While our ambition is to cater to the entire pharmaceutical industry, we aim to initially focus on empowering small and medium-sized companies, including manufacturers and merchant exporters, throughout India.

From our analysis, we categorize firms into two main groups: (1) Contract Manufacturing Organizations (CMOs) who must comply with regulatory standards to expand their market presence and ensure survival, and (2) Merchant Exporters.

In the case of CMOs, many rely on single ERPs offered by unverified sources to operate their businesses. They typically update their portfolio only during regulatory audits or when establishing operations, often with minimal compliance measures. Consequently, they lack compliance in various areas and face challenges in streamlining their operations. Our internal assessments reveal that these software solutions are outdated and tailored for specific functions, requiring significant effort to maintain proper documentation. 

Regarding Merchant Exporters, their primary focus tends to be on Track and Trace systems, which have either become or will soon become mandatory requirements.

Traceability:

Some notable Track and Trace solutions include TraceLink, rfxcel, and Track-and-Trace by Optel. However, it's worth noting that some of these solutions may not offer the full scope of work (L1 to L5) and might not be cost-efficient to many companies, especially to small and medium.

Document Management System:

Two additional solutions worth considering are AmpleLogic and MasterControl. However, when compared to our DMS Infinity, solutions like AmpleLogic and MasterControl may not offer the same level of efficiency and elaboration, particularly in handling legacy documents, which is a regulatory requirement for document retention.

Quality Management

The Indian market currently has few players, presenting a significant untapped opportunity. Tracewise is gaining popularity, yet there remains a gap. Our quality assurance solution, QMS Sparks, manages Change Controls, CAPA, and Investigations effectively. Addressing the longstanding challenge of Quality Controls, our solution LIMS Direct handles sample management and stability testing. Our main competitor, Calibre, faces criticism for poor implementation, particularly within Hyderabad firms, as noted by industry leader Biological E.

In terms of pricing, standalone implementations typically start at a minimum of 10L to 25L for 20 licenses. However, pricing structures can be convoluted due to various combinations, making it challenging to provide precise figures.

A more targeted approach could be to engage the respective Heads of Departments (HODs) for each category:

1. For Traceability & Artworks, reaching out to the Packaging Department would be ideal.
2. Document Management & QMS could be best addressed by liaising with Quality Assurance / Quality Control teams.
3. Equipment Maintenance & Calibration should involve collaboration with the Engineering Department.
4. Warehouse Management concerns could be addressed by engaging with the Supply Chain Management (SCM) department.
5. Training initiatives could be coordinated through the Human Resources (HR) department.

Starting with the implementation of one solution and gradually expanding to others based on its success is a common and effective strategy. It allows for a focused approach, demonstrating the value of the initial solution and building momentum for further adoption. This incremental approach not only helps in gaining purchase orders but also fosters trust and confidence among stakeholders as they witness tangible benefits from each implemented solution.

Our  typical sales cycle can vary depending on the software product or service being sold, and the specific sales process of a company. However, it generally involves the following stages:

1. Prospecting: We identify potential customers or leads who may have an interest in our product or service. Prospecting methods can include cold calling, email outreach, networking events, and social media prospecting.
2. Qualification: Our team gathers information about the lead's needs, budget, timeline, and decision-making authority.
3. Needs Assessment: We engage with the qualified leads to understand their specific needs, challenges, and goals. This involves asking probing questions to uncover pain points and determine how the product or service can provide value to the prospect.
4. Presentation or Demonstration: Once the needs are understood, we presents the product or service to the prospect, highlighting its features and benefits. This may involve giving a product demo, sharing case studies or testimonials, and addressing any concerns or objections the prospect may have.
5. Proposal: After the presentation, we submits a proposal that outlines the solution offered, pricing, terms, and any other relevant details. The proposal is tailored to address the specific needs and concerns discussed during the sales process.
6. Negotiation: This stage involves negotiating with the prospect to address any objections, negotiate pricing or terms, and finalize the details of the sale. Both parties may engage in back-and-forth discussions to reach a mutually acceptable agreement.
7. Closing: Once the terms are agreed upon, we closes the deal by obtaining the prospect's commitment to move forward with the purchase. This may involve signing a contract, processing payment, or scheduling the next steps in the implementation process.
8. Follow-up and Support: After the sale is closed, We provide support to the customer, ensuring a smooth transition to using the product or service. This may involve training, ongoing communication, and addressing any post-sale issues or concerns. Basically we hand-hold the customer until they get confortable using the s/w. For large orders, we place our technical person as supervisor on-site for 6 months sometimes.
9. Retention and Upselling: The final stage involves nurturing the customer relationship to encourage repeat business and upsell additional products or services.   

