India revokes patent on GSK's Tykerb

The country's Intellectual Property Appellate Board upheld a GSK patent granted on the active pharmaceutical ingredient in Tykerb, lapatinib, citing innovative merit. However Tykerb is the salt form of lapatinib and the board decided it represents an incremental innovation, so patent protection for the drug has been pulled.

Authorities in India have revoked a patent on GlaxoSmithKline's breast cancer drug Tykerb,in the latest blow to big pharma in terms of intellectual property.
The move follows the end of the long-running landmark case settled in April  when the Supreme Court of India rejected Novartis' application to patent an updated version of its cancer drug Glivec (imatinib). The Tykerb case was brought by Fresenius which had challenged patents granted to GSK for both the original molecule and Tykerb, saying both lacked innovation.

GSK issued a statement, reported by Reuters, said that "we are studying the IPAB's decision but maintain our belief in the inventiveness of the lapatinib ditosylate salt and will consider the possibility of taking further steps before the appropriate authorities to validate this". However the firm added that it is pleased the board upheld the basic patent for the lapatinib compound, which expires in January 2019.

GSK had already cut prices of Tykerb by a third in India as part of a flexible pricing programme for certain emerging markets. Reuters reported that a strip of 10 Tykerb tablets costs about 4,160 rupees (about £45) and a patient should take five tablets a day for 21 days if the cancer is in an advanced stage.

Links

www.gsk.com

Cipla announces Q2 FY 1213 Unaudited Financial Results

Mumbai, India: Cipla Limited (BSE: 500087, NSE : CIPLA) today announced its Unaudited Financial Results for the quarter ended September 30, 2012 (Q2).
Key Financial & Performance Highlights Q2 FY1213 vis-a-vis Q2 FY1112:

• Gross revenues grew by 23.6% to Rs. 2220 cr, up from Rs. 1796 cr in Q2 FY1112
• Operating margins grew by 57.7% to Rs. 677 cr, up from Rs. 429 cr in Q2 FY1112
• Profit after tax grew by 61.8% to Rs. 500 cr during Q2 FY1213, up from Rs. 309 cr (Q2 FY1112)

Profit & Loss Highlights:

• Material cost at 36.3% of Total Sales decreased by 4.2% during Q2 FY1213 as compared to Q2 FY1112.
• Operating margins increased by 57.7% and is at 30.5% of Income from Operations during Q2 FY1213 as
  compared to 23.9% during Q2 FY1112.
• Profit after tax increased by 61.8% to Rs. 500 cr during Q2 FY1213 as compared to Rs. 309 cr during Q2
  FY1112.

Performance Review:
Domestic business:

• Domestic revenues grew by 13.5% to Rs.962 cr during Q2 FY1213, up from Rs. 847 cr during Q2
  FY1112.
• The growth in domestic revenues was largely on account of growth in anti-asthma, anti-biotics and
  cardiovascular therapy segments.

International business:

• Exports of formulations grew by38.2% to Rs. 1039 cr during Q2 FY1213, up from Rs. 752 cr during Q2
  FY1112.
• Exports of APIs grew by 9.0% to Rs. 174 cr during Q2 FY1213, from Rs. 159 cr during Q2 FY1112.
• The growth in export revenues was primarily due to growth in anti-depressants, anti-ulcerant and anti-asthma segments.

About Cipla:
Cipla laid foundations for the Indian pharmaceutical industry back in 1935 with the vision to make India
self‐reliant in healthcare. Over the years Cipla has emerged as one of the most respected names not just in
India but worldwide. Its state of the art R&D centre has given the country and the world many firsts. This
includes the revolutionary AIDS cocktail for less than a dollar a day. With over 34 manufacturing units
across the country, Cipla manufactures over 2000 products in 65 therapies.
With a turnover of over US $ 1.4 billion, Cipla serves doctors and patients in over 170 countries. It has
earned a name for maintaining one global standard across all its products and services. Cipla continues to
support,  improve  and  save  millions  of  lives  with  its  high‐quality  drugs  and  innovative  devices.
(www.cipla.com).

Biological E’s Japanese Encephalitis vaccine prequalified by WHO

Biological E (BioE) and European biotech company Valneva SE (Valneva) are now prequalified by the World Health Organization (WHO) for the global use in adults of the former Japanese Encephalitis vaccine. This is the first prequalification of a Japanese Encephalitis vaccine, and is a key step in ensuring the vaccine can be distributed to developing countries.

The company also expects the pediatric indication to be prequalified by the end of the year.

