About Authors:
Dr. D.k. Sanghi, Rakesh Tiwle*, Puja Karanjekar, Priyanka Hemne, Dileshwari Madavi, Padma Tembhre
Shri Laxmanrao Mankar Institute of Pharmacy,
Amgoan, Gondia, Maharashtra, India- 441902.
rakesh_tiwle@rediffmail.com
Abstract
A pharmaceutical formulation and its research invasis play important role in the young generation of the pharmacy students because without seeing the process we don’t know about the formulation and development of any medicine because of that a industrial visit should be compulsory to the pharmacy students. Pharmaceutical industry is a most diverse, R&D oriented, hypercompetitive and knowledge sensitive industry. Competitive intelligence (CI) is a process of ethically and systemic data gathering from operating system to draw important business conclusions. Use of CI for drawing important conclusions regarding present scenario and future forecasting is very important and growth determining practice of pharmaceutical industries. Intellectual property rights (IPR) is an integral part of the industry and IPR related information is freely available in public patent databases. By analyzing patents company can derive important conclusion regarding competitor’s R&D activities, quality of research, collaboration and alliance and can convert this information to knowledge which can play important role in taking future decisions. Present review is fully focused on advent of IPR in getting very good information regarding competitor’s strategies and tactics.
INTRODUCTION
Pharmaceutical industry in one of the prominent industry though out the globe and further it is in growing phase1, 2, so innovative activities and strategies play important role in the growth of industry2, 3. However the flip side is that, there is stiff competition between companies for same drug molecule, same disease area or for the same treatment3, 4, 5. Ethically looking over strategies and tactics of Competitors, company can drive important conclusions regarding present scenario and can also forecast about future, 6. Intellectual property rights (IPR) is an integral part of the pharmaceutical industry7, 8. Information of patents is freely available in various patent databases. By analyzing intellectual property (IP) information important conclusion regarding rivalry activities can be drawn out7, 8, so pharmaceutical industry uses IP as a tool for competitive intelligence (CI) 8,. Further advents of IP in CI are elaborated in coming section.
GMP- It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use. WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization?” GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures have been taken; full traceability of a product through batch records and distribution records; and systems for recall and investigation of complaints.
Quality assurance- It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use.
Quality control- Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use.
Figure 1: Flow Chart of GMP.
DRUG DEVELOPMENT STAGES
Stage 1
The first stage, the discovery of a potential NME, is not covered by a regulatory standard, nor is studies that demonstrate proof of concept. The WHO has recently published guidance on this early research phase : Quality Practices in Basic Biomedical Research – QPBR.
Stage 2
The position of GLP studies within the drug development process is specific to the second stage. These studies are termed “non-clinical” as they are not performed in humans. Their primary purpose is safety testing. Toxicology and safety pharmacology studies, with a potential extension to pharmacokinetics and bioavailability, are those studies where compliance with GLP is required. From the diagram above.
Stage 3
The third stage, following on from safety studies of stage 2, encompasses clinical studies in human subjects. Here, GCP is the basic requirement for quality standards, ethical conduct and regulatory compliance. GCP must be instituted in all clinical trials from Phase I (to demonstrate tolerance of the test drug and to define human pharmacokinetics) through Phase II (where the dose-effect relationship is confirmed) to Phase III (full scale, often multi-centric, clinical efficacy trials in hundreds or thousands of subjects).
Stage 4
The fourth stage is post-approval. Here the drug has been registered and is available on the market. However, even after marketing approval, the use of the drug is monitored through formal pharmacovigilance procedures. Any subsequent clinical trials (Phase IV) must also comply with GC.
VISITED PHARMACEUTICAL INDUSTRIES
Vama Pharma
Figure 2: Arco Pharmaceutical
Vama Pharmaceutical has been established in 2006 based at central India's largest city Nagpur, Vama Pharma is an integrated pharmaceutical company, producing a wide range of quality products that have earned the trust of the medical fraternity in states of India. Central India's premier pharmaceutical manufacturing company Vama Pharma is a single-point source for all your pharmaceutical and contract manufacturing requirements. They have highly experienced technical team for manufacturing pharmaceuticals preparations & manufacture pharmaceutical formulations in according to the cGMP norms. In that industries a world-class, manufacturing plant is equipped with all amenities & high standard machineries to manufacture medicines We have highly qualified and trained staff for production management.
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Products of Vama Pharma
DEEPTI PHARMACEUTICALS
Deepti Pharmaceuticalsis a registered company under Indian Pharmacopoeia to deliver quality Pharmaceuticals Products. They are Manufacturer and Supplier of a wide range of pharmaceutical products that are supplied to the different parts of the country. The major products of the company include Benzyl Benzoate, Borax Glycerin, Glycerin, Glycyrrhiza, Hydrogen Peroxide Solution, Isopropyl Alcohol, Sodium Bicarbonate, Turpentine Liniment, Cough Syrup and Ginger etc best quality products are the outcome of continuous research and development with the latest technology of advanced medical science. All the products are properly examined and tested by the dept professionals to provide the reliable, effective and immediate healing. They manufacture the products under strict vigilance and from the best quality raw material that we obtain from reliable sources. The products are supplied to the different states of India in the fine quality packaging to retain their good condition.
Products of Deepti Pharmaceuticals
Turpentine Liniment I.P.
