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FDASmart Inc. is a global pharmaceutical, biotech, medical devices US FDA regulatory and CRAMs/CMOs outsourcing China/India partnerships/ consulting entity assisting US companies with outsourced services business or new markets and business development for India, China and Middle East markets.

All Best Business Practices with Indian pharma CRAMs/CMOs and our Legal Track online or onsite seminars in Edison, NJ or Mumbai, India will feature an actual Case Study involving a breach of contract in New Jersey courts by the Dishman Group which bound its Dishman USA subsidiary into the signed MOU/Contract.

For the first time, FDASmart will launch a series of online seminars & on-site networking events in Edison, NJ and Mumbai, India on US & Indian OUTSOURCING PARTNERSHIPS with Indian Pharmaceutical CRAMs and CMOs featuring best business practices (or lack thereof!), sourcing or manufacturing partnerships, acquiring APIs or DMFs, etc. Large American or European Pharma/Biotech companies and conglomerates usually have presence in India, but what if you are a small-to-medium sized American or European that plans to enter into an outsourcing, contractual arrangement with Indian CRAMs or CMOs?

The featured litigation Case Study is headed to trial in New Jersey after Dishman USA (wholly owned by Dishman Group parent DPCL Dishman Pharmaceutical & Chemical Ltd of India) appeal in New Jersey failed with its motion to dismiss for failure to state a claim, i.e. the Chairman & Managing Director of the Dishman Group and MD of DPCL parent who signed the MOU contract chose to bind ALL of its global subsidiaries in the performance of the contract. The Indian parent DPCL however was dismissed from the lawsuit due to lack of jurisdiction in New Jersey courts.

See December 29th, 2016 Appellate Court ruling and order (Approved for Publication) of the breach of contract now proceeding on merits against Dishman USA, the New Jersey resident subsidiary.

Litigation Case study will include New Jersey legal case facts, pleadings, motions, briefs and all other publicly available court records. Case Study will START with defeating Dishman USA’s motion to dismiss cases using NJ Rule 4:6-2(e),”failure to state a claim upon which relief might be granted”. Dishman USA’s answers to the Plaintiff complaint will be discussed and shown as a "weak stretch". NJ Appellate Court Ruling Dec 29th agreed with the Trial court the Chairman and MD of the entire group intended to bind its flagship parent and all subsidiaries worldwide hence ordered to proceed on merits against subsidiary.

Indian corporations are often owned and run by a so-called HUF-Hindu Undivided Family-i.e translated to English – corporation you are signing a contract with is OWNED, CONTROLLED and DOMINATED by the FOUNDING FAMILY and often the Majority shareholders of corporations in India ! In other words, they call the ‘shots’!

So if you’re thinking that the Indian CRAMs or CMO signed contracts performance is under the regulatory oversight of India’s Companies Act 2013 or NCLT (National Company Law Tribunal) or SEBI (Securities Exchange Board of India-US SEC equivalent), it might be time to look under the ‘hood’ with FDASmart’s upcoming Best Business Practices & Legal Track seminars. Ever heard of IST – Indian Stretchable Time? The same might just apply to your contracts without your company’s adequate business development oversight and legal contractual diligence.
Allow us to share some past FDASmart business endeavors and successes that include:

a Successful planning, delivery & management of an outsourced clinical data group assembled for the world's largest pharmaceutical company-Pfizer Inc. via the start-up presence established by FDASmart for this purpose in India during mid-1990s through its CEO- Ram Balani ( Pfizer Central Research, Groton, CT. USA-FDASmart as CRO to Pfizer Inc.)

FDASmart created, staffed then managed entire operations in India, monitored deliverables between FDASmart India and Pfizer Central Research Clinical Research, Groton, CT.

a Established a successful India-China market strategy in 2009 for Beijing based Reed Sinopharm Exhibits (RSE), China’s leading pharma conference organizer. Project culminated in increased market exposure for API industry in India and launch of SIPP- Sino-India Partnership Pavilion-SIPP original concept and SIPP program organized and hosted at API China in Xian and Chengdu trade show floors by FDASmart.

a FDASmart’s ALSO organizes, and hosts webinars, on-site networking events in the global pharmaceutical/biotech, CRAMs/CMOs and medical devices industry both in the US and India.

