Tuesday, December 29, 2009

After 30 years' gap, IPC prepares National Formulary of India

After a long gap of 30 years, the updated edition of National Formulary of India (NFI) will be available in the country soon as the Indian Pharmacopoeia Commission (IPC) is giving final touches to the NFI and will be published soon. This will be the fourth edition of the NFI and the third edition was published way back in 1979.According to sources, the IPC has almost finalised the new edition and will soon be distributed to the stakeholders like eminent doctors, pharmacists and even nurses in the country for their comments and suggestions before sending the much awaited reference material to final print.

The new edition will have around 1000 pages and will be available for the stakeholders at a nominal price which will be fixed at a later stage. Sources also said that around 1.5 lack copies will be printed in the first stage and after revising the edition and making it timely in tune with the growth of industry, the Commission will publish the editions on a regular basis, so that it reaches the stakeholders as a book of reference.

Experts are of the view that the restarting the publication of NFI is important especially in view of the fact that the category and doses of various medicines have not been included in the Indian Pharmacopoeia-2007. The various textbooks of pharmacology and medicine prescribe different doses schedule and one is at a loss which should be taken as a correct standard dose. The physicians, the pharmacists and the nurses are equally affected since the physician would not know the standard dose while pharmacists and nurses would not be able to correct the medication errors in doses in the absence of any standard text book.

Sunday, December 27, 2009

Staff Development Programme @ Periyar College of Pharmacy

STAFF DEVELOPMENT PROGRAMME "CURRENT TRENDS IN CLINICAL RESEARCH" Sponsored By All India Council For Technical Education New Delhi Organized

Click here to view the photos from this programme.

One Day Workshop on Impurities in Drug Substances

The overall quality of a drug substance or pharmaceutical most often depends on the extent to which the level of impurity in it has been controlled. Unfortunately impurities, suggestive of risks, can rarely be brought down to zero, and efforts can only be made to reduce them to the lowest levels that are reasonably practical. Several international guidelines have been arrived at to aid the drug developers and regulatory agencies to evaluate and control the impurities in drug substances these methods for detecting and controlling the impurities are subject to continuous review and improvement, and the concerned departments need to keep updated by keeping a close watch on the various guidances being issued by the authorities, understanding the rationale and requirements fully.

This workshop will study the current regulatory environment in which the drug developers operate, with a special focus on genotoxic impurities arising in drug substances. Concerns of the small to mid-sized company, possible strategies that could be adopted while dealing with the regulatory authorities, development and validation of analytical methods to manage genotoxic impurities, study of the recent causes of concern vis-a-vis genotoxic impurities etc. will be examined in addition to an overview of the existing official Guidelines and protocols, reporting practices etc.


The workshop is recommended for scientists working in R&D, Regulatory Affairs, Quality Control / Quality Assurance, Toxicology, Manufacturing, Compliance, Preclinical Development etc.

Venue: AIPS, Mumbai

Date: January 23, 2010

For more details: info@aips.ac.in

Wednesday, December 23, 2009

GATE Examination for Pharmacy Students

The National co-ordination Board for GATE 2010 in its 35th meeting held on 23rd November at Guwahati has resolved as under -

“It was decided that examination for PY paper would be conducted along with the JAM 2010 examination. The AICTE will be responsible for the examination and will announce it. The AICTE will handle setting of question papers, evaluating answer scripts, declaring results and all other aspects. The GATE committee will provide all the necessary help and guidance in conducting the examination for PY paper in 2010.”

Non-approval of MS Programmes by PCI under the Pharmacy Aact 1948.

PCI has clarified that only following qualifications acquired from an institution approved by PCI u/s 12 of the Pharmacy Act are approved for the purpose of registration as a pharmacist under the Pharmacy Act –
a) D.Pharm.

b) B.Pharm.

c) Pharm.D.


In view of it, the said MS Programmes are not approved by the PCI either for the purpose of registration as a pharmacist under the Pharmacy Act to practice the profession OR any other purpose like teaching in approved pharmacy institutions.

2nd International Symposium on Drug Metabolism and Pharmacokinetics (DMPK)

National Institute of Pharmaceutical Education and Research (NIPER) is oragnizing the International Symposium on Drug Metabolism and Pharmacokinetics (DMPK) Applications toward Drug Discovery and Development jointly with Bristol Meyers Squibb.

The main goals of the Symposium are to: 1) provide a better understanding of the role that drug metabolism, drug transporters, pharmacokinetics, and pharmacodynamics play in the drug discovery/development process; 2) evaluate new and current techniques and models associated with drug metabolism and drug transporters, as well as development of pharmacokinetic-pharmacodynamic models; 3) gain insights into the issues encountered during the drug discovery process and the interface between discovery and clinical development; and 4) identify processes for reducing the attrition of drug candidates through a better understanding of metabolism and in vitro and in vivo correlations.

