Monday, 31 July 2017

Pharma Innovation Yatra_July 2017

Pharma Innovation Yatra was launched in the month of January 2017. In the month of July, the yatra was relaunched after summer break. This month the yatra reached Gujarat state with a national level workshop, which was sponsored by APTI Gujarat state Branch and Ganpat University.

Also, the yatra reached the partner institute Pharmacad as a part of their first anniversary celebrations. 



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.

10. Enaltec Labs
Website:
Type of industry:
Pharmaceuticals
Location:
Ambernath, Maharahtra.

11. S. K. Patel College of Pharmaceutical Education and Research***
Website:
http://www.skpcper.ac.in/
University:
Ganpat University, Mehsana
Location:
Mehsana, Gujarat.
***This was part of National level workshop at the institute in association with APTI, Gujarat state.

12. Pharmacad**
Website:
http://www.pharmacad.in/
Type of industry:
GPAT coaching classes
Location:
Mumbai.
**This was part of the first anniversary celebrations for team Pharmacad.

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. 


Sunday, 30 July 2017

Differentiated Products Is The Way Forward For Indian Drug Makers: Pankaj Patel

This is time for Indian generic drug makers to aggressively focus on capabilities for developing differentiated products to sustain growth in a challenging era, which sees price erosion, significantly increasing competition and more stringent regulations in the global market, said Pankaj R Patel, chairman, Cadila Healthcare, and president, Federation of Indian Chambers of Commerce and Industries.

Differentiated products not only offer better margin but also helps companies to create a niche in the market with less competition and even to build stronger business with comparatively smaller marketing infrastructure and team, Patel said while delivering his key note address as the chief guest at the Businessworld-Yes Bank Life Sciences Forum 2017 held in Mumbai on Friday, July 28.

Businessworld Life Science Forum was a unique knowledge initiative conceived for thought leaders from pharmaceuticals and biopharmaceuticals to further drive sectoral business growth and leverage the resurgence of the Indian economy. The forum, which was attended by top, senior and middle management professionals and entrepreneurs from the industry, brought together business leaders from these sectors and help focus attention on the sector, build on its natural advantages, highlight and help remove roadblocks if any, and recommend suitable policy measures that would catalyse the sector’s growth.

The Forum’s theme this year was ‘Indian pharma transition from generics to complex/niche generics to re-align itself and prepare for the next big leap’. 

Currently, the pharmaceutical industry is putting best efforts to re-align itself and prepare for a big leap in the high value markets as Indian firms are present in these market mostly in the traditional generics segment. While the opportunity to grow and expand in specialty generic area is huge, the Forum was aiming at bringing together top the Indian pharma players operating to have an involved discussion on the emerging trends of the sector.

Talking about the quality issues currently being associated with several of India drug makers in a panel discussion, S M Mudda, Director, Global Strategy (Technical), Micro Labs, said that, “We should create our own quality management system, so that we can make ourselves robust in our operations.”

According to Sundeep Bambolkar, Joint Managing Director, Indoco Remedies, over the years, the entire manufacturing process in the industry has become extremely different from the traditional and it is thus important that we must take extra care for quality.

Explaining the way to become a successful player, Dr Ranjana Pathak, Global Head – Quality at CIPLA, suggested it is the three key aspects such as training,  talent and capabilities of people who work in an organisation basically touch the product and processes.

Murtaza Khorakiwala, Managing Director, Wockhardt, said in fire side discussion titled “Indian pharmaceutical Industry 2030 – The Way Forward’ moderated by Amit Kumar, Group President and  Country Head, Corporate Banking, YES Bank, said the next decade will be an era of innovation in the Indian pharmaceutical industry.


“The Indian pharmaceutical industry witnessed a host of policy challenges, which forced the industry to engage in a series of discussions with the government,” said Deepnath Roy Chowdhury, MD, Strassenburg Pharmaceuticals Ltd., and National President, IDMA.

