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Wednesday 4 February 2015

Govt to sell 504 drugs under 'Jan Aushadhi'

NEW DELHI: From July 1, you can walk up to a chemist and ask for a 'Jan Aushadhi' brand for your medicine, with the government set to launch its own brand to sell low cost generic medicines.

The Centre will procure medicines in bulk from public as well as private drug manufacturing firms and rebrand them under 'Jan Aushadhi'. These will be sold in the retail market at a competitive price, allowing consumers to buy a cheaper yet quality product from the government, official sources said.

To start with, the government has identified 504 essential medicines, which include antibiotics, painkillers, vitamins and medicines used in treatment of cardiovascular, respiratory, diabetes and gastroenterology diseases. "In the first phase, we have mostly identified medicines from the top 100 drugs based on their sales. More medicines as well as medical devices will be included in the second phase," an official in the know of developments told TOI.

In the first phase, these drugs will be made available to 800 select chemists, mostly across Delhi. However, the government plans to expand the reach to most metros by the end of the year.

The Bureau of Pharma Public Sector Undertakings of India (BPPI), the nodal agency under the department of pharmaceuticals (DoP) for implementing this project, has already floated the tender seeking application for supply of medicines for the programme.

The Indian pharmaceutical retail market, pegged at Rs 87,000 crore annually, is dominated by branded generic products, unlike developed markets like the US and Europe. In other words, while there are very few patented medicines sold in India, most of the medicines available in the market are branded products sold by private firms.

Pharmaceutical firms spend huge amounts in creating these brands. However, since prescription-based medicines cannot be promoted through advertisements, companies often push these brands through doctors and chemists. Consumers, who are often unable to make an informed choice for purchasing medicines, have to rely on the doctor's prescription or on chemists. The government's latest move providing an umbrella brand for generic drugs is aimed at enabling consumers to make that choice.

However, there are concerns on whether the government will be able to maintain and monitor quality of all products sold under this brand since they will be procured from different firms. Government officials say procurement norms and sampling will ensure quality control.

The government, along with BPPI, has held consultations with various stakeholders including pharmaceutical firms to ensure there is regular and adequate supply of medicines. The proposal has also been vetted by the doctor fraternity, bringing on board the Medical Council of India as well as the Indian Medical Association to ensure doctors prescribe Jan Aushadhi drugs.

"Initially, the government had apprehensions that doctors would not support such a move because it may hurt the private sector. However, we have ensured them full support if the quality of products is maintained," IMA secretary general K K Aggarwal said. Once the brand is rolled out, the government also plans to make it mandatory for public hospitals to prescribe it wherever possible, an official said.

India heavily reliant on China for 12 essential medicines

If Prime Minister Narendra Modi's Make in India mantra has to be implemented in some sector first, it has to be in the pharma industry. The reason: In the past four financial years, India has imported from China bulk drugs and active pharmaceutical ingredients (APIs) worth about Rs 38,186 crore. Most of these have gone into making essential drugs.

TOI had reported in November 2014 that national security adviser Ajit Doval had warned the government about over-dependence on China.

If submissions to the government by the department of pharmaceuticals are any indication, there is significant dependence on imports in the case of 12 essential drugs. "Approximately 80-90% of these (essential drugs) imports are from China," the department has said. "The decision is based on economic considerations."

The 12 drugs are: paracetamol, metformin, ranitidine, amoxicillin, ciprofloxacin, cefixime, acetyl salicylic acid, ascorbic acid, ofloxacin, ibuprofen, metronidazole and ampicillin. Eight of these are on WHO's Model List of Essential Medicines.

Documents of the department of pharmaceuticals show there has been a consistent growth in the import of drugs and APIs from China. In 2011-12, Rs 8,798 crore worth of bulk drugs and APIs were imported from China. This was Rs 11,000 crore in 2012-13, Rs 11,865 crore in 2013-14, and Rs 6,521 crore during April-September in 2014-15.

Sudhansh Pant, joint secretary, department of pharmaceuticals, told TOI from Delhi: "China out-prices India when it comes to APIs and bulk drugs. There is a need to see how to change this situation. A committee of secretaries under Dr VM Katoch (secretary, department of health research) is looking into the matter."