This is primarily a lecture-based symposium intended for students and scientists from industry, academia, health-based government organizations, and healthcare professionals with a background in chemistry, biology, or the pharmaceutical sciences, with some experience in the principles and techniques of drug metabolism and pharmacokinetics. The symposium is also intended for experienced researchers in these areas who wish to broaden or supplement their area of expertise, as well as contribute to the discussion topics. Experts from India and abroad in drug metabolism and pharmacokinetics will give presentations and lead discussions at the Symposium.
INVITED SPEAKERS
Dr. Dhiren Thakker, Universtity of North Carolina, USA
Dr. Don Richards, Pfizer Global, UK
Dr. Jasminder Sahi, CellzDirect, USA
Dr. Jyoti Paliwal, Ranbaxy, Gurgaon
Dr. Krishna Iyer, Bombay College of Pharmacy, Mumbai
Dr. Michael Sinz, Bristol-Myers Squibb, USA
Dr. Nimish Vachharanjani, Advinus, Banagalore
Dr. Prasad V. Bharatam, NIPER, S.A.S. Nagar
Dr. Prashant V. Desai, Eli Lilly and Co., USA
Dr. Punit Marathe, Bristol-Myers Squibb, USA
Dr. Ramaswamy Iyer, Bristol-Myers Squibb, USA
Dr. Sandhya Mandlekar, Bristol-Myers Squibb, Bangalore
Dr. Saranjit Singh, NIPER, S.A.S. Nagar
Dr. Timothy Olah, Bristol-Myers Squibb, USA
Dr. Vijay Gombar, Eli Lilly and Co., USA
Dr. Vikram Ramanathan, Advinus, Bangalore

SCIENTIFIC PRESENTATION
The oral presentations will be through invited lectures.
For poster presentations, a poster board will be provided to interested participants. The size of the poster board is 48 (height) x 32 (width) inches.
A one page abstract (A4 size) containing title (Arial bold 11 font), address (Roman Times 11 font), followed by the text of the abstract (Roman Times 11 font) is to be sent. A soft copy needs to be submitted via e-mail: dmpk2010@niper.ac.in. LCD projector will be provided for lecture presentations.
NUMBER OF DELEGATES (MAX)
Students : 50Teachers / scientists : 30
BOARDING AND LODGING
Accommodation will be provided on NIPER Campus at nominal charges (per person) for three days as follows. Students in hostel : Rs. 300.00 Others in guest house : Rs. 750.00
If you wish to make your own arrangements, nearest hotels are Sarao Hotel (Ph. 0172-2215885) and Majestic Hotel (Ph. 0172-2232777)
REGISTRATION FEES
(includes scientific matter, food arrangements)
Students : Rs. 2000/-Faculty / scientists : Rs. 3000/-Industry personnel : Rs. 10,000/-
IMPORTANT DATES
Receipt of Abstract : 1st Feb. 2010
Intimation of acceptance : 15th Feb. 2010
Receipt of Reg. Fee : 15th Feb. 2010
Receipt of Acc. Charges : 15th Feb. 2010
Dates of symposium : 27th & 28th Feb. 2010

Reward Scheme for whistleblowers in the fight against the menace of spurious or fake drugs, cosmetics and medical devices

Central Government has devised a scheme for giving monetary rewards to the whistleblowers who can take risk of providing the information about the perpetrators of such crime. Such scheme is already operational in other enforcement departments of Government which pays good dividend also in terms of voluminous catches / seizures. The Reward scheme provides for giving handsome rewards to the informers who provide specific information to the designated authorities leading to the seizures of spurious, adulterated, misbranded and not of standard quality drugs, cosmetics and medical devices. This reward scheme will be applicable to both the informers as well as the officers of the CDSCO. In the fight against the menace of spurious or fake drugs, cost of such social participation will be minimal given the proportion of damage inflicted by the perpetrators of the crime on the health of the society and the economic progress of the country.

The salient features of the aforesaid reward scheme are as follows:-
(i) The reward scheme shall be applicable for whistleblowers in the area of drugs, cosmetics and medical devices.

(ii) Reward is to be given to the whistleblowers i.e. the informers / officials only when there is a confirmation of the seizure of spurious, adulterated and misbranded drugs, cosmetics and medical devices by the designated officers of the CDSCO.

(iii) The reward of maximum of upto 20% of the total cost of consignments seized will be payable to the informer / officials which should not in any case exceed Rs 25 Lakh in each case.

(iv) In respect of an officer of the Government / CDSCO, the reward should not in any case exceed Rs 5 Lakh for one case and a maximum of Rs 30 Lakh in his / her entire service.

(v) With a view to ensure that the informers are not made to wait till the final disposal of the matter, 25% of the amount will be given at the time of filing of the charge sheet in the court of Law.

(vi) Further, with a view to ensure that the informers do not turn hostile during the trial of the case and continue to assist the court in deciding the matter in favour of the Government, 25% of the amount will be given to them at the time of disposal of the case in favour of the Government in the first court of law.

(vii) The remaining 50% amount will be paid only when the case has been finally disposed of in favour of the Government and no appeal with respect to the matter is pending in any other Court of Law in the country.

Role of DIC in Promoting Rational Drug Use

India is the country with significant drug use problems. There is concern regarding the irrational production, prescription and use of drugs in India. There are many examples regarding irrational use of drugs in our country like, overuse of antibiotics and antidiarrheals for nonspecific childhood diarrhea, indiscriminate use of injections in children, polypharmacy in geriatric population, use of antibiotics for mild non-bacterial infection, tonics and multivitamins for malnutrition. Given that the vast majority of drug purchase costs are borne out of pocket, the ultimate burden of this irrational drug use falls entirely on the patient.