Source: http://businessworld.in/article/Differentiated-Products-Is-The-Way-Forward-For-Indian-Drug-Makers-Pankaj-Patel/29-07-2017-123118/

Wednesday, 26 July 2017

You need not always complete full course of antibiotics: Doctors

Is it important to complete a full course of an antibiotic? Yes, according to conventional wisdom, which says stopping a course mid-way could lead to drug resistance. But several scientists have now challenged this claim.

In many situations, stopping antibiotics sooner is a safe way to reduce antibiotic overuse, said a paper published in the British Medical Journal. "Patients are put at unnecessary risk from antibiotic resistance when treatment is longer than necessary," said the authors from Brighton and Sussex Medical School in the UK.

Dr Randeep Guleria, director, AIIMS, however, warned patients against stopping antibiotics on their own. Stopping or extending a course of antibiotics "is a clinician's call", the AIIMS director said, while agreeing that there was a need to critically look at prescription patterns.

Dr Suranjit Chatterjee, senior consultant, internal medicine at Apollo hospital said an antibiotic course need not be treated as sacrosanct. "It can be de-escalated or stopped if patient's condition improves," he said.

Chatterjee said antibiotics are prescribed to many patients on an empirical basis if they have high fever or diarrhea. "If tests reveal he or she does not have typhoid or other serious infections as suspected and this is reflected in his clinical condition, antibiotic course can be altered," the doctor said.

Guleria and Chatterjee said in diseases such as tuberculosis and typhoid, a patient may feel better after a few days but the antibiotic course still needs to be completed because not doing so increases the risk of relapse and emergence of resistant bacteria.

Traditionally, antibiotics are prescribed for recommended duration or courses, say for five to 10 days or more, depending on the condition.

The BMJ article argued that fundamental to the concept of an antibiotic course is the notion that shorter treatment will be inferior. But the scientists pointed out that studies to identify minimum effective treatment duration have simply not been performed for most conditions.

"For example, pyelonephritis (inflammation of kidney due to bacterial infection) has historically been treated for two weeks. Trials have shown shorter courses of quinolones are effective (seven days for ciprofloxacin and five days for levofloxacin), but no such data exist for B-lactams which are the main antibiotic class used," the BMJ study said. It added that current international guidelines recommend 10-14 days' treatment with B-lactams, based purely on absence of data for shorter courses.
The experts also argued that the concept of an antibiotic course ignores the fact that patients may respond differently to the same antibiotic, depending on diverse patient and disease factors.

Many bacteria, for example Staphylococcus aureus, live harmlessly in our body (the gut, skin or mucus membranes). When a patient takes antibiotics for any reason, species and strains sensitive to it are replaced by resistant species and strains ready to cause infection in the future. "The longer the antibiotic exposure these opportunistic bacteria are subjected to, the greater the pressure to select for antibiotic resistance," the BMJ article explains.

Dr Anoop Mishra, chairman, Fortis C-Doc, said concerns about antibiotic resistance due to overuse are important but they shouldn't be allowed to prejudice the minds of patients to unilaterally alter the antibiotic course. "The compliance rate of medicine prescription is already very low in India. It is a major cause of emergence of drug-resistant tuberculosis, for example," he said.



Tuesday, 25 July 2017

IPC to hold workshop on 'Establishment of Pharmacovigilance System in Pharmaceutical Industries" on Aug 31 at Chandigarh

The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre-Pharmacovigilance Programme of India (PvPI), will organise a workshop on "Basics of Pharmacovigilance & Establishment of Pharmacovigilance System in Pharmaceutical Industries - A Way Forward" on August 31, 2017 at PGIMER, Chandigarh. 

The main objective of this 2nd regional workshop is to sensitize manufacturers, importers, distributors and other stakeholders about the need for a properly-designed Pharmacovigilance system across the user domain, to monitor Adverse Drug Reactions (ADRs) aimed at establishing safer drug use in the country.

The workshop is aimed at bringing together regulatory authorities and pharma professionals/experts to discuss the practice of pharmacovigilance in the country. It will also widen the knowledge spectrum of pharma professionals in the field of pharmacovigilance. 

