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Pharmaceutical Supply And Distribution Chain
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The pharmaceutical industry in India is growing at a high rate of 13% from the last six years. From the last 3 decades it has been observed that the pharmaceutical segment have been increasing rapidly not only in India but also internationally. In spite of such a change Indian markets really need to focus on modernizing the pharmaceutical supply chain. Currently India’s distribution has posed greater risks for biotech products, which require very careful control throughout its transit period. The lack of knowledge towards this importance of such requirements makes pharmaceutical suppliers get more vulnerable to mishap during distribution. However, the infrastructure for cold chain in yet to be developed in India.
The Indian government has sent out a strong message to drug companies and trade channels to ensure that supply of essential drugs is undisturbed, after reports of shortage of drugs came to light. The National Pharmaceutical Pricing Authority (NPPA) has warned that the Essential Commodities Act may be invoked against those who disrupt the supply and distribution of essential medicines.
India is a diverse country with extreme climates that make distribution a crucial function. The long channel of distribution and high occurrence of brand substitution makes it mandatory for a company to make all its stock keeping units (SKUs) available at all levels at all times. In India, most of the brands have many substitutes and find all other sources to increase their profit margins. To reduce risks of substitution, manufacturing companies must make sure their products are made available to the stockists and retail shops. The American pharmaceutical industry get a fair share of generics which are outsourced from India, it is important how top Indian pharmaceutical companies conduct their programs on track. The pharmaceutical suppliers in usa and the Director General of Foreign Trade has notified every exporter to comply with the bar coding system by July 2014. The American suppliers are go through a very crucial phase of supply chain especially when they receive exports from the other countries. Due to the manipulation in the drug industry they make sure that there are no middlemen or agents who are involved in the transaction.
The reduction in the revenue has impacted the company's Botulism Antitoxin (BAT), along with decreased commercial contract manufacturing pharma revenue. The expectations between a sponsor company and contract service provider define not only the nature of the outsourced relationship but also dictate the quality of the material being supplied or service provided. Quality agreements between contract manufacturers and their pharmaceutical customers are a well-established practice. Recent draft guidance by FDA brings quality agreements into greater focus by applying the science- and risk-based approach inherent in quality risk-management principles and practices. Industry groups and pharmaceutical companies have offered their input of the draft guidance.
One major concern is raised by several companies and industry group is that the draft guidance did not adequately address developmental operations. The Biotechnology Industry Organization (BIO) offered the following comment: “The Draft Guidance applies to commercial manufacturing of product. However, BIO notes that quality agreements are equally important during the development phase. They are a useful tool to provide both thoughtful consideration of reasonable quality expectations based on the item being procured and to provide standards during development and manufacturing.
For the past 3 years I have been writing informative and high quality articles on pharmaceuticals. In the above article have covered topics such as pharmaceutical suppliers, pharmaceutical suppliers in usa, and contract manufacturing pharma.
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