The prescribers, pharmacists, nurses and the patients are the four actors involved in drug use and some times lack basic and scientific drug information. Physicians frequently have inadequate information with new drugs/combinations; pharmacists often are not knowledgeable about the drugs they dispense; nurses do not know regarding the drugs they administer and similarly patients are often completely ignorant about the drugs they consume. The drug information from commercial sources requires careful evaluation. Pharma industry is a major sponsor of scientific conferences and symposia in which information to doctors often emphasizes only the positive aspects of products and over looks or gives little coverage to the negative aspects. Such information about drugs and drug promotion can greatly influence the way in which drugs are used.

Thus, drug information from commercial sources is very often biased and hence noncommercial, independent, unbiased source of drug information is important. Drug Information Centre (DIC) can be the unbiased, non-commercial and reliable source for pharmacists, drug regulators, doctors and the common man to obtain in-depth and focused drug information thus improving patient compliance and minimize irrational drug use. Drug information is also the basis for the development of tools like formularies and standard treatment guidelines essential for rational prescribing.

It is said by an expert “Information is the Best Prescription”. So if the prescriber is equipped with authentic updated information on medicines given by DICs then the prescribing habits will surely become rational and if consumer drug information also comes from DIC in a user friendly manner, then poor patient compliance, non adherence to treatments prescribed, self medication will be on decline. The World Health Organization (WHO) has been advocating promotion of rational drug use (RDU) and appropriate as well as rational use of medicines is likely to become the priority for health professionals, government and consumers in the years to come. Our DIC is already engaged in dissemination of updated unbiased drug information to drug regulators, pharmacists, doctors and common man and has realized through various queries received in past 5 years that all stake holders of medicines are much curious and hungry for right information and this is the right time to initiate imparting drug information, by pharmacists trained to run Drug Information services. Drug information is a fine-tuning channel for optimizing drug therapy. The National Human Rights Commission (NHRC) has already recommended to the Government of India to set up computerized drug information centers in large hospitals for the benefit of all concerned.

Role of DIC in Promoting Rational Drug Use

India is the country with significant drug use problems. There is concern regarding the irrational production, prescription and use of drugs in India. There are many examples regarding irrational use of drugs in our country like, overuse of antibiotics and antidiarrheals for nonspecific childhood diarrhea, indiscriminate use of injections in children, polypharmacy in geriatric population, use of antibiotics for mild non-bacterial infection, tonics and multivitamins for malnutrition. Given that the vast majority of drug purchase costs are borne out of pocket, the ultimate burden of this irrational drug use falls entirely on the patient.

The prescribers, pharmacists, nurses and the patients are the four actors involved in drug use and some times lack basic and scientific drug information. Physicians frequently have inadequate information with new drugs/combinations; pharmacists often are not knowledgeable about the drugs they dispense; nurses do not know regarding the drugs they administer and similarly patients are often completely ignorant about the drugs they consume. The drug information from commercial sources requires careful evaluation. Pharma industry is a major sponsor of scientific conferences and symposia in which information to doctors often emphasizes only the positive aspects of products and over looks or gives little coverage to the negative aspects. Such information about drugs and drug promotion can greatly influence the way in which drugs are used.

Thus, drug information from commercial sources is very often biased and hence noncommercial, independent, unbiased source of drug information is important. Drug Information Centre (DIC) can be the unbiased, non-commercial and reliable source for pharmacists, drug regulators, doctors and the common man to obtain in-depth and focused drug information thus improving patient compliance and minimize irrational drug use. Drug information is also the basis for the development of tools like formularies and standard treatment guidelines essential for rational prescribing.

It is said by an expert “Information is the Best Prescription”. So if the prescriber is equipped with authentic updated information on medicines given by DICs then the prescribing habits will surely become rational and if consumer drug information also comes from DIC in a user friendly manner, then poor patient compliance, non adherence to treatments prescribed, self medication will be on decline. The World Health Organization (WHO) has been advocating promotion of rational drug use (RDU) and appropriate as well as rational use of medicines is likely to become the priority for health professionals, government and consumers in the years to come. Our DIC is already engaged in dissemination of updated unbiased drug information to drug regulators, pharmacists, doctors and common man and has realized through various queries received in past 5 years that all stake holders of medicines are much curious and hungry for right information and this is the right time to initiate imparting drug information, by pharmacists trained to run Drug Information services. Drug information is a fine-tuning channel for optimizing drug therapy. The National Human Rights Commission (NHRC) has already recommended to the Government of India to set up computerized drug information centers in large hospitals for the benefit of all concerned.

By 2010, India will have maximum no. of diabetics

The global projections by International Diabetes Federation (IDF) also show that India has a much lesser prevalence of the disease than most other countries including US.

But that is just about the only satisfying bit of statistics unveiled in IDF's latest Diabetes Atlas. IDF, which tracks the global spread of this scourge, says that by next year, the country will be home to 50.8 million diabetics, making it the world's unchallenged diabetes capital. And the number is expected to go up to a whopping 87 million -- 8.4% of the country's adult population by 2030.
China stands second in this infamous table with 43.2 million diabetes cases at present, which is expected to increase to 62.6 million by 2030.