Professionals in pharmacovigilance, quality assurance (QA) and regulatory affairs (RA) in pharmaceutical companies and healthcare systems are the targeted audience of this workshop. And creation of an agreeable roadmap for pharmaceutical companies and healthcare providers for the establishment of a harmonised and sustainable pharmacovigilance system for collection, collation and processing Aes/ADRs is the expected outcome of this workshop.  

The pharmaceutical products are primarily approved by CDSCO and subsequently licensed for either manufacturing and/or import by Drug Regulatory Authorities at centre and states for marketing in the country. During pre-market test and trials many adverse reaction related to such medicines may remain unnoticed. When a larger section of population belonging to various age groups and socio-economic strata are exposed to such medicines, many undesirable AEs/ADRs may emerge. This has necessitated the strengthening of pharmacovigilance standards and realization of the importance of a properly-designed pharmacovigilance system in the pharmaceutical companies as well as healthcare system. 

The Union Health Ministry launched a nationwide PvPI in 2010 to monitor the ADRs ensuring that the benefits of medicine outweigh the risks associated with its use and the IPC has been functioning as NCC for PvPI since April 15, 2011. To monitor the ADRs, Adverse Drugs Monitoring centres (AMCs) have been established across the country under the PvPI. The PvPI has taken a leap forward during the last five years. The programme has broadened its scope of activities and influence, providing a stage for interaction and partnership in the sphere of Pharmacovigilance. In compliance with the recent amendment to Schedule Y, Drugs & Cosmetics Rules, 1945, vide Gazette Notification No. G.S.R. 287 (E) dated March 8, 2016, Pharmacovigilance has been mandate for Marketing Authorization Holders (MAHs) in India. To ensure the effective implementation, there is an urgent need for the MAHs to set up a Pharmacovigilance system at their site. 

Sunday, 23 July 2017

PHARMACAD now in Thane_Creating Quality Pharmacists

If you plan to appear for GPAT/NIPER/Pharma MBA in 2018 or 2019, this is the right time to join this young, enthusiastic team of professionals. Yes, PHARMACAD is now also in Thane. Also, they are celebrating their first anniversary this month. Team Pharma Literati wishes this young team best wishes for the future.





For details, please visit: www.pharmacad.in


Thursday, 20 July 2017

Consumers are overcharged for more than 100 drugs, finds a report

A document released by the National Pharmaceutical Pricing Authority (NPPA) shows that consumers are being overcharged for more than 100 drugs sold on the market.

The government body released the data on its website last month. It shows that several pharmaceutical firms have been overcharging customers for commonly used drugs, such as anti-diabetic and cholesterol lowering tablets.

The NPPA, which puts out this quarterly data on its website, has issued notices to the pharmaceutical companies. The report shows that they overcharged consumers to the tune of Rs36.8 crore for a single drug.

Pharmaceuticals overcharge in many ways. Companies that manufacture non-scheduled drugs cannot increase the prices more than 10% of the MRP. However, they do so,” said Dr Bhupendra Singh, chairman, NPPA.

It all depends on the market volume of the drugs. The company may have overpriced a drug by between 50 paisa and Rs10, but when one looks at the cumulative figures, the amount runs into lakhs and crores,” he added.

The ceiling price of the drugs has been fixed by the government under the Drug Price Control Order (DPCO) 13, which makes them affordable to most.

Doctors who have been working to improve the affordability of healthcare said this was yet another example of profiteering by big pharmaceutical companies.

It is not surprising to see pharma companies overcharging commonly sold medicines,” said a doctor from a health activist group.

In February, the NPPA capped the price of stents in India slashing the cost up to 85%. The price of drug eluting stents was fixed at Rs 29,600, while that of bare metal stents was capped at Rs7,260.



Sunday, 16 July 2017

APTI Workshop at Shree S. K. Patel College of Pharmaceutical Research, Mehsana and Launch of second phase of Pharma Innovation Yatra

APTI Gujarat state Branch and Ganpat University, Shree S. K. Patel College of Pharmaceutical Research, Mehsana, Gujarat jointly organized One day National Workshop on "Creative Thinking, Innovation and role of patents in Pharmaceuticals field" on 13th July, 2017. 