In 2005, Biological E and Valneva inked a partnership for the development and commercialization of a Japanese encephalitis vaccine for endemic regions, based on latter’s JEV technology. The vaccine, which was successfully developed under this partnership, is being marketed in India under the trade name JEEV and commercialization in other JE-endemic countries is planned.

Valneva is a new European biotech company focused on vaccine development and antibody discovery. It was created in 2013 through the merger between Intercell AG and Vivalis SA.

Mahima Datla, MD of Biological E Limited, said that it was an extremely important achievement for the vaccines community. Our vaccine’s prequalification is well in time to support GAVI’s plans of introducing the JE vaccine in several developing countries.

 “We share the excitement for this great achievement and are pleased that our technology used for IXIARO which is FDA and EMA approved will now help introducing an excellent vaccine in countries of substantial needs, stated Thomas Lingelbach, Valneva’s president and CEO and Franck Grimaud, Valneva’s president and chief business officer.

Biological E has emerged as a fast growing company. Early this year, the company also entered into a five year pentavalent supply arrangement with GAVI. In this regard, it has entered into a joint venture with GSK to develop a six-in-one paediatric vaccine combining the latter’s IPV It had also entered into a licensing pact with Novartis’s phase II typhoid conjugate vaccine.

Japanese encephalitis caused by a flavivirus that affects the membranes around the brain. Approximately one in 200 infections results in severe disease characterized by rapid onset of high fever, headache, neck stiffness, disorientation, coma, seizures, spastic paralysis and death. The case fatality rate can be as high as 60 per cent among those with disease symptoms; 30 per cent of those who survive suffer from lasting damage to the central nervous system. The severity of JE infections has been recognized by the medical community and the global health authorities have emphasized the need for routine vaccination, campaigns and travelers vaccine for endemic countries. The disease is endemic to many regions in Asia and South East Asia including in India, Bangladesh, Bhutan, Myanmar, Cambodia, Indonesia, Laos, Malaysia, Nepal, Pakistan, Philippines, Sri Lanka, Thailand and Vietnam.

Sun Pharma recalls brain haemorrhage treatment drug in US

Drug major Sun Pharma has recalled certain lots of Nimodine capsules, a drug indicated to treat brain haemorrhage, in the United States market due to crystal formation.

As per the US Food and Drug Administration ( USFDA) website, the company is recalling the Nimodine capsules, 30 mg, due to " crystallisation".

The recall falls under Class II category, and it is done in a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

As per the USFDA, 46,387 cartons of the drug have been distributed in the US market. The recall has been initiated voluntarily by the drug maker and the same was intimated to the drug regulator through a letter on May 21.

Comments from the company could not be obtained immediately.

Last year, the Mumbai-based firm had recalled one lot of the drug as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution.

Nimodipine Capsules, 30 mg, are used to decrease problems due to subarachnoid haemorrhage (bleeding in the brain).

Shares of Sun Pharma on Friday closed at Rs 1,080.25 apiece on the BSE, down 3.35 per cent down from the previous close.

Health Ministry to check if Pharma FDI policy mars public health

The health ministry will hold an inter-ministerial meeting on Monday 15,july to ensure that the existing foreign direct investment policy in the pharmaceutical sector is not at variance with the public health goals of the country.

Besides the Department of Industrial Policy & Promotion (DIPP), the nodal ministry for framing FDI policy, and the Department of Pharmaceuticals, a range of other stakeholders, including healthcare experts from the Public Health Foundation of India, will participate in the deliberations.

DIPP may float a discussion on how multinationals in the last few years have targeted specific therapeutic verticals such as injectables and cancer therapy for takeovers here, which has significantly eroded the strength of Indian drug makers to provide low-cost alternatives in these affected segments.

This comes in the wake of commerce and industry minister Anand Sharma requesting Prime Minister Manmohan Singh to revisit the FDI policy for brownfield investments in the pharmaceutical sector by calling a high-level meeting with the Finance, Health and Family Welfare, and Fertilizer and Chemicals Ministers. Sharma cautioned that the present policy may weaken domestic capabilities, compelling India to depend on imports or on domestic facilities owned by MNCs for life-saving drugs.

A section of the government is concerned that Indian generic drug industry is losing its edge in some of the highly-specialized and complex niche therapies such as oncology and injectables verticals, where only a few domestic players have been able to build capacities. If MNCs swallow these select players, this could mark the end of cheaper generic version of these drugs, these officials fret.

