Dr Reddys Q4 net up 67 pc at Rs 571 cr

Drug firm Dr Reddy's Laboratories on Tuesday reported a 66.58 per cent rise in its net profit to Rs 570.89 crore for the quarter ended March 31, 2013 mainly on account of robust sales across all segments.

The company had posted a net profit of Rs 342.70 crore for the corresponding quarter previous fiscal, the company said in a statement.

The company's major segments include global generics, pharmaceutical services and active ingredients.

Net income from sales and services of the company rose to Rs 3,339.94 crore for the quarter under consideration from Rs 2,658.45 crore for the same period year ago.

In a separate filing to BSE, the company said its Board of Directors have recommended a final dividend of Rs 15 per share of Rs 5 face value, for the financial year 2012-13.

For the fiscal year ended March 31, 2013, net profit of the company stood at Rs 1,677.62 crore as against Rs 1,426.21 crore for the previous fiscal.

Net sales of the company also rose to Rs 11,626.56 crore for the fiscal year ended March 31, 2013 from Rs 9,673.74 crore for the same period year ago.

Shares of Dr Reddy's Laboratories were on Tuesday trading at Rs 2,046.00 per scrip in the afternoon trade on BSE, down 1.68 per cent from its previous close.

 

Challenging times for the Indian clinical research industry: Coping with adversity.

One is tempted to think that tighter controls and stringency of law will result in weeding out situations that result in human or material harm. When cases of deaths in clinical trials and compensation came to the front pages of news papers, similar sentiments were expressed by the polity and the media. An entirely new regime was put in place rapidly to correct all ills ailing the conduct of clinical trials in India.Will this suffice to protect the rights, safety and well being of Indian clinical trial participants? Will there be no coercion, exploitation or malpractice as has been suggested in some quarters? The question to ask is, do more laws or increasing the stringency produce more compliance. Let’s look at the case of building laws in India. One might argue that it doesn't compare to clinical trials where human life is involved. However, a closer look at construction and building requirements will make us realize their effect on human life and more importantly the environment.

A recent media report compared building bye laws and approval requirements between India, Hong Kong and Singapore.In Hong Kong there are 6 approvals required and these take on an average 2 months and 7 days. Singapore has 11 approval requirements which take 26 days on an average. In contrast in India 34 approvals are to be put in place for a housing project. These take 6 months and 16 days on an average.

So, are our big cities like Delhi, Mumbai and Bangalore any better than Singapore or Hong Kong? Is the construction more robust, are there no mishaps and is our environment better than these countries that have lesser approvals or less cumbersome processes.

The Clinical trial environment is a much regulated one. The industry has a universal preamble- to safeguard the rights, safety and well being of human participants. Every trial should have a sound scientific basis. The benefits should outweigh the risks for any research. No study procedure should be conducted unless an informed consent is given by the participant on their own free will. Every law and guideline governing the industry has these tenets enshrined in bold. Every stake holder swears by these requirements. In India there are at least 3 guidelines, ICH GCP (international), ICMR and Indian GCP that serve as a road map that must be followed. Compliance to these is mandated in the Indian Drug and Cosmetics act, specially the Schedule Y. Over and above if the trial is for registration in other GCP regions then Indian stakeholders have to be compliant to these regions legal requirements as well. (Eg. 21CFR of the US FDA or Directives of the EMA).  These laws also make it mandatory for periodic review of the conduct of trials by independent quality control and assurance personnel. Every step, person, task and stakeholder in clinical trials is required by law to comply. There are standard operating procedures that set the boundaries in which clinical trials have to be conducted. In an already regulated environment, merely bringing in more bureaucratic controls will not help mitigate the risks highlighted by various NGO’s or the press.

We have road safety laws. Everyone knows how important it is to use helmets while riding two wheeler s  We have red lights, pedestrian crossings, subways, over bridges and fines for over speeding. Yet everyday there are reports of road traffic accidents or pedestrians being overrun. One might argue that these are a result of lack of application of laws, corruption or lenient fines. These are the same arguments that are being used to tighten controls in clinical trials.

