How to Effectively Source OTC, Generic Formulations and APIs from Indian Pharmaceutical Manufacturers | June 13, 2013, 10:30-12:00 PM EST | Balani
April 22nd, 2013 // 7:57 pm @ jmpickett
In this upcoming webinar on May 14, Ram Balani, CEO-Founder at FDASmart.com will get under the hood and help you understand Indian pharma to your sourcing advantage with the following:
- Make you understand where India fits in today’s global pharmaceutical scenario
- Bring you up to speed with India’s pharmaceutical history and evolution, the regulatory mandates at each step of this evolution and Indian companies took advantage
- Explain how the Indian government lack of support for product patents propelled India to mastering reverse engineering chemistry and process perfecting their skills so drugs can be produced at a fraction of the innovators who developed the drugs in the first place
- Provide you with a sourcing road-map that includes different strategies depending on whether you are sourcing from a big enterprise or SMEs (Small Medium Enterprises. India has 20,000 pharmaceutical manufacturers of various types and geographical regions and sizes. Indian pharma is indeed a very fragmented channel to navigate until you learn of the 5- major states where 70% of Indian drugs are produced
- Provide you with sourcing sites, tips and tricks to source from India successfully including dealing with the famous Indian practice of haggling (Indian style negotiations deftly crafted to your disadvantage if not understood), supplier quality agreements and GMP regulatory compliance
- Provide you with a comprehensive list of Indian pharma regulatory agencies, industry associations and how to tap them to your buying or sourcing advantage
- Cover the Indian culture and religion and how those affect your doing business with India. How many for instance have heard of the Indian head wobble and what that means when face to face in a business meeting with Indian suppliers?
Overview
India is today’s “800-lb gorilla†in the pharmaceutical global market for generic drugs and will continue to dominate the US supply of generics in American medicine cabinets for years to come.
How did it get there? If your company plans to get into the pharmaceutical generics market or will soon source or have been sourcing OTC, generics or APIs from India—you need to Know how India got here!
80% of prescription drugs taken in the US are now generics and India supplies 25% of that total amount , it must be doing something right. India has the most number of US FDA approved manufacturing plants outside the US.
However, challenges remain when sourcing Over the Counter or Generic drugs or APIs (Active Pharmaceutical Ingredients) from India.
But not all is good with then Indian pharmaceutical business. Challenges remain that affect even the venerable Ranbaxy, India’s largest pharmaceutical company. Ranbaxy was recently slapped by the US FDA with a consent decree and import ban causing the company a huge missed opportunity to jump-start the Lipitor generic opportunity after Pfizer’s patent expired in November 2011. Reasons for Indian pharma deals imploding include but are not limited to GMP mis-steps or melt-downs, lack of senior management commitment and due diligence, sheer ignorance or worst resistance to best manufacturing practices to cut costs leading up to what India calls “spurious drugsâ€, in some cases counterfeits.
To source from India, one needs to understand India, its pharmaceutical roots and evolution since 1947, the Patent Act of 2005 (TRIPS) and how India mobilized and shaped itself every step of the way. Armed with this understanding, you will have a better chance of avoiding costly mistakes, source from qualified and dependable suppliers, create long-lasting mutually beneficial partnerships with Indian drug or API manufacturers.
India is a land of contrast with what is a complex and mostly unknown culture, religion and business practices in the West. Though English is spoken widely, India remains a mystery for most Westerners who travel and do business in India from lack of understanding and ability to get into the Indian mindset.
About the Speaker
Ram Balani- Acting CEO- FDASmart Inc.
Ram’s professional and entrepreneurial experience spans bio-medical research, IT (information technology) and software consulting & development in the pharmaceutical industry. He created and managed a wholly-owned clinical data management group for Pfizer Central Research in India. FDASmart is based in New York with offices in India and soon China. FDASmart provides pharmaceutical regulatory compliance, GMP audits & pharma manufacturing consulting with supply chain strategies /intelligence to assist Western companies with business development in emerging regions.
Ram speaks at global pharmaceutical conferences and conceptualized a wearable, wireless, totally freely-roaming mobile tele-presence technology now in use at Pfizer and Bristol Myers Squibb to assist with China API sourcing and with process technology transfer for biologics manufacturing of Orencia, BMS new rheumatoid arthritis drug. SmartInspect enables an “almost being there†remote collaboration conferencing system to assist pharma companies manage the complex pharmaceutical global supply chain.He also hosts the one-day pharma conferences FDASmart organizes in India.
The company actively assists global pharmaceutical companies with generics drugs sourcing , outsourcing contract manufacturing or pharmaceutical drug development in India. www.fdasmart.com/emerging.pdf