The disease will prove costly for India, both in terms of lives lost and money wasted. In India, it will kill around 10.07 lakh people in the age group of 20-79 years every year the majority being women (5.81 lakh) from 2010.

Diabetes will cost the world economy dear -- $376 billion in 2010, or 11.6% of total world healthcare expenditure. Though India will spend only 1% of the total diabetes spending worldwide, the amount itself is staggering -- $2.8 billion. US, on the other hand, will account for $198 billion or 52.7% of the total diabetes spending worldwide. By 2030, diabetes is expected to cost the world economy $490 billion.

According to the latest figures released on Tuesday night at Montreal, Pakistan, which now stands 7th in the "top 10 worst affected countries with diabetes" list with 7.1 million diabetics, will jump three places by 2030 to become the 4th worst affected with 13.8 million diabetics. Another of India's neighbours, Bangladesh, which at present does not figure in this list, will make an entry in another two decades, to claim the 7th worst affected country slot with 10.4 million diabetics.

Globally, the number of diabetes patients has risen sharply. While in 1985, 30 million people had diabetes, the number rose to 150 million in 2000. In 2010, 285 million people (6.6% of the global population in the age group 20-79) were found to be diabetic. However, by 2030, an estimated 435 million people are expected to suffer from this disease -- 7.8% of the adult population.

Paddy Upton, Indian cricket team’s trainer tested for swine flu

The Indian cricket team’s trainer and mental conditioning coach Paddy Upton has been tested for suspected swine flu. The results of the test are expected later in the day.

Upton, who arrived in Nagpur on Wednesday afternoon for Friday’s second One-Day International against Sri Lanka, showed symptoms of swine flu on Tuesday and was taken to a private hospital in Rajkot, venue of the first India-Sri Lanka one-dayer.

Earlier, Indian pacer S Sreesanth had tested positive for swine flu and missed India’s second Twenty20 match against the Lankans in Mohali on December 12.

The Kerala speedster was admitted in a private hospital there and discharged on Tuesday.
The Indian think-tank spent some torrid moments in Mohali when opener Gautam Gambhir, manager Mayank Parekh and video analyst Dhananjay showed similar symptoms and had to be tested, the results of which proved negative, much to their relief.

It was a matter of concern, since cases of swine flu are on the rise in Chandigarh, which had registered 10 deaths in the previous 10 days.

Afghanistan first in world to use new vaccine against polio

A new vaccine against polio will be used for the first time today in polio immunization campaigns in Afghanistan. The bivalent oral polio vaccine (bOPV), recommended by the Advisory Committee on Poliomyelitis Eradication, the global technical advisory body of the Global Polio Eradication Initiative as a critical tool to eradicate polio, can provide the optimal concurrent protection needed by young children against both surviving serotypes (types 1 and 3) of the paralysing virus. This will vastly simplify the logistics of vaccination in the conflict-affected parts of this country. This sub-national immunization campaign, from 15-17 December, will deliver bOPV to 2.8 million children under five in the Southern, South-Eastern and Eastern Regions of Afghanistan.

Of the three wild polioviruses (known as types 1, 2 and 3), type 2 has not been seen anywhere in the world since 1999. This achievement led to the development of monovalent vaccines, which provide protection against a single type with greater efficacy than the traditional trivalent vaccine. To determine whether a bivalent vaccine could effectively protect children living in areas where both types circulate, a clinical field trial completed in June 2009 compared bOPV with the existing vaccines. For both types 1 and 3 polio, bOPV was found to be at least 30% more effective than the trivalent vaccine and almost as good as the monovalent vaccines, yet in a package that could deliver both at once.

The bOPV allows countries to simplify vaccine logistics and to optimize protection using a mix of the available polio vaccines according to local needs. In southern Afghanistan, where access to children can be limited depending on the security situation, using bOPV helps maximise the impact of each contact with a child.

Most of Afghanistan is polio-free: 28 out of the 31 children paralysed by polio this year come from 13 highly insecure districts (of 329 districts in the country). In 2009, polio eradication efforts in Afghanistan have focused on improving operations and creating a safe environment for vaccination teams. Nongovernmental agencies have been contracted and local leaders involved to ensure that parties in conflict are approached, safe passage for vaccinators assured and children reached. Due to such preparations and strengthened supervision and staffing, the proportion of the nearly 1.2 million children under five years old in the Southern Region who could not be reached was reduced from more than 20% in early 2009, down to 5% during the July and September 2009 campaigns. The availability of bOPV multiplies the effect of such improvements. However, in the 13 highest-risk districts of Kandahar and Helmand provinces in the Southern Region, the proportion of children who are still unimmunized is well above 20% – and more than 60% in some areas.