Will modifying cars that do not allow speed over 10 km per hour or disallowing people from walking reduce accidents. In other words you cannot have regulations that strike at the very basis of processes. To travel you need vehicles that can drive at different speeds, people will need to walk to different points. Similarly clinical research has scientific basics that cannot be interfered with by regulations. An example of this dangerous trend is seen in the recently implemented rules. If there is no benefit from an investigational product the participant has to be compensated. While framing this rule, some one just forgot that one of the major purposes of conducting a trial is to see if an investigational product produces any effect. It is like asking people not to walk and stay indoors.

Why have clinical trials in India at all? India survived without them till 2005. There was no dearth of medicines. Is the ‘Innovation’ tag enough to support the continuance of trials in India.  To understand this one has to look at why clinical research is needed. No medical management today is even near perfection. There are various safety issues with even simplest of drugs like paracetamol or aspirin. In many diseases even after seeing the best doctors and having the best management, patients continue to suffer. It is this suffering or unmet need that clinical research hopes to fill one day- the need for better and safer medicines. Some will argue that why subject Indians to the un-certainties of research, when owing to its market size, pharma companies will eventually come around to sell their products. This is unethical. The populations that benefit from research should share the burdens of research as well. 

Moreover medicine is progressing towards biological, gene based therapies and personalized medicines. If India doesn't participate we will never know if a particular medicine behaves abnormally in Indians. It may be too late when the medicine has been used by millions after coming directly to the Indian market, without scientifically sound clinical trials.

There is enough data (again obtained from research) to show that participants in clinical trials benefit by merely being part of the study. These benefits are especially in terms of greater information on the disease and its management resulting in better self care. The Investigators who conduct these studies interact with their global counterparts; get a better feel of international guidelines & recommendations on disease management. This translates into better clinical practices even for the routine non study patients.

Then there are the economics of the matter. Even though the bio-services space may be much smaller than other industries like IT or banking it still is one of the only remaining growth stories in the Indian economy. Market estimates put a 12-15% growth rate for bio-services. This is in comparison to the single digit growths being recorded by most industries in India. According to recent estimates the bio-services industry generated revenues around US $ 750 million in 2011-12, despite suffering a 20-30% decrease in growth from previous years owing to the uncertainties in the regulatory environment. World over there is a movement by governments to foster innovation and science. Biotechnology, and pharmaceuticals are important for humans as they help us achieve health.  Future economies of countries will depend on ownership's and participation in these innovations. Putting in place regulations that drive the innovators away will harm India in the long run.

What remains to be seen is how the bio-services industry copes with this adversity. Many industries have faced similar predicaments and come out with better coordination and measures. Take the recent case of the tourism industry that was hit by the series of rapes that happened in 2012-13. The sequence of events started with the brutal Delhi gang rape in Dec 2012. Then in early 2013 there were reports of tourists being raped. According to press reports, Associated Chambers of Commerce & Industry of India estimated a 25 % fall in tourist inflow into India. The female tourist flow was severely affected.The industry reacted by trying to bring in a sense of assurance that they would take greater security measures. There were whole floors devoted to female travelers who were coming to India alone, all female staff to manage hotel check-ins and housekeeping of floors. Greater regulation and checking of the travel services availed by female tourists were some of the measures that the industry undertook.

Another case to look at is the BPO industry and its reaction to cases of credit card fraud. At the height of the BPO boom, Indian firms were hit my numerous scandals involving fraud and theft of sensitive data, especially involving bank or credit card details. The Indian Information Technology Act, 2000 was considered inadequate. Indian laws did not treat this as a criminal offence, even if the data theft was proved. There were even cases where foreign media houses ran sting operations and then published these sensationalizing the issue.

Similar media exposure has happened for clinical trials in India. Some of these have been widely publicized the world over. These have then been used to paint the entire clinical research field in India as being the black sheep. Rather than fostering a healthy debate, all this misguided media exposure has led to, ad hoc mechanisms being put in place without any careful thought to implementation. How can an already overburdened regulator cope with more paper work and regulations to apply? The government has to seriously look at the infrastructure required to sustain the new processes not only in terms of numbers but also in terms of experienced people manning the posts.

