of the Jharkhand chapter of Indian Pharmaceutical Association, welcomed the move, saying if the project materialised, it would prove to be a big boon not just for the state but for all of eastern India.

"During the days of undivided Bihar, many pharma manufacturers used to operate in the Jharkhand region. But, over the years, owing to lack of support, these have ceased to function. In West Bengal, there are a few manufacturing companies but the situation there too is unfavourable. Therefore, we have a big gap to fill in this sector," he said.

The advantages, he added, were manifold. "Not only will jobs be created, we can also expect quality and cheap drugs if shops are set up here," Sinha said.



Pharma in need of growth pill

The domestic pharmaceutical industry, which has often been in the spotlight for actions taken by the US drug regulator, could be staring at more disappointing news.

The growth trajectory for the industry is expected to moderate following slowing growth from the US - its key market, increased competition, and a regulatory overhang, apart from the base effect.

According to credit rating agency ICRA, revenue growth from the US between 2011 and 2015, which saw a compounded annual growth rate (CAGR) of 33 per cent, has come down to 15 per cent in 2015-16 and further down to 12 per cent in the nine-month period of this fiscal despite currency benefits.

Further, there are limited major FTF (first to file) launches in the US market in the near term. As a result of all these factors, the base business is expected to continue to face competitive pressures, affecting growth from the US market.

An FTF status for a generic drug gives the applicant a 180-day marketing exclusivity, thereby pushing up the firm's revenues.

"Aggregate revenue growth for ICRA's sample is projected at 9-11 per cent in the period between 2016-17 and 2018-19 after mid-to-high double-digit growth over the last five years,'' it disclosed.

The rating agency added that going forward the growth momentum is likely to face further pressure.

Moreover, increased regulatory scrutiny and consolidation of the supply chain in the US market, which result in pricing pressures and increased R&D expenses, is also expected to have an impact on the profitability of domestic pharmaceutical companies.

Drug firms have over the past few years increased their R&D budgets because of the focus both on regulated markets and complex molecule segments.

The aggregate R&D spends of the top few companies in domestic pharmaceutical markets have gone up from 6 per cent of sales in 2010-11 to around 9 per cent at present.

Subrata Ray, senior group vice-president, ICRA, pointed out that the revenue growth for the domestic pharmaceutical industry remains moderate for the US, with the base business in that geography continuing to face high single-digit price erosion and regulatory overhang for select companies.

The rating agency felt that in the domestic market, continued regulatory interventions are also expected to put some pressure in the near term.

Long-term growth prospects for the domestic pharmaceutical market remain healthy because of increasing penetration, accessibility and continued launches.



Tuesday, 7 March 2017

CDSCO to go online for all services in six months

The Central Drugs Standard Control Organisation (CDSCO) is set to become paperless within six months with completely shifting its services to online portal Sugam. The agency digitized 60-70 per cent of its services through Sugam portal so far.

In another six months we are planning to go completely electronic for all our services by doing away with requirement of any physical documents, said a senior CDSCO official.

With the launch of Sugam on November 14, 2015, firms can apply online for grant of registration certificates for import of drugs or import license of drugs in Form 10, under D&C Rules. They can also file online applications with respect to import registration and license of medical devices. Online submission has also been started for grant of approval to conduct bioequivalence studies for  export purposes.

CDSCO has recently started process for online submission for clinical trial approval for Biologicals (Vaccines) on Sugam. Firms can request to test vaccine samples at CDL Kasauli and receive batch release certificate online. Firms can add their license details issued by State FDA's on Sugam. They can submit online application for grant of approval for import and manufacture of new vaccine, registration and import license for vaccines, conducting clinical trial.

The agency is in process of starting online submission for clinical trial approval of new chemical entity. Over next three months, it will start online submission for FDC approval, grant of Certificate of Pharmaceutical Product to WHO GMP certified manufacturing units where inspections have been conducted, he informed.

Besides this, we have integrated all seven laboratories of CDSCO with Sugam and data related to samples of drugs tested in these laboratories will be uploaded on the portal from next month which will enable us to immediately alert the state drug controllers if poor drug quality is detected. It will eventually facilitate drug recall in a timely manner, he opined.

We have also developed database of drug retailers and wholesalers from ten states including Maharashtra, Goa, Gujarat, Puducherry, Delhi, Jharkhand which will soon be published on CDSCO website. The database proves to be effective in pan India drug recall, he stated.

Some states have started online process for grant of drug distribution and manufacturing licences. These portals are affiliated to CDSCO enabling it to get access to all the data generated through the system.

Apart from drug traders’ database, the agency is set to put in place a single platform containing data pertaining to manufacturing facilities in the country in a month. Efforts are being made to get states onboard so that software is provided to manufacturers who put their plants’ data in the software, said the official.

Recently the ministry of health and family welfare has notified Medical devices rules. The new rules will go into effect January 1, 2018. An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, intending to import medical devices, will be required to make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the ministry. The services of Sugam will be extended to application with respect to grant of import licence for medical device.

The agency will soon start online submission of drug samples by its drug inspectors for lab testing. The sample analysis report will be put online by the respective CDSCO laboratory. It will lead to reduction in time required in submitting the hard copy to the respective lab by drug inspectors and fast track the drug testing process. The initiative is a part of slew of measures initiated by CDSCO to make its services online, he said.

The main aim of this e-governance drive is to bring in transparency, accountability and competency in CDSCO which allows creating a real time platform and improve the safety and security programmes taken up by it.