Four countries in the world have never stopped polio transmission – Afghanistan, India, Nigeria and Pakistan. Types 1 and 3 polio circulate in limited parts of all these countries, and the others will follow Afghanistan's lead in using bOPV during the coming months, marking the adoption of a major new tool in the international effort to eradicate polio. While the Global Polio Eradication Initiative, a public-private partnership leading the effort, has reduced the incidence of polio by more than 99% (from an estimated 1000 children affected daily in 1988 to 1483 children in all of 2009 to date) polio still has a foothold in the four endemic countries. The consequences are severe beyond those areas: 16 previously polio-free countries are currently suffering outbreaks following importations of the virus; in four of these, polio transmission has lasted more than a year.

The availability of bOPV is part of a range of new and area-specific tactics in 2009 to reach eradication more quickly. The swift production of the vaccine was the result of extraordinary collaboration between the World Health Organization, UNICEF, vaccine manufacturers and regulatory agencies.

The vaccination campaign in Afghanistan is financed by the Government of Canada. Canada, which assumes presidency of the G8 in 2010, first placed polio on the group's agenda when it last held the presidency in 2002. The G8 is the single-largest donor bloc to polio eradication.
The Global Polio Eradication Initiative is spearheaded by the World Health Organization, Rotary International, the US Centers for Disease Control and Prevention and UNICEF.

Job News

* Work Packaging Development Officer in Shasun Drugs & chemicals
Bachelor's degree in Pharma. Exp Min 3-6 years; Good exposure to Pharmaceutical finished dosage line, Packaging development and printing, Regulated market Industry.
* Opportunity to work in Ajanta Pharma in PMT
High Compensation. Besides field, 4-5 yrs exp in PMT. Exceptional technical background&knowledge of Marketing, development processes.
* Product Manager in INDI Pharma
Minimum 2 yr experience in a Pharma company. Strong analytical skills and ability to create and implement action plans to improve results.
* Job in TIL as Scientific Officer
Candidates with 1-2 Years of Experience in any Pharmaceutical Company or Freshers with good Communication skills.

* Work as Research Officer in Natural remedies
Should be a M.Pharm in Pharmacognosy or Chemistry freshers. Should have excellent communication.

Tuesday, December 15, 2009

Gujarat pharmaceutical companies bid good bye to SEZ and return home

Gujarat-based pharma companies are turning homewards, as their honeymoon period in the tax-free havens of hill states like Himachal Pradesh and Uttarakhand ends in March 2010.

We have not done the right thing in shifting our units to hill states, and will now concentrate on our production units in Ahmedabad.” said I A Modi, chairman of Cadila Pharmaceuticals Ltd, which had shifted production worth Rs 250 crore from Ahmedabad to its Samba facility near Jammu in 2006.

Gujarat had seen exodus of many pharmaceutical units to tax-exempted states such as HP, Uttarakhand and Sikkim, as pharma is a cost-sensitive business. The state’s share in national pharma production, once 42 per cent, fell below 20 per cent after the pharma tax-free zones were formed.

Lack of adequate manpower and power cuts have been a cause of worry for the pharma companies who have shifted to places like Baddi in HP, said an industry source.

“Pharma production in Gujarat is picking up now. We hope by the end of this year, the state’s share would reach around 35 per cent of national pharmaceutical production, which is around Rs 90,000 crore,” said Chirag Doshi, secretary, Indian Drug Manufacturers’ Association.

The graph, he said, is back on its upward curve for the past two years, for two reasons. One, the deadline for tax exemption in most hill states is nearing the deadline. Two, the excise duty is now down to 4 per cent from 16 per cent in 2006-07, so the hill states are not as attractive, he told Business Standard on the sidelines of a pharma event in Ahmedabad.

“Gujarat did see a migration of units in the pharma sector. However, the reversal has already started. We have been able to re-capture one third of India’s drugs and formulations market,” Jaynarayan Vyas, the state government’s minister of health and family welfare had said recently.

Today, Sikkim is home to as many as 14 major pharma companies, with significant investments in the state. These include units by Cipla, Sun Pharma, Zydus Cadila, Alembic, IPCA, Alkem Lab, Intas Pharma, Torrent Pharmaceuticals and Unichem.

The attractiveness of the hill states lie in the multitudes of tax benefits they have to offer. These include excise duty exemption on finished products, income tax exemption and capital investment subsidy on investment in plant and machinery, among others. This led to nearly 180 pharma units flocking to Baddi, making it a pharma manufacturing hub. As for Sikkim, it was included in the ‘North East Industrial and Investment Promotion Policy, 2007’, as a part of which all new units and existing ones going for expansion in the state get a fulll exemption from income tax and excise duty, apart from a 30 per cent subsidy on investment in plant and machinery, together with interest subsidy at 3 per cent on capital loan and even reimbursement of 100 per cent insurance premium.

Industry sources indicated that once the tax-related policies in Special Economic Zones (SEZs) become clear, export oriented units like Zydus Cadila would look at concentrating more on Gujarat-based SEZs.

Most pharma companies are in the process of setting up SEZs, where one can avail tax benefits. This is another reason for the homeward move of the state’s pharma majors.

A slew of SEZs for the pharma industry have been planned by various players like Zydus Group, J B Chemicals, Dishman Pharma and Cadila Healthcare. Together, they aim to draw investment of Rs 10-15,000 crore in the next couple of years, according to industry sources.

