The Tamil Nadu Drugs Control Directorate has initiated stringent action against 14 medical stores functioning in the city suburbs for selling sleeping pills without prescription.All the shops were given memos by the drugs control administration seeking explanation for the alleged malpractice.
According to Director of the Drugs Control department, the state health department has received complaints from public that certain pharmacy shops outside the city are selling sleeping pills without prescription. He said according to the instruction of the health minister and the secretary, the DDC has formed five groups of drug inspectors who have conducted surprise raids on 14 pharmacy shops on Saturday in various places adjacent to the city.M Bhaskaran, the drugs controller, said the inspectors have taken possession of the sales and stock registers of medicines from these stores for flouting the norms of Drugs and Cosmetics Act.
Pharmacies operating at Padappai, Mannivakkam, Mudichur, Perungalathur and Sriperumpudur were subjected to the regulators' actions. The stores working in Padappai are Muthayya Medicals and Sridevi Medical stores. In Perungalathur, the pharmacies received notices are Duke & Co, Pharma Unlimited, Sri Venkiteswara Medicals & General Stores, and Jayasree Medicals.
In Mudichur, action was initiated against Sri Mahalakshmi Medicals, Stanely Medicals & General Stores, and Jose Medicals.In Sriperumpudur, medical stores such as Sri Vasuki Medicals, Sri Ambal Medicals, and Sridevi Medicals. Action was also taken against Ravi Medicals at East Tambaram and Sri Sai Ram Medicals at Old Perungalathur
Wednesday, July 29, 2009
Tuesday, July 28, 2009
Pharmexcil Awards for Outstanding Export Performance
The Committee of Administration of the Pharmaceuticals Export Promotion Council has decided to institute ‘Pharmexcil Export Awards’ for the outstanding export performance. There will be one Trophy and one Merit certificates and one Award for Emerging Exporter in each of the category covered under council
Caterories include:
Click here for more info on eligibility criteria and nominations.
Caterories include:
- Drugs & Pharmaceuticals
- Formulations
- Bulk Drugs & Intermediates
- Herbal related Products
- Biotech Products
- Medical Devices
- Veterinary Products
Click here for more info on eligibility criteria and nominations.
Saturday, July 25, 2009
Glenmark alerts DCGI on data manipulation in Gujarat trial site
The Mumbai-based Glenmark Pharmaceuticals Ltd revealed that it had sounded an alarm against a government-funded Guru Gobind Hospital, Jamnagar, which allegedly manipulated data on the multi centric ongoing phase-IIb trial of the company's lead COPD/asthma molecule, Oglemilast.
The company announced that it is discontinuing the study in the hospital and has submitted an update report on the activities in the site to the Drug Controller General of India (DCGI) in June. The trial is conducted in collaboration with the US-based Omnicare Clinical Research, a leading Clinical Research Organisation (CRO), which informed its suspicion on the activities in the site to Glenmark.
"Without delay, Glenmark along with Omnicare carried out the appropriate for-cause audit and confirmed the fraud. This was immediately brought to the attention of the Chairman of the Ethics Committee at the concerned Hospital," details the Glenmark spokesperson. Omnicare along with Glenmark promptly closed the site in line with normal regulatory requirements for the safety of the patients. The company assured that no patients have been put at risk, and no more patients will be recruited for the clinical study at Jamnagar.
Further, the company will not consider any data received from this site pertaining to the study. The phase-IIb study will continue to progress as per the plan at other sites across the country, added the company spokesperson. "The incident took place in March and we have taken adequate steps to stop any damage to the patients. Now, some people have raised the issue as a case against the quality of our research. We would like to point out that Glenmark conducts all clinical trials in accordance with the internationally recognised ethical norms laid down by the Declaration of Helsinki and ICMR Ethical Guidelines," he added.
The phase-IIb human trials on the therapeutic effects of Oglemilast on asthma patients has been commenced in 28 sites in India in the end of 2008 in collaboration with Omnicare Clinical Research, even as another clinical trial on COPD for the same molecule is ongoing in US.
Friday, July 24, 2009
M.Tech (Pharmaceutical Technology) ADMISSIONS 2009-2010
M.Tech (Pharmaceutical Technology) ADMISSIONS 2009-2010
North Maharashtra University (NMU Jalgaon)
P.B.No. 80, UmavinagarJalgaon-425001 Maharashtra
Eligibility: B.Pharm/B.tech (Pharma)/M.Sc in Drug Chemistry
The applicant must hold minimum 55% marks in qualifying examination. Those who are awaiting final year results may also apply but they will have to submit their results on or before 31st July 2009
Completed application form in prescribed format with copies of certificates & D.D. of Rs. 250/- in favour of Registrar, North Maharashtra University, Jalgaon payable at Jalgaon should reach in time to the Director/Head of respective School/Department, North Maharashtra University, Jalgaon on or before 24th July, 2009.
Further Info about NMU MTech Pharmaceutical Technology 2009 Admissions
North Maharashtra University (NMU Jalgaon)
P.B.No. 80, UmavinagarJalgaon-425001 Maharashtra
Eligibility: B.Pharm/B.tech (Pharma)/M.Sc in Drug Chemistry
The applicant must hold minimum 55% marks in qualifying examination. Those who are awaiting final year results may also apply but they will have to submit their results on or before 31st July 2009
Completed application form in prescribed format with copies of certificates & D.D. of Rs. 250/- in favour of Registrar, North Maharashtra University, Jalgaon payable at Jalgaon should reach in time to the Director/Head of respective School/Department, North Maharashtra University, Jalgaon on or before 24th July, 2009.
Further Info about NMU MTech Pharmaceutical Technology 2009 Admissions
Pharmaceutical Outsourcing Congress India
Date: July 29-30, 2009
Venue: JW Marriott, Mumbai
Summary: The Ideas Exchange in partnership with Indian Drug Manufacturers Association (IDMA) is organising Pharmaceutical Outsourcing Congress India in Mumbai. This two day conference will bring key industry and regulatory experts together to debate the future of pharma outsourcing in India.
