Healthcare & Life Sciences Professionals
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Activity:
40 views;
last activity : 07 06 2010 20:18:09 +0000
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Ensuring drug safety standards performed on a regular basis to avoid punitive measures.
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Improving safety standards with regular inspections by regulatory agencies.
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Structure and policy changes with resource problems
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Ensuring drug safety standards performed on a regular basis to avoid punitive measures.
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Keep abreast of all the new safety reporting requirements so that you can run an efficient compliant safety department and plan an effective surveillance system to monitor potential new signals and readjust risk/benefit for your products. |
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Drug safety guidelines are given by US FDA and it is proven to be standard all over world. Implementation of these guidelines are more important to ensure safety. In India, very few plants have US FDA approval. Also, using good quality (Grade) row material for manufacturing is the key to produce good quality drugs. Their must be check point during each process (quality control & assurance) and final product must be strictly approved by FDA of India before it comes to the market. There are many companies who produce spurious drugs and has very strong distribution network in India.
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Organisations should understand safety requirements and prepare for the increasing number of pharmacovigilance inspections conducted by regulatory agencies. Standard operation procedures (SOPs) should be written to cover the various aspects of drug safety and staffs should be advised on the requirements of safety reporting. A seamless approach should be provided to drug safety for products undergoing both clinical and post-marketing assessments. |
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It may require structural and policy changes within the drug regulatory authorities. Moreover, a lot of sensitization and setting up of new systems will consume resources such as good labs, patient's ability to pay for tests, infrastructure for proper causality assessment, identification of funding agency and certainty of funding, etc. |
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Good one suresh...... very informative.... :) |
We have used this kind of tactics earlier also by using messages, warnings and many things in tobacco and cigarette packets. He who is concerned about his health has left intoxicating but the addicted had no effect on them. So, we can be sure of one... |
I think it will take time for the rural market to accept the product. The product should appeal the customers the price should be affordable. It should be easily accessible by people from all the segments of the society they should be informed about... |