Dishman Pharma is planning to invest Rs 500-600 crore in its SEZ over the next five years, that would be developed by Dishman Infrastructure Ltd (DIL) with an investment of Rs 400 crore.

“Work on the first phase will start in the first week of January and will take 15 months to complete,” J R Vyas, managing director of Dishman Pharma said. The company plans to build four facilities for contract manufacturing in the first phase. Torrent Pharma would invest Rs 350 crore to set up a facility at the Dahej SEZ and has started work on land development. This SEZ is a 50:50 joint venture between the Gujarat Industrial Development Corporation (GIDC) and ONGC. Already, 28 companies have finalised their plans for setting up manufacturing units in the area.

Cadila Pharma has plans to set up around seven to eight units in the coming PhaEZ near Ahmedabad over the next six years, with an estimated investment of around Rs 600-700 crore. About 30 units, involving investment of Rs 1,500-3,000 crore, are expected to come up in the PhaEZ Park.

Zydus Infrastructure has filled up Phase-I of its SEZ with nine units at an investment of Rs 200 crore. The 49.5 hectare SEZ already has a few operational units like Oxygen Bio, Fischer Scientific and Femicare. The company is now looking at developing the 67-hectare Phase-II of the SEZ. Besides a few joint venture units, Zydus Cadila is aiming to invest Rs 100 crore for manufacturing transdermal patches and various injectables.

Tokyo’s Eisai injects Rs 250 cr for pharma plant in Vizag

Tokyo-based Eisai Co Ltd, focusing on R&D, manufacturing and marketing of chemicals, food additives along with machinery and equipment for pharmaceutical production, has invested Rs 250 crore for setting up a pharma manufacturing plant in Vizag. A wholly-owned subsidiary of Eisai, this facility is called Eisai Pharmaceutical Technology and Manufacturing Ltd. It also houses the Eisai Knowledge Centre.

The manufacturing facility at Vizag is in the Pharmacity Special Economic Zone and is spread over 50 acres with over 80 employees in the first phase. Over a period of time, the company would be looking at setting up an R&D centre in India or Singapore which would focusprimarily on neglected diseases such as malaria, HIV, TB, among others.

“We are looking at both combination of basic R&D and reverse engineering process. Besides, we will have a data management global centre for clinical research,’’ Kenji Toda, senior vice-president, government relations, also the chairman of International Affairs Committee of Japan Pharmaceutical Manufacturers Association, told FE. The proposed research centre would focus on process research, combination of drug development, among otherd. “We are also in talks with some of the research institutes in India and working to develop drugs in a cost-effective manner,’’ Toda explained.

According to Toda, Vizag will be Eisai’s second global API supply site after the Kashima plant in Japan which supplies APIs to all countries. The facility will house drug substance and drug product manufacturing.“Production in Vizag will allow Eisai to offer affordable prices in developing nations and cope with changes in the business environment,’’ he said. In the process, the company aims to make the Vizag site supply the most cost-effective medicines to the world. Currently, the capacity for API production is 30 tonne which can be increased to 60 tonne per annum and drug production capacity increased two-fold from one billion to two billion per annum.

Friday, December 11, 2009

Conference on Current trends and challenges in Clinical Research

Sunday, 20th December, 2009
9.00 a.m. to 5.00 p.m.

Venue:
Torrent-AMA Management Centre, Core-AMA Management House,
AMA Complex, Dr. Vikram Sarabhai Marg, Ahmedabad 380 015

Fee:
Rs.1000/- per participant. (Students Rs.500/- per person). Fee includes course fee, cost of reading materials, lunch and refreshments. The cheque may please be drawn in the name of ‘Ahmedabad Management Association’.

Registration:
Please send your registration along with participation fee to:
Executive Director,
Ahmedabad Management Association,
ATIRA Campus, Ahmedabad 380 015.
Phone:079-26308601, 32512847 • Fax: 079-26305692.
E-mail: amaahd@gmail.com • Website: www.amaindia.org

Thursday, December 10, 2009

Railways to establish 18 medical colleges, 7 nursing colleges along with its hospitals

The Indian Railways will soon establish 18 new medical colleges attached to the existing Railway hospitals through the Public Private Partnership (PPP) programme. These proposed medical colleges will be opened in Chennai, Hyderabad, Bilaspur, Lucknow, Barasat, Bhubaneshwar, Mysore, Kharagpur, Guwahati, Dibrugarh, Jodhpur, Gardenreach, Nagpur, Ahmedabad, B R Singh Hospital/Kolkata, Bhopal, Jammu and Thiruvanthapuram.

The Railways will also establish seven Nursing Colleges attached to existing Railway Hospitals through the PPP programme. These places are Delhi, Kolkata, Mumbai (Kalyan), Chennai, Secunderabad, Lucknow and Jabalpur. Railways also propose to set up a training institute at Dankuni (West Bengal).

Besides, the Railways has also decided to establish medical facilities in long distance trains. This First Aid facilities will be provided for travelling passengers in all the long distance trains. Proposals to depute a doctor on few long distance trains, having practically no stoppages en-route is under process. All long distance passenger carrying trains are provided with First Aid Boxes containing essential drugs and dressing materials. The First Aid Box is available with the Guard of the train.

