To empower the Professionals community with knowledge of Pharma as to provide the platform & opportunity to the young minds to enter the world of R&D sector of Pharma Industry.

Friday, February 26, 2010

Pharma industry welcomes tax incentives for R&D

Tax incentives given by the Budget for research and development made the Indian pharmaceutical firms sport a smile but they are left wondering if the hike in excise duty to 10 per cent on all non-petroleum products will be applicable to them.


Finance Minister Pranab Mukherjee proposed a weighted tax deduction on expenditure incurred in in-house research and development activities to 200 per cent from the current 150 per cent in the Budget.


"We welcome the government's move to increase weighted tax deduction to 200 per cent as research and development activities is a must and in pharma sector, where it is most urgently required," Indian Drug Manufacturers Association Executive Director Gajanan Wakankar said.


However, lack of clarity on whether the pharma sector would also be covered under the increased excise on all non-petroleum products from 8-10 per cent, held back the sector from celebrating.


Currently, the pharma sector attracts 4 per cent excise duty after CENVAT was cut by 4 per cent in December 2008 as part of a stimulus package.


"We are waiting for more clarity over the issue and then only we will assess the impact," Pharmaceutical exports council (Pharmaexcil) founder Chairman D B Mody said.


Piramal Healthcare Director Swati Piramal also said, "We are still looking at the (Budget) papers."She, however, said the tax incentives on R&D was long overdue.


"We were demanding tax deduction on R&D for the last five years and this is a welcome move as India is lagging behind other countries in R&D, such as China, Israel and others," Piramal said.


Consulting firm Ernst & Young Partner Life Sciences Practice Hitesh Sharma said, "This is a welcome move to incentivise and promote India as a R&D destination."


Mukherjee had also announced giving tax incentives on contribution to scientific research association, IITs and approved national laboratories. He proposed 175 per cent weighted deduction on such contribution, up from 125 per cent earlier.


Expressing his displeasure over the Budget, Fortis Healthcare Managing Director Shivinder Mohan Singh said, "From the healthcare perspective, we don't see any bold initiatives in this Budget, except for some reduction in duties on medical equipment.

Thursday, February 25, 2010

Indian Pharma Industry Third Largest Globally: Eco Survey

The Indian Pharmaceutical industry has become the third largest in world in terms of volume and ranks 14th in terms of value at over Rs one lakh crore, the Economic Survey tabled today in Parliament said.

"The Indian pharmaceutical industry has grown from a humble Rs 1,500 crore turnover in 1980 to approximately Rs 1,00,611 crore in 2009-10," the pre-Budget survey said.

The growth of the Indian pharmaceutical industry has been fuelled by exports, which increased 25 per cent in 2008-09.

"Exports of pharmaceuticals have consistently outstripped imports," The survey said.

India exports drug, intermediaries, active pharmaceutical ingredients (APIs), finished dosage formulations, bio-pharmaceuticals and clinical services.

The top five destinations for such exports are the USA, Germany, Russia, UK and China.

Wednesday, February 24, 2010

Gujarat drug manufacturers resort to novel method to urge govt not to hike excise duty

Concerned over the speculation that the central government in its forthcoming budget may hike the central excise from 4 per cent to at least 8 per cent, the pharmaceutical manufacturers in Gujarat have started a new method to drive home the point that any hike in excise duty for pharma sector will result in closure of thousands of units in the country.

Under the new method, every Gujarat drug manufacturer will individually send memorandum to the Union finance minister Pranab Mukherjee once in every three days, urging him not to hike excise duty on pharmaceuticals which will put the industry on the verge of closure.

If the government increases excise from 4 per cent on pharma products, then the industries in the 23 states of excise zone will be on the verge of death, said Kamlesh Patel, managing director of West-Coast Pharmaceutical Ltd in Gujarat. He said the excise zone pharma industries will have to cut their production because their business will be transferred to excise free zones in the country resulting in increase in unemployment in all these 23 states of excise zone.

"We also kindly draw your attention towards the increases in new self financed pharmaceutical college all over the country and in near future Pharmaceutical graduates and post graduates will come out. To give employment to such technical persons drug and pharmaceutical industry should be flourished in all parts of India which is only possible if industry stands in competition," the memorandum said.

Patel, who is also the president of IDMA Gujarat state chapter, said that if the government increases the excise duty, pharma industries' economy will become unbalanced. Due to creation of excise free zone, balancing in working of the industry is disturbed and state as well as central government will lose revenue and cost of medicines will increase again.

The memorandum said that the pharmaceutical industries in the excise zone (23 states) were producing more than 70 per cent of pharmaceutical products (medicines) before the government declared excise free zones. Due to creation of excise free zone in various states, several units are facing a lot of difficulties to capture domestic market and many units in excise zone are closed or are on the verge of closure. From the excise free zone, the government is not getting any revenue but on the other hand expenditure increases to develop infrastructure in excise free zones.

The government's steps to come out from recession were appreciable to reduce excise duty from 8 per cent to 4 per cent and that is the reason majority of pharma industry in the excise zone of 23 states survived in recession period. Due to decrease in excise, many companies passed on the benefit to the customer by decreasing the MRP on drugs and pharmaceuticals, the memorandum said.

Monday, February 22, 2010


Local players to continue domination in anti-fungal drug market in India: F&S

With fast-paced advancements in technology, the number of patients diagnosed with systemic fungal infections (SFIs) is expected to increase steadily over the next five years, says a new analysis from Frost & Sullivan entitled Systemic Fungal Infection Therapeutics Market – India.

Alongside this development, a high premium on products that are capable of tackling emergent, problematic pathogens will also contribute to changing market dynamics. Estimates reveal that the global prevalence of SFI has risen to 4 for every 1,000 of the global population, notes the report.

The high incidence of SFI over the years is attributed to the widespread use of broad–spectrum antibiotics, which reduce non–pathogenic bacterial populations that compete with fungi, and the growing number of persons with compromised immune systems caused by acquired immunodeficiency syndrome (AIDS), immunosuppressant drugs, and chemotherapy agents.

The report finds that local manufacturers are expected to continue to dominate the SFI drug market due to their output of generic medication, although multinationals are trying to gain a foothold through the introduction of newly patented medication.

“Early diagnosis of systemic fungal infections has been shown to be critical to treatment outcome,” said Mr Carole Gaffud, Program Manager at Frost & Sullivan. “Advances in diagnostic capabilities are paving the way for more increased usage of targeted therapy for systemic fungal infections; this is reflected in the growing proportion of patients treated definitively in the last five years.”

Although key therapeutics have been in the market to treat the most causative pathogen (Candida Albicans), there is still an unmet need to treat more resistant pathogens such as Aspergillus. Despite the advent of more advanced molecular diagnostic technologies, physicians in India continue to use empiric and prophylactic therapies to treat SFI. As more resistant pathogens in systemic fungal infections emerge, treatment is centered on ensuring that the right treatment is administered to the patient.

“Doctors are under pressure to ensure that they identify the most suitable mode of treatment, based on universal criteria, such as risk factors, clinical, radiological, microbiological or other diagnostic evidence,” says Mr Gaffud. “The task is made easier for physicians with the growing availability of non-microbiologic and clinical diagnostic techniques, such as Platelia, Fungitell and PNA FISH, to identify the onset of infection.”


