The pharmaceutical industry is comprised of companies engaged in researching, developing, manufacturing and distributing drugs for human or veterinary use. New drugs have an enormous positive influence on global health, prosperity and economic productivity by saving lives, increasing life spans, reducing suffering, preventing surgeries and shortening hospital stays.
Advances in medicine have eliminated deadly diseases and have brought other life-threatening conditions under control. Drug therapy is now an integral part of nearly every facet of healthcare, and new breakthroughs promise to revolutionize the treatment of non-communicable diseases.
Innovative (originator) chemically-derived drugs are developed through extensive R&D and clinical trials in both humans and animals. The innovator relies on patents, regulatory data protection and other forms of intellectual property rights (IPR) to justify the investment required to bring a product to market.
We recognize the potential of pharmaceuticals industry to drive the global economy and help in making a healthier population. With our experienced team, our focus is to deliver results with significant cost-efficiency and effectiveness.
The U.S. patent term is 20 years, and drugs are eligible for at least five years of market exclusivity depending on the time between patent validity and U.S. Food and Drug Administration (FDA) approval. The pharmaceutical industry is heavily dependent on the development of new molecules to replace the revenue stream of older drugs that are approaching the expiration of their patent terms. Pricing of new drugs is designed to cover past and future R&D expenditures.
Our team has the expertise to accurately analyze the existing situation of our clients and help them to mitigate and navigate through changing healthcare regulatory compliances, operational inefficiencies, and development & research hurdles.
The major areas where the pharmaceutical industry has its focus on include:
• Regulatory Compliance: Taking a risk-based approach to compliance planning, execution, and monitoring may help in a heightened regulatory environment. It may enable companies to focus on critical risk areas that need attention while reducing emphasis and effort on less critical ones.
• Research and Development: To promote the novel research and development in critical areas such as tuberculosis and malaria, there is a need for short/medium/long term policy to further incentivize the private sector for new drug development and bringing down the commercialization barrier in these areas.
• Intellectual Property Rights: The pharmaceutical companies need to be encouraged to undertake new drug discoveries, innovate new dosage forms, and new uses of existing drugs.
• Clinical Research & Trials: To address unethical practices in clinical research and encourage more clinical trials, the approval mechanisms for protocols need to be more transparent and time efficient.
• Pharma-SME Development: There is an urgent need for provision of sufficient low cost finance, strengthening access to national research laboratories, promoting pharmaceutical SME clusters, and continuous training and skill development programs in Trans nationalization.
• Cluster Development: Setting up of pharma specific clusters in SEZ formats may help the industry in addressing the regulatory requirements and resultant costs.
• Skill Development and Training: Skill development is required in various functional disciplines in the industry, such as analytical, manufacturing and quality management.
• Pricing of Formulations: A stable pricing policy or market based price control may continue to encourage the formulation industry to invest in R&D in NDDS and dosage forms. Industry is of the view that prices of patented products may be regulated on Purchasing Power Parity basis
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