"Whenever a buy-out is proposed, we must thoroughly analyse the ramification on public health. To do that, we must look at the therapy competencies of the target Indian drugmaker, how much market share the company's drugs command in its relevant vertical in the domestic market and compare the prices of its products to the competition products to get a clear understanding of what the country may lose," said an official, who didn't wish to be identified

A DIPP official confirmed participation for Monday's meeting.

"We should be in a position to produce a drug in an emergency. If all the front-end facilities are gone, you cannot compel foreign entities to produce it for your domestic market," said another government official, adding that during the formulation of the pharma FDI policy, no one imagined companies specializing in drugs other than just solid formulations, like vaccines and injectables, could be taken over like this. Similar concerns led DIPP to raise objections on US-based Mylan Inc's plan to acquire Agila Specialties, the injectable division of Bangalore-headquartered Strides Arcolab. This deal worth $1.6 billion, which was deferred by the Foreign Investment Promotion Board, is one of the largest in the pharma space in recent years after Abbott's takeover of Piramal Healthcare in 2010 and Daiichi Sankyo's acquisition of Ranbaxy Labs in 2008.

It cited the instance of Shantha Biotechnics, which was bought over by the French drug innovator Sanofi Aventis in 2009. It was the only facility to manufacture the Hepatitis B vaccine in the country and it supplied this vaccine at a fraction of the cost in India against prices in other markets of the world, an official had pointed out. The highly specialised state-of-the-art facilities for oncology drugs and injectables in India have been the targets of MNCs. Mylan, just before announcing the Agila deal, bought over Hyderabad-based SMS Pharma's manufacturing plants, including some of its advanced oncology units in late 2012.

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Falling standards of pharma companies is industry's big bane: GV Prasad, Chairman, Dr Reddy’s Lab

The pharmaceutical industry is facing pressure from regulators in the US because companies have allowed standards to decline, the head of one of India's biggest drug makers has said.

GV Prasad, who took over as chairman of Dr Reddy's Laboratories in April from the company's late founder Anji Reddy, said the increased scrutiny is good for the industry and will help it get its act together.

"Increasing regulatory pressures are largely because the companies have slipped off in terms of quality, in terms of systems, in terms of integrity. And we are feeling the pressure of that," he told ET in an interview, his first to an Indian publication since becoming chairman. "In the long run it is good for the industry to get its act together and comply with the regulations."

Prasad's statement comes in the backdrop of a record $500-million ( Rs 3,000 crore) fine imposed by the US on Ranbaxy Laboratories BSE 0.77 %. Now owned by Japan's Daiichi Sankyo, Ranbaxy pleaded guilty to violating manufacturing norms and falsifying statements to US drug regulator FDA.

Prasad, whose company sold drugs worth over Rs 11,600 crore in 2012-13, said Ranbaxy under its new owners has improved and adopted an "uncompromising approach towards quality". India has emerged as an important global supplier of low-cost generic medicines, helping to drive down prices of drugs that were hitherto inaccessible to low-income patients.

In 2012-13, Indian pharmaceutical companies are estimated by the government to have exported drugs worth over Rs 90,000 crore.

Following such success, multinational pharmaceutical companies have in recent years acquired Indian generics makers, among them Ranbaxy and Piramal Healthcare Solutions (bought by American firm Abbott). This has prompted tighter rules from the government, which says its approval is required if a foreign firm is to buy an Indian pharma company. The government's argument is that it is trying to balance public health concerns with strengthening domestic manufacturing capacity.

Prasad, who said Dr Reddy's has no intention of being sold, was, however, of the view that hurdles in the way of acquisitions are not right. "Today nobody restricts us from buying their companies anywhere in the world. Why should we put all these things? Competition will take care of pricing."

The government's decision to impose price caps on essential drugs, he observed, is not ideal but better than the earlier cost-based pricing system. "I think the government has a role to keep prices affordable and we take it in our stride. It's not something we are happy about, but what can we do?"

On the other hand, Prasad, a chemical engineer, said complaints from multinationals about violation of intellectual property rights and weak patent protection are misplaced. In the most high-profile case on the issue, patent authorities and the Supreme Court rejected an application by NovartisBSE 2.09 % claiming protection for its cancer drug Glivec by saying innovation was only incremental.

"I think we are on that path of giving full respect to all intellectual property. That doesn't mean we will blindly follow everything that is there and that is what has been demonstrated in the Glivec case."