This places greater emphasis on matching anti-fungal choice to pathogen susceptibility, increasing the demand for rapid typing of pathogens to ensure informed, targeted drug choices. Consequently, there would be a reduction in the use of prophylaxis in the ‘at-risk’ patient group and the empiric therapy in, for example, patients in this group with a persistent fever or other suggestive symptoms.

Considering the relatively niche nature of SFI, it is vital for key participants to differentiate their products, especially as advances in diagnostic techniques bring about a restriction of prescriptions to specific therapeutic uses. Therapeutics are shifting away from broad and empiric indications, and pharmaceutical manufacturers need to position their products to address more specific indications defined by pathogen species (and sub species) and patient populations, rather than a broad spectrum. This gives room for a higher degree of differentiation, protecting the specific drug from generic erosion in the future.

The changing epidemiology of causative pathogens has caused the effectiveness of existing therapeutic options to decline. In such a scenario, pharmaceutical manufacturers need to develop drugs that address specific indications, in terms of pathogen coverage and patient groups, that is, solid organ transplant, cancer, neonates, HIV/AIDS, and surgical patients, says the report.
SIRO forms alliance with Korean CRO DreamCIS

SIRO Clinpharm, a contract research organization (CRO) with presence in India, Western and Central Eastern Europe, and the US has announced its alliance with DreamCIS, a leading CRO based in Seoul, South Korea.

DreamCIS has experience in offering clinical research services to pharmaceutical companies, bio venture companies, medical device manufacturers, and functional food producers. Their services range includes clinical trial management, pharmacovigilance, post marketing surveillance (PMS), data management, biostatistics and quality assurance services.

“This pact will help us to build a strong competitive advantage in the Asia Pacific region, while on the other hand it will create a sustainable value for our existing as well as potential customers,” said Mr Ajit Nair, President, SIRO Clinpharm, India. He further added that, “Our goal is to offer a wider platform of patient recruitment capabilities from Asia Pacific region for our global client base.”

“We are one of the leading and fast growing CROs in South Korea. However, looking at the increasing number of global clinical trials and the rapid growth in Asian clinical trials market, we were looking at associating ourselves with a CRO having a global exposure; not only from business vertical perspective but also from perspective of moving up on the learning curve. I think our mutually beneficial alliance with SIRO is a definite step in this direction,” said Mr Won-Jung Choi, President, DreamCIS.

“Korea is a rapidly growing clinical trials market due to various advantages it offers pre-approved and well-equipped clinical trial sites, trained professionals, and transparent and efficient regulatory processes. We are confident this alliance will be of immense value addition to SIRO and widen our global service capabilities," said Mr Chetan Tamhankar, Chief Executive Officer, SIRO Clinpharm. 

Friday, February 19, 2010

Update on Clinical Trial using Embryonic Stem Cells

Worcester: Advanced Cell Technology,Inc. a biotechnology company applying cellular technology in the field of regenerative medicine, announced that it has received notification from the US Food and Drug Administration(FDA) that the Agency is currently drafting a response to the company relating to the investigational New Drug(IND)Application it filed in November seeking clearance to initiate a phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt's Mascular Dystrophy (SMD).ACT is currently on clinical hold pending a response from the Agency, which it expects within the next few weeks.
"we look forward to receiving the FDA's response and working with them to address any questions that they may have." said Willium M. Caldwell IV, Advanced cell's chairman and CEO. "Although ACT has taken important steps to advance our RPE program during the last several years, we anticipate the need for further discussions with the Agency before clinical trial can proceed."

Pharmaceutical industry deserves priority status

In this arena, we believe there should be two broad priorities for India. First, to ensure that there is timely access to affordable quality medicine for the underprivileged.

Second, due to the global scale and impact of the Indian pharmaceutical industry, to ensure that we give it the most comprehensive support that it deserves.

The pharma industry is arguably India’s most global industry (in terms of operations, employees and manufacturing). It is ranked as the third-largest producer of drugs and pharmaceuticals globally, with over 20,000 players. This is testimony to the strong R&D, clinical and manufacturing resource and infrastructure in India.

Our huge and potential domestic market, and the global opportunity, provide a potent reason to strengthen our industry, and decide on the rules for domestic engagement and important partnerships/alliance on our terms.

Much resource has gone in reviving the general economy. What is now required is a targeted allocation of resource. The industry needs support — to invest in R&D, in scale; to mitigate the risks of global business; as also contribute to better access of medicine in India.

Instead, the focus is on price control, in a situation wherein India is among the lowest prices of medicine globally. We have to divorce the process of ensuring access of affordable medicine for the underprivileged, from the normal operations of the pharma industry.

Otherwise, we would impact the very foundation of a strong global scale industry. The Budget affords an opportunity to kick start the process of recognising the global status and vast potential of this industry. The industry deserves priority status akin to that of infrastructure, when the government considers tax and other fiscal support measures. Further, some specific proposals are:

First, removal of excise duties across the board for all essential drugs is imperative.

Second, to ensure the industry remains committed to R&D, the incentive of weighted deduction of 150% needs to be at least doubled; and extended for another 10 years. Also, since all R&D cannot be done in house, certain essential costs that are incurred outside the tax approved facilities should clearly qualify for the weighted deduction.

Third, we need to ensure that the overall tax burden should not increase through a change in MAT provisions and withdrawal of tax incentives; particularly for companies that have committed capital investments in SEZs and other notified backward areas.

Fourth, the increasingly heavy investment on environment, health and safety norms, despite low margins, needs to be subsidised.

A couple of decades ago, some wise people in government helped set up the generic pharma industry through a decision on patents. The industry is one of the few where we are ahead of China; though predictably they are catching up fast and strong, with all at their command. It is time for some wise people of today to reinforce this industry, to ensure it endures on a global scale for decades hence.

Thursday, February 18, 2010

Doctors from IIT? Govt to brainstorm

Will Indian Institutes of Technology (IITs) soon start producing doctors? The health ministry is meeting on Tuesday to decide. Health secretary K Sujatha Rao has called a meeting of top ministry honchos, directors of medical institutes and chairmen of medical councils on Tuesday to ascertain whether allowing institutes like IITs to teach medicine will “help medical education or dilute its quality”.

This will be the first major meeting to discuss the issue. Those called to attend include directors of All India Institute of Medical Sciences, PGI (Chandigarh), Sanjay Gandhi Post Graduate Institute (Lucknow), JIPMER, NIMHANS, National Institute of Communicable Diseases, National Institute of Paramedical Sciences and principal of CMC Vellore. Chairmen of the Medical Council and the Nursing Council of India will also attend the meeting along with eminent doctors like Dr Ranjit Roy Choudhury, Dr Devi Shetty, Dr Anupam Sibal and cardiologist Dr K Srinath Reddy.


The all important meeting will discuss three major issues: whether IITs be allowed to start MBBS course, how to create the National Council for Human Resource in Health (NCHRH) — the overarching regulatory body that would replace the existing Medical, Dental, Nursing and Pharma Councils of India — and how to reduce shortage of medical personnel in India.