We are engaged in manufacturing and supplying of Turpentine Liniment I.P. to all government hospitals of Maharashtra and Karnataka. It is available in packing of 100ml, 400 ml, and 500 ml. We provide high quality Turpentine Liniment I.P. that is properly tested and made to provide effective and immediate relief from rheumatic pain, counter irritation, etc. Turpentine Liniment I.P. is supplied to various parts of the country. Our Turpentine Liniment I.P. is made from the best quality raw material to provide tension free solution to our clients.
Isopropyl Alcohol I.P.
Isopropyl Alcohol I.P.are supply to various states of the country. Isopropyl Alcohol I.P. is properly tested by the expert professionals of the company before delivering to the customers. Our Isopropyl Alcohol I.P. is made from high quality raw material that we obtain from trusted sources. The solution is available at an affordable market price for the clients.
Hydrogen Peroxide Solution I.P
We are one of the manufacturers of Hydrogen Peroxide Solution I.P. I.P 20 vol available in 100ml, 450 ml, and 5 lit packing. Our Hydrogen Peroxide Solution I.P. is the perfect solution to use as an antiseptic treatment. The product has been properly tested to provide effective and immediate solution for the specific purpose. Our Hydrogen Peroxide Solution I.P. is made from the best quality raw material that we collect from trusted sources. Our Hydrogen Peroxide solution I.P. is available at an affordable market price.
ARCO PHARMACEUTICALS
Arco Life Sciences (I) Pvt. Ltd. is a central India based reputed pharmaceutical formulation manufacturing company. The production facilities are located at MIDC Area, Hingana, Nagpur.
It possesses one of the best and modern manufacturing facilities in the area.
Arco Life Sciences (I) Pvt.Ltd. was established in April, 2004. Arco is running successfully since inception and achieveing new heights day by day. under the experienced leader ship of Dr.N.D.Agrawal (M.pharm, Ph.D, DBM), Director of the company. He was developed this unit up to the mark of standard ISO-9001:2008 within this short period. He is very much attentive towards quality control and research and development in his Organization.
Brand product
ACINORM (Ranitidine Inj. I.P., 25 mg/ml), ARMIKACIN (Amikacin Inj. I.P., 50 mg/ml), BIOCIN (Gentamicin Sulphate Inj. I.P., 40 mg/ml),
R-PRIN (Heparin Sodium Inj., 5000 IU/ml)
Generic name
Atropine Sulphate Inj. I.P.(0.6 mg/ml), Adrenaline Inj. I.P. (1 mg/ml), Aminophylline Inj. I.P. (25 mg/ml), Chloroquine Phosphate Inj. I.P. (40 mg/ml),
Opthalmic product
Gentamicin Eye Drops I.P. (0.3 % w/v), Norfloxacin Eye Drops I.P. (0.3 % w/v), Ciprofloxacin Eye Drops I.P. (0.3 % w/v).
SCOPE OF PHARMACEUTICAL TRAINING8
Pharmaceutical training give us deep knowledge about the formulation and quality of the products. It gives an idea about industrial orientation, it enhance the practical skill of the students, It gives an instrumental handling
CONCLUSION
Competitive intelligence CI can play important role in hypercompetitive, highly R&D oriented and knowledge sensitive pharmaceutical industry. By analyzing IP back ground important conclusion regarding R&D activity, research collaboration and financial resources of competitors can be drawn out. Sometimes certain companies do unethical practice and enter at back door of competitor’s premises to unveil confidential information, this is very serious concern but most of companies do not pursue that practice. Conclusively, using IP ethically as a tool of CI, pharmaceutical company can look global scenario of pharmaceutical word and can attend higher growth. Information and technology oriented word could develop higher technology for searching, collecting and analysis of patent databases and IP knowledge. Development of super computers which automatically search and analyze information is highly awaited and could make whole process easy and more accurate.pharmaceutical formulation and its research invasis play important role in the young generation of the pharmacy students because without seeing the process we don’t know about the formulation and development of any medicine because of that a industrial visit should be compulsory to all the pharmacy students.
Acknowledgement
The authors would like to acknowledge the assistance provided by Supervisor Dr. D.K SANGHI and Co- supervisor Rakesh Tiwle and kind cooperation by Secretary Shri Keshavrao Mankar Bhavabhuti Shikshan Sanstha “Shri Laxmanrao Mankar Institute of Pharmacy” Amagoan, Gondia Maharashtra, INDIA.
REFERENCE
1. Global pharma outlooks-2015, Express pharma-2011. expresspharmaonline.com
2. Global pharma and Biotech M&A report-2012, An IMAP industry reports-2012. imap.com.
3. 2012 profile: Pharmaceutical industry. PhRMA report-2012. phrma.com.
4. Andrew M. Lacy. Analyzing competition in pharmaceutical industry. Economic committee newsletters, 10 (1), 2008.
5. Competition and regulation issues in pharmaceutical industry. OECD-2000, oesd.org
6. Pharmaceutical competitive intelligence for the regulatory affairs professional. Terkko Navigator-2012. terkko.helsinki.fi.
7. Pallavi Mahajan. Advent of intellectual property rights in the pharmaceutical industry. Social science research network, 1820627, 2011
8. Gillian Chaloner-Larsson, Ph.D, GCL Bioconsult, Ottawa. A WHO guide to good manufacturing practice (GMP) requirements Part 2: Validation.
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REFERENCE ID: PHARMATUTOR-ART-2012
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