Professional Documents
Culture Documents
CAGR of 9% to 10 % annually
The domestic Indian pharmaceutical market is likely to reach US$ 20 billion by 2015
About 67 Million Indians are expected to reach the age of 67 years by 2011
People of this age group spends around 3 to 4 times more on drugs than people in younger age groups
Forms of drugs
Clinical trials
Introduction of new drugs Import licenses for new drugs
New Drug Approval application must be submitted to Drugs Controller General of India (DCGI), along with the documents
Drug's regulatory status in other countries Restrictions of use in approved countries Free sale certificate from the country of origin Sample of the marketing information, including draft labels and cartons
Sample of the pure drug substance along with testing protocol for analysis at the Central Drugs Laboratory (CDL) in Calcutta
R&D Department
Manufacturin g unit
Testing Department
Chemist
Regulators
Pharma Company
Patients
Distributors
Medical Representative
Doctors
Value chain
Manufacturing of medicine
Distribution
Testing of Chemical
Could not be designed Complex structure Out of scope Technology not available Human expertise not available Time constrains
Testing of Chemical
Require further testing Chemical fails Test are not showing proper results
Manufacturing Stage
Packaging
DCI
Distribution
Counterfeiting Substitution Delay in reaching Expired material delivered Copying the formula
Has more than 250 companies Located in 57 countries around the world
PHARMACEUTICALS
Counterfeit
products
are
products
that
are
counterfeiting
All kinds of medicines have been counterfeited, from medicines for the treatment of lifethreatening conditions to inexpensive generic versions of painkillers
Counterfeit medicines may include products with the correct ingredients without or with the wrong with
ingredients,
active
ingredients,
Counterfeit medicine
Country/Year
Report
Anti-diabetic traditional China, 2009 medicine (used to lower blood sugar) Metakelfin (antimalarial)
Contained six times the normal dose of glibenclamide (two people died, nine people hospitalized) United Republic of Tanzania, Discovered in 40 pharmacies: 2009 lacked sufficient active ingredient Smuggled into Thailand from an unknown source in an unknown country of America, Contained no active ingredient and sold via Internet sites operated outside the USA Detected in the legal supply chain: lacked sufficient active ingredient
Viagra & Cialis (for erectile Thailand, 2008 dysfunction) Xenical (for fighting obesity) United 2007 States
Zyprexa (for treating bipolar United Kingdom, 2007 disorder and schizophrenia)
Genuine producers find themselves in direct competition with counterfeiters suffer a direct loss in sales
Creates a loss of goodwill as ultimately the consumers blame the genuine producers for faulty products
Involves expenditure in protecting and enforcing intellectual property rights - costly investigations and litigation when combating counterfeiters
Governments lose out on unpaid tax and incur large costs in enforcing intellectual property rights
Counterfeit medicines pose a public health risk because their content can be dangerous or they can lack active ingredients
The more complex the path through the supply chain, the easier it is for a counterfeit product to enter the system
Medicine would not reach the consumers timely Problem of substitution Revenues will be affected No proper flow of information
To investigate, quantify the scope of the problem and determine the causes for these problem
To expand the investigation to regions around the world (Europe, Asia Pacific, Latin America, etc.)
Executives in the companys financial, legal, risk and quality operations were also involved
1.
Business Culture
2.
3.
Each of its regional and operating companies was tackling with counterfeiting and gray market issues with different strategies
They were developing their own anti-counterfeiting and anti-grey market solutions
A black market is the trade of goods and services that are illegal in themselves and distributed through illegal
channels, such as the selling of stolen goods, certain drugs or unregistered handguns.
Investigation to confirm suspicion towards gray market Estimate the revenue loss to arbitrage
In 2003, a returned product was sent for quality assurance process to determine that it was fake
The company appointed E&Y to validate its findings, quantify the scope of its problems, and determine the companys vulnerable points
MD&D asked E&Y to expand the investigation to regions around the world
E&Y with the companys executives help found out the nature, scope and size of gray market
The counterfeiting incidents, the industry and business practices that lead to gray market were all analyzed
1.
2.
3.
Market enforcement
monitoring
and
Protection of intellectual property Accountability issues Protection of products Supply chain standards Incident reporting and
Enforcement protocols
Roles and responsibilities were defined for product protection, supply chain management and incident reporting and enforcement
Buy from authorized distributors and limit buying from brokers or independent distributors
parts
Non-clonable ID nanotag has been proposed which can be affixed on the strip of medicine.
Date of manufacture and expiration date, which must not exceed 60 months.