The BPO industry responded to this onslaught by self regulation and taking measures to clean its own house with the help of industry body NASSCOM.

How the CRO and pharmaceutical industry finds its way out of this mess still remains to be seen. Will the industry survive this deadly blow to its credentials?

What will really help is self regulation & discipline. Not that this does not exist at present in clinical trials. As stated earlier, clinical trials are conducted in one of the most regulated systems existing. Greater diligence and coordination between stakeholders is required. Efforts have to be made to share information and devise mechanisms to prevent the rights, safety and well being of participants from being violated. The industry has to be upright in providing compensation where it is due and required on a case to case basis.

The greatest measure has to be in the form of sensitization of the general public, media, political class and bureaucracy of the finer nuances of clinical research. This will require greater interaction, public debates and campaigns. The public has to be assured that the human participant’s rights will be safeguarded. This has to be put in practice not only in words but in actions.

The regulator and the government have to be informed about the dangers of some of the rules put in place. Many of these could be counterproductive and in-fact may introduce malpractices in public. Any cancer patient who is sick could be enrolled in a study with a hidden motive of availing the benefit of the compensation clauses being put in place without adequate safety measures.

The industry will also have to work with the regulator to work out the implementation of some of the new requirements and help them assess the impact. The Indian regulator mandated on 08 Feb 2013 the registration of ethics committees (ECs') in India. Only registered ECs’ can review and approve protocols. This is a very important and good move to weed out non committed players from the field. The regulator moved swiftly to invite applications (by 25 Mar 2013). It earnestly started examination of all applications from ECs’ throughout India. The first list of approved EC’s was released on 1 April 2013. This shows the seriousness and pro-activeness of the regulator.  However a look at the list of approved ECs’ shows that at least in the initial approvals, only institutional ECs’ are being approved. What happens to Independent ECs’ is not clear at the moment? Currently there will be a significant proportion of independent ECs’ that are providing oversight to sites in already running protocols. What happens if an amendment has to be moved in one of these studies involving independent ECs’? There are many experienced investigators that work with Independent ECs’, will their experience be lost as they can no longer participate due to the lack of an institutional EC? Moreover what happens to those independent ECs’ that have a vast experience and robust system in place? Will we lose out on their expertise? The industry will have to approach the regulator to work out a mechanism for these scenarios. The industry could look at an accreditation system for independent ECs’. They can then approach the regulator to register the accredited ECs’. This will both place an independent safeguard and provide an assurance of standards.  One such accreditation could be the Association of Accreditation of Human Research Protection Programs (AAHRPP).

It will not be easy. All stakeholders will have to come together. They will have to ignore their silos and work hand in hand to change the negative perception and ensure greater discipline and self regulation. The threats will come from within the ranks.

Inspiration should be taken from a group in Mumbai called ‘Responsible road users club’. Members of this group brave all the taunts and honks from outside and within to steadfastly follow road safety rules, even when their own friends and family push them to break red lights.

Such single minded doggedness will be required by each member and stakeholder of the clinical research fraternity if the industry is to recover from the black hole it finds itself hurtling towards.

Note: The views expressed represent the personal opinion of the author.

Plan panel sets $100 billion target for pharma sector by 2020

Plan panel sets $100 billion target for pharma sector by 2020

NEW DELHI: The Planning Commission has set a target for the Indian pharmaceutical industry to reach $ 100 billion by 2020 and account for 5 per cent share of the global drug industry in the next five years.

According to the final draft for 12th Five Year Plan (2012-17) by the panel, the objective of the sector will be to cross the $ 60 billion mark in 2017, which will be 5 per cent of global pharma industry.

"By 2020, the (pharma) sector should be at $ 100 billion," it said.

Currently, the Indian pharmaceutical industry is valued at $ 22 billion and is the third largest in terms of volume and 13th in terms of value globally.

According to the draft plan, the exports of pharma products should rise to Rs 1.3 lakh crore by the end of the 12th Five Year Plan.