India is mulling a separate policy for APIs so as to create an environment for production of the same within the country. A lot of this policy will be derived from the Katoch committee's recommendations.

But India may to have find another way to reduce dependence before the policy bears fruit.

At the outset, I agree that heavy dependence on one vendor or a single country for active pharmaceutical ingredients (APIs) and bulk drugs can affect the public health system. There could be issues related to quality, among other things.

Take Paracetamol for instance. Thousands of people, especially children, take it every day; it's used for fever and other ailments. One must be wary of the quality of products that come in, and depending on a single vendor for essential drugs may not be good.

Take the circumstances which has led to this dependency. There have been considerable discussions on this matter, but one must understand that in India, there is a cap on pricing for pharmaceutical products. If the manufacturer cannot sell a pharmaceutical product above a certain prescribed rate and has to also (it goes without the need for emphasis) meet quality requirements, it is natural for one to look at procuring APIs at cheaper costs.

At a seminar in Delhi last month, there was a detailed discussion on the matter and some interesting presentations were made. It is important to study how China is able to deliver these products at costs cheaper than those in India and other places.

As told to Chethan Kumar

US Federal Trade Panel wraps up review of Sun Pharms's Ranbaxy acquisition

Sun Pharmaceutical has moved closer to wrapping up its proposed acquisition of Ranbaxy Laboratories with the US Federal Trade Commission completing its review.

MUMBAI: Sun Pharmaceutical has moved closer to wrapping up its proposed acquisition of Ranbaxy Laboratories with the US Federal Trade Commission (FTC) completing its review of the $4-billion deal. The FTC has granted early termination of the waiting period under the Hart-Scott-Rodino Anti-trust Improvements Act of 1976, one of the conditions for closing the Ranbaxy acquisition.

"Sun Pharmaceutical and Ranbaxy also announced that the FTC accepted a proposed consent agreement pursuant to which, Sun and Ranbaxy have agreed to divest Ranbaxy's interests in generic minocycline tablets and capsules to an external third party," Sun said in a statement. "Sun Pharmaceutical and Ranbaxy are working closely towards completion of the transaction and will comply with the conditions laid down in the FTC consent agreement within the specified time."

Govt plans regulatory pathway to assist pharma companies

NEW DELHI: In line with Prime Minister Narendra Modi's action plan to enhance ease of doing business in India, the health ministry has proposed a regulatory pathway for pharmaceutical companies conducting clinical trials and planning to launch products in the country.

The ministry has proposed 'pre-submission meetings' to enable technical deliberations between the drug regulator and stakeholders to address concerns even before companies make formal application seeking product approvals or permission for clinical trials.

"Stakeholders feel that there should be a window for technical deliberations with the regulator and subject experts before submission of formal application. This would mean there is a discussion over the regulatory pathway and companies addressing concerns or making applications in a more systematic way fulfilling the requirements," an official said. He added that the exercise would save time and resources for both - the industry as well as the regulator which has to scrutinize several applications in detail.

The idea is to facilitate speedy approvals, while bringing in transparency, accountability and predictability, a latest notice by the Drugs Controller General of India (DCGI), proposing the move, said. DCGI, operating under the health ministry, is the drug quality regulator with a mandate to approve new drugs, clinical trials and medical devices. It also monitors the quality and efficacy of pharmaceutical products sold in the market.

Experts say the move is likely to enhance efficiency in the sector, which has been witnessing muted growth faced with regulatory hurdles and policy uncertainties in the domestic market pegged at over Rs 87,000 crore.

The drug manufacturing industry, one of the top contributors to the country's exports, is a major investment destination and a focus area for the Modi government's 'Make in India' campaign.

However, in the past few years, the sector witnessed a significant slowdown in product approvals, clinical trials approval along with almost a year long ban on foreign investment approvals in the absence of a clear FDI policy for the sector.

Last year, the government said it was aiming to improve India's ranking in the World Bank's 'Ease of Doing Business' index to 50th position in the next two years, even as the country slipped to 142 in 2014 from 134 in the previous year. The World Bank had clarified the rankings were based on data available till May 2014 and did not take into account measures taken by the new government.

Improving India's credentials as a business-friendly destination is likely to help the new government attract much-needed foreign direct investment, experts say.