These stages may overlap or vary in length depending on the complexity of the sale and the specific circumstances of each prospect. Additionally, some sales cycles may be longer or more complex, especially with the customers from the North India/West India belt, particularly in industries with high-value or enterprise-level products or services. The users want s/w to ease their work but the management takes its own time to make the decision.

We've been advocating for the Software as a Service (SAAS) model where applicable, tailored to the customer's business configuration. It's noteworthy that while large and mid-level firms may embrace the SAAS model, they often prefer services to be set up within their premises due to concerns about regulatory agencies potentially accessing cloud-based systems. As far as we understand, only Regulatory submissions and Track and Trace (L4/L5) are exceptions to this preference. Our discussions are framed with the global market in mind.

On the other hand, smaller firms tend to favor procuring Commercial Off-The-Shelf (COTS) software or, in your terms, "upfront software." This distinction helps us cater to the diverse preferences and requirements of different segments within the industry.

We concentrate on three categories of equipment:

1. Line Master: This is tailored for a straightforward Track and Trace (TNT) setup. Each production line requires a Line Master unit, pre-installed with the TNT software, which communicates with the TNT server when applicable. For this setup, laptops used for aggregations and handheld barcode scanners are sourced from third-party firms like Data Logic and Dell/Lenovo. We provide specifications for these accessories, but the customer is responsible for sourcing them.
2. Multi Carton Liners: Designed for firms requiring packing speeds exceeding 250 cpi (cartons per minute). Typically, large firms with sizable batches opt for this equipment to meet tight delivery timelines. In this setup, there's no need for handheld scanners as the Multi Carton Liner comes equipped with TNT software and connects directly to the central TNT server.
3. 360 Bottle Liners: This equipment serves the same purpose as the Multi Carton Liner but is specifically designed for scanning bottles without human intervention. Currently, we've limited production of these machine learning-enabled devices and only fulfill orders upon customer request. We do not maintain inventory for these items.

The implementation time varies depending on the number of solutions being implemented at the plant. We typically complete software setups within a week, but we have no control over the time it takes for customers to source web servers. Additionally, some firms may take longer to complete equipment qualification. Our standard expectation is that each solution, including qualification, will take approximately 30-45 working days, with the exception of the 360 bottle liner.

True! There has been a long-standing need to find ways to "reduce the counterfeit in drugs to ensure patient safety."

Look, our loved ones, or we have consumed medical drugs in some form or other in our lifetime. Did we ever question before administering the medication? A few queries have evolved, like does this drug have any side effects? Or How long should the medication be taken etc., but how do we judge whether our sickness is reduced after using the medicine? We depend heavily on our doctors. Right!.

We should be lucky to be cured of the diseases if our local pharmacist delivers the originally manufactured batch of drugs. The results would be evil if any medical drugs were counterfeited or spurious. The best we can expect is the placebo effect of it just being some sugar pill, but consider the counterfeit drugs suppliers are adding some chemicals to make our immune system respond in a way that makes us feel like the drug is working.