Based in Hyderabad, Dr Reddy's operates plants in India, the US, UK and Mexico. It has technology development centres in Hyderabad, Cambridge in the UK, and the Netherlands. In Russia, an important emerging market for the company, Prasad said the company would set up a local manufacturing facility if it makes a "significant

Generic Pharma Association study says patent settlements netted $25.5 bn in savings for US health system

Generic pharmaceuticals launched prior to patent expiration due to a patent settlement helped the US health system save $25.5 billion from 2005-2012 and brought generic medicines to market on average 81 months sooner than patent expiry, according to a new analysis conducted for the Generic Pharmaceutical Association (GPhA) by the IMS Institute for Healthcare Informatics. An additional $61.7 billion will be saved if the current level of savings continues through to patent expiry for each molecule analysed, the study projects.

“For years, opponents of pharmaceutical patent settlements with consideration have stated that settlements create a cost for consumers, the government and others. This new analysis provides the most current, complete and transparent estimate of the impact of patent settlements on health costs, and it shows that the opposite is true,” said Ralph G Neas, president and CEO of the Generic Pharmaceutical Association.

“In particular, the new analysis estimates that patent settlements – including those with consideration – have led to billions in savings. For example, the settlement involving Lipitor alone will save $22 billion over the next four years. This is critical for lawmakers to understand, because any further restrictions on settlements will put these savings at risk.”

The study analysed a set of 33 molecules subject to patent settlements between 2005 and 2012 and measured the savings resulting from lower cost generics entering the market in advance of the each molecule’s patent expiration date as recorded in the FDA’s Orange Book. In addition, arithmetic modeling was used to estimate the proportion of patent settlements with consideration to derive estimated savings.

Generic pharmaceuticals launched prior to patent expiry as a result of a patent settlement reduced drug costs by $25.5 billion from 2005-2012. The Federal government benefits from almost one-third ($8.3 billion) of these savings. Savings from patent settlements with consideration, those at issue in the Court and legislation, would be between $11.8 and $13.6 billion if these settlements are typical of all settlements. The Federal government’s share of such savings would be between $3.8 and $4.4 billion.

Further, in addition to the $25.5 billion saved by patent settlements from 2005 to 2012, the study projects an additional $61.7 billion saved if the current level of savings continues through to patent expiry for each molecule analysed. That equates to more than $87 billion in savings from settlements.

The study also looked at the savings that would have been negated if patent settlements had not been an available course of action. Applying the success rate of 48 per cent, derived from a separate Royal Bank of Canada analysis of patent challenges from 2000-2009, the IMS Institute found that realized (from 2005-2012) and projected (from 2013 until each molecule’s patent expiry) savings of $87 billion would have been reduced by nearly half, to only $45 billion.

“Recent IMS Institute and Department of Labour studies have shown the first decline in drug expenditures in 55 years. We believe generic medicines, including those that come to market through settlements and settlements with consideration, have contributed to this historic success,” said Neas.

Govt may ban sale of TB drugs in open market

Sale of Tuberculosis drug could be prohibited in open market as part of efforts to ensure calibrated and monitored administration of these medicines which would then only be given on daily basis free of cost by government registered outlets to patients.

The Health Ministry is proposing changes in view of irregularity in administration of these drugs to patients and lack of proper monitoring which is hindering efforts to check the disease, sources said.

According to a WHO estimate, India is home to the largest number of TB patients, 2.2 million of the world's 8.7 million.

Patients are administered TB medicines either through government-run hospitals and clinics free of cost or by private practitioners.

According to the Health Ministry, about 65 per cent of the TB patients avail these drugs under the government's DOT (Daily Observed Therapy) System while the rest opt for treatment by private practitioners and buy drugs from the chemists based on their prescription.

The latter results in irregularity of treatment which leads to relapse of the ailment as there is lack of proper monitoring, the sources said citing experts.

To address this, the government is planning to prohibit sale of drugs in open market.

Under the new initiative, patients going to private practitioners for treatment will get medicines free of cost from chemists but only after the doctor informs them through a dedicated call center

The changes are being brought to ensure that all TB patients are administered the drugs on daily basis instead of intermittently as at present.

Recently, Health Minister Gulam Nabi Azad had expressed concern on the issue saying that the irregular regime is leading to growing resistance to anti-TB drugs.

The Health Ministry officials recently had held a meeting with WHO and other experts who had emphasised on changing intermittent dosage system to daily regime.

During the meeting, it was informed that many other countries including Brazil, China, which were following the intermittent dosage system, have now turned to daily regime.

to be set up by the government.