A health ministry official said, “We want to meet experts to understand whether it is feasible to allow IITs to start medical courses and whether it will help better medical education. Once we know their view, the ministry will form its opinion on the proposal and send it to the HRD ministry.” Opinion is clearly divided on the proposal. However, the MCI has come out in support. Speaking to TOI, MCI chairman Dr Ketan Desai said, “We welcome the move. We know that if IIT starts a medical school, they will have the same standard as their other courses. They will ensure they have the best faculty as their reputation will be at stake.”

Some IITs, like Kharagpur and Hyderabad, are working on starting medical schools in about three years. Ministry officials said IIT Kharagpur has supposedly signed an MoU with University of California, San Diego, to set up a hospital which will offer graduate, PG and research programmes in medicine and bio-medical engineering.

IIT Hyderabad has been expressing its interest to offer MD degrees in three years. In recent meetings with IIT directors, HRD minister Kapil Sibal had asked them to expand their courses.

Global Market for Equipment used in Biotechnology Applications

According to a new technical market research report, Global Market for equipment used in biotechnology applications (BIO070A) from BCC research, a leading publisher of market research reports and technical publications, the global market value for biotechnology equipment is an estimated $5.5 billion in 2009, but is expected to increase to nearly $7.3 billion in 2014, for a 5 year compound annual growth rate (CAGR) of 5.8%.

The largest segment of the market, imaging, is expected to increase at a 5-year CAGR of 4.9%, from $1.7 billion in 2009 to $2.1 billion in 2014. the second –largest segment, electrophoresis, is expected to reach a value of $1.2 billion in 2014. The market in 2009 is estimated at more than $966 million. Thus, the 5-year CAGR is projected to be 4.9%. The segment projected to see the largest growth from 2009 to 2014 is array. It is expected to increase from an estimated $326 million in 2009 to more than $504 million in 2014, for a 5-year CAGR of 9.1%. The biotechnology equipment market includes the instruments used in separation, purification, and analysis of biomolecules in drug discovery and diagnostics. The market growth of biotechnology instruments has been driven by the growth in drug discovery research, which itself follows the increased demand for newer drugs and therapies worldwide. Moreover, the end of the human genome project has marked revolutions in genomics and proteomics, thus enhancing global research on genes, proteins, and related biomolecules. This technology market includes chromatography, electrophoresis, sequencers, and synthesizers, laboratory automation, an array market, immunoassay, imaging, and mass spectrometry. The end user market examined in this report includes biopharmaceuticals, academic institutions, government, agriculture, food and beverages, environmental testing labs, gene/protein expressions, toxicogenomics, pharmacogenomics, pharmacoproteomics, life science and clinical imaging.

The intended audience for the report would be professionals in pharmaceutical and biotechnology companies, analytical instrument manufacturers, distributors and suppliers, pharmaceutical and biotechnology associations, and contract research organizations.


Wednesday, February 17, 2010

Astra Zeneca and Rigel Pharmaceuticals Sign Worldwide License Agreement

AstraZeneca and Rigel Pharmaceuticals today announced an exclusive worldwide license agreement for the global development and commercialisation of fostamatinib disodium (R788), Rigel's late-stage investigational product for rheumatoid arthritis (RA) and additional indications. Fostamatinib disodium, which has completed a comprehensive Phase II programme, is the furthest developed oral Spleen Tyrosine Kinase (Syk) inhibitor being evaluated for RA. Inhibiting Syk is thought to block the intracellular signalling of various immune cells implicated in the destruction of bone and cartilage which is characteristic of RA.
RA is a systemic autoimmune inflammatory disease, which causes damage to the joints and other organs, affecting approximately 1 in 100 people. It is a major cause of disability and it is also associated with reduced life expectancy, especially if not adequately treated. Despite current treatment options, many patients still experience pain, worsening of joint destruction and disability, so new treatment options are needed. The RA market was estimated to be approximately $13bn globally in 2009, having grown from $1.3bn in 1998.
Once the agreement is effective, AstraZeneca will make an upfront payment to Rigel of $100 million with up to an additional $345 million payable if specified development, regulatory and first commercial sale milestones are achieved. Rigel will also be eligible to receive up to an additional $800 million of specified sales-related milestone payments if the product achieves considerable levels of commercial success, as well as significant stepped double-digit royalties on net sales worldwide. AstraZeneca is responsible for all development, regulatory filings, manufacturing and global commercialisation activities in all licensed indications under the contract. Effectiveness of the agreement is contingent on expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
AstraZeneca will design a global phase III programme, anticipated to begin in the second half of 2010, with the goal of filing new drug applications with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) in 2013. Fostamatinib disodium is being developed as a next generation oral RA therapy in adults who have failed to respond adequately to a traditional disease modifying anti-rheumatic drug (DMARD), such as methotrexate, where a TNF biologic add-on treatment would currently be considered. Under the terms of the agreement, AstraZeneca will also receive exclusive rights to Rigel's portfolio of oral Syk inhibitors, as well as for additional indications for fostamatinib disodium beyond RA.
Anders Ekblom, Executive Vice President of Development, of AstraZeneca said: "There is a very real and pressing unmet medical need in the area of rheumatoid arthritis. Given the debilitating effect this disease can have on patients, AstraZeneca looks forward to working together with Rigel to continue development of this innovative investigational compound. Collaborations such as this one, which further strengthen our late-stage pipeline, demonstrate the key role externalisation continues to play in AstraZeneca's strategy."

James M. Gower, chairman and chief executive officer of Rigel Pharmaceuticals, Inc. said: "This collaboration fulfills our expectations in two key ways. First, AstraZeneca has made an expansive commitment to develop fostamatinib disodium for the treatment of RA, which means that the work we have begun for patients with this disease will be completed with a substantially larger clinical programme. Second, Rigel will receive royalties on potential future sales, appropriate to its investment in the development of R788."
About Fostamatinib disodium

Fostamatinib disodium, which has completed a comprehensive phase II programme is at the most advanced stage of development of the oral Spleen Tyrosine Kinase (Syk) inhibitors being evaluated for an RA indication. Inhibiting Syk is thought to block the intracellular signaling of various immune cells implicated in the destruction of bone and cartilage, which is characteristic of RA. Inhibition of Syk signaling is therefore a very attractive research approach to RA treatment.
About Fostamatinib disodium Phase II data

Three Phase II trials have been completed. TASKi1 and TASKi2 studied patients with an incomplete response to methotrexate. TASKi3 studied patients who had failed treatment with biologic therapies.
TASKi2 was a multi-centre, randomized, double-blind, placebo-controlled Phase IIb trial of 457 RA patients in the target population of those with inadequate response to methotrexate. Treatment with stable doses of methotrexate in combination with fostamatinib disodium 100 mg twice daily, 150 mg once daily, or placebo were evaluated at six months. At six months, 100 mg twice daily fostamatinib disodium therapy (a dose planned to be taken forward in Phase III) yielded responder rates of 66% versus 35% of the placebo group for the primary end point of ACR 20 improvement. ACR 50 response was achieved by 43% versus 19%: ACR 70 responder rates were observed in 28% versus 10%. All achieved p values of <0.001. DAS28 remission was achieved in 31% versus 7% (p<0.01).
This replicates the signal seen in the original smaller TASKi1 study in a similar population (n=189) where 100 mg of fostamatinib disodium twice daily yielded responses of 65% versus 38% of the placebo group for ACR20. ACR 50 response was achieved by 49% vs. 19% and ACR70 was achieved by 33% vs 4%. DAS28 remission was achieved in 26% vs 8%. All of these endpoints achieved p values of p<0.05 or better. In both studies clinical effect was seen as early as one week.
TASKi3 was a smaller study which included 219 patients who had failed biologic therapies. Although there was some evidence of efficacy on the MRI imaging, and on some other parameters, the study did not meet its primary endpoint.
These data indicate further studies of fostamatinib disodium are warranted in RA.
Combining all three trials, the most common side effects have been GI disturbances such as diarrhoea, elevated blood pressure, transient and mild neutropenia, increased transaminases and a slight increase in infections, although not serious or opportunistic infections.