TN govt to appoint 25 new drug inspectors after a gap of 10 years

The government of Tamil Nadu will appoint 25 new drug inspectors in 15 days to fill up the existing vacancies in various parts of the state. Further, it plans to speed up the procedures to fill up the vacancies of Pharmacists in the health department, according to V K Subburaju, principal secretary & commissioner, Health & Family Welfare Department

The principal secretary was inaugurating the 48th National Pharmacy Week Celebration jointly organized by Indian Pharmaceutical Association TN chapter and TN Pharmaceutical Sciences Welfare Trust, in Chennai.

Sources from the Drugs Control Directorate said the process of recruiting fresh drug inspectors has been completed by the state public service commission and the health department is processing the procedures. The directorate is getting a group of drug inspectors after a period of ten years. The last recruitment through PSC was held in the year 1999, they said. The written examination for the Drug Inspector test was conducted in May last.

On the sidelines of the meeting, the principal secretary told Pharmabiz that many hospitals and clinical centres in the state were deprived of pharmacists and those vacancies would be filled up soon. Steps have already been taken to speed up the activity.

While addressing the audience, Subburaju said his department is ready to fill up all the vacancies, but there are so many procedural problems. Some senior posts are still lying vacant in the department. When the government plans to appoint a person through promotion, somebody will go to the court for claim. It becomes bottlenecks for the procedure, he said.

M Bhaskaran, director of Drug Control department, R Narayanasamy and J Jayaseelan from IPA, and N Sreenivasan from Pharmaceutical sciences welfare Trust were present in the meeting.

Wednesday, December 9, 2009

First year common for Medical studies, Dental, Pharmacy and midwifery

By a recent amendement in education system in France, The first year of health studies is common in medical studies, dental, pharmacy and midwifery. It may also be allied with some training under conditions laid down by order of the ministers responsible for health and education.

More Japanese companies coming to India

India has become the most sought destination for investment by Japanese companies, next to China and ahead of other Asian countries and emerging economies like Russia, Brazil, Mexico and even the US and UK.

According to a recent survey by the Japan Bank for International Cooperation (JBIC) covering 620 leading Japanese manufacturing companies, 278, or 58 per cent, wanted to do business with India in the medium term, behind 74 per cent for China. The next best destination for Japanese manufacturers after India is Vietnam, way below with 31 per cent support.

The survey reflects Japanese companies' mounting interests in Indian businesses, especially in sectors such as automobiles, IT, infrastructure, steel, power and pharmaceuticals.

Japan now ranks sixth in the list of foreign direct investments (FDI) in India, in a list dominated by Mauritius, which accounts for 44 per cent of cumulative FDI in India. Japanese companies invested only Rs 382 crore in India in 2006-07. This rose to Rs 3,386 crore in 2007-08 and then dipped to Rs 1,889 crore in 2008-09. Up to this September, the FDI inflow from Japan has touched Rs 3,857 crore, the highest ever in a year.

Besides money, Japan's advanced technologies are also flowing to India. Of the 8,000-plus foreign technology transfers (FTC) so far approved by the Indian government, Japan accounts for 10.88 per cent, with 879 approvals, in third position behind the US and Germany.

Takeda Pharmaceuticals, the largest drug maker in Japan, will start selling drugs in India. So is Astellas Pharma, the second largest Japanese drug maker, which started Indian operations a few months earlier. The third largest, Daiichi Sankyo, had stunned the pharma world in India last year by acquiring the largest drug maker, Ranbaxy Laboratories, for Rs 19,803 crore.

“We teamed with Ranbaxy to create a hybrid long-term model in drug business globally, leveraging the innovator capabilities of Daiichi Sankyo and Ranbaxy's great generic drug-making skills and global reach,” says Tsutomu Une, chairman of Ranbaxy Laboratories and executive director of Daiichi Sankyo.

Eisai Co, another leading Japanese drug maker, is making India its major manufacturing hub and is setting up a huge facility at Visakhapatnam, with an investment of Rs 1,900 crore.

Japan's business interests are obvious, as India's pharmaceutical market is expected to reach an estimated $20 billion by 2015, with one of the highest growth rates in the world, at 12 per cent.

“Building relationships and winning their trust are the two key factors in establishing business links with Japanese companies. Then comes factors like time lines, quality and project management skills,” notes Abhijeet Ranade, associate director, PricewaterhouseCoopers.

Japan is also showing interest in India's infrastructure development. JBIC had extended a Rs 715-crore loan for L&T-MHI Boilers (LTMB) and L&T-MHI Turbine Generators, two joint venture companies being set up by India's engineering major Larsen & Toubro (L&T) and Japan's Mitsubishi Heavy Industries (MHI), to make boilers and turbines for thermal power plants at Hazira in Gujarat.

It will also fund close to Rs 20,000 crore in developing the Mumbai-Delhi rail freight corridor. Japan International Cooperation Agency (JICA), a government arm, had provided a ¥137-billion (Rs 7,000 crore) loan for 2008 to set up drinking water facilities in Hogenakkal, Kerala and Guwahati, besides constructing the Delhi Metro.

Cumulative investments by Japanese companies in India are to the tune of over Rs 15,000 crore, about 3 per cent of the overall FDI in India, according to data from the Department of Industrial Policy and Promotion.