Zydus pioneers a breakthrough with LIPAGLYN, India’s first NCE to reach the market

The Zydus Group announced a breakthrough in its research efforts with LipaglynTM (Saroglitazar), a novel drug targeted at bridging an unmet healthcare need for treating Diabetic Dyslipidemia or Hypertriglyceridemia in Type II diabetes, not controlled by statins alone. The drug has been approved for launch in India by the Drug Controller General of India (DCGI). With a novel action that offers lipid and glucose lowering effects in one molecule, LipaglynTM is the first Glitazar to be approved anywhere in the world.
“LipaglynTM provides patients suffering from diabetic dyslipidemia the option of a once-daily oral therapy that has a beneficial effect on both lipid parameters as well as glycemic control,” said Mr. Pankaj R. Patel, Chairman and Managing Director, Zydus Cadila. "It has always been our dream to take a molecule right from the concept stage up to its launch. Today, we have realized this dream. It is an important breakthrough and I would like to dedicate this to all the Indian research scientists in the field of drug discovery,” Mr. Patel added.
Diabetic Dyslipidemia is a condition where a person is diabetic and has elevated levels of the total cholesterol, the "bad" low-density lipoprotein (LDL) cholesterol and the triglycerides and a decrease in the "good" high-density lipoprotein (HDL) cholesterol concentration in the blood. Optimal LDL cholesterol levels for adults with diabetes are less than 100 mg/dL, optimal HDL cholesterol levels are equal to or greater than 40 mg/dL, and desirable triglycerides levels are less than 150 mg/dL. LipaglynTM , a non-thiazolidinedione, is the first therapy to be approved for this condition.
World over, it is estimated that 30% of all deaths occur due to cardiovascular diseases (CVD). In India, one out of every five persons is at serious risk of developing CVD. Research has shown that diabetes is one of the major risk factors of CVD. India has a population of nearly 65 million diabetics and 77 million pre-diabetics. 85 - 97% of the diabetes patients suffer from dyslipidemia or lipid abnormalities. Hence, addressing the problem of diabetes and dyslipidemia is crucial in tackling the health risk posed by CVD.
Discovered by the Zydus Research Centre, the dedicated NCE research arm of the Zydus group, LipaglynTM is a best-in-class innovation, designed to have a unique cellular mechanism of action following an extensive structure-activity relationship study initiated in the year 2000. LipaglynTM has a predominant affinity to PPAR alpha isoform and moderate affinity to PPAR gamma isoform of PPAR nuclear receptor subfamily. The molecule has shown beneficial effects on lipids and glycemic control without side effects. This molecule underwent extensive pre-clinical characterisation and the IND was submitted in the year 2004.
As a part of the clinical development programme, extensive Phase-I, Phase-II and Phase-III clinical trials were conducted to evaluate the phamacokinetics, pharmacodynamics, efficacy and safety of LipaglynTM. The new drug application for LipaglynTM was based on a comprehensive clinical development programme spanning eight years.
Results from the first Phase III programme with Pioglitazone as a comparator drug in diabetes patients showed that the 4 mg dose of LipaglynTM led to a reduction of triglycerides and LDL (bad) cholesterol, and an increase in HDL (good) cholesterol and also showed a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbA1c) thereby confirming its beneficial effects of both lipid and glycemic control in diabetic patients.
In the second Phase III study, LipaglynTM was studied in diabetic dyslipidemic patients insufficiently controlled with statin therapy. The results from this study confirmed that LipaglynTM had a pronounced beneficial effect on both the lipid and glycemic parameters in these subjects.
In both the studies, LipaglynTM was well tolerated and had a better safety profile than the comparators. Importantly LipaglynTM has a non-renal route of elimination, and did not show adverse events like edema, weight gain, myopathies or derangement of liver and/or kidney functions, thus making it safe and efficacious. LipaglynTM is recommended for once daily administration as 4 mg tablets.
Zydus will offer a dedicated LipaglynTM support programme to patients and caregivers. The programme shall provide important support and information regarding access, adherence, education and thereby help patients to start and appropriately manage their disease and therapy over time.
About Zydus Cadila
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. From a turnover of Rs. 250 crore in 1995, the group posted revenues of over Rs. 6300 crore in FY2013. With 20 discovery research programmes under various stages of clinical development, the group invests over 7% of its turnover in research. At the group’s state-of-the-art research arm, the Zydus Research Centre, over 400 research scientists are engaged in NCE research alone. The group employs over 15,000 people worldwide and is dedicated to creating healthier communities globally. It aims to be a leading global healthcare provider with a robust product pipeline; achieve sales of over $3 billion by 2015 and be a research-based pharmaceutical company by 2020.

past present and future of pharmacy

In India, the profession of pharmacy is still in its developing

stages and is yet to bloom to its fullest extent. Here the pharmacist performs
a job of a drug seller and does not practice the profession independently
and depends on a doctor who is the decision maker.