Tuesday, February 16, 2010


Indian Pharmaceutical Industry

The pharmaceutical industry in India is among the most highly organized sectors. This industry plays an important role in promoting and sustaining development in the field of global medicine. Due to the presence of low cost manufacturing facilities, educated and skilled manpower and cheap labor force among others, the industry is set to scale new heights in the fields of production, development, manufacturing and research. In 2008, the domestic pharma market in India was expected to be US$ 10.76 billion and this is likely to increase at a compound annual growth rate of 9.9 per cent until 2010 and subsequently at 9.5 per cent till the year 2015.

Industry Trends
  • The pharma industry generally grows at about 1.5-1.6 times the Gross Domestic Product growth.
  • Globally, India ranks third in terms of manufacturing pharma products by volume.
  • The Indian pharmaceutical industry is expected to grow at a rate of 9.9 % till 2010 and after that 9.5 % till 2015.
  • In 2007-08, India exported drugs worth US$7.2 billion in to the US and Europe followed by Central and Eastern Europe, Africa and Latin America.
  • The Indian vaccine market which was worth US$665 million in 2007-08 is growing at a rate of more than 20%.
  • The retail pharmaceutical market in India is expected to cross US$ 12-13 billion by 2012.
  • The Indian drug and pharmaceuticals segment received foreign direct investment to the tune of US$ 1.43 billion from April 2000 to December 2008
Challenges

Every industry has its own sets of advantages and disadvantages under which they have to work; the pharmaceutical industry is no exception to this. Some of the challenges the industry faces are:
  • Regulatory obstacles
  • Lack of proper infrastructure
  • Lack of qualified professionals
  • Expensive research equipments
  • Lack of academic collaboration
  • Underdeveloped molecular discovery program
  • Divide between the industry and study curriculum
Government Initiatives

The government of India has undertaken several including policy initiatives and tax breaks for the growth of the pharmaceutical business in India. Some of the measures adopted are:
  • Pharmaceutical units are eligible for weighted tax reduction at 150% for the research and development expenditure obtained.
  • Two new schemes namely, New Millennium Indian Technology Leadership Initiative and the Drugs and Pharmaceuticals Research Program have been launched by the Government.
  • The Government is contemplating the creation of SRV or special purpose vehicles with an insurance cover to be used for funding new drug research.
  • The Department of Pharmaceuticals is mulling the creation of drug research facilities which can be used by private companies for research work on rent.
India's Domestic Pharmaceutical Market (12 Months Ended January 2009)


Company Size
($ Billion)
Market
Share (%)
Growth
Rate (%)
Total Pharma Market 6.9 . 100.0 9.9
Cipla .36 5.3 13.4
Ranbaxy .34 5.0 11.5
Glaxo Smithkline .29 4.3 -1.2
Piramal Healthcare .27 3.9 11.7
Zydus Cadila .24 3.6 6.8
Source: ORG IMS

Future Scenario

With several companies slated to make investments in India, the future scenario of the pharmaceutical industry in looks pretty promising. The country's pharmaceutical industry has tremendous potential of growth considering all the projects that are in the pipeline. Some of the future initiatives are:  
  • According to a study by FICCI-Ernst & Young India will open a probable US$ 8 billion market for MNCs selling expensive drugs by 2015
  • The study also says that the domestic pharma market is likely to reach US$ 20 billion by 2015
  • The Minister of Commerce estimates that US$ 6.31 billion will be invested in the domestic pharmaceutical sector
  • Public spending on healthcare is likely to raise from 7 per cent of GDP in 2007 to 13 per cent of GDP by 2015
  • Dr Reddy's Laboratories has tied up with GlaxoSmithKline to develop and market generics and formulations in upcoming markets overseas
  • Lupin, a Mumbai based pharmaceutical company is looking to tap opportunities of about US$ 200 million in the US oral contraceptives market
  • Due to the low cost of R&D, the Indian pharmaceutical off-shoring industry is designated to turn out to be a US$ 2.5 billion opportunity by 2012.

Monday, February 15, 2010

FDA’s New Process Validation Guidance: Its as easy as 1, 2, 3

The US FDA’s Guidance on general principles of Process validation, first published in 1987 had many shortcomings. These were addressed in a subsequent publication, Pharmaceutical cGMPs for the 21st Century- A risk based Approach. While the new guidance states that FDA’s current thinking on process validation is consistent with the principles first introduced in 1987, the new document redefines process validation, John Hyde, Chairman and founder, Dr. Peter Walter, Chief Technology officer, and Karan Manocha, Regional Manager, Asia Pacific, Hyde Engineering + Consulting present some highlights of this new guidance.

In 1987, FDA published guidance on general principles of Process Validation, based upon the request of several firms for clarification of FDA expectations. The guidance cites regulatory requirements related to process validation from the US code of federal regulations and it defines Process Validation as follows:
Process Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics. In time since the guidance was published in 1987, industry and regulators have generally interpreted this definition as:
Establishing highly defined and controlled procedures for manufacture of the product. Verifying the efficacy of the process at commercial scale through the production of a certain number of successful consecutive demonstration or conformance lots, typically three. Assuring the consistency of production by putting controls in place, often SOP based, that confirms that the production of subsequent lots is done identically to the demonstration lots. Using time based criteria, periodically “re-validate” the process to show consistency of production operations and to confirm that the process has not “drifted” from the demonstration lots initially tested.

The main problem with this approach to process validation is that it relies heavily on the ability of the manufacturer to consistently and identically duplicate the process that was used for the production of the demonstration lots without necessarily defining, understanding or controlling critical process parameters and this approach does not account for inherent variability of process inputs. Time based re-validation is another significant problem with this approach as if failures result during re-validation, an entire timeframe of production may be called into question. With these shortcomings in mind and with a view toward more progressive approaches to manufacturing as discussed in FDA’s publication titled Pharmaceutical cGMPs for the 21st Century – A risk based approach and process development, Risk management and Quality Systems tools outlined in ICH Q8, Q9 and Q10, a new process validation guidance draft has been developed and issued for comment.

Highlights of the new FDA Process Validation Guidance
While the new guidance states the FDA’s current thinking on process validation is consistent with the principles first introduced in 1987, the new document redefines process validation as follows:

Process validation is defined as the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

This new definition characterizes process validation as a lifecycle rather than a discrete event, as implied in the definition in the 1987 guidance. The new guidance goes on to say that “Process Validation involves a series of activities taking place over the lifecycle of the product and process” and the new guidance describes process validation activities in three stages including process design, process qualification and continued process verification. Or stated another way, process validation may be defined as:
Process Validation = Lab Studies + Development History + Commercial Scale Manufacturing @ Target Values + Ongoing Monitoring.