FDA approves breast cancer drug from Pfizer

WASHINGTON - Federal health regulators have approved a new medicine from Pfizer Inc. to treat postmenopausal women with a certain type of advanced breast cancer who have not previously taken other drugs.
The Food and Drug Administration approved Ibrance for women who have tumors that overproduce a protein known as HER-2. This protein causes cancer cells to divide and grow faster than usual. The injectable drug is intended to be used in combination with another cancer drug known generically as letrozole.
The agency granted the drug accelerated approval based on research showing it slowed the progression of breast cancer. Patients taking Ibrance and letrozole lived 20.2 months on average before their tumors worsened. That was about twice as long as the benefit for women in a comparison group who only received letrozole.

India, China offer big opportunity for surgical device industry

MUMBAI: India and China present the largest emerging market growth opportunity for the medical device industry, according to a report.

Both the countries are shifting towards enabling quality surgical care at an affordable cost, at a pace faster than many western healthcare systems, it said.

The Indian surgical device market is valued at $ 2.75 billion, while China's market is significantly larger at $ 8 billion - and both are growing at 15 per cent a year, with more than three-quarters of high-value surgical devices imported, according to the report from product design and development firm Cambridge Consultants.

But surgery in emerging markets will not share the same future as surgery in developed markets. Different commercial, clinical, user and technical challenges will drive 'need-based' innovation - resulting in new products and solutions that are tailored for emerging markets, it said.

To better understand the challenges and opportunities for surgical innovation, Cambridge Consultants team of product development and human factors engineers visited Indian hospitals, interviewed surgeons, nurses and hospital executives, and observed a variety of surgical procedures.

The hospitals ranged from top-tier multi-speciality centres to small, fast-growing village hospitals.

Only 25 per cent of India's population has health insurance, so most Indian patients pay for their healthcare, including surgery, out of their own pockets - emphasising the importance of surgical device value when developing new products for emerging markets, the report said.

Surgeons in India are rarely employed by a single hospital - they are consultants at multiple hospitals, bringing in their own patients while hospitals provide the infrastructure and patient services. They usually rely on the surgical equipment available at the various hospitals - and may need to switch between multiple types of equipment on a day-to-day basis, it said.

Laparoscopic surgery, for example, often requires frequent tool changes in a confined space, and proper execution of these changes can be difficult even with a surgical team that has worked together for years, the report added.

1 million people will die due to diabetes in India: IDF

1 million people will die due to diabetes in India: IDF
Over 10 lakh people in India will die due to diabetes and its complications by the end of this calendar year, an International Diabetes Federation (IDF) report has stated.
In a statement issued on the World Diabetes Day, IDF president Jean Claude Mbanya said that a recent IDF report has suggested India has 6.13 crore people living with diabetes, second only to China. "Moreover, nearly 60% of diabetics in India have never been screened or diagnosed due to lack of awareness. A recent IDF survey shows that a staggering 62.6% of the people in India are not even aware about the complications of the disease."

"The lack of awareness is something we all need to tackle with a strong will. Diabetes is preventable and diabetics can effectively manage their condition to live better lives without burdening their families and society at large. Over 10 lakh people in India will die from diabetes and its complications by the end of this calendar year."

Stating that diabetes often strikes those under 60 years of age and in their most productive years, Mbanya said, "Such a high numbers of undiagnosed cases means people are putting their lives at risk from diabetes complications such as nerve disease, which can lead to ulceration and amputation of limbs."

This spread of awareness will empower them to defeat diabetes through prevention and management, he added.

"A number of activities have been rolled out as part of the Sanofi Diabetes Blue Fortnight 2012 campaign, to effectively engage the masses in India. These include Doctor for Diabetes Care (D4DC) initiative, an opportunity for doctors and healthcare experts to join and support India's largest ever diabetes awareness drive by pledging to help reduce India's diabetes burden, educate and motivate diabetes patients and their family members to opt for regular blood sugar screening," he said.

"Besides, free screening camps for checking blood sugar were conducted in several cities including Jalandhar. The walk for diabetes and flash mobs that reached out to the masses and mobilised people at the grass-root level to wear blue, gather in groups and walk in their localities to spread awareness about diabetes are also being conducted so as to spread importance of screening, preventive measures and to share information on how to live with diabetes by implementing better management methods," he said.