To cater to these needs presently, B. Pharm. & M. Pharm.
is available and D. Pharm. being the minimum need. But all these higher courses
are regular courses and the practicing pharmacist may not get an opportunity
to attend the college regularly for updating the educational qualification.
With advancement in every field, the profession of pharmacy has also witnessed
tremendous changes. The community expects more professional services from
pharmacists and not as just drug sellers. There are many community pharmacists
serving the country with just D. Pharm. qualification, who are not well equipped
with adequate information. The pharmacy council of India has taken a decision
to discontinue the D. Pharm. course soon. India being one of the developing
countries is yet to meet the needs of people as basic education, health, hygiene
etc. Most of our people live in rural areas and do not have basic facilities
such as primary health centers, clinics or even approach roads. This rural
population including the urban population needs multifarious activities from
pharmacists. The PCI defines Pharmacy as a profession which is concerned with
the art and science of preparing from natural and synthetic sources, suitable
and convenient materials for distribution and use in the treatment and prevention
of disease. It embraces a knowledge of the identification, preservation, combination,
analysis and standardization of drugs and medicines besides synthesis of new
drug molecules, manufacturing of various dosage forms, (Liquid orals, powders,
tablets, capsules, ointments, injections, ophthalmic products, etc.) quality
control, clinical trials, bio-availability, research, side-effects, compatibility,
in-compatibility, indications, contra-indications, pharmacokinetics, pharmacodynamics,
toxicology etc.

A Flashback: Germination of Pharmacy Education

The history of
pharmacy education in India is as old as when the country was being gravitated
towards British Emperorship. A wind of revolution had been started to innovate
something different in the education system of Indian Medical Services. Upto
the middle of the nineteenth century, the pharmaceutical education and training
remained in a state of neglect. The scenario of pharmacy practice was pathetic.
The dispensing of prescriptions continued to be carried out by compounders, who
had a low level of preliminary training and education.  The compounders were lowly paid
professionals. There were a few European trained pharmacists who were employed
by private firms. The seed of the pharmacy education in India was sown first by
Medical College, Madras in 1860. Steps were taken to start pharmacy classes to
impart pharmaceutical skills for the students qualifying for medical degrees or
diploma or hospital assistance ship. The steps proved to be useful for the
students intending to qualify as chemist and druggists. Broadly it was copying
the practice as it prevailed at the time in Britain. The classes continued with
increase of the duration of study to 2 years and entry qualification being made
matriculation in due course.
The Materia
Medica proved supportive to boost up the pharmacy education. The students were
taught Materia Medica and instructed in the mode of preparing the principle
compounds of the Pharmacopoeia and Materia Medica. In the middle of the
nineteenth century these professionals got scientifically educated and trained.
Initially the 'chemist and druggist' class at Madras Medical College didn't get
popular and attracted less than half dozen students per annum. The reasons
could have been the limited prospects of employment for the so qualified
personnel.  Voices were raised favoring
the view that the "present chemist and druggist course be washed out".
However the class remained in operation and received Government sanction for
continuance in the Madras Medical College as a permanent arrangement. The
curriculum of studies was revised with inclusion of study of organic chemistry
also. After that the course underwent various revolutions at many times and
also started in some other universities like Medical College, Visakhapattnam.
The pharmacy
education in India was going to pass through a mutation when the founder of
Banaras Hindu University Mahamana Pt. Madan Mohan Malviya met Prof. M.L. Schroff
and Mahamana offered him to join B.H.U. By the nontiring efforts of Prof.
Schroff in July 1937 "Pharmaceutical Chemistry" and
"Pharmacognosy" were introduced as the subjects for B.Sc. degree.
Since then there has been no looking back. Pharmacy came to be recognized as a
well-established course with fruitful outcomes.