Ram Balani, FDASmart CEO, has in fact participated in past speaking presentations at CPhi (Lunch time series), delivered webinars on topics including US FDA GMP in Emerging Regions (India-China),(Frankfurt, Germany 2011), etc. To view more speaking engagements,
please see --

To access CPhi Show Daily Feature on FDASmart Inc. click here:

To access for FREE at no cost, the entire FDASmart Lunchtime series on “Pharmaceutical cGMP in Emerging Regions” (Perspectives from China and India) presentation by Ram Balani-CEO, FDASmart- click here:

    a FDASmart presented a Poster Presentation in Philadelphia at the HPAPI Summit on the nascent HPAPI markets in India/China including key player HPAPI outsourcing partner companies in Asia that will surely competitively challenge Western HPAPI manufacturing in time as India/China has accomplished in the past with Asia’s (India/China) API & pharmaceutical finished dosage & generic drugs lower labor costs, technology transfer from the West partnerships, etc.

    To Access the FDASmart HPAPI Summit Poster Presentation with focus on China/India,
    please click:

Some of the Best Business Practices & Legal Track series Topics for FDASmart online and on-site seminars include:
a Westerners outsourcing with Indian CRAMs /CMOs expecting Western best business practices standards and commercial deliverables on contracts (or not?)
a Western companies entering into Indian commercial contracts with India, i.e a contract with India is not always what it seems ! Beware. (** specially when dealing with an India-based HUF- Hindu Undivided Family ** that has majority shareholders corporate ownerships and management control to boot!) ( HUF=Hindu Undivided Family –India’s corporations are often majority owned by founding families to publicly trade in Indian stock exchanges and presumably in compliance with India’s government and corporate statutes BUT MAYBE NOT!)
a New Jersey legal jurisdiction on Indian/Chinese companies in the US—US companies can hail jurisdiction on India foreign companies with certain legal doctrines met. Alter-ego vs Agency Theory
a India’s common law legal system – India inherited the British common law legal system, so did the America-but THERE ARE DIFFERENCES, litigating in India is a whole different ball game
a Indian civil procedure code (CPC 1908)
a India’s Contract Act 1872 – a contract is a contract right ? It sometimes depends on which side of the ‘pond’ you’re on !
a India’s Companies Act 2013 (governs corporate oversight in India) – or it seems, Hindu Undivided Family majority shareholders of private even publicly traded companies subsumes all if not most the regulatory oversight in India, i.e. Indian interpretation of a contract vs US client may be FAR apart !
a New CBDT (CBDT is equivalent to US IRS) Place of Effective Management (POEM) policy for determining tax residence in India. There are  consequences for  US or European based companies that establishes a presence in India for tax residency determinations or for an Indian holding company with overseas located  US subsidiaries masquerading to be an independent wholly owned subsidiary company but in fact constitutes a piece of ONE SINGLE PARENT ENTITY in INDIA !
a Foreign companies with presence in India via a separate corporate entity or distribution /agency agreements—watch out – no less than Google Ireland got stung with its Google India Distribution arrangements --
a Group of companies doctrine, Europe’s ‘qualified defacto company group theory), etc.
a Legal seminar "Defamation in India"- uniquely Indian - can be both CIVIL & CRIMINAL OFFENSE ( punishable by up to TWO years in PRISON)

  All the legal tracks mentioned above will feature real lawsuit case facts & actual public court records of a  New York based US  company vs an Indian holding company/CRAMs/CMO  in Gujarat, India for  breach of contract. Lawsuit was filed against the parent holding company in India and its wholly owned subsidiary in New Jersey.
Our seminars and  on-site networking presentations will feature ACTUAL public court case records  when appropriate to illustrate New Jersey  legal statutes, Indian applicable laws,  disputes in the  interpretation of what constitutes a valid binding contract in the US vs India,  the challenges of obtaining  US foreign jurisdiction on an  Indian company with subsidiary in New Jersey, India’s HUF abuses(Hindu Undivided Family –India’s corporations are often majority owned by founding families though publicly trade in Indian stock exchanges and presumably in compliance with India’s government and corporate statutes)

On-site events in the US will be held at Edison, NJ while in India we will host ALL events in Mumbai. Webinars will be forthcoming and will feature India legal experts, outsourcing companies with actual experiences with India CRAMs, CMOs (good & bad!  Including take-away learning) etc.


GMP Services Consultant Emerging Services in India & China GCP Train by US FDA Reviewer
OTC - Generics & APIs Pharma Webinars & Conferences Mobile Healthcare Application Development
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