Written by me:
1 million people will die due to Diabetes : IDF report
As per the stated report of IDF(International Diabetes Federation), over 10 lakh people in India will be die due to diabetes and its complications by the end of this calendar year., IDF president Jean Claude Mbanya said in his statement , there are 6.13 crore people are suffering from Diabetes , being counted second in no. after China, moreover , nearly 60% of diabetic patients do not diagnosed or screened due to lack of awareness and 62.6% people doesn’t know complication about the disease.
As People have necessary to make consciousness for the disease and Diabetes is preventable and can effectively manage their complication to live better  without disturbing their families and society and Mbanya also said, those people under the age of 60 years , putting their lives at risk from diabetes complications such as nerve disease, which leads to ulceration and amputation of limbs. Hence spread of awareness is necessary to defeat diabetes through prevention and management.
Sanofi Aventis has been rolled out no. of activities namely Sanofi Diabetes Blue Fortnight 2012 campaign efficiently engage in this activity in India. Activities such as Doctor for Diabetes care(D4DC) initiative. This campaign helps to reduce India’s diabetes burden, educate and motivate diabetes patients and their family members to opt for regular blood sugar screening
In addition, free screening camps had been conducted in several cities including Jalandhar. A large no. of people have been reached out in such a wonderful organized campaign for diabetic patients and it was really great because people who involved in this campaign put on blue dress code, and walked in their localities to spread awareness about diabetes such as how to live with the disease by implementing better management methods, he added.


Lupin launches generic cholesterol lowering drug in US

Lupin launches generic cholesterol lowering drug in US
New Delhi, Nov 20 (IANS) Drug?maker Lupin Tuesday said its subsidiary Lupin Pharmaceuticals Inc has launched cholesterol lowering drug Fenofibrate tablets in 48mg and 145mg strengths in the United States.
The Mumbai?based company's Fenofibrate tablets are a generic version of Abbott's Tricor tablets.
Lupin had received US Food and Drug Administration approval for the drug earlier.
"We are very happy to bring this product to market in the United States. Patients can be assured that they are receiving the same high quality product they have been accustomed to at a more affordable price," Vinita Gupta, Lupin group president, said in a statemen

Written by Me:
 GENERIC VERSION OF FENOFIBRATE OF ABBORT’ TRICOR TABLET COME UP IN U.S MARKET: LUPIN
Drug Maker Lupin Tuesday Nov 20 said its subsidiary firm LUPIN PHARMACEUTICAL INC. has been launched Cholesterol Lowering Drug Fenofibrate tablet which is a generic version of Abbott’s Tricor tablet in 48 mg and 145 mg strengths in the United States.
Lupin has also received USFDA approval for this drug.

Lupin has given assurance to patient to provide same high quality product at affordable price for the long term, said Vinita Gupta, LUPIN group president in a statement.

List of important books related to GPAT

List of important books related to GPAT

PHARMACEUTICS

Physical Pharmacy
Alfred Martin, Physical Pharmacy

Subrahmanyam CVS. Physical Pharmacy, Vallabh Prakashan
Unit Operation
Subrahmanyam CVS.Pharma Engineering, Vallabh Prakashan
Microbiology
Pelzar

Kokare

Carter S. J., Cooper and Gunn’s Tutorial Pharmacy

Strictly Bentley, book for Pharmaceutics

Satyanarayan for Biotechnology

Pharmaceutical Technology
Lachman L., Lieberman H. A., The Theory and Practice of Industrial Pharmacy

Aulton’s ME  Pharmaceutics

Remington

Bio Pharmaceutics
Aulton ME, Pharmaceutics


Cosmetics
M Mithal, RN Saha, A hand book of cosmetics

Jurisprudence
Jain N. K., Text book of Forensic Pharmacy
G K Jani
Dispensing Pharmacy
Dispensing Pharmacy by Cooper and Gunn’s

Tutorial Pharmacy by Cooper and Gun’s









PHARMACEUTICAL CHEMISTRY

Inorganic Pharmaceutical chemistry
Block J., Roche E.B., Sonie T.O., Wilson C.O., Inorganic Pharmaceutical chemistry