With this programme, Pharma Literati team is proud to announce the second phase of Pharma Innovation Yatra 2017. The workshop included the presentations of Creative Thinking, Innovation and role of patents in Pharmaceuticals field.

The national workshop was inaugurated by the auspicious hands of Dr. Mahendra Sharma, Director General, Ganpat University, Mehsana, Gujarat in the presence of 

1. Dr. Rakeshkumar Patel, Dean, Faculty of Pharmacy, Ganpat University, Mehsana.
2. Dr. Paresh U. Patel, Professor, Shree S.K.Patel College Pharmaceutical Education and Research.
3. Dr. Jayvandankumar K. Patel, APTI, President, Gujarat State Branch.
4. Dr. Richa Dayaramani, APTI, Vice President, Gujarat State Branch.
5. Dr. C. N. Patel, Dean, Member, Academic Council, Gujarat Technological University.

The program was conducted by Mr. Vijaykumar Shivpuje, Co-founder and CEO, FlexiTutr. Students and faculty members of various pharmaceutical institutes attended the program.


Tuesday, 11 July 2017

Pre-GST medicine stocks can be relabeled with revised MRPs: CDSCO

India's central drug regulator, Central Drugs Standard Control Organisation (CDSCO), has clarified that pharmaceutical companies can re-label old stocks of their medicines with the revised Maximum Retail Prices (MRP) applicable following implementation of the Goods and Service Tax (GST) regime. 

"... subject to provisions of Legal Metrology Act & Rules and other provisions of Act and Rules relating to Goods and Service Tax, this office has no objection for alteration of label (stickering) by the manufacturers under rule 104A of the Drugs and Cosmetics Rules, 1945, if required for implementation of GST," stated the Central Drugs Standard Control Organisation in a notification on Monday evening. 

The Ministry of Consumer Affairs, Food and Public Distribution last week stated in a circular that manufacturers, packers and importers of pre-packaged commodities should declare the post GST MRPs of unsold stocks which were manufactured, imported or packed before July 1. 

So far, chemists had been selling old stocks of medicines at their pre-GST MRPs and pharma companies were expected to declare the new MRPs on the batches they manufactured after July 1. 



Friday, 7 July 2017

India’s short supply of basic antibiotics is making its drug resistance problem worse

Fist line antibiotics are missing in India and that’s making its drug resistance problems worse.
Some essential antibiotics are under price control & drug manufacturers are less inclined to make them.

India is witnessing an alarming rise in antibiotic resistance, much of which has been triggered by over prescription of the drugs by doctors, overuse by patients and unregulated use on farms and fisheries. But another factor contributing to this rise in antibiotic resistance is the unavailability of simple antibiotics that should be used as the first line of treatment.

The lack of such first line antibiotics has resulted in people across India using stronger drugs to treat simple infections. Pathogens, therefore, develop resistance to these stronger drugs faster and render even the more basic antibiotics ineffective.

On June 6, the World Health Organisation updated its Essential Medicines List, revising the antibiotic section extensively. Keeping in mind extensive and growing antibiotic resistance across the world, the WHO grouped antibiotics into three categories - access, watch and reserve with recommendations on when each drug can be used.

The “access” category has 29 first-generation antibiotics that should be widely available and affordable, states the WHO document. The “watch” group of antibiotics can be the first and second choice for treatment of a small set of infections but whose use should be reduced as much as possible to prevent resistance. “Reserve” antibiotics are last resort medicines to be only in the most severe circumstances when all other alternatives have failed.

In India, many of the “access” group antibiotics are only sparsely available.

Antibiotics such as benzathine penicillin, ampicillin and nitrofurantoin are not available in the country,” said Dr Sumanth Gandhra from Centre for Disease Dynamics, Economics and Policy, a public health research organisation with its headquarters in Washington DC. “At least not as much as they are supposed to be.” Gandhra, who works at the centre’s Delhi office, was an advisor to the WHO committee that updated the Essential Medicines List. Benzathine penicillin injections are commonly used for treating syphilis and rheumatic heart disease in children. Ampicillin is used to treat a variety of bacterial infections and nitrofurantoin is used to treat urinary tract infections.

