Medicines manufactured by Indian companies have received Highest Quality approvals from the likes of USFDA, EDQM and MHRA
The future of affordable Pharmaceutical lie in India.
The Indian pharmaceutical industry is estimated to have over 10,000 manufacturing units.
Exports have been the major growth enabler of the Indian pharmaceutical industry in recent years. India exports pharmaceutical products, APIs and intermediates to more than 200 countries across the world.
Europe accounts for the highest share of over 23% of Indian Pharma exports followed by North America and Asia.
An increase of over 5% of respective sales turnovers for R&D activities in the last 5 years alone has made Indian pharma industry as an evolving entity. Indian pharma companies are constantly working towards new drug discovery in the areas of infections and metabolic disorders.
Key strengths of Indian pharma companies lie in -
• Cost competitiveness
• Strong manufacturing base
• Excellent GMP (Good Manufacturing Practices)
• Network of laboratories and R&D infrastructure
• Highly trained pool of scientists
• And potential ground for clinical trials.
Indian companies develop cost-effective technologies in the shortest possible time for drug intermediates and bulk activities without compromising on quality. This is possible through the country's strengths in organic chemicals' synthesis and process engineering.
A number of Pharmaceutical MNCs are outsourcing their manufacturing to Indian companies due to low costs. Many Indian companies have made their plants cGMP compliant (Good Manufacturing Practices as directed and regulated by FDA and EU agencies). Apart from this, Indian pharma industry -
• has the largest number of USFDA-approved plants outside USA.
• and, tops in filing the drug master files (DMF) with the US FDA.
India has stringent laws and acts for Indian pharmaceutical industry to regulate the import, manufacture, distribution and sale of drugs. Some of them are:
• The Drugs and Cosmetics Act
• The Pharmacy Act and,
• Good Clinical Practice (GCP) Guidelines
A paradigm shift occurred in the Indian pharmaceutical industry with India becoming a signatory to the WTO order, ushering in the Product Patent Regime. It has boosted the confidence amongst western Pharma companies to have R&D collaborations with Indian Pharma companies in the field of NDDR.
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