Dr G R Chatwal , Inorganic Chemistry


Physical Chemistry
Physical chemistry  by Behl and Tuli

Organic Chemistry
Morrison R. T.& Boyd R. N., Organic Chemistry


Biochemistry
Satyanarayana

Deb AC, fundamentals of biochemistry

medicinal chemistry

Hari Kishan Singh

Wilson & Gisvold’s,
Testbook of Organic medicinal & Pharmaceutical chemistry ( Most Imp )

W. O. Foye, Principles of
medicinal chemistry

S.N Pandaya


Pharmaceutical Analysis


Y.R. Sharma( Most Imp )

Kasture AV et al. Pharmaceutical analysis

UV, IR (Chatwal GR, Anand SK, Instrumental Methods of Chemical analysis)

MASS ( Silverstain)

NMR ( Willam KEMP)

Chromatography (Remington )











PHARMACOLOGY


PHARMACOLOGY

Rang M.P., Dale M.M., Riter J.M.,Pharmacology

Tripathi, K.D., Essentials of Medical Pharmacology

R K Goyal , Pharmacology

Lippencott’s Pharmacology



Walker Rozer. Clinical Pharmacy and Therapeutics



PHARMACOGNOSY
PHARMACOGNOSY
Kokate C. K., Purohit A. P. and Gokhale
S. B., Pharmacognosy


Trease G. E. Pharmacognosy and Evans W. C., Baillers

Ansari, SH. Essentials of Pharmacognosy


INDUSTRIAL PHARMACOGNOSY
Kalia,
An. Text book of Industrial Pharmacognosy. CBS Publishers

Traditional Drugs
Kalia,
An. Text book of Industrial Pharmacognosy. CBS Publishers

Ayurvedic Pharmacopeia

Biosynthetic Pathway
Rangari, VD, Pharmacognosy and Phytochemistry





General Prescription habit of Doctors:literature Review:

literature Review:
General Prescription habit of Doctors:
This manual focuses on the  process of prescribing. It gives you the tools to think  for yourself and not blindly follow what other people think and do. It also  enables you to understand why certain national or departmental standard treatment guidelines have been chosen, and  teaches you how to make the best  use of such guidelines. The manual can be used for self-study, following the  systematic approach outlined below, or as part of a formal training course.
Part 1: The process of rational treatment
This overview takes you step by step from problem to solution. Rational treatment requires a logical approach and common sense. After reading this chapter you will know that prescribing a drug is part of a process that includes  many other components, such as specifying your therapeutic objective, and  informing the patient.
Part 2: Selecting your P-drugs
This section explains the principles of drug selection and how to use them in  practice. It teaches you how to choose the drugs that you are going to prescribe  regularly and with which you will become familiar, called P(ersonal)-drugs. In  this selection process you will have to consult your pharmacology textbook,
national formulary, and available national and international treatment guidelines. After you have worked your way through this section you will know  how to select a drug for a particular disease or complaint.
Part 3: Treating your patients
This part of the book shows you how to treat a patient. Each step of the process  is described in separate chapters. Practical examples illustrate how to select,  prescribe and monitor the treatment, and how to communicate effectively with  your patients. When you have gone through this material you are ready to put  into practice what you have learned.
Part 4: Keeping up-to-date
To become  a good doctor, and remain one, you also need to know how to  acquire and deal with new information about drugs. This section describes the  advantages and disadvantages of different sources of information.


Annexes

The annexes contain a brief refresher course on the basic principles of pharmacology in daily practice, a list of essential references, a set of patient  information sheets and a checklist for giving injections.

THE BRAND PLAN

The Blueprint of every brand.

Friends, have you noticed over this years that a few companies rise like the Indian Rope and then they are lost as if they were never in the race. For example,Cadila Pharma: Once a 7th ranked company (1998-99) and within a decade, its nowhere to be seen.

I have been a part of the PMT there during the sinking times. I am convinced that weak and directionless leadership has been the reason behind its fall. The fall of the companies is synonym to the falling and failing brands.

And hence, I also believe that PMT across companies have been the ones who lead therapy baskets, then divisions, SBUs and ultimately the big corporates. Don't you think that the Indian Pharma PMT should have a larger say when its comes to brand strategies rather than being mere followers of the whims and fancies of the so called "Strategists"?