The following is a brief discussion of each stage and typically the activities of which they are compromised.

Stage-1: Process design-
As stated in the guidance, the commercial process is defined during this stage based on scientific knowledge gained through development and scale-up. Process knowledge is established and the process is defined through lab laboratory and pilot scale studies. Sources of variability are identified and understood, and their impact on product quality is defined. The degree of management of the sources of variability is commensurate with the risks to product and patient safety that the variability poses. Potential critical process parameters are identified and and evaluated through multivariate analyses and effects of scale are assessed. Process controls are established to manage critical process parameters and variability to process inputs. Design of Experiment (DOE) methodologies are used to perform mechanistic modeling to establish process design and operating spaces. As a part of the establishment to design and operating spaces, “worst case” conditions and parameters are evaluated. The primary objective of the stage 1 work is to define the process in enough detail so that the control of critical parameters and sources of variability is effective at commercial scale.

Stage-2: Process Qualification-
The purpose of the work in this stage is to confirm that the process design is capable of commercial manufacturing. Prerequisites to these activities include completion of activities in stage 1, qualification of the facility and critical utilities, qualification of process systems and equipment, validation of sampling and analytical methods, and performance of manufacturing operations by trained staff using approved manufacturing instructions and records. The process qualification (PQ) work is documented in a protocol which defines manufacturing condition, operating parameters, processing limits and raw material inputs; the data to be collected and how it will be evaluated; the tests to be performed for each significant process step and acceptance criteria for those tests; a sampling plans including sampling points, number of samples, and frequency of sampling based upon statistical rationale; and criteria to provide rationale to conclude that the process produces a constant product including statistical methods to be used in the evaluation of data and a pre-addressed plan for addressing deviations and non-conformances. The work is documented in a report summarizing the testing and results and their conformance with expectations that confirm the consistence of manufacturing operations. Additional in-process material and product testing beyond that for routine manufacturing operations is expected.

Stage-3: Continued Process Verification –
The object of this stage is to continuously verify that the process is in a state of control and is performing consistently and in accordance with the process that was tested during the process qualification stage. Detection of deviations or excursions from the operation of the qualified process is essential to effectively perform continued process verification. This is done by collecting and analyzing process information in real time, especially critical process parameter data, to assess process performance and to make process corrections to assure that a consistent product is produced from each manufacturing run. The guidance recommends that a person or persons trained in statistical process control establish sampling plan and methods for statistical evaluation of real time process data for purposes of trend analysis and real time process correction. These statistical data may also be used as a basis for process improvement and assessment of process variability. These analyses are essential elements in the evaluation of process “drift” and they may provide a basis for the need to perform process re-qualification activities.

Summary
FDA’s new process validation guidance modernizes concepts of process validation to reflect a lifecycle approach that is based upon principles of risk assessment and management. It formally include process development activities which define the scientific bases for the process, characterize and evaluate sources of variability, establish design and operating spaces that can be scaled, and identify critical control parameters and key quality attributes. The guidance also addresses qualification of the process at commercial scale based upon process knowledge established during the process development stage, and it provides a pathway to consistent process performance through continued process verification by collection and statistical evaluation of critical process data coupled with trained analysis and real time process correction. The principles outlined in this new guidance will provide the basis for a much higher level of process consistency, product quality and patient safety through better process development and more comprehensive process understanding and monitoring, while potentially resulting in lower cost of goods through fewer process deviations, excursions and failures.

Abbott Receives U.S. FDA Approval for Heat-Stable Norvir® (ritonavir) Tablets

Monday, 15 February 2010

Abbott announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new tablet formulation of the company's antiretroviral medication Norvir® (ritonavir). The new Norvir tablets can be stored at room temperature and do not require refrigeration, making it more convenient for patients. The Norvir tablets and the Norvir soft-gelatin capsules both contain 100 mg of ritonavir. While the rate of drug absorbed is different, there is no requirement for dosage change. Norvir is used in combination with other antiretroviral medications to treat HIV. All forms of Norvir, including the soft-gel capsule and liquid form, remain available in the United States.
"Norvir has been a critical component of HIV treatment for many patients. The innovation behind the development of the Norvir tablet is the direct result of years of effort by Abbott scientists to address the needs of people living with HIV," said Scott Brun, M.D., divisional vice president, infectious disease development, Global Pharmaceutical Research and Development, Abbott. "Abbott has been dedicated to finding new and more convenient ways for patients to manage their HIV through the development of novel diagnostics testing methods and medications for more than 20 years."
Abbott scientists evaluated several candidate formulations before developing the final Norvir tablet formulation. The Norvir tablet was developed using Abbott's Meltrex® technology, a proprietary melt-extrusion process, making it more heat-stable. This is the same technology used to develop Abbott's Kaletra® (lopinavir/ritonavir) tablet, which combines lopinavir and ritonavir.
"Approximately one-third of all HIV-positive patients in treatment use Norvir in combination with other antiretroviral medicines. The heat-stable tablet formulation may allow these patients greater flexibility to store and carry their medication with them," said Renslow Sherer, M.D., professor of medicine, section of infectious diseases and global health and director, International HIV Training Center, University of Chicago Hospitals. "For patients who may not have access to refrigeration, this new formulation is also important."
For more than 20 years, Abbott has made a significant contribution to the fight against HIV/AIDS through the development of innovative tests and medicines.
• In 1985, Abbott developed the first licensed test to detect HIV antibodies in the blood. The company remains a leader in HIV diagnostics today
• In 1992, Abbott was the first company to receive FDA approval for an HIV diagnostic assay. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply
• In 1996, Norvir was approved for the treatment of HIV in the United States. Norvir was one of the first protease inhibitors on the market and remains one of the most commonly prescribed medicines as part of combination therapy
• In 1997, Norvir became one of the first protease inhibitors to receive FDA clearance for use in children
• In 2000, Abbott received FDA accelerated approval for Kaletra
• In 2005, the tablet form of Kaletra received FDA approval
• In 2006, Kaletra tablets received EMEA approval
• In 2007, Abbott received FDA approval for a new lower-strength Kaletra tablet suitable for pediatric use
• In 2007, Abbott's RealTime HIV-1 Viral Load test was approved by the FDA for use on the m2000â„¢ molecular diagnostics instruments
• In 2009, Abbott received approval from the FDA for its ABBOTT PRISM HIV O Plus test, the first fully-automated blood screening test for HIV-1/HIV-2
• In 2010, the FDA approved the new Norvir tablet

FDA Licenses New Influenza Vaccine Designed Specifically For People 65 Years of Age and Older

Fluzone® High-Dose (Influenza Virus Vaccine) strengthens immune response in the 65+ population, an age group that suffers disproportionately from influenza and its complications
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental biologics license application (sBLA) for licensure of Fluzone High-Dose (Influenza Virus Vaccine). The new vaccine, for adults 65 years of age and older, will be available to health-care providers for immunizations administered this fall in preparation for the upcoming 2010-2011 influenza season.

This new addition to Sanofi Pasteur's vaccine portfolio reflects our long-standing commitment to public health and to research and development of new vaccines for enhanced prevention of influenza," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "In 2011 the first baby boomers will turn 65 and, by the year 2030, the number of adults over age 65 is anticipated to double and surpass 70 million people, or 20 percent of the U.S. population. We are excited to introduce Fluzone High-Dose vaccine which will provide health-care professionals with a new vaccine to help prevent influenza in their patients over the age of 65.