India's leading IT players have significant presence in Japan and majors such as IBM, Accenture, Wipro, Infosys, TCS and Patni have already set shop there to outsource work to India. Japan is the second largest IT spender in the world at over $108 billion annually, next to the US.

“At present about 40 per cent of IT work related to Japan is done in India and this may increase to 60 per cent within the next few years,” said a specialist in the global IT scene.

JFE Steel Corporation, the world's sixth biggest and the second largest steelmaker in Japan, will invest in Sajjan Jindal-promoted JSW Steel, to pick up a minority stake, besides jointly making auto grade steel and setting up a mega integrated steel production facility in West Bengal.

“We are working out the details and JFE Steel's investment in JSW Steel will happen in a few months,” said Sheshagiri Rao, joint managing director and group chief financial officer of the JSW Group.

Analysts feel Japanese companies are likely to invest above Rs 1 lakh crore in India in the coming three to five years.

Automobiles have been attracting huge investments from Japan. For two decades, Indian roads have been flooded with Maruti Suzukis. Soon, more Japanese-made small cars will debut on Indian roads, like Nissan's Micra. Nissan is planning to shift the entire production of Micra, from the UK to India, to be followed by two more models. The company is setting up a plant in Bangalore, with an investment of over Rs 4,500 crore.

Similarly, Toyota Motors will also make India a hub for making its small cars. Toyota will invest over Rs 2,500 crore by 2011 to set up a second plant in Bangalore to increase its capacity by four times. Another Japanese automobile major, Honda Motors, will launch its small car in India by 2011.

Japanese truck maker Hino Motors is also planning to sell over 700 trucks in India this financial year and will set up a manufacturing unit within three years, say sources. And tyre maker Bridgestone is setting up a new plant at Pune with an investment of over Rs 2,000 crore.

"For sustainable growth of the Indian economy, India and Japan have to move forward in environmental cooperation by making most use of Japanese environmental technologies and financing,” says Takashi Hongo, JBIC’s Special Advisor and head of its environment finance engineering department.

Monday, December 7, 2009

All India Pharmacy Students Cartoon Competition 2009-2010

All India Pharmacy Students Cartoon Competition 2009-2010

Eligibility: All students studying in Final D.Pharm/B.Pharm/M.Pharm for academic year 2009-2010 are eligible.

Conditions: Separate cash prizes and citations for D.Pharm/B.Pharm/M.Pharm category. The original cartoons in A4 size paper should reach the ACPI head quarts by post. The submitted cartons will not be returned and remain the property of the ACPI. The Name, Category, email id should be mentioned on the back of the page. Bonafide certificate from Principal regarding the student status is essential.

There is no entry fees.
First Prize Rs 1000:
Second prize: 750;
Third prize 500

Entry may be sent to: President, Association of Community Pharmacists of India, MCOPS, Manipal 576104.India.

Results will be announced on Association website and Winners of the prizes will be intimated by email and prize money shall be paid by Demand draft along with Citations.

Themes for Competition
M.Pharm: "Community Pharmacist and Dispensing of Ethical Medicines”
B.Pharm: "Community Pharmacist and Primary Health Care”
D.Pharm: "Community Pharmacist, Doctors and Nurses"

For more detail enquiry to: acpindia08@gmail.com

Thursday, December 3, 2009

FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary Angioedema

The U.S. Food and Drug Administration approved Kalbitor (ecallantide) on Dec. 1 to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).

HAE is caused by a defect in the blood protein C1 esterase-inhibitor, which plays a role in regulating how certain immune system and blood clotting pathways function. Decreased function of this protein can lead to rapid and serious swelling of the face or other parts of the body, which may result in permanent disfigurement, disability or death. Swelling of the digestive tract may cause excruciating abdominal pain, nausea, and vomiting, while airway swelling puts patients at risk of suffocation. About 10,000 people in the United States have HAE.

Kalbitor is a liquid that is intended to be injected under the skin for patients age 16 and older who experience HAE attacks.
For more information, please visit: Kalbitor

Tuesday, December 1, 2009

FDA Approves Agriflu Seasonal Influenza Vaccine

The U.S. Food and Drug Administration today approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.
Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved using the FDA’s accelerated approval pathway, which helps safe and effective medical products for serious or life-threatening diseases become available sooner. In this case, Novartis demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.
Agriflu is administered as a single injection in the upper arm and is available in single dose, pre-filled syringes that do not contain preservatives.
“The approval of the new seasonal influenza vaccine, Agriflu, is an important step in adding to the production capacity to enhance the supply of vaccine for the United States for future influenza seasons,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Common side effects in clinical studies included pain, swelling and redness at the injection site, headache, muscle aches and malaise. People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

As part of the accelerated approval process, Novartis is required to conduct further studies to verify that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza. The company also manufactures another licensed seasonal influenza vaccine, Fluvirin, for use in the United States. Fluvirinis approved for people ages 4 years and older. Agriflu is not intended to protect against the 2009 H1N1 influenza.
For more information, visit FDA’s Webpage on 2009 – 2010 Season Flu Vaccines
at:http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm100139.htm