It will feature radical industry shaping content updates on the latest trends in India's outsourcing sector. It will also deliver practical lessons and strategies in order to improve commercial success and network with senior peers from across the country and the globe.
Contact details:
Vikas VijManaging
Director, The Ideas Exchange'
702 Sunrise BuildingWaterfield Road
Bandra, Mumbai 400 050
Email: vikas.vij@ideas-exchange.in
Website: www.pharmaoutsourcingindia.in
Tel: 0091 98 2047 1059
Workshop on Advance GCP - Theory to practice
Clinical Research Education and Management Academy (CREMA) announced a two day workshop on “Advance GCP – Theory to Practice” by Dr. Arun Bhatt MD (Med) FICP (Ind) MFPM (UK) FICR (UK), President ClinInvent Research Pvt Ltd.
Date : August 7th & 8th, 2009
The two day workshop aims to provide practical application of GCP for important clinical trial processes.
Learning Objectives
• Review and update GCP knowledge
• Recognize the challenges of site selection
• Understand the issues involved in planning of clinical trial
• Analyze ethics committee approval process
• Assess acceptability of informed consent
• Discuss monitoring aspects of protocol compliance
• Comprehend identification and handling of safety issues Who Should AttendThis course is recommended for experienced Clinical Quality Assurance Professionals, Clinical Research Associates, Project Managers, Investigators, and Study Coordinators.
Venue: Clinical Research Education and Management Academy
401 - Shree Amba Shanti Chambers
Next to Leela Business Park
Andheri Kurla Road
Andheri EastMumbai - 400 059
Board No : +91 - 22 - 66715491 - 92
Fax No : +91 - 22 - 66715490
For more information please log on to www.cremaindia.org
Or ContactAmit Sethi +91-9987028131amitsethi@cremaindia.org
Refresher course for working pharmacists
Vinayaka Mission College of Pharmacy, Salem will conduct a refresher course for all the registered working pharmacists in Salem districts on July 26. The course is sponsored by Tamil Nadu Pharmacy Council and will be conducted in the college campus.
Dr T Elango, registrar of the TNPC said its president Dr K Chinnasami will deliver a speech on 'the impact of cardiac and diabetic drugs' while inaugurating the refresher programme.Dr P M Balasubrahmaniam, chairman of the Adverse Drug Reaction Committee constituted by the pharmacy council, Dr B Jaikar, principal of the College, Dr S Gopalakrishnan, professor and HoD, Dept of Pharmaceutical Practice, Dr S Sriram, professor and HoD, Dept of Pharmaceutical Chemistry Ramakrishna Institute of Pharmacy Practice, Coimbatore and S Selvaraj, Assistant Director of Drugs Control, Salem zone will speak on this occasion.
Later the first meeting of the Adverse Drugs Reaction committee will be held in the college, said Dr T Elango. The meeting will evaluate and formulate the modus operandi of the ADR Committee. The Principal of the Vinayaka Mission College, Dr B Jaikar is the convener of the ADR Committee. He said certain hospitals in the district have been selected to collect the patients' reactions on newer drugs.
Dept of Pharmaceuticals submit project report on NIPER-Madurai to Azhagiri
A project a report on the proposed National Institute of Pharmaceutical Education and Research (NIPER) unit in Madurai was submitted to the Union minister for chemicals and fertilizers, M K Azhagiri on July 21 by R C Jha, director, Department of Pharmaceuticals following his visit to Madurai with an expert team last week.
Jha said that the Ministry has formed a 20 member committee comprising members from industry, government and academic institutes with respect to establishment of NIPER in Madurai. The committee is exploring all the possibilities for establishing the project.
Last week the team after visiting Madurai, called on the faculty members of the School of Biotechnology of the Madurai Kamaraj University. They inspected the advanced laboratory facilities at the University. Later they visited Madurai Medical College also, Jha said. He will further visit the state by the end of this month to have more discussions with the government officials and the university staff.
It is learnt that the department of pharmaceuticals is looking for an academic collaboration between the biotechnology department at the university and the NIPER at Madurai. "We are exploring all the facilities and all the ways, including those of the Medical College," he said. According to sources, the laboratory and hostel facilities of the university would be utilized for the proposed NIPER to start with.
The director said he cannot assure anything about the courses to be started in the beginning. However it is learnt that the academic collaboration with the University would be for offering two postgraduate courses such as Pharma Informatics and Pharmaceutical Biotechnology.
Dr Reddy’s Laboratories turnover increased 21 per cent for 1Q 2009
Dr Reddy’s Laboratories’ net more than doubled and the turnover increased 21 per cent for the first quarter ended June 30, riding on growth in generic business in North America, restructuring of research, and improvement in Betapharm performance in Germany.
The Vice-Chairman and Chief Executive Officer of Dr Reddy’s, Mr G.V. Prasad, said the US business registered an upside with Sumatriptan aiding the good performance. North America contributed 39 per cent of revenues, up from 26 per cent.
Mr K. Satish Reddy, Managing Director and Chief Operating Officer, told a press conference on Tuesday that the restructuring process, including discovery business and operations in Hyderabad, shutting down of the Atlanta office, and changes to the German business, aided in the growth. The momentum would continue, he said.
The company’s foreign exchange losses were Rs 8.4 crore against Rs 17.6 crore in the corresponding quarter last year. The closure of the Atlanta research centre at a cost of $1.5 million will potentially save up to $5 million a year and the one-time severance package offered to employees in Betapharm cost the company about €7 million.
The company launched 24 new generic products and filed 22 new generic product registrations. The second half would see more product launches by the company.
Wednesday, July 22, 2009
Graduate Aptitude Test in Engineering (GATE) 2010
Graduate Aptitude Test in Engineering (GATE) is an all-India examination administered and conducted jointly by the Indian Institute of Science and seven Indian Institutes of Technology on behalf of the National Coordinating Board - GATE, Department of Education, Ministry of Human Resource Development (MHRD), Government of India.
Changes in 2009:
Changes in 2009:
- From GATE 2009, the validity of GATE score will be ONE YEAR only.
