Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Authentication Solutions to stop the Scourge of Spurious Medicines

284 views

Published on

Authentication Solutions are a must to curb spurious medicines
There are a variety of solutions available, as per requirement, through member companies of ASPA. The Government of India has already taken steps to protect medicines that are exported. Now it is time to protect medicines that are being distributed and consumed within India.

Published in: Health & Medicine
  • Be the first to comment

Authentication Solutions to stop the Scourge of Spurious Medicines

  1. 1. ©2015 www.aspaglobal.com Authentication Solutions to stop the Scourge of Spurious Medicines ASPA Press Event Lucknow 24th May, 2016
  2. 2. ©2015 www.aspaglobal.com Spurious drugs. –For the purposes of this chapter, a drug shall be deemed to be spurious, – (a) If it is manufactured under a name which belongs to another drug; or (b) If it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or (c) If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or (d) If it has been substituted wholly or in part by another drug or substance; or (e) If it purports to be the product of a manufacturer of whom it is not truly a product. Spurious Medicines: Definition Drugs and Cosmetics Act, 1940
  3. 3. ©2015 www.aspaglobal.com Scale of the Problem in India 2012 7% of anti-malarials are fake 2014 10.9% of antibiotics and TB medicines failed basic quality tests 2016 1 in 7 painkillers (diclofenac sodium) tested found to be substandard
  4. 4. ©2015 www.aspaglobal.com How Authentication Solutions can Help Image courtesy: PharmaSecure
  5. 5. ©2015 www.aspaglobal.com Benefits • Empower patients and increase consumer confidence • Give police and drug inspectors a valuable tool to find counterfeiters • Increase collection of tax • Enhance reputation of country’s industry • Be in line with international standards • USA, European Union, Turkey, China, South Korea, etc., all have authentication solution mandates (“track-and-trace”)
  6. 6. ©2015 www.aspaglobal.com Security Technologies Authentication Logical Cryptographic Structure analysis Physical Printed Inks/Taggants OVD / Hologram Serialization Identification Track & Trace Types of Authentication Solutions  *Use at-least one level of overt authentication  *Focus on ethical vendor who provide multi layered security solution instead just one technology  *To select technology take help of published standards such as ISO 12931 and NASPO
  7. 7. ©2015 www.aspaglobal.com Case Study: Serialization Image courtesy: PharmaSecure
  8. 8. ©2015 www.aspaglobal.com By applying an identity to each unit of the product, the following benefits can be attained: • Anti-counterfeiting /product authentication • Loyalty management • Bundling services with products • Warranty registration • Fulfill regulatory serialization mandates • and many more… Label on bottle Code on Rubber (Tyre) Code printing on medicine blister Regulatory labelling Label on FMCG product What is Serialization?
  9. 9. ©2015 www.aspaglobal.com Brand Protection solution to meet the anti-counterfeiting needs • The solution starts from Coding/Serializing a product right at the manufacturing line to verification of this coded product by the consumer at the time of purchase of medicine. • The above solution also provides a means of communication with the consumers at a later point of time. It’s time for your next injection of _________.
  10. 10. ©2015 www.aspaglobal.com How to Serialize Labels that are pre-printed, branded, with/without added security features (e.g. scratch peel off) which can be applied on the monocartons with available automated industrial grade label applicator systems. Labels will be supplied to brand owners according to his need to be affixed on your consumer packs at your manufacturing / warehousing facility. Depending upon order size, it can be applied manually or with use of industrial grade on-line label application systems.
  11. 11. ©2015 www.aspaglobal.com Direct Printing: Software can provide encrypted code files directly on printing line which can be decrypted and shared with any printer capable of doing variable printing. The selection of printer is dependent on the parameters like substrate, line speeds, space on the line, any other preferences. How to Serialize
  12. 12. ©2015 www.aspaglobal.com Regulatory Requirements (DGFT – India) • A Parent-Child relationship between the Secondary and Tertiary levels be maintained • Tracking movement of the packages through the supply chain • The data out of the parent-child relationship shall be uploaded on the central portal of the Government of India by the manufacturer or its designated agency before release of the drugs for sale or distribution
  13. 13. ©2015 www.aspaglobal.com Summary • Authentication Solutions are a must to curb spurious medicines • There are a variety of solutions available, as per requirement, through member companies of ASPA • The Government of India has already taken steps to protect medicines that are exported • Now it is time to protect medicines that are being distributed and consumed within Uttar Pradesh, and within all of India
  14. 14. ©2015 www.aspaglobal.com Thank You For more information visit www.aspaglobal.com Or email at info@aspaglobal.com . Courtesy

×