I would like to have your views on the diminishing significance of "The Brand Plan". How can it be effectively used as a tool to bring out the real brand manager and thus the leader, in us?

I think its the only tool left to streamline all promotions leading to better branding and overall growth and development of us. I NEED YOUR COMMENTS!

THE ADVERTISING BRIEF: PREPARATION

PREPARATION:
Product Characteristics: The most important part of formulating a Communication Strategy is analysing product characteristics. Take help of ORG Stock&Sales Analysis, Rx Audit to understand the curent and past prescription behaviour.
Brand Characteristics: This analysis will clearly provide an insight about how the brand is shaping up the product / market life cycle. Brand characteristics would include describing its personality, the need catered by this brand (the disease it treats, the therapy it augments / replaces and the economy of therapy).
Brand vis-a-vis Market Performance: Includes the sales analysis of the brand (internally, market reflection and the Rx audit). Studying the trend would help you gain greater insights.
Competitive Analysis: Product vs Competitors - includes analysing the sales trend of directly competing product and even complementing products. Brand vs Competitors - includes analysing the sales and Rx trend of directly competing brand from the same product category and even indirect competing brands from directly competing products.
The Brand History: A brand is a personality which is build through a series of communication assaults done by the brand manager. Understanding brand includes the running through the series of its earlier communication. This would include all previous advertising campaigns, colour associated, tag lines, fonts used, mnemonic, communication at relevant life cycle stage of the brand and the impact on the sales trend. All Ads used for print, video, hoardings, visual aids and even the copy matter of the Ads. The inclinic activities done throughout the brand life cycle.
Perceptual Mapping: Carry out a primary brand recall and perceptual study of different competitor brands from the target segments and construct a perceptual map for the therapy for various brands based on various factors. Perceptual Mapping is a very important tool which precisely provides information of positioning of different brands and various viable options for probable positioning. The true place of your brand in the mind of your customers can be known through these maps.
Budget: Includes analysing the % spend vs the sales budget. Current budget available for the campaign. This also should be studied with the total investment to be done on the customer directly. Even Seasonality and Regionality of the campaign need to be studied.

TOP SELLING MEDICINAL BRANDS IN 2012

TOP SELLING MEDICINAL BRANDS IN 2012

Generic Name
Brands
Companies
Indications
Sales
( USD Billions )
Atorvastatin
Lipitor
Pfizer, Astellas
Cholesterol

12.66
Clopidrogel
Plavix
Bristol Myers Squibb, Sanofi Aventis
Atherosclerosis, prevention of clot related events

8.82
Infliximab
Remicade
J&J, Merck, Mitsubishi Tanabe
RA, UC, CD, Ps, PsA, AS

6.04
Fluticasone Salmetrol
Advair
Glaxo Smith Kline
Asthma, COPD

8.47
Etanercept
Enbrel
Amgen, Pfizer, Takeda
RA, JIA,  Ps, PsA, AS

6.17
Bevacizumab
Avastin
Roche
Cancer: lung, colon, kidney, glioblastoma

5.53
Aripiprazole
Abilify
Otsuka, BMS
Schizophrenia, Depression, Bipolar

5.43
Rituximab
Rituxan
Roche
NHL, CLL, RA

5.03
Adalimumab
Humira
Abbott
RA, Ps, JIA, PsA, AS, CD

5.96
Valsartan
Diovan
Novartis
Hypertension

4.16
Rosuvastatin
Crestor
Astra Zeneca,

Shionoggi
Cholesterol

6.8
Enoxaparin
Lovenox
Sanofi Aventis
Anticoagulant DVT

4.28
Quetiapine
Seroquel
Astra Zenec
Schizophrenia
5.6
Trastuzumab
Herceptin
Roche
Breast Cancer

4.17
Esmoprazole
Nexium
Astra Zeneca
Ulcer

8.36
Olanzapine
Zyprexa
Lilly
Schizophrenia, Depression, Bipolar

5.74
Montelukast
Singulair
Merck
Asthma, allergy
4.9
Insulin glargine
Lantus
Sanofi Aventis
Diabetes

4.69
Pioglitazone
Actos
Takeda
Diabetes

4.32
Glatiramer
Copaxone
Teva, Sanofi Aventis
Multiple sclerosis

4.0