- It has been decided to discontinue the offering of Pharmaceutical Sciences (PY) paper with effect from GATE 2010.
Lecture cum Practice on Patent Specification Drafting and Patent Prior Art Search
The Academy of Intellectual Property Studies (AIPS) has announced two new lecture series.
Lecture Series on Patent Specification Drafting
This course comprises five full day lecture cum practice sessions, and is designed for IP / Patent professionals wanting to improve specification writing and claim drafting skills. Expert faculty will guide the participants through both mechanical and chemical cases, and group and individual exercises will provide hands-on practice. One session is expected to be devoted especially to Pharmaceutical Drafting.
Commencement August 8, 2009
Timings 9.30 am - 5.30 pm .
Dates : August 8, August 22, August 29, September 5 and September 12, 2009 . (Saturdays only)
Lecture cum Practice Sessions on Patent Prior Art Search
The sessions will cover the basics of patent documentation, search tools and techniques, study of the search results and preparation of the search report. Participants will be taught to initiate search proceedings in the most appropriate manner, retrieve relevant documents and thereafter prepare the search reports. The Faculty will be covering both the web based free databases and a few paid sites.
Commencement August 8, 2009.
For details, contact AIPS at info@aips.ac.in
Certificate of participation will be issued for both the courses.
Lecture Series on Patent Specification Drafting
This course comprises five full day lecture cum practice sessions, and is designed for IP / Patent professionals wanting to improve specification writing and claim drafting skills. Expert faculty will guide the participants through both mechanical and chemical cases, and group and individual exercises will provide hands-on practice. One session is expected to be devoted especially to Pharmaceutical Drafting.
Commencement August 8, 2009
Timings 9.30 am - 5.30 pm .
Dates : August 8, August 22, August 29, September 5 and September 12, 2009 . (Saturdays only)
Lecture cum Practice Sessions on Patent Prior Art Search
The sessions will cover the basics of patent documentation, search tools and techniques, study of the search results and preparation of the search report. Participants will be taught to initiate search proceedings in the most appropriate manner, retrieve relevant documents and thereafter prepare the search reports. The Faculty will be covering both the web based free databases and a few paid sites.
Commencement August 8, 2009.
For details, contact AIPS at info@aips.ac.in
Certificate of participation will be issued for both the courses.
Monday, July 20, 2009
Central Drugs Standard Control Organization (CDSCO) Initiative: Year 2008-2012
Central Drugs Standard Control Organization (CDSCO) announced its initiatives for the period 2008 - 22 and the following were noteworthy:
Clinical Trial:
Clinical Trial:
- Mandatory registration of Clinical trials in centralized clinical trial registry (www.ctri.in) w.e.f 15th June 2009
- Registration of CROs, Ethics Committee & Clinical Trial Sites
- GCP Training of investigators by accredited body.
- Inspection of Clinical Trials
- Building of regulatory capacity in respect of First in man (i.e. Phase 0/Microdosing studies)
National Pharmacovigilance Program
All medical colleges, premium medical institutions, corporate hospitals etc to have a Pharmacovigilance center
Transparency & Accountability
- Regular posting of approvals on CDSCO website at www.cdsco.nic.in
- Regular posting of guideline document for industry/stakeholders.
- Display on 2 LCDs of various approvals at FDA Bhawan
- Turn around time for various applications such as BE, NOC for export, test licence tc.
- Interactive sessions with stake holders.
Vacancy for Lecturers at Hyderabad
Lecturers for the following branches are wanted.
Pharma Chemistry
Pharmaceutics
Pharmacognosy
Pharmacology
Pharma Biotechnology
Pharma Analysis
Pharmacy Practice
Experience: MPharm with first class, at least 2 years experience desired but fresh candidates will also be considered
Scale: AICTE Pay Scales.
Applications along with biodata & copies of certificates should reach the office on or before 7th August, 2009.
Contact:
Sri Venkateshwara College of Pharmacy
86, HiTech City Road, Madhapur
Hyderabad AP 500081
Ph:040 23118528
Email: surabhivanirao@hotmail.com
Friday, July 17, 2009
Government gives go-ahead for swine flu vaccine production
India's drug regulator has given approval to three domestic biotech firms to start tests and analyses to develop a vaccine for swine flu, or the H1N1 virus.
Bharat Biotech, Panacea Biotech and Serum Institute will now be able to procure seed strains from labs in the US and UK to manufacture the vaccine. The domestic companies are expected to take at least six months before they apply for an approval for the next stage of trials. Once the companies submit their preliminary test and analysis data, they will have to apply for potency test, pre-clinical trials and finally clinical trials before launching the medicine in the market. But it is believed that by September, global companies might be able to roll out a vaccine in the country.
Bharat Biotech, Panacea Biotech and Serum Institute will now be able to procure seed strains from labs in the US and UK to manufacture the vaccine. The domestic companies are expected to take at least six months before they apply for an approval for the next stage of trials. Once the companies submit their preliminary test and analysis data, they will have to apply for potency test, pre-clinical trials and finally clinical trials before launching the medicine in the market. But it is believed that by September, global companies might be able to roll out a vaccine in the country.
Highlights of Budget 2009-10 for Pharma Sector
Highlights of the Budget
ECGC Cover:
An adjustment assistance scheme to provide enhanced Export Credit and Guarantee Corporation (ECGC) cover at 95 per cent to badly hit sectors had been initiated in December 2008 to mitigate the difficulties faced by the exporters. In view of the continuing contraction in exports, the benefits of this scheme have been extended up to March 2010.
MDA:
The Market Development Assistance Scheme provides support to exporters in developing new markets. With many traditional markets still under financial stress, greater effort is required to identify and develop new markets. It has been proposed to enhance the allocation for this scheme by 148% over BE 2008-09 to Rs.124 crore.