"The sector should employ 15 lakh people by 2015, 18.98 lakh by 2018 and 24.64 lakh people by 2022," it added.

According to the draft plan, which will be submitted to National Development Council (NDC) tomorrow, all the Central Public Sector Undertakings (CPSUs) involved in production of pharmaceutical products should be self-sustaining by 2020.

In order to achieve the target, the Planning Commission has recommended various steps which include capacity building of private sector to meet WHO-GMP (World Health Organization- Good Manufacturing Practice) standards and other international manufacturing requirements.

The other recommendations include developing a common infrastructure in drug discovery and development such as manufacturing, distribution, exports and medical devices.

India aims to clock $15.5 bn pharma exports in FY'13

India aims to clock $15.5 bn pharma exports in FY'13

SINGAPORE: India is aiming to export pharmaceutical products worth $ 15.5 billion in 2012-13 fiscal, a jump of around 17 per cent compared to $ 13.22 billion in 2011-12,Ministry of Commerce and Industry Joint Secretary Mridul Jain said here today.

The $ 25 billion target, however, for pharma exports in 2013-14 would be a challenging task in view of global slowdown, she added.

"Our industry has told us about the economic impacts on pharmaceutical orders especially from Africa and least developed countries where health campaigns have slowed down," Jain told PTI after addressing an Indian pharmaceutical seminar in Singapore.

"...it would be challenging to meet the $ 25 billion export target for 2013-14," she said.

The industry was in a position to capture other emerging opportunities, especially manufacturing of "off patent" products or products with expired patent, which would offset some of the decreases in orders, Jain added.

Underlining the Indian government's policy of "zero tolerance" on quality of pharma products, she said "track and trace barcodes" has been introduced on consignments exported to the global market as part of the ongoing promotions and quality assurances of "Made-in-India" products.

"We continue to stress on efficiency, efficacy and quality of the pharmaceutical products," said Jain.

The European and American markets accounted for 55 per cent of the Indian pharmaceutical product exports, reflecting that most of these products were made to the highest specification of the US Food and Drug Administration (USFDA).

"The export volumes to the European and US markets speak volume about the high quality of Indian pharmaceutical products," said Jain, adding that the products were shipped to some 220 countries.

The Indian pharmaceutical industry reported business growth of about 15 per cent on compounded aggregated growth rate between 2006-07 and 2011-12.

Further, market initiatives were underway to promote exports, especially the International Exhibition for Pharma and Healthcare (IPHEX) to be held April 24-26, 2013 in Mumbai.

"We will be hosting 300 international buyers and 100 regulators from major markets at the exhibition to showcase Indian products," she said.

Over 600 Indian companies would participate in IPHEX, being organised by the Pharmaceuticals Export Promotion Council of India, set up by the Ministry of Commerce and Industry. 

Cheminformatics Workshop on 6 jan,2013

One day Workshop from BII Noidahttp://bii.in/chem/Cheminformatics.html

Seminar on Pharma Regulation & Lifescience

 

This is to inform all the aspirants that Bioinformatics Institute of india, Noida is organising a seminar on Pharma "Regulation & Life science" in February 2013.

There will be a poster presentation also. Other Details regarding seminar will announced shortly.

Please keep a watch on this space.

For Registration kingly contact:

BIOINFORMATICS INSTITUTE OF INDIA

C-56A/28, Sector - 62,

Noida - 201 301 (U.P) (INDIA)

Call : 0120-4320801/02

Mobile : 09818473366,09810535368

E-mail : info@bii.in 

 website: www.bii.in

 

 

 

 

 

 

Wish you a joyous Navratri and a Happy Dussehra

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Bioinformatics Institute of India

Bioinformatics from aartisoni12

Pharma Regulatory Affairs Course

Pharma Regulatory Affairs from aartisoni12

Bioinformatics Institute of India

Bioinformatics Institute of India (BII), set-up in the year 2002 has acquired international reputation by conducting industry oriented knowledge enhancement programs in the emerging domains of life science. BII was established by the prestigious Confrere Educational Society. Within a short span of a decade, BII has traversed many milestones in academic excellence and is today recognized as premier institute for providing the training in the area of Bioinformatics, Biotechnology, Pharma, Clinical Trials etc. The course-curriculum has been designed on global industrial pattern to fill the gap between academia and industry has lead BII to attain professional expertise in the field of life science and its allied area.