So, how do we enforce Patient Safety? From quality control to manufacturing to packaging and delivery, that is where various regulatory agencies place multiple guidelines so that the drugs' supply chain is accountable. That accountability is referred to as "Drug Traceability." There are multiple approaches to achieving this traceability.

I wish to share some alarming facts about counterfeit and spurious drugs researched by leading research-funded agencies. But maybe in another session.

I want to cite HealthResearchFunding.org, which has compiled a list of alarming acts. I will share a few of them.

• An estimated 10%–30% of medicines sold in developing countries are counterfeit.

• The value of the counterfeit drug market annually: is $200 billion.

• A 10-day crackdown against counterfeit drugs coordinated by Interpol a few years back led to the confiscation of 8.4 million doses of counterfeit drugs.

• 237 people were arrested worldwide, and 10,603 websites selling counterfeit medicines were shut down.

• An estimated 80% of the counterfeit drugs that are consumed in the United States come from overseas.

• Internet sales of counterfeit drugs account for $75 billion of the total market.

• Most of the counterfeit drugs that are made have been manufactured in either India or China.

• The WHO also estimates that between 1% and 10% of drugs sold worldwide are counterfeits, but it may be as high as 50% in some countries.

For more statistics, I recommend you check out the updates at the HealthResearchFunding.org website.

TrackNTrace has become an enabler to ensure that all the drugs manufactured within the warehouse are shipped with barcodes following GS1 Standard to establish traceability.

As mentioned earlier, we need to track the movement of medical drugs to reduce Smuggling and illegal sale of drugs. How is this mission being accomplished? Let me explain this in straightforward procedural steps.

Every barcode that is tagged to the primary pack is defined by GTIN, which is the global tracking Identification Number that is unique to each manufacturer. By decoding the barcode, we can establish the manufacturing source and track the movement of the drugs from the warehouse to the consumer.

Firstly the format of decoding is the same as per the recommendation of various regulatory agencies. But each guideline spells out what needs to be part of the barcode differently.

At a very high level, a barcode label is affixed to all your packaged items, usually called Primary (the pack closest or carrying the medication), secondary and Intermediate secondary packs (IS1, IS2 …), and Tertiary/Pallet.

I will need to go more in-depth by speaking about the technical requirements, but it would be more appropriate for the audience to check out our webinars on track n trace awareness. It is being offered Free as Knowledge Services. Check out our PharmaMax Knowledge Center site for more information, and I implore you to share the links with your audience.

What do you think, they would be? From a simple common sense perspective, our medications are NOT counterfeited. In short, we want to know that there is no damage to our bodies. Isn't it? Hence everything should stem towards one single goal: "patient safety." To add more to this, the other motivations would be :

• To be able to Track the movement of medical drugs to reduce Smuggling and illegal sale of drugs

• Governmental and Regulatory agencies are exerting pressure to ensure medication product security.

• A perfect storm is driving the development of track-and-trace solutions within the pharmaceutical supply chain.

• Providers are becoming increasingly concerned about the quality of care and patient safety, including securely administering bar code-labeled medications correctly to patients.

• Suppliers seek economical and effective methods to support manufacturing operations, control inventory and manage recalls/returns.

But for the larger audience, let me break the question into three categories.

1. About the barcode construct
2. Differences/Gaps in the regulatory guidelines
3. Levels of Serializations in a Track N Trace System

Now, let me address the barcode information. Firstly, the barcode in encoding contains the following information 1) the manufacturer's name identified by GTIN - Global Trading Identification number, 2) the Batch or the Lot Number of manufacturing - (helps to establish the traceability within the manufacturing plant's units, 3) Expiry Date of the drug 4) the most important one is the UNIQUE serial number by decoding the individual information referred to as Application Identifiers (AI) of a barcode.