Support to MSMEs:
Micro, Small and Medium Enterprises (MSMEs) have been affected by the slowdown in exports and the indirect effect of the global crisis on domestic demand. To support this sector, it has been proposed to facilitate the flow of credit at reasonable rates, by providing a special fund out of Rural Infrastructure Development Fund (RIDF) to Small Industries Development Bank (SIDBI). This fund of Rs.4,000 crore will incentivize Banks and State Finance Corporations (SFCs) to lend to Micro and Small Enterprises (MSEs) by refinancing 50 per cent of incremental lending to MSEs during the current financial year.
NHRM:
The National Rural Health Mission is an essential instrument for achieving our goal of Health for all. There has been to increase of Rs.2,057 crore over and above Rs.12,070 crore provided in the Interim Budget.
Rashtriya Swasthya Bima Yojana (RSBY)
Rashtriya Swasthya Bima Yojana (RSBY) was operationalised last year. The initial response has been very good. More than 46 lakh BPL families in eighteen States and UTs have been issued biometric smart cards. This scheme empowers poor families by giving them freedom of choice for using health care services from an extensive list of hospitals including private hospitals. Government proposes to bring all BPL families under this scheme. An amount of Rs.350 crore, marking 40% increase over the previous allocation, is being provided in 2009-10 Budget Estimates.
Fringe Benefit Tax:
The Finance Act, 2005 introduced the Fringe Benefit Tax on the value of certain fringe benefits provided by employers to their employees. It has been proposed to abolish the Fringe Benefit Tax on ESOP, Sweat Equity and Superannuation Funds. The tax burden will now be borne by Employees.
Research and Development:
The competitive ability of an economy rests on its progress in the area of Research and Development (R&D). In order to incentivise the corporate sector to undertake R&D work, It is proposed to extend the scope of the current provision of weighted deduction of 150% on expenditure incurred on in-house R&D to all manufacturing businesses except for a small negative list.
Customs, Excise and Countervailing Duty on some life saving drugs
On influenza vaccine and nine specified life saving drugs used for the treatment of breast cancer, hepatitis-B, rheumatic arthritis etc. and on bulk drugs used for the manufacture of such drugs, it has been proposed to reduce the customs duty from 10 per cent to 5 per cent. They will also be totally exempt from excise duty and countervailing duty.
Customs duty will also be reduced from 7.5 per cent to 5 per cent on two specified life saving devices used in treatment of heart conditions. These devices will be fully exempt from excise duty and CVD also.
With the Government's proclaimed objective of introducing a Goods and Services Tax (GST) both at the national and State level, some more steps in that direction are necessary. One measure that would facilitate the process is the further convergence of central excise duty rates to a mean rate - currently 8 per cent. FM has reviewed the list of items currently attracting the rate of 4 per cent, the only rate below the mean rate. There is a case for enhancing the rate on many items appearing in this list to 8 per cent, which It is proposed to do, with the following major exceptions:- drugs, pharmaceuticals and medical equipment besides other sectors.
Exemption of Service tax for Councils:
The Export Promotion Councils and the Federation of Indian Export Organizations (FIEO) provide a valuable service in augmenting our export effort. It has been proposed to exempt them from the levy of service tax on the membership and other fees collected by them till 31st March, 2010 .
Direct Taxes:
It has been proposed to raise the tax exemption limit for:
· Senior citizens by Rs 15,000/- from Rs.2.25 lakhs to Rs. 2.40 lakhs;
· Women by Rs 10,000/- from Rs. 1.80 lakhs to Rs. 1.90 lakhs;
· For all other individual tax payers by Rs. 10,000/- from Rs. 1.50 lakhs to Rs. 1.60 lakhs.
· It has been proposed to phase out the 10% surcharge on personal income tax.
· To tide over the slow down in Exports, the tax holiday for the sector has been increased by a year to include 2010-2011.
ECGC Cover:
An adjustment assistance scheme to provide enhanced Export Credit and Guarantee Corporation (ECGC) cover at 95 per cent to badly hit sectors had been initiated in December 2008 to mitigate the difficulties faced by the exporters. In view of the continuing contraction in exports, the benefits of this scheme have been extended up to March 2010.
MDA:
The Market Development Assistance Scheme provides support to exporters in developing new markets. With many traditional markets still under financial stress, greater effort is required to identify and develop new markets. It has been proposed to enhance the allocation for this scheme by 148% over BE 2008-09 to Rs.124 crore.
Support to MSMEs:
Micro, Small and Medium Enterprises (MSMEs) have been affected by the slowdown in exports and the indirect effect of the global crisis on domestic demand. To support this sector, it has been proposed to facilitate the flow of credit at reasonable rates, by providing a special fund out of Rural Infrastructure Development Fund (RIDF) to Small Industries Development Bank (SIDBI). This fund of Rs.4,000 crore will incentivize Banks and State Finance Corporations (SFCs) to lend to Micro and Small Enterprises (MSEs) by refinancing 50 per cent of incremental lending to MSEs during the current financial year.
NHRM:
The National Rural Health Mission is an essential instrument for achieving our goal of Health for all. There has been to increase of Rs.2,057 crore over and above Rs.12,070 crore provided in the Interim Budget.
Rashtriya Swasthya Bima Yojana (RSBY)
Rashtriya Swasthya Bima Yojana (RSBY) was operationalised last year. The initial response has been very good. More than 46 lakh BPL families in eighteen States and UTs have been issued biometric smart cards. This scheme empowers poor families by giving them freedom of choice for using health care services from an extensive list of hospitals including private hospitals. Government proposes to bring all BPL families under this scheme. An amount of Rs.350 crore, marking 40% increase over the previous allocation, is being provided in 2009-10 Budget Estimates.
Fringe Benefit Tax:
The Finance Act, 2005 introduced the Fringe Benefit Tax on the value of certain fringe benefits provided by employers to their employees. It has been proposed to abolish the Fringe Benefit Tax on ESOP, Sweat Equity and Superannuation Funds. The tax burden will now be borne by Employees.
Research and Development:
The competitive ability of an economy rests on its progress in the area of Research and Development (R&D). In order to incentivise the corporate sector to undertake R&D work, It is proposed to extend the scope of the current provision of weighted deduction of 150% on expenditure incurred on in-house R&D to all manufacturing businesses except for a small negative list.
