By admin on Wed, 02/16/2011 - 23:19

I understand that Government of India has announced that all pharmaceutical export shipments must have track & trace feature to avoid any spurious Indian pharmaceutical products in the market. Governemnt of India has recommended 2D bar coding. This is the great positive step by authorities and I feel that it would definitely help India's pharmaceytical image to be further enhanced. While with all good things associated, implementing total track & trace will have its own limitations and advantages. We would like to hear the following:

1. Will it really help?

2. How can this be done?

3. What are the real challenges?

4. Which vendors can offer the services?

5. Why should this be only for exports and why not for local market within India?

Thank you, Sandeep Goyal www.PackagingConnections.com

Comments

Good to know that this is going further as now there is a news that drug aithorities are also planning to implement it for domestic Indian business with additional feature of unique number with sms confirmation. See the attached article in Times of India
Sun, 02/20/2011 - 11:30

Here is the text of Public Notice PUBLIC NOTICE NO 21/ (RE-2011) / 2009-14, Dated: January 10, 2011 Sub: Procedure relating to tracing and tracking of export consignment of pharmaceuticals and drugs- regarding In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2009-14, as amended from time to time, the following shall be added and in supersession of Public Notice No. 173 dt . 13 th April ,2009 , henceforth the following procedure for strengthening the enforcement mechanism available under the Drugs and Cosmetics Act, 1940 will be followed. a. Primary Level packaging: Incorporation of 2D (GS 1 Data matrix) barcodes on medicines at strip/vial/bottle level encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Primary pack. b. Secondary Level packaging Incorporation of barcodes (1D or 2 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Secondary pack. c. Tertiary Level packaging Incorporation of barcodes (1 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Tertiary pack (shipper/carton) 1. The trace and track technology as per Serial Number 3 above, will come into effect from 1 st July, 2011. 2. Effect of this Public Notice: (a) Exporters of pharmaceutical products will be required to affix barcodes on their export products to facilitate tracing and tracking of their products. In order to enable exporters of pharmaceutical products for incorporation of this technology, adequate time is being given and that is why para 3 will be made applicable on 1 st July 2011. (b) Exporters would also be required to submit certificate of analysis as per Para 2. (This is not a new stipulation, it was included in Public Notice of 13 th April, 2009) F.No . 01/91/180/648/AM09/Export Cell ( Anup K.Pujari ) Director General of Foreign Trade  
Sun, 02/20/2011 - 11:35

Hi, This issue is not confined to so-called emerging markets which in reality are now powering ahead of the mature markets.There are constant concerns in Eu countries regarding counterfeit products and despite much legislation and inspection, it is still prevalent ,albeit to a lower extent in recent times. The Eu is probably even more regulated than the US or Japanese markets but irrespective, non-approved drugs and cosmetics with significant impurities still come into the market. The Chinese economy has grown beyond recognition in recent times but their new found entrepreneurial culture does not appear to recognise IP.Patents or Copyright and it seems that established licensed products are considered "fair game" to be ripped off by illicit traders. No amount of technological improvement to eg the packaging will prevent this as they are perfectly capable of replicating even the most sophisticated packs and coding, thus circumventing even more patents. No doubt our UK and Eu Trading Standards officers will continue to work hard to overcome this but it is frustrating that the cultural ethics have not developed at the same speed as the desire for growth. Equally, the virtually unrestricted e-commerce market holds some responsibility as it is known to be virtually impossible to police effectively. In the UK, there are many medical practitioners who have relatives in the pharmaceutical distribution sector and several scams have been discovered involving repackaged out of date or substitute drugs. Manufacturers and licensing bodies need to work even more closely to prevent this but no doubt costs are prohibitive and the timescales for validation allow plenty of time for copies to be made and for them to infiltrate the market.
Mon, 02/21/2011 - 10:43

Hi My name is Nelson i am in pharma industry for nearly 18 years  just affixing BArcode or hologram will not stop Duplication of  the products and it require lot of awareness  Becoz In india our counterfeiters are so expert that they can easily adopt the system to make the product exactly lookalike. What we need is strong  and Immediate Penalty for such counterfeiters thats all Becoz they are plaing with life of People.
Mon, 02/21/2011 - 21:41
Nelson Lopes (not verified)

It could be labour pain to the industry, but we need to take this as an opportunity, All packaging professionals will get prospect  to come in limelight due to the notification issued by govt. of india.     Thank you Sandeep,
Mon, 02/21/2011 - 21:45
TEJESH BIRJE (not verified)

Sir, Spurious medicines must be controlled.  At the same time when the original manufacturer gets the same manufactured from other industries with quality compromise while asking them to put his brand name and enjoying heavy profits Then the spurious manufacturer thinks any thing wrong done by original manufacturer is right but if done by some one else is wrong.  Drug controller have to have a continous quality control process in this regard. Thanks M M Gupta
Tue, 02/22/2011 - 03:00
Madan Mohan Gupta (not verified)

This is main issue all over the world, at present this issue is growing worlwide becuase transfer of technology and export import of all kind of materials and drugs due to globalization. The bar code and 2 d Bar code is not gone fix this issue, US is already using this technolgy but still they face this challenge. The drug counterfeit issue is from production to shipment to consumers. production to shipment can be check by bar code and 2D code technology. How about at retail level. What incentive he has for selling good stuff vs bad stuff. How to identify at consumer level if I am getting correct product or not.  Even the bottle as correct product inside or not . Track and trace is great concept but many thing are missing to make complete circle, becuase the main objective is to stop conterfeit drug to makrket but same time to protect consumer who know what he is buying. Thanks
Tue, 02/22/2011 - 09:03
Dr Raj (not verified)