Now, let me address the guidelines surrounding the barcodes. Every country has a regulatory body to monitor the sale of medical drugs. They either conform to any existing guidelines of other regulatory agencies or have one on their own. It should be fine as long as traceability can be established. From US FDA, MHRA, DGFT India, ANVISA, TGA, NAFDAC, SFDA, etc., most follow an almost similar format, but the order of placement of the AI varies; in addition to holding additional application identifiers. So check out our knowledge center, which details the barcoding guidelines for each regulatory agency.

Coming to Levels 1 thru 5 references, let me simplify them for you. It has nothing to do with compliance but with the work activities, equipment/roles & responsibilities. MNCs provide Level 4 and 5 Support and charge hefty fees, which I would term Monstrous Costs for just cloud hosting. So don't get caught up with these MNCs who scare the hell out of you. One mustn't focus on the last mile but take the footprints from the beginning.

To begin, it is essential to understand that Each "level" is a stage of the serialization process, primarily focused on information management and exchange. If you lack any of the components at each level, you put your business at risk of costly and time-consuming mistakes in the field.

Level 5 – Network: A global network enables the management of all serialization and regulatory data with partners, customers, and regulatory authorities. A serialization solution vendor provides it with a worldwide supply chain network.

Level 4 – Enterprise (Enterprise Repository EPCIS): A global enterprise system enables management of all serialization and regulatory data, and business processes. Provided by a serialization solution (like PharmaMax Counterfeit Risk Management - CRM), an L4 is necessary to manage and verify the data that must accompany each serial number. When you begin serialization on the packaging line (L1-L3), you must simultaneously determine how you will use and integrate the strings with your enterprise architecture (L4).

The L4 and L5, as I mentioned earlier, can be handled and managed on a cloud or internal web server and saves you a lot of top dollars.

The remainder of the serialization levels, L3, L2, and L1, are usually supported by LMS Vendors.

Level 3 - Site-level serialization: Software that allocates serial numbers to lines, verifies the integrity of information submitted to the enterprise system, and performs changes to aggregation hierarchies and processing of shipments. Traditionally provided by individual line management system (LMS) vendors to work with their specific equipment, but LMS-agnostic site servers that can work with different line systems are beginning to emerge.

Level 2 - Packaging pick/pack: Line software that maps with your L1 to manage hardware and printing systems in conjunction with your packaging line. L2 software works devices that serialize and pack products and supports integration with site systems for warehouse operations—provided by LMS vendors.

Level 1 – LMS Devices: This includes hardware devices such as cameras, printers, and vision inspection equipment that perform printing, Vision Inspection, rejection, and materials handling on the line. It is provided by LMS vendors.

As stated earlier, the support you receive in person is from the LMS providers, and they should have an equal share in overall budgets allocated to Traceability. If you take initial solid steps, compliance could be effectively managed. So I recommend picking an ideal partner who can meet your in-person support and hand-holding requirements to get on board.

Barcoding at the secondary level of packaging can be done using either a 2D/Matrix barcode symbology (i.e., GS1 DataMatrix) or 1D/linear barcode symbology (i.e., GS1-128) barcode.

As per the DGFT notification, if the importing country regulator has mandated their specific requirements for barcoding, the exporter need not comply with the DGFT stipulations for identification and marking of various levels of packaging. However, this first needs to be confirmed with all the concerned authorities

Yes. As per the GS1 GTIN Allocation Rules, a change or modification to any essential elements that characterize a trade item will usually lead to a change. Product Name, Product Brand, and Product Description are essential predefined characteristics of a trade item.

For primary packaging, the GTIN, expiry date, batch number, and unique serial number may be printed in the human-readable form if desired, as marking products at the primary level is optional. 

The box containing the six shrink-wrapped bottles will be considered the secondary pack & the shipper carton will be treated as the tertiary/logistic pack. The packages should be identified accordingly with barcodes for each of the packaging levels.

The mandate applies to all drugs and pharmaceutical products. For details, refer to the public notice. 

Refer to section 4.14 of the DGFT Implementation Manual. "Human Readable Interpretation (HRI) Rules" of the GS1 