Fluzone High-Dose vaccine was specifically designed to generate a more robust immune response in people 65 years of age and older. This age group typically does not respond as well to the standard dose of influenza virus vaccines as younger individuals because they have weakened immune systems.

This indication is based on the immune response elicited by Fluzone High-Dose vaccine and there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine.

Fluzone High-Dose vaccine contains 60 mcg of hemagglutinin per strain of influenza virus in the vaccine as compared to 15 mcg of influenza virus hemagglutinin per strain of influenza virus in standard-dose Fluzone vaccine.
EC approval is mandatory for all trials including herbal medicines

If any patient had been withdrawn due to pharmacokinetic reason e.g. emesis, will such an adverse event be considered a significant adverse event or not?
Bhumi Vyas

Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as import medical events that may not be immediately life-threatening or result in death  or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These should also usually be considered serious.

The decision whether an even is serious or not is governed by medical/scientific judgement of the investigator.

For clinical trials of herbal medicines, is it essential to 1) obtain DCGI approval 2) obtain EC approval and 3) register the trial in CTRI?
Ajay Vijay

As per Indian GCP an NCE from herbal should undergo all regulatory requirements before being evaluated clinically. For the herbal remedies and medicinal plants that are to be clinically evaluated for use in the Alopathic System and which may later be used in allopathic hospitals, the procedures laid down by the office of the DCG (1) for allopathic drugs should be followed. It is  advisable to obtain DCGI approval.

The EC approval is mandatory for all trials including herbal medicines. The CTRI registration is mandatory for all trials approved by DCGI office. For other trials it is voluntary. However, most journals are willing to accept a clinical trial for publication only if the trial has been registered in a public registry.

What data are essential before planning a trial of herbal medicines?
Dr. Anand Virkar

Indian GCP7.5.2 recommends
 
  • It is important that plants and herbal remedies currently in use or mentioned in literature of recognized Traditional System of Medicine is prepared strictly in the same way as described in the literature while incorporating GMP norms of standardization
  • Before conducting phase II toxicity studies will be required if there are reports suggesting toxicity or when the herbal preparation is to be used for more than 3 months. It should be necessary to undertake 4-6 weeks toxicity study in 2 species of animals in the circumstances pointed out or when a larger multicentric phase III trial is subsequently planned based on results of phase II study.
  • Clinical trials with herbal preparations should be carried out only after these have been standardized and markers indentified to ensure that the substances being evaluated are always the same. Be approved by the appropriate scientific and ethical committees of the concerned Institutes.
  •  It is essential that such clinical trials be carried out only when a competent Ayuvedic, Siddha or Unani physician is a co-investigator in such a clinical Trial.
 
What are fees for regulatory department in India?
Balaji K
 
The Drugs and Cosmetics Act 122DA. – Application for permission to conduct clinical trials for New Drug/Investigational New Drug – cover the fees.
  • For human clinical trials (phase-I) on a new drug shall be made to the Licensing Authority in Form 44 accompanied by a fee of Rs. 50,000 
  • For exploratory clinical trials (Phase-II) on a new drug fee of Rs. 25,000
  • For confirmatory clinical trials (Phase-III) on a new drug fee of Rs. 25,000.
Can a nutritional supplement be tested in a comparative study in pregnant women to get the supplement approved for marketing India even if the same supplement can tested in other patient population (non pregnant subjects) for its desired therapeutic effect?
Nitin Chandarkar
 
Guidelines for nutritional supplements are undergoing revision. Please see the Food Safety and Standard Act 2006 and consult Food Safety and Standards Authority of India in Delhi. They have a website www.fssai.gov.in

Pregnancy is an important medical condition. Studies in pregnancy will have to follow Indian GCP guidelines.

Pregnant or nursing women:
Pregnant or nursing women should in no circumstances be the subject of any research unless the research carries no more than minimal risk to the foetus or nursing infant and the object of the research is to obtain new knowledge about the foetus, pregnancy and lactation. As a general rule, pregnant or nursing women should not be subjects of any clinical trial except such trials as are designed to protect or advance the health of pregnant or nursing infants, and for which women who are not pregnant or nursing would not be suitable subjects.

Dr. Arun Bhatt is currently,
president, ClinInvent,
Research Pvt. Ltd. Mumbai.
Readers can send their queries
at: arunbhatt@clinInvent.com
 
Indian Bio-pharma industry accounts for 65% of the biotech sector

Indian bio-Pharma industry is valued at Rs. 7,883 crore and is registering 14.25 per cent annual growth. The sector accounts for 65 per cent of the total biotech sector which is valued at Rs. 12.137 crore, according to the Association of Biotechnology Led Entrepreneurs and Biospectrum survey.

The bio Pharma sector continues to grow, stated Kiran Mazumdar-Shaw, CMD, Biocon.

Emerging markets is certainly a strong focus now with many global biopharma companies. Emerging markets are seen to be the highest growth opportunities and this is really about addressing stagnating top line growth amongst companies. Late stage asset acquisition is another very interesting trend. This is, again, to address the declining pipelines and filling them up with late stage assets that can accelerate time to market, stated Shaw at the JP Morgan Healthcare Conference held at San Francisco early this month.

One of the biggest risk that the industry is addressing is about the increasing risks and costs associated with drug development. And here, industry is beginning to experiment with new risk sharing models. Co-development is an interesting strategy. Outsourcing R&D services to reduce cost is another way of looking at cost mitigation in drug innovation, she added.

India has a handful of dedicated bio-Pharma companies which manufacture using fermentation process known as MAbs  which primarily include cancer drugs, insulin, growth hormones, and cell culture to produce vaccines, While Biocon is the largest in the space with range of bio-pharma products gearing a revenue of Rs. 100 cr to its total turnover of Rs. 1,739 cr. The other companies are Panacea Biotec, Novo Nordisk, Shanta Biotech, Jubilant, Bharat Biotech India Immunologicals, Bharat Serums, Themis Medicare, Concord Biotech, Intas Biopharma, GSK, Wockhadt Serum International, Dr. Reddy’s Lab and Aventis.

Thursday, February 11, 2010

Health Ministry begins process for upgradation of Clinical Trial Registry of India

Aiming to incorporate several new features as per the requirements of the World Health Organisation (WHO), the Union Health Ministry will soon upgrade the Clinical Trial Registry of India (CTRI) which was introduced by the government in July 2007 as part of its exercise to regulate the by far unregulated clinical trial industry in the country.

According to senior ICMR officials, the National Institute of Medical Statistics (NIMS), an arm of ICMR mandated with the responsibility of setting up and maintaining the CTRI, has already started the process of upgradation of the Registry. The NIMS, mandated to provide latest methodologies in the field of biostatistics for project planning with a component of research and to conduct need based training programmes in medical statistics, has invited expression of interest to develop the website for this purpose.

Senior officials said that a lot of new features have to be incorporated in the existing Registry which the NIMS has been running as a pilot project for about two and a half years. Since the Indian Registry is getting applications from all over the world, it has to be on line with the international standards. In the present Registry, a lot of requirements of the WHO are missing. For example, there is no clause for audit of trial without which the authorities will not be able to track the changes constantly in the data of the trial. As the companies very often make changes in the data, it is very necessary to include such a clause in the Registry, officials said.