HI, I am Dinesh Vaghasiya , looking after packgin development activity , It is really good idea to implement track and track  but at present it is very difficult to print  2D matrix on blister/Strip with serial number because of supplier of printer is not ready with solution .Lots of cost will also involve to implement this solution .It is better to print 2D matrix on saleable  box only.
Wed, 02/23/2011 - 04:40
Dinesh Vaghasiya (not verified)

  SSIs seek PM's intervention to scrap DCGI's plan to implement bar coding for drugs Ramesh Shankar, Mumbai Wednesday, February 23, 2011, 08:00 Hrs  [IST]   The small scale pharma units in the country have sought Prime Minister Dr Manmohan Singh's intervention to scrap Drugs Controller General of India's (DCGI) proposal to make bar coding mandatory for all medicines which is being implemented to check spurious (fake) drugs in the country. “It is obvious that use of bar codes is not going to benefit the common man as the DCGI proposal will only help increase the prices of medicines”, they argue. Terming the DCGI proposal a ‘fake solution to a fake problem,’ the small scale industry said that the bar codes are used by manufacturers to prevent counterfeits and they have no role in ensuring quality of the products. Even a poor quality or fake item can have a bar code, they said. The small scale industry argues that an owner of a brand name must register it with the Trade Mark authority to prevent use by others. But 90 per cent trade names of medicines in India are not registered. Even large manufacturers have not registered many of their top selling brands. Hence the use of bar codes will serve no purpose unless it is made mandatory to register all trade names. But, DCGI is neither concerned nor empowered to insist on the registration of brand names. It is also the government’s policy to proactively encourage the use of cheaper drugs under generic names where brand names are not used and therefore bar codes have no utility. Opposing the DCGI proposal tooth and nail, secretary general of SME Pharma Industries Confederation (SPIC) Jagdeep Singh said, “the bar code technology is not fool proof. It is possible for counterfeits to copy, create and use bar codes. If ATM cards can be duplicated, so can bar codes. Spurious drugs can also have bar codes.” Expressing the unviability of the bar coding system, the small units say that strips of many drugs are so small (such as Zentel 30mm x 30mm) that even legally mandatory information on ingredients, schedule with warning, batch number, price, name and address of manufacturer can not be accommodated. It is impossible to include a bar code in the available space even if it were to serve any useful purpose. Moreover strips are cut into pieces and sold. The bar code can not appear on such cut strips. There is no way bar code can be provided on a tiny ampoule of tetanus toxoid (15mm x 15mm). A bar code on the carton or container is meaningless because its contents can be replaced and in any case consumers do not have access to it. Besides, customers, on their own, can not use bar codes to identify genuine from counterfeits. Moreover, the problem in India is certainly not of counterfeit medicines. According to a survey done by the DCGI in 2009, around 24,136 samples were lifted and only 11 were found to be counterfeits. Hence, such an action on counterfeits has no justification, the small scale industry feels.  
Wed, 02/23/2011 - 23:06

New Pharma Directive (safety features) on Counterfeit Medicine adopted by EU Parliament This week the amendments on the Directive EC 2001/83/EC to combat counterfeit medicines (The Pharma Package) have been discussed in the European Parliament. The EU Parliament adopted the amendments with an overwheling majority of votes. The link is http://www.gmp-compliance.org/eca_news_2439_6748,6737,6762,6892.html  Key points are: The proposed amendments, which will have to be transferred into national law within two years include introduction of safety features (serial numbers and/or tamper-evident seals) more stringent rules for importation of APIs better controls of the supply chain (traders and wholesalers) Rules for the internet sale of medicines Harmonisation of GMP inspections
Wed, 02/23/2011 - 23:17

A good step indeed. In general top marketing folks have contra stand of not being pro-active about overt public-verifiable anti-counterfeit measures. General opinion is that implementing overt anti-counterfeit might be good in larger public interest but it might counter-productive for their products as medical practitioner will shift to other brands. So let there be some percentage of counterfeited drug in market as long as their sales are not impacted. Need of hour is to realize that being in denial mode will not help and just more than hidden covert feature which anyway becomes useless after certain period, implementing oveert, evident and  public-verifiable method is the way to go. This circular endorses the same view point and let us hope that pharma companies will take this in right spirit and express their honest intention to fight counterfeited version of their own drug.
Wed, 02/23/2011 - 23:54
shirish goyal (not verified)

Why do we need this? I was going through Boschpackaging website and got to see the following: Why is this Security Measure Needed? 1.       Increasing number of counterfeit pharmaceutical products on the market 2.       Counterfeit products present a threat to patients worldwide and can harm brand reputations 3.       Track and Trace enables counterfeit products to be easily identified: 4.       • Helps you to protect your brand 5.       • Helps you to protect your consumers Various governments demand the mandatory introduction of security systems More details at www.boschpackaging.com
Thu, 02/24/2011 - 21:44

I am realy happy to hear this good fact and hope from an experienced  WHO certified company and your comment  realy gave me hope and courge to do all my best in my study.  thanks you    
Tue, 05/27/2014 - 01:05