Many of these “access” category antibiotics are narrow spectrum drugs that target certain kinds of bacteria and do not attack the beneficial bacteria that are generally found in the human body. Stronger antibiotics are broad spectrum drugs that are more effective. But continued and widespread use of these stronger antibiotic makes pathogens resistant to them faster and also resistant to the less potent, basic drugs. The basic drugs then fail to kill the new drug-resistant pathogens. Therefore, the availability of “access” category drugs is important to control the spread of antibiotic resistance.

At the same time, there are a few cases in which drugs that had been rendered ineffective decades ago due to resistance seem to be working in the Indian population again. In the 1980s, there were many cases of multi-drug resistant typhoid, which led to the reduced use of ampicillin that was used to treat the disease. Now, samples of the Salmonella typhi bacteria are showing sensitivity to ampicillin again.

Dr Yogesh Jain, one of the founders of the Jan Swasthya Sahyog and who runs the community hospital in Bilaspur, Chattisgarh, said only certain pharmaceutical distributors stock first line antibiotics and other essential medicines. “Sometimes these drugs are more often available in Chhattisgarh than in Delhi,” said Jain.

First line antibiotics are also more easily available in government run facilities than in private pharmacies, clinics and hospitals. This is because these drugs are part of the National Essential Medicines List that is used to procure medicines in the public sector.

Dr Mukesh Agarwal, head of pediatrics at KEM Hospital in Mumbai said that the municipal teaching hospital is able to procure drugs like benzathine penicillin even though it is difficult to find in private facilities. Benzathine penicillin is given as an injection once every 21 days to children suffering from rheumatic heart disease. Another option to treat the disease is with the an oral pill of erythromycin, which is the less preferred mode of treatment. “The chances of defaulting on taking the medication is higher when the doctors prescribe the pill,” said Agarwal.

Even public hospitals that have better supply of first line antibiotics do not get as much of these medicines as required. Shortages sometimes compel pharmacists to give patients have the amount of medicine required for a five-day course and ask them to collect the remaining medicines after two days.

The patient starts feeling better after two days of taking medicines,” said Dr Anita Kotwani, professor at the department of Pharmacology at VP Chest Institute in Delhi. “Will he come back to collect the rest of his dose? No. This suboptimal dose kills only half the bacteria in the body. The other half become resistant.”
Some antibiotics like doxycycline are easily available in combinations but not as single molecule formulations. “Combination drugs are more likely to cause drug resistance,” said Kotwani.

The price control factor

Kotwani has conducted several surveys on the availability and affordability of essential medicines. In 2013, just before the government released its Drug Price Control Order, she found that doxycycline was easy to find at both public and private health facilities in Delhi. In 2015, the drug, which had come under price control, was not as easily available. Drug manufacturers are less inclined to make drugs that are under price control and therefore less profitable than those for which prices are not regulated, said Jagannath Shinde, chairman of All India Organisation of Chemists and Druggists. “After price control, companies feel that it is not affordable for them to produce the drug,” said Shinde. “They do not stop production. They just reduce the quantity of drugs they produce. Naturally, it will not be as easily available everywhere.” The general availability or lack of antibiotics affects what medicines doctors prescribe.

It is a vicious cycle,” said Dr Vijay Yewale, a pediatrician from Navi Mumbai and former president of Indian Academy of Pediatrics. Doctors stop prescribing antibiotics that are in short supply and, in turn, manufacturers make less of these antibiotics that doctors are no longer prescribing as much.

S Srinivasan, who runs a generic drug manufacturing company in Vadodara called LOCOST and is also part of the All-India Drug Action Network said that many of these first-generation antibiotics are “out-of-fashion”.

Often the doctors fall prey to the marketing of the pharma companies,” said Srinivasan, about why some doctors might prescribe more advanced antibiotics.

Kotwani said that doctors also try to retain their patients with quick cures, prescribing what they call “effective” and expensive broad spectrum antibiotics instead of first line antibiotics.

Said Yewale: “There are some doctors who are not as rational in their prescription and have not upgraded themselves. If the patient is not very ill, why not try the simple narrow spectrum drugs first and check if it works?”