Current Scenario

Pharmaceutical education plays a very prominent role in
attaining sustainable and equitable development of a country. The curriculum of
the degree in some developed countries (B. Pharm.) usually requires 5 academic
years of study. In most of the European countries successful completion of a
university degree leads to a one-year internship. The formal pharmacy education
in India (3 year degree in BHU) dates back 1932, and since then, there has been
a continuous growth in number of such institutions. As per PCI 2005 diary
calendar, the total numbers of recognized degree institutions are 220 with
intake of 12506 students. And as per AICTE, the total number of degree colleges
are 445 with the intake of 24672 students as well 30 institutions for the post
graduation in various fields.
The number of accredited institutions like the
National Institute of Pharmacy Education Research (NIPER) is very few. Faculty
strength and its quality is a problem. The education system is not geared for
the WTO era. Management is not proactive in providing facilities and necessary
educational environment. National pay scales are not fully implemented and
hence good academia is missing. There are a few centers of excellence where
students get all the facilities and are well placed after their graduation. In
the next decade, pharmaceutical industries will scout for pharmacy graduates
who are inclined to research. Therefore, pharmacy colleges must appoint the
right faculty.

Education Standards at Present

There is no doubt that currently there is enormous gap
existing between education and practice of pharmacy. Most of the academic
institutions providing education in pharmacy are away from practice
environment. The overall basis of pharmacy education is still extrabiological
synthesis, physicochemical studies, analysis, and manufacturing aspects of
drug. It is a common feeling that the medical practitioner is better placed for
pharmacists' job than the pharmacists themselves. The dispensing services are
poor. The syllabus and duration of the two-year diploma course in
pharmacy education in India is completely outdated and irrelevant in the
present industry context. It is a heterogeneous mixture of clinical and
industrial subjects. Since clinical subjects are there PCI comes into the
picture and AICTE came in because of industrial orientation of pharmacy
syllabus. Pharmacy as a nascent science developed like this in the last
century. During 1940s and 50s, hospitals and industries were established in
large numbers in India. Consequently, pharmacists and pharmaceutical chemists
were required in huge numbers. Hence pharmacy education was developed in such a
way to satisfy the requirement of industry and hospital. Short-term compounders
and or D. Pharm. course to satisfy the needs of hospital and medical shops and
B. Pharm. course for the industry were started. This is proved by the fact that
in the last few decades D. Pharm. holders are not employed by the industry and
B. Pharm. holders are not in many numbers in hospitals or medical shops.
In the West, pharmacy education is patient-oriented and is responsible for
Healthcare Management, while in India pharmacy education is industry-oriented.
Nearly 55 per cent of the jobs are available in the industry sector while 30
per cent in education. There are only three per cent jobs in healthcare. There
must be revolutionary changes in the healthcare system e.g. making laws for
appointing pharmacists at each Primary Health Centre and government hospitals.
There should be adequate staff in the state drugs control departments for
better control of drug distribution system. It is crystal clear that separation
and improvement of clinical and industrial subjects in the pharmacy syllabus is
a compulsion of the time. But it is yet to be completed, that is why there is
such a situation and a lot of infighting among government authorities. Present
B. Pharm. syllabus can be divided into 2 major courses like B. Pharm.
(Clinical) and B. Pharm. (Industrial) as it has been already decided to abolish
D. Pharm. course. Such an arrangement will increase the confidence and
competitive skills of pharmacy graduates among health care team and technocrats
and some sort of specialization during under graduation itself. If two B. Pharm.
courses are created as above, needless to say clinical course can be controlled
by PCI and industrial course by AICTE. Private college managements can opt for
any one of the courses. If any college wants to run both the courses they
should accept both masters, there is no other go. Existing D. Pharm. colleges
who are in the verge of closure can adopt B. Pharm. (Clinical) and continue to
serve the profession. This stunted growth of
professional pharmacy in our country is the result of misplaced belief that
profession is same as vocation. This belief has kept Indian pharmacy academics
completely focused on industrial pharmacy at the cost of real - community
pharmacy. While the justification for focusing pharmacy education on Industrial
Pharmacy after attaining national freedom was valid, its review to make it
relevant in contemporary scenario is already too late.
Our present system has produced half a million
''qualified'' pharmacists but not many ''trained'' professionals. This has
effectively led to a situation where neither there is a need felt by the
society nor is there anyone available to fulfill that "professed"
need. This situation feeds on itself to such an extent that any attempt to keep
one's knowledge updated and work professionally has strong economic disincentives
in Indian retail pharmacy practice. Gravity of the situation dawns upon us when
we think about petitions filed in High courts that propose scrapping of the
Pharmacy Act because the pharmacists - according to petitioners - do not play
any role other than selling the drugs like all other commodities. There is
virtually a complete lack of any training or incentive to professionalize - as
a result of which even the most enthusiastic pharmacists gradually convert into
mere traders. The uninspiring implementation of statutory provisions has led to
a cancerous proliferation of retail drug shops and the situation now threatens
the profession itself. The retail pharmacist shall be relevant to the society
`only'' if he can make a difference to the patient - by providing him information
about drug usage to achieve better outcome than the patient obtains by
uninformed usage of drugs.
The president of this IPC - Prof. Kulkarni - himself
conceded in his inaugural address of IPC 2001 that talking about Community
Pharmacy has become a pass-time lately. A lot of credit for this new
fascination about community pharmacy goes to the Community Pharmacy Division of
IPA, which launched a persistent campaign to nudge the retail pharmacists, the
academicians, professional association managers and lately the society itself. Apart
from whatever else is taught in pharmacy colleges under the garb of
"Pharmacy Practice"- I feel the following are mandatory subjects:
Pharmaco-therapeutics, Communication skills and Hands down training on computer
operations. He must be trained and experienced in working as a health-care team
member and this factor is not to be underestimated in the formal education
design.
Driving an automobile can be learnt only in an automobile -
on a road. Or - you at least need a simulator to learn driving. Similarly,
pharmacy practice cannot be taught in an institution that has no affiliation
with a patient-care set up. This fundamental principle must be kept in mind
before a Pharmacy Practice course is conceived. The pharmacy teacher's
community should take notice of this critical and important issue and involve a
cross section of practicing pharmacists to review and suggest a relevant
curriculum. Any further delay will diminish whatever slim chances we believe we
have today of projecting Pharmacy as a socially relevant profession.