Besides, ever since the registration of clinical trial was made mandatory by the DCGI Dr Surinder Singh from June 15, 2009, there has been an added momentum in the number of registration of clinical trials in the country. Under this background, the NIMS decided to implement a fresh well designed Web Hosted Clinical Trial Registry to meet the expectations of the various stakeholders including the pharmaceutical industry, researchers, publications, administrators and the public at large. Being a front runner, among the first ten across the world, in the implementation of the mandate of registration of clinical trials, the Clinical Trial Registry of India will be keenly monitored across the world, an official said.

Action Steps for Designing India's Drug Regulatory System

Significant changes in the regulatory system are needed to keep abreast with changing trends in the healthcare sector and medical technology industry.

“Medicines fall under two separate legal and regulatory systems: the intellectual property system and the drug regulatory system. These systems have different objectives, are administered separately and function independently. Efforts to integrate these two systems via data exclusivity, “linkage” or other means are likely to have negative implications for access to medicines. Thus, (developing) countries would be well advised to keep these systems separate, and to reject any and all efforts to make connections between them.”

Current structure of Regulation not only restricts global firms entering the market but also curb the opportunities for India in Global market. Before proceeding further with the impact and benefits of Central Drug Authority, CDA lets discuss the scenario and status of Drug Regulatory and Pharmaceutical Industry in India and globally.

Status of Drug Regulatory in India

DRA not being an autonomous body vary immensely in their rules and law making in state and Center. The overall objective to ensure that medicinal products quality, Safety and efficacy remains the same but implementing the policy and measures taken tends to differ a lot in the states.
Whereas the manufacturing / sale and quality monitoring of drugs in the country is looked after by state govt respectively, on the other hand the making of legislation, laying down standards, monitoring imports and exports and Clearance of New drugs comes under the scrutiny of Central government.
Besides this there stands some responsibilities that are performed by both State and Center in collaboration jointly. The duties to be performed jointly are mainly approval of license for the manufacture of the following drugs:

• Vaccine & Sera
• Blood bank & Blood Products
• r- DNA
• Large Volume Parenternals
• Medical Devices.
• WHO-GMP approvals

The amalgamated responsibilities held differently have left the global companies between major haves and haves not. Juxtaposition of Central and state government distinct statutory functions under the act in India , other countries such as USA, Canada, China, South Africa, Malaysia, Australia, Thailand holds Centralized Drug Regulatory Authority.’

In the recent past, India has seen significant growth in the healthcare sector with international expansion strategies through mergers and acquisitions, bringing in increasing investment in core R&D activities. The global pharma and biotech industry has been looking at opportunities of cost effective drug development and India has emerged as a favorable location for drug development. In addition, India-based drug companies have increased their capacity to develop and launch new drugs through their own research efforts. This has heightened the importance of developing adequate internal standards to conduct their operations to be able to compete with the globalization demands.
With rising health care costs, patients, doctors, and health care purchasers, all demand more value from the medical treatments they use. With concerns about health care affordability, it is important to ensure that new medical therapies are effective and provide accurate and current information about using them. More treatments are in development than ever before and finding better ways to demonstrate their effectiveness for particular kinds of patients is essential for making sure that people get the most value from their health care spending. Last few years have also seen an increase in drug safety concerns with some high profile drug withdrawals. This has led to formation of more stringent parameters for safety evaluation of products and therapies by various stakeholders more importantly by the regulatory authorities.
Drug development has also witnessed a significant change through new technologies such as genomics, proteomics, bioinformatics systems, and new imaging technologies. These new technologies have the potential to provide tools to detect safety problems early, identify patients likely to respond to therapy, and lead to new clinical endpoints. New medical technologies, including bioengineered tissues, cellular and gene therapies, nanotechnology applications, novel biomaterials, and individualized drug therapies are being applied to get better therapeutic outcomes.
Regulatory scenario
While there have been advancements in technology, regulations have been trying to keep pace with these changes. Internationally, regulatory agencies have responded to such developments relatively faster than local Indian regulations which are still evolving.
It is understandable that regulations have to be implemented with due consideration to local priorities and capacities yet we in India have been lagging behind probably due to our existing legislative and political system.
The government through several programmes, policies and initiatives has been actively promoting scientific technologies but there has been a relative neglect or a mismatch of the rapidity of technology development versus the development of regulatory aspects, be it relating to health, safety, ethical or environmental dimensions. While various regulatory laws and guidelines have been developed especially in the last few years, there have been inherent challenges with these in terms of interpretation, consistency and enforcement. The issues of manpower capacity at the Central Drugs Standard Control Organization (CDSCO) have been there for years though some of it is being addressed. The regulatory authority will have to be equipped with well trained manpower to address the worries associated with application of emerging technologies associated with drug development.
The national pharmacovigilance system was put into place by the government in 2005. Most countries have such systems since it serves as an important tool to collect data relating to the risk profile of the drug generated under real conditions. The importance of post-marketing surveillance by the regulatory authorities has also been reiterated by a number of high-level committees. Under the current regime, indirect supervision has been mandated through information reporting requirements by the R&D institutions and pharma companies. The task ahead for us is the enforcement of this system across the nation.
There is an urgent need to set up a drug regulatory authority that will oversee all aspects of drug regulations. The concept of one window clearance has to be put in place for anything that is related to healthcare solutions- pharmaceuticals, biotech, foods, diagnostics, devices etc. Significant changes in the regulatory system are needed to keep abreast with the changing trends in the industry. Some of these include—
• Strengthening the authority with trained scientific and medical reviewers for various aspects of research be it ethical, scientific, safety and environmental and also help build a helpful regulating body.
• Building and maintaining a robust pharmacovigilance system and making pharmacovigilance reporting mandatory.
• Coming out with guidelines on fast tracking approvals of drugs or therapies for unmet medical needs (orphan drugs). Considering flexibility in effectiveness criteria (eg partial responses versus survival rates for anti-cancers)
• Developing guidelines on confidentiality, patient privacy and data protection and having well defined ones for research on alternative medicine—AYUSH
• Strengthening and defining regulations for medical devices and other interventional medical or diagnostic procedures involving healthcare.
With globalisation it is important to consider various regulatory developments taking place worldwide and modify the Drugs and Cosmetics Act and rules accordingly. As we continue to change this paradigm of regulations, we have to remember that all the stakeholders have to be participative and contributory to this initiative. All the stakeholders—industry, academia and the regulators can then only realise the real benefits of technological advancements of healthcare.
Future
Any drug regulatory body is an important participant in advancing the development of science, and hence has an important role to play. As an example the US Food and Drug Adminsitration's (FDAs) standards are often used to guide development program-mes, and a standard-setting process is informed by the best science, with the goal of promoting efficient develop-ment of safe and effective new medical treatments.
For India to be a leader in the development of newer technologies and new therapies, the CDSCO or to be formed National Drug Authority (NDA) will help identify the challenges to development, and will work with the larger scientific community on developing solutions. As promoter and protector of public health, the CDSCO/NDA is responsible for ensuring that safe and effective medical innovations are available to patients. This will be accomplished by using available scientific knowledge to set product standards. Ongoing reviews of emerging data on safety, efficacy, and product quality will be conducted by the scientists at the CDSCO/NDA during clinical testing of therapies.
In case of problems, CDSCO/NDA scientists will address them by bringing them to the attention of the scientific community, or by conducting or collaborating on relevant research. The CDSCO/NDA will be issuing guidance documents that will be publicly available summarising best practices in a development area. These guidance documents will be based on the best practices, successes, failures and the drawbacks during clinical trials that the reviewers will observe during the review process. These documents will share the CDSCO's insights into specific issues or topics and also help in ensuring that the current standards of safety and effectiveness are updated. The CDSCO/NDA will help to resolve the product developmental problems identified during the review process by bringing together the stakeholders to identify and address the most significant problems in order to deliver better and affordable healthcare solutions to our patients. All of the above look like a wish list for Indian regulations but in true honesty, these are the important ingredients of any modern healthcare regulatory agency that a nation like India anyway deserves. It is just a question of time and conviction. Through scientific research focused on these challenges, we can improve the process for getting new and better treatments to patients. Directing research not only to new medical breakthroughs, but also for developing new treatments, is an essential step in providing patients with more timely, affordable, and predictable access to new therapies.
The DCG(I) will be involved in setting standards for development of new medical products; we must take proactive steps to use the best science to guide the development process and ensure that development standards are rigorous, efficient, and achieve maximum public health benefit.