Customs, Excise and Countervailing Duty on some life saving drugs
On influenza vaccine and nine specified life saving drugs used for the treatment of breast cancer, hepatitis-B, rheumatic arthritis etc. and on bulk drugs used for the manufacture of such drugs, it has been proposed to reduce the customs duty from 10 per cent to 5 per cent. They will also be totally exempt from excise duty and countervailing duty.
Customs duty will also be reduced from 7.5 per cent to 5 per cent on two specified life saving devices used in treatment of heart conditions. These devices will be fully exempt from excise duty and CVD also.
With the Government's proclaimed objective of introducing a Goods and Services Tax (GST) both at the national and State level, some more steps in that direction are necessary. One measure that would facilitate the process is the further convergence of central excise duty rates to a mean rate - currently 8 per cent. FM has reviewed the list of items currently attracting the rate of 4 per cent, the only rate below the mean rate. There is a case for enhancing the rate on many items appearing in this list to 8 per cent, which It is proposed to do, with the following major exceptions:- drugs, pharmaceuticals and medical equipment besides other sectors.
Exemption of Service tax for Councils:
The Export Promotion Councils and the Federation of Indian Export Organizations (FIEO) provide a valuable service in augmenting our export effort. It has been proposed to exempt them from the levy of service tax on the membership and other fees collected by them till 31st March, 2010 .
Direct Taxes:
It has been proposed to raise the tax exemption limit for:
· Senior citizens by Rs 15,000/- from Rs.2.25 lakhs to Rs. 2.40 lakhs;
· Women by Rs 10,000/- from Rs. 1.80 lakhs to Rs. 1.90 lakhs;
· For all other individual tax payers by Rs. 10,000/- from Rs. 1.50 lakhs to Rs. 1.60 lakhs.
· It has been proposed to phase out the 10% surcharge on personal income tax.
· To tide over the slow down in Exports, the tax holiday for the sector has been increased by a year to include 2010-2011.
Karnataka DC raids chemists, seizes huge stocks of substandard drugs made outside state
Karnataka drugs control department has seized drugs not-of-standard quality medicines sold at chemist outlets in the State. The drug test lab which conducted the analysis of the drugs has found that medicines were found non compliant with the analysis. The drugs have been manufactured mostly by companies outside the state. These include companies from the excise free zone at Baddi in Himachal Pradesh.
The reasons for drugs not being of standard quality are inadequate quantum of active ingredients, non compliance with the requirement of sterility, disintegration, assay requirements, weight uniformity and presence of undesirable substances. Companies need to maintain the highest quality of manufacture and have to ensure re-checks at every stage to avoid getting into this situation, stated Dr BR Jagashetty, Karnataka drugs controller. "We have alerted the pharmacy outlets, hospitals and nursing homes in the state not to sell or stock these drugs. The public have also been alerted to avoid purchase of these drugs which are available over-the-counter", he added.
The reasons for drugs not being of standard quality are inadequate quantum of active ingredients, non compliance with the requirement of sterility, disintegration, assay requirements, weight uniformity and presence of undesirable substances. Companies need to maintain the highest quality of manufacture and have to ensure re-checks at every stage to avoid getting into this situation, stated Dr BR Jagashetty, Karnataka drugs controller. "We have alerted the pharmacy outlets, hospitals and nursing homes in the state not to sell or stock these drugs. The public have also been alerted to avoid purchase of these drugs which are available over-the-counter", he added.
Wednesday, July 15, 2009
Timeline for Approvals by DCGI
Found a document stating the timelines for approval by DCGI and here it is.
click on the image to magnify
click on the image to magnify
India - 4th largest producer of drugs.
India is at present 4th largest producer of drugs in the world volume wise. Thus India is poised to be the Pharmacy of the World in the near future. At present India is manufacturing drugs worth Rs.85,000 crores of which drugs worth Rs.35,000 crores are exported. India has 119 USFDA approved manufacturing sites in the country.
Shri Debasish Panda, Joint Secretary of Drugs Consultative Committee, stated at the 40th Meeting of the Drugs Consultative Committee held on 29th June, 2009
Shri Debasish Panda, Joint Secretary of Drugs Consultative Committee, stated at the 40th Meeting of the Drugs Consultative Committee held on 29th June, 2009
NIPER like institute at Madurai
The Union Ministry of Chemicals and Fertilizers is all set to establish a NIPER (National Institute of Pharmaceutical Education and Research) like institute in Madurai soon. A team of experts from the Department of Pharmaceuticals has made two rounds of visits and identified the site for the project in the city last week.
Madurai would be the sixth place in the country to establish an institute like NIPER. At five locations in the country namely Mohali (Chandigargh), Hyderabad, Kolkata, Rae Bareli and Guwahati NIPER like establishments are already operating. The Ministry wants the unit to be established in Madurai from the next academic year, it is learnt.
The NIPER at Madurai will have three courses in the initial stage, Pharma Informatics, Pharmaceutical Biotechnology & Pharmacology, and Toxicology and Biotechnology. More courses will be introduced later. It is learnt that the classes for the courses will be started either at Madurai Medical College or Madurai Kamaraj University.
The members of the team who visited the sites included P Rama Rao, director, NIPER, C L Kaul, former director; and R C Jha, director, Department of Pharmaceuticals. They inspected sites at Edaiyapatti and Ambalapatti around Madurai. Sources said the establishment of the unit is part of establishing industries and bring in development works to the southern districts of the state.
NIPER like institute at Madurai
The Union Ministry of Chemicals and Fertilizers is all set to establish a NIPER (National Institute of Pharmaceutical Education and Research) like institute in Madurai soon. A team of experts from the Department of Pharmaceuticals has made two rounds of visits and identified the site for the project in the city last week.
Madurai would be the sixth place in the country to establish an institute like NIPER. At five locations in the country namely Mohali (Chandigargh), Hyderabad, Kolkata, Rae Bareli and Guwahati NIPER like establishments are already operating. The Ministry wants the unit to be established in Madurai from the next academic year, it is learnt.