Quality Policy


Notice:
BII is determined to maintain its reputation as an authority which will not tolerate any kind of fraud. We have no branches & no sister concerns. Some people are misleading the students in the name of BII. Students are warned to be aware of duplicacy / piracy of certificates and course materials offered in the name of BII by any individual organisation other than our corporate office

BII Quality policy is as per ISO certification number NS-EN ISO 9001:2008 requirements which have been developed and implemented according to quality management system to demonstrate its ability to consistently provide education and training in the life sciences and pharma domain. Our quality management system complies with the requirements of the ISO and meets the end-user statutory and regulatory requirements through the effective application of the educational systems as per vision and mission of the institute. BII establishes documents, implements and maintains the quality management system and continually improves its effectiveness in accordance with the requirements of ISO:9001:2008.

BIOINFORMATICS INSTITUTE OF INDIA

C-56A/28, Sector - 62,
Noida - 201 301 (U.P) (INDIA)
Call : 0120-4320801/02
Mobile : 09818473366,09810535368
E-mail : info@bii.in
www.bii.in

Admission open in University Programs of Jamia Humdard

Bioinformatics Institute of India (BII), offers University Programs of Jamia Hamdard (3304) :
Jamia Hamdard Programs (3304)

•Post Graduate Diploma in Bioinformatics(PGDB)

•Post Graduate Diploma in Chem Informatics(PGDC)

•Post Graduate Diploma In Pharmaceutical regulatory Affairs (PGDPRA)

Course Duration:
•Minimum one year.
•Maximum two year.

Medium of Instruction: English

Program Eligibility
A candidate seeking admission to the above programme must passed B.Sc. examination in Biology or B.Sc. in Maths/Statistics with Biology as one of the subjects in 10+2 examination, from a recognized institution. No age bar.

Admission Procedure


•Submission of Application
•Enclosures:
For More Detail Contact:

BIOINFORMATICS INSTITUTE OF INDIA

C-56A/28, Sector - 62,
Noida - 201 301 (U.P) (INDIA)
Call : 0120-4320801/02
Mobile : 09818473366,09810535368
E-mail : info@bii.in
Website : http://bii.in/programs/regularPrograms/jamia_hamdard_programs.html#

Cheminformatics: An Emerging Computational tool

In the life path of researchers who emphasize to generate as much data as possible and then race into the next project, the next data set, the next batch of compounds to screen, and the next big drug candidate to send through clinical trials and ultimately, hopefully, to market. Chemoinformatics is rapidly becoming a core part of drug designing. The article features the academic and commercial educational programs that are available in chemoinformatics. Lets start the new journey of computational chemistry:

Field details:

It is the fusion of IT and Chemistry. This new branch is called “Chemin-formatics”. In Cheminformatics chemical information is stored, managed and chemical problems are solved with the help of Information Technology.

 The field that studies all the aspects of the representation and use of chemical and related biological information on computers i.e design, creation, organization, management, retrieval, analysis,  dissemination, visualization and use of chemical information.

Concepts and techniques: Molecular similarity, Quantitative-structure Activity Relationship(QSAR), Substructure Search, Molecular Depiction, 3D structure generation. These are Combinatorial Chemistry and High Throughput Screening (HTS).

“Cheminformatics exploits systems chemical biology to find pathways involved in adverse drug reactions. The second one was visualization of compound on ADME landscape. The internship programs in some pharmaceutical companies not only provided the opportunity to learn the whole process of drug discovery, but also allowed to study the hot research topic in the industry.

Cheminformatics is highly related to some other areas:

·      Computational Chemistry: the application of mathematical and computational methods  particularly to theoretical chemistry.

·      Molecular Modeling: using 3D graphics and optimization techniques to help understand the nature and action of compounds and proteins.