Pharmaceutical Package

Safe, innovative and accessible medicines: A renewed vision for the pharmaceutical sector

The EU has been losing ground in pharmaceutical innovation. European patients still suffer from inequalities in the availability of information about medicines, whilst counterfeits are on the rise. To address these challenges, the Commission has tabled a package, consisting of four key parts:

1. A communication to launch reflections on ways to improve market access and to develop initiatives to boost EU pharmaceutical research,

2. A proposal to tackle the growing issues of counterfeiting and illegal distribution of medicines,

3. Proposals to enable citizens to have access to high-quality information on prescription-only medicines and,

4. Proposals to improve patient protection by strengthening the EU system for the safety monitoring ('pharmacovigilance') of medicines.

Thursday, February 4, 2010

Indian Pharma sector: Strong growth outlook beyond defensive play 

Though the growth in chronic (lifestyle) disease treatments will outplace the market; acute segments will also report a healthy performance with growth in excess of 10 percent. Jay Shankar Economist Vice President, Relegate Capital Markets, highlights the key growth drivers.

 Resilient and high yielding that is how we continue to describe the Indian pharmaceutical sector considering it more than just a defensive play, the sector has combated the recession of 2008-09, with relative ease, drawing support largely from the inelastic demand for therapeutic drugs and healthcare facilities. The journey ahead, in our opinion, also seems to be set on a smooth terrain as the growth outlook for the sector appears to have improved significantly.

A few pointers:


Where the Opportunity Lies
Country
Generic Penetration
Opportunity
USA
65-70%
Mature, Large
Germany
70%
Mature, Large
UK
60-65%
Mature, Large
Japan
19%
Growing, Large
Netherlands
50%
Mature
France
20%
Growing, Large
Spain
18%
Growing
Italy
10%
Growing
Global Opportunity
$90 billion

Source: ICRA, Data as of 2008


Recent Emerging Market Acquisitions and Tie-ups
MNC Name
Target
County
Sanofi-Aventis
Shantha Biotech
Zentiva
Medley Pharma
Kendrick
Bioton Wostok
India
CEE Region
Brazil
Mexico
Russia
GSK
BMS
Aspen
Strides Arcolab,
DRL
Middle East
South Africa
India
Daichii-Sankyo
Ranbaxy
India
Hospira
Orchid Chemicals
India
Pfizer
Aurobindo
Claris Life Sciences
Vetnex Animal Health
India
India
India
Novartis AG
Novartis India
India
Mylan Pharma
Matrix Labs
India
Vetoquinol
Wockhardt Animal Health
India
Valeant Pharma
Tecnofarma
Mexico
Source: o3 Capital Analysis

  • The domestic pharma industry continues to grow at 11-12 percent, dwarfing the global average of fivesix percent. Similarly, improved traction in productivity trends has prevented margin pressures, notwithstanding the intensifying competitive landscape domestically.
  • The CRAMS (contract Research and Manufacturing Services) segment continues to enjoy the benefits of a low base effect.
  • There will be a deluge of patent expiries in the next three-four years, having implications for the generics. Also, there is an emerging consensus globally in favour of generics and low-cost medical facilities especially because of world population ageing being unprecedented, pervasive, and enduring. This has forced global pharma players to re-orient their business models towards generics and developing markets in a bid to protect their margins and market shares. Alliances like Pfizer-Aurobindo and GSK-Dr Reddy’s Laboratories (DRL) are the consequences.
  • Indian pharma majors like Sun Pharma and DRL are likely to derive significant benefit from some non-recurring Para-IV earnings.
  • The competitive environment in the US has improved of late, as indicated by the declining trends in NDA filings in the past few quarters.

     Product Development Pipeline
    Company
    Drug Discovery
    Pre-clinical
    Phase 1I
    Phase 2
    Phase 3
    Sun Pharma
    -
    2
    -
    1
    -
    Biocon
    -
    4
    -
    1
    2
    Cadila
    -
    4
    1
    -
    -
    Piramal
    5
    5
    3
    5
    -
    Glenmark
    4
    3
    1
    4
    1
    Ranbaxy
    8-10
    4-6
    -
    1
    1
    Dr. Reddy’s
    5
    3
    2
    -
    1
    Source: o3 Capital Analysis

      Government pitches in Sector to get Rs 20 billion stimulus

      The government’s Vision 2015 statement indicates an 18 percent plus CAGR for the pharma sector, translating to a doubling of revenues to $40 billion over the next five years. Growth will be driven by all verticals: domestics formulations, generics exports, and outsourcing (CRAMS). The government has recently announced the setting up of a venture fund that will target the infusion of Rs 20 billion into the sector. The idea is to facilitate investments  has recently announced the setting up of a venture fund that will target the infusion of Rs. 20 billion into the sector. The idea is to facilitate investments in the fund that are expected to come mainly from the industry.



       Attractive Sector valuations – a clear edge

      Our pharma sector lead (Vikas Sonawale) expects the base pharma business to record a 16 percent CAGR over FY09-FY11, driven by growth in both,  domestic as well as US markets.

      Sector valuations continue to be attractive at a P/E of 17.9x FY10E and 16.3x FY11E base business earnings. Large caps trade at 18-20x FY10E, a 10-30 percent premium to the broader market – justified by lower earnings risk and stronger balance sheets. Mid caps are available at 8-14x FY10E, The risk reward is therefore favourable in our view. Our top picks in the sector include Sun Pharma DRL, and Biocon.

      Sector to see broad-based growth ahead

      Rising purchasing power and increasing penetration of health insurance will  support strong growth of 12-14 percent in the domestic formulations business over the next five years. This growth will be driven by every user segment metros, tier-II cities, rural markets, hospitals, and OTCs. Though the growth in chronic (lifestyle) disease treatments will  outpace the market, acute segments will also report a healthy performance with growth in excess of 10 percent.

      Unfavourable currency movemens (mainly US  dollar and Euro) and rising regulatory pressures, however, remain our key converns for the sector.