The NIPER at Madurai will have three courses in the initial stage, Pharma Informatics, Pharmaceutical Biotechnology & Pharmacology, and Toxicology and Biotechnology. More courses will be introduced later. It is learnt that the classes for the courses will be started either at Madurai Medical College or Madurai Kamaraj University.
The members of the team who visited the sites included P Rama Rao, director, NIPER, C L Kaul, former director; and R C Jha, director, Department of Pharmaceuticals. They inspected sites at Edaiyapatti and Ambalapatti around Madurai. Sources said the establishment of the unit is part of establishing industries and bring in development works to the southern districts of the state.
Madurai would be the sixth place in the country to establish an institute like NIPER. At five locations in the country namely Mohali (Chandigargh), Hyderabad, Kolkata, Rae Bareli and Guwahati NIPER like establishments are already operating. The Ministry wants the unit to be established in Madurai from the next academic year, it is learnt.
The NIPER at Madurai will have three courses in the initial stage, Pharma Informatics, Pharmaceutical Biotechnology & Pharmacology, and Toxicology and Biotechnology. More courses will be introduced later. It is learnt that the classes for the courses will be started either at Madurai Medical College or Madurai Kamaraj University.
The members of the team who visited the sites included P Rama Rao, director, NIPER, C L Kaul, former director; and R C Jha, director, Department of Pharmaceuticals. They inspected sites at Edaiyapatti and Ambalapatti around Madurai. Sources said the establishment of the unit is part of establishing industries and bring in development works to the southern districts of the state.
Tuesday, July 14, 2009
5 new cases of A(H1N1) in Chennai
Five new cases of A(H1N1) virus have been confirmed in Chennai, taking the total count to 14 in the city.
Confirmatory results came from the National Institute of Virology, Pune, on Monday and the five patients were immediately put on the drug Tamiflu, according to the Director of Public Health, S. Elango.
Of the five persons, two were students who were part of a seven-member exchange programme to the United States.
The three persons are part of a family that flew in from Saudi Arabia, he added.
The others who were quarantined at the Communicable Diseases Hospital, Tondiarpet, on suspicion of harbouring the swine flu virus have been allowed to go home, officials informed.
Confirmatory results came from the National Institute of Virology, Pune, on Monday and the five patients were immediately put on the drug Tamiflu, according to the Director of Public Health, S. Elango.
Of the five persons, two were students who were part of a seven-member exchange programme to the United States.
The three persons are part of a family that flew in from Saudi Arabia, he added.
The others who were quarantined at the Communicable Diseases Hospital, Tondiarpet, on suspicion of harbouring the swine flu virus have been allowed to go home, officials informed.
Sunday, July 12, 2009
Draft rules for Registration of Clinical Research Organisation
The Drug Controller General of India (DCGI) has released draft rules for registration of clinical research organisations (CROs) mandating strict adherence of standard operating procedures by the individuals, institutions or organisations conducting clinical trials in the country.
The guidelines cover all organisations, individuals, institutions and companies that take the responsibility of the initiation or management or coordination of a clinical trial even as the clinical trial sites are exempted from registration.
Click here to read the draft
The guidelines cover all organisations, individuals, institutions and companies that take the responsibility of the initiation or management or coordination of a clinical trial even as the clinical trial sites are exempted from registration.
Click here to read the draft
Monday, July 6, 2009
Rimonabant ban in Karnataka
Karnataka drugs control department has issued a circular to stop the production and sales of Rimonabant. This order comes well before the drugs controller general of India circular to all the state departments.
"Going by the reports on the ban of Rimonabant across the world, we have taken a decision to ensure that this product is not available in the state. We are giving the pharmacy outlets across the state a month's time to withdraw and return all samples to the manufacturers," Dr BR Jugashetty, Drugs Controller, Government of Karnataka told.
The anti-obesity market in India is valued at Rs 75 crore. Leading players in the country include Sun Pharma, Cadila, Cipla, Glenmark, Torrent, Dr Reddy's, Ranbaxy and Intas.
Saturday, July 4, 2009
Promotion of Indian Clinical Trials Industry in USA - A FICCI initiative
Theme India dominated the 45th Annual DIA meeting this year.
The only country pavilion in the DIA with 8 Indian companies exhibiting together in addition to other India focused activities, this FICCI initiative was hailed as one of the key highlights of the DIA this year. Ms. Marie Dray, President DIA during her meeting with the Secretary, Dept of Pharmaceuticals Mr. Ashok Kumar at the India Pavillion thanked the government of India for choosing the DIA Annual meeting in the USA for showcasing the Indian Clinical Trials industry, and extended an invitation to the next years’ program.
The only country pavilion in the DIA with 8 Indian companies exhibiting together in addition to other India focused activities, this FICCI initiative was hailed as one of the key highlights of the DIA this year. Ms. Marie Dray, President DIA during her meeting with the Secretary, Dept of Pharmaceuticals Mr. Ashok Kumar at the India Pavillion thanked the government of India for choosing the DIA Annual meeting in the USA for showcasing the Indian Clinical Trials industry, and extended an invitation to the next years’ program.
Earlier at the India Evening Dinner Reception on June 23rd in San Marriott Hotel, Mr. Ashok Kumar unveiled the FICCI-E&Y study titled “The Glorious Metamorphosis – Compelling reasons for doing clinical research in India”. Addressing the 100 plus attendees to this reception the Secretary outlined the larger vision of making India the global hub for Pharmaceutical innovation, and shared the government initiatives of encouraging Public Private Partnerships and invests in capacity building and infrastructure. He pointed out the advantages that India has to offer in conducting clinical research projects in India, and informed the audience about the NIPER initiative for capacity building for the industry. Mr. Bruce Ross, from US FDA, who would be shortly taking over as Country Director in India shared the collaborative training programmed that have been initiated for clinical trial oversight audit in India.