Control of Pharmacy Education by The PCI

The PCI controls and regulates the standards for a better
pharmacy education in India. The main aims of PCI are:
• To prescribe minimum standard of education required for qualifying
as a pharmacist i.e. framing of Education Regulations prescribing the conditions
to be fulfilled by the institutions seeking approval of the PCI for imparting
education in pharmacy.
• To ensure uniform implementation of the educational standards through
out the country.
• To approve the courses of study and examination for pharmacists i.e.
approval of the academic training institutions providing pharmacy courses.
The curriculum of pharmacy education has been designed to produce the following
professional categories of pharmacists;
• Community and hospital pharmacists who will work as an important link
between doctor and patient and will counsel the patient on various facets
of drugs like usage, side effects, indication, contra-indications, compatibilities,
in-compatibilities, storage, dosage etc.
• Specialist in research and development i.e. research of new drug molecules,
biotechnical research etc.
• Occupational specialist (industrial pharmacist engaged in pharmaceutical
technology) i.e. manufacture of various dosage forms, analysis and quality
control, clinical trials, post-marketing surveillance, patent application
and drug registration, sales and marketing.
• Academicians i.e. Teachers of Pharmacy education.
• Manager and Administrators of Pharmaceutical Services working for
various regulatory authorities and pharmaceutical systems.
• Chemists and Druggists engaged in selling of medicines.
Future: An Overview
In the future, drug treatment will be increasingly and
confidently tailored to the individual through the help of specific
diagnostics. Many new drugs will be given parenterally and targeted for
specific diseases. The pharmacists will need to adapt to this changing pattern
in order to be seen by the patient as part of health care team. However in
spite of many lacunae in pharmacy education system, the fact cannot be
overlooked that tremendous development in the field of new drug discovery and
research activities, has taken place. Research centers attached with
pharmaceutical institutions have played a major role in this regard. Notable
among them are BRNCRC, Mandsaur; TIFAC CORE in JSS College of Pharmacy,
Ooty; TIFAC CORE and ACCUNOVA in Manipal College of Pharmaceutical Sciences,
Manipal and many more. These steps taken at present to upgrade the pharmacy
education must be maintained for proper development and utilization of the
course. Apart from these, emphasis should be given on fields like Biotechnology,
Bioinformatics, Clinical Trials, Drug Regulatory Affairs (National and
International).

Conclusion

Overall, the
education system is based not only on infrastructure but also on the teachers,
immorality and mismanagement has taken over education. Pharmacy teachers, have
to regulate themselves, update their knowledge, deliver excellence and inspire
students by adapting values, time management is the other factor that they must
bring in their own personality. Education, which they have to deliver, must be
of highest standard so that the upcoming pharmacists should not be a liability,
but should be able to deliver excellence at national and international levels.
                    “Success can not be harvested until and unless its seed
is sown”