·      Computer-Aided Drug Design: the discipline of using computational techniques to assist in the discovery and design of drugs.

·      Chemogenomics - the study of relationships between chemical compounds and genes.

·      Cheminformatics has some traditional areas of application (pharmaceutical drug discovery, databases of available chemicals, journal article indexing, patent databases) and some newer ones (pathway databases, probe discovery, polypharmacology, toxicology, etc). In particular, there has recently been a big increase in the amount of chemical information in the public domain, and a deeper integration with other related areas.

Future porspects:

Cheminformatics has wide applications in drug discovery. Many companies offer Data management in cheminformatics. However, there is still a lot of variety, and almost every lab will need to turn to more than one provider for their chemical information needs. Open source software, beloved of academics for decades, is now beginning to penetrate the pharmaceutical industry.

Bio-Rad, a company best known for research and development in electrophoresis, officially became the Informatics Division in 2001. That year also saw the first release of BioRad’s premier chemical data management program. This program provides tools for storing and searching chemical ‘meta-data’ from infrared and NMR spectroscopy and mass spectrometry, as well as structures and other chemical information.

Hungarian cheminformatics company Chem-Axon, founded in 1998, is quite a new entrant to the field. Its first product, a chemical structure and reaction editor, Marvin, was released two years later, and a database management tool, JChem Base, developed to go with it.

Cheminformatics is to enable scientists to design and run their own complete drug discovery projects in a seamless electronic environment and to test drugs targeting the central nervous system and preclinical safety testing. The cheminformatics software industry is a relatively small one, and, increasingly, many vendors look to collaborate on particular projects rather than compete.

In the near future,  there is booming scope for the students who have studied Cheminformatics will be required not only in India but in foreign countries too.

Educational institutions:

The Indian institutes which offer training programs / diploma courses include :

1. Malabar Christian College, Kozikode. (1 Year P.G. Diploma in Cheminformatics, Eligibility for the course is M.Sc. (Chemistry) / M.Sc. (Bio – informatics) / M.Pharma)

2. Institute of Cheminformatics Studies, Noida.

3. Department of Chemistry, Jamia Hamdard Deemed University, New Delhi.

In USA and in Britain several universities have started M.Sc. courses in cheminformatics. Some of these are :

1. Johns Hopkins University, School of Medicine

2. University of Manchester – www.manchester.ac.uk.

3. University of Sheffield – www.shef.ac.

4. University of Indiana – www.informatics.indiana.edu.

Apart from the above, Bioinformatics Institute of India(www.bii.in), situated in Noida, U.P, India is a pioneering Institute of Life Sciences(distance learning and short term programmes), which is providing opportunities to the students, professionals to develop an expertise in the field of Bioinformatics. BII guide and train the students in the field of cheminformatics and its various aspects regarding drug designing such as virtual  screening, combinatorial library generation, pharmacophore and QSAR analysis with some specialized tools and softwares.

ELIGIBILITY:

B.Sc/ M.Sc/ M.Phil/ MS/ Ph.D Bioinformatics/ Microbiology/ Biochemistry/ Biotechnology/ Agriculture/ Food Technology/ Organic Chemistry/ Botany/ Zoology/ Statistics/ Life Sciences and other Divisions of Life Sciences like B.VSc, BAMS, BHMS, MBBS/ BDS/ B.Pharm/ M.Pharm/ B.E/ B.Tech / M.E/ M.Tech.

Job Opportunities:

The aim of this field is to cultivate researchers and scholars in chemistry and associated disciplines with knowledge and skills appropriate for career as cheminformatics specialists in the Pharma industry and related industries. Even provides comprehensive understanding of this fast growing field in science and technology starting from basic principles to the point of application in various fields of chemistry, biotechnology, drug development and drug designing. Cheminformatics helps to increase researchers efficiency for designing better drugs faster. Chemical, Agrochemical, Biotechnology and Pharmaceutical companies are in great need of students with extensive knowledge of chemistry and computer science, that is, cheminformatics.

Bashah Javed

Faculty of Bioinformatics

Bioinformatics Institute of India.

Noida.

E-mail: bashah@bii.in