The finale of the India focus activities was the India focus session in the DIA conference on June 24th, titled “Global Clinical Trials- Destination India”. The speakers in this session were Secretary, Department of Pharmaceuticals, Mr. Ashok Kumar, Dr. TS Rao, Advisor DBT, Dr. Vasudeo Ginde, CEO Diagnosearch and Ms. Bishakha Bhattacharya FICCI. The Secretary shared the vision of India becoming a hub for clinical trials as an extension of the larger vision of excellence in pharma innovation. He highlighted the critical role of clinical research and its vital link to the Drug discovery process.
Promotion of Indian Clinical Trials Industry in USA - A FICCI initiative
Theme India dominated the 45th Annual DIA meeting this year.
The only country pavilion in the DIA with 8 Indian companies exhibiting together in addition to other India focused activities, this FICCI initiative was hailed as one of the key highlights of the DIA this year. Ms. Marie Dray, President DIA during her meeting with the Secretary, Dept of Pharmaceuticals Mr. Ashok Kumar at the India Pavillion thanked the government of India for choosing the DIA Annual meeting in the USA for showcasing the Indian Clinical Trials industry, and extended an invitation to the next years’ program.
Earlier at the India Evening Dinner Reception on June 23rd in San Marriott Hotel, Mr. Ashok Kumar unveiled the FICCI-E&Y study titled “The Glorious Metamorphosis – Compelling reasons for doing clinical research in India”. Addressing the 100 plus attendees to this reception the Secretary outlined the larger vision of making India the global hub for Pharmaceutical innovation, and shared the government initiatives of encouraging Public Private Partnerships and invests in capacity building and infrastructure. He pointed out the advantages that India has to offer in conducting clinical research projects in India, and informed the audience about the NIPER initiative for capacity building for the industry. Mr. Bruce Ross, from US FDA, who would be shortly taking over as Country Director in India shared the collaborative training programmed that have been initiated for clinical trial oversight audit in India.
The finale of the India focus activities was the India focus session in the DIA conference on June 24th, titled “Global Clinical Trials- Destination India”. The speakers in this session were Secretary, Department of Pharmaceuticals, Mr. Ashok Kumar, Dr. TS Rao, Advisor DBT, Dr. Vasudeo Ginde, CEO Diagnosearch and Ms. Bishakha Bhattacharya FICCI. The Secretary shared the vision of India becoming a hub for clinical trials as an extension of the larger vision of excellence in pharma innovation. He highlighted the critical role of clinical research and its vital link to the Drug discovery process.
The only country pavilion in the DIA with 8 Indian companies exhibiting together in addition to other India focused activities, this FICCI initiative was hailed as one of the key highlights of the DIA this year. Ms. Marie Dray, President DIA during her meeting with the Secretary, Dept of Pharmaceuticals Mr. Ashok Kumar at the India Pavillion thanked the government of India for choosing the DIA Annual meeting in the USA for showcasing the Indian Clinical Trials industry, and extended an invitation to the next years’ program.
Earlier at the India Evening Dinner Reception on June 23rd in San Marriott Hotel, Mr. Ashok Kumar unveiled the FICCI-E&Y study titled “The Glorious Metamorphosis – Compelling reasons for doing clinical research in India”. Addressing the 100 plus attendees to this reception the Secretary outlined the larger vision of making India the global hub for Pharmaceutical innovation, and shared the government initiatives of encouraging Public Private Partnerships and invests in capacity building and infrastructure. He pointed out the advantages that India has to offer in conducting clinical research projects in India, and informed the audience about the NIPER initiative for capacity building for the industry. Mr. Bruce Ross, from US FDA, who would be shortly taking over as Country Director in India shared the collaborative training programmed that have been initiated for clinical trial oversight audit in India.
The finale of the India focus activities was the India focus session in the DIA conference on June 24th, titled “Global Clinical Trials- Destination India”. The speakers in this session were Secretary, Department of Pharmaceuticals, Mr. Ashok Kumar, Dr. TS Rao, Advisor DBT, Dr. Vasudeo Ginde, CEO Diagnosearch and Ms. Bishakha Bhattacharya FICCI. The Secretary shared the vision of India becoming a hub for clinical trials as an extension of the larger vision of excellence in pharma innovation. He highlighted the critical role of clinical research and its vital link to the Drug discovery process.
Free online courses on Intellectual Property Rights
WIPO Worldwide Academy provides the following free online courses on Intellectual Property Rights
DL-001 Primer on Intellectual Property
Summary: Covers briefly the fundamental aspects of intellectual property
Tutored: No
Duration: 3
Cost: Free of
Next Session: Open
Exam:
Certificate: No
DL-101 General Course on Intellectual Property
Summary: This course covers the main areas of intellectual property, namely copyright, related rights, patents, trademarks, geographical indications, industrial design, plant breeders' rights, unfair competition and international registration systems.
Tutored: No
Duration: 50 hours
Cost: Free of
Next Session: October 1 to November 15 (Exam: November 16-18)
Enrollment: July 1 to September 20,
Course Administrator: DL101e.academy@wipo.int
101PCT General Primers - Introduction to the Patent Cooperation Treaty
Summary: This course provides an introduction and general overview of the Patent Cooperation Treaty (PCT), an international system for seeking patents on a global scale.
Tutored: No Duration: 4
Cost: Free of
Next Session: Open
Exam:
Certificate: No
Course Administrator: pct.our@wipo.int
Click here for more details and to enroll
DL-001 Primer on Intellectual Property
Summary: Covers briefly the fundamental aspects of intellectual property
Tutored: No
Duration: 3
Cost: Free of
Next Session: Open
Exam:
Certificate: No
DL-101 General Course on Intellectual Property
Summary: This course covers the main areas of intellectual property, namely copyright, related rights, patents, trademarks, geographical indications, industrial design, plant breeders' rights, unfair competition and international registration systems.
Tutored: No
Duration: 50 hours
Cost: Free of
Next Session: October 1 to November 15 (Exam: November 16-18)
Enrollment: July 1 to September 20,
Course Administrator: DL101e.academy@wipo.int
101PCT General Primers - Introduction to the Patent Cooperation Treaty
Summary: This course provides an introduction and general overview of the Patent Cooperation Treaty (PCT), an international system for seeking patents on a global scale.
Tutored: No Duration: 4
Cost: Free of
Next Session: Open
Exam:
Certificate: No
Course Administrator: pct.our@wipo.int
Click here for more details and to enroll
Friday, July 3, 2009
Dr. M.G.R University M.Pharm Counselling 2009 - Revised Counselling Schedule
The Revised Counselling Schedule for the M.Pharm Course at DR. M.G.R Medical University is as follows:
Date: 22.07.09
TIME:
10.00 am - All physically challenged candidates and all Service candidates
10.30 am - All Non Service Candidates from Rank 1 to 100
11.30 am - All Non Service Candidates from Rank 101 to 150
2.00 pm - All Non Service Candidates from Rank 151 to 304 and all eligible SCA candidates.
Date: 22.07.09
TIME:
10.00 am - All physically challenged candidates and all Service candidates
10.30 am - All Non Service Candidates from Rank 1 to 100
11.30 am - All Non Service Candidates from Rank 101 to 150
2.00 pm - All Non Service Candidates from Rank 151 to 304 and all eligible SCA candidates.
A SEMINAR /WORK SHOP ON “EXPORT OPPORTUNITIES FOR PHARMA AND HERBAL INDUSTRIES “
In order to help the SMEs to venture / improve their exports in Pharma Sector, PHARMEXCIL, is conducting a seminar on “EXPORT OPPORTUNITIES FOR PHARMA AND HERBAL INDUSTRIES “
Date: Friday 17th July, 2009
Time: 9.30 am - 5.00 pm
Venue: The Residency Towers, Press Road Statue, TRIVANDRUM 1
Pharmexcil, DGFT, ECGC, EXIM Bank, SIDBI and SMERA etc will make Presentations. Topics pertaining to Herbal Product Registrations in the regulated and semi regulated markets for Exports are covered. Also the Kerala Drug Regulatory Authorities would participate in the one to one question answer session.
Registration Fee: Rs. 300 per Participant
You may send DD/ Cheque in the name of “Pharmaceuticals Export Promotion Council” payable at Hyderabad before 14th July 2009.
Cash payment at the venue is accepted for the members registering in advance.For registrations, Please contact info@pharmexcil.com,
Mr. G. Vijay Kumar, Consultant Advisor, Pharmexcil, (09849015527)
Mr MP George, Drugs Controller, Kerala (9447010210)
Prof Vimala Devi, President, FIHI (09486366075)
Thursday, July 2, 2009
Free Seminar on 'Careers in Clinical Research Industry'
A free seminar on 'Careers in Clinical Research Industry' will be held at the MIT Campus of the Anna University at Chromepet in Chennai on July 4.
Free Seminar on Careers in Clinical Research Industry
Date : Saturday the 4th July 2009
Time: 10. 00 AM to 12.30PM
Venue: Rajam Hall, MIT Campus (Chromepet)
Contact: Mr. K Srinivasan, Cell: 9677054411
It is co-sponsored by AU-KBC Research Centre of the University and Apollo Hospitals Education and Research Foundation, Chennai.Sources from the University said the seminar is aimed at acquainting graduates and postgraduates of science, engineering and medicine about the emerging clinical research scenario in the country as well as highlighting the career opportunities that this area offers to them. It will outline the training and the skills that are necessary to get absorbed in this industry.
The seminar will provide an opportunity for the participants to listen to various aspects of this subject from leading experts and practitioners. It would also provide details of the full time and part time training programmes being conducted at the University centre.
Dr Vasantha Muthuswamy, former deputy director general, ICMR, New Delhi, Dr VTS Sriram, medical director & academic coordinator, AU-KBC Research Centre, Jayanthi Swaminathan, general manager, AHERF, Chennai, Dr G Ramesh Kumar, academic coordinator, AU-KBC Research Centre are among the speakers participating in the seminar.
Those are interested to participate in this Free Seminar may register here.
Free Seminar on Careers in Clinical Research Industry
Date : Saturday the 4th July 2009
Time: 10. 00 AM to 12.30PM
Venue: Rajam Hall, MIT Campus (Chromepet)
Contact: Mr. K Srinivasan, Cell: 9677054411
It is co-sponsored by AU-KBC Research Centre of the University and Apollo Hospitals Education and Research Foundation, Chennai.Sources from the University said the seminar is aimed at acquainting graduates and postgraduates of science, engineering and medicine about the emerging clinical research scenario in the country as well as highlighting the career opportunities that this area offers to them. It will outline the training and the skills that are necessary to get absorbed in this industry.
The seminar will provide an opportunity for the participants to listen to various aspects of this subject from leading experts and practitioners. It would also provide details of the full time and part time training programmes being conducted at the University centre.
Dr Vasantha Muthuswamy, former deputy director general, ICMR, New Delhi, Dr VTS Sriram, medical director & academic coordinator, AU-KBC Research Centre, Jayanthi Swaminathan, general manager, AHERF, Chennai, Dr G Ramesh Kumar, academic coordinator, AU-KBC Research Centre are among the speakers participating in the seminar.
Those are interested to participate in this Free Seminar may register here.
Biotechnology Leadership Camp (BioCamp) at Hyderabad
Novartis India is organising its Biotechnology Leadership Camp (BioCamp) on August 11 and 12, 2009 in Hyderabad to bring in young students from diverse fields and different universities to form a talent pool for pharma and biotech industries.
BioCamp is open to postgraduate students and young researchers in science, pharmacology, medicine, biotechnology, business management (preference to students with a science background) or law (specialization in Intellectual Property Rights) interested in pursuing a career in the pharma and biotech industry.
Selected students will have the opportunity to learn from and network with leaders in the pharmaceutical, biotechnology and business sector as well as increase their team building skills. The top two students from the India BioCamp will represent India at the International BioCamp being held at the Novartis Institute of BioMedical Research, Cambridge, USA from October 27 to 31, 2009, informed a Novartis press release. Last date for receiving applications is July 10, 2009and more information would be available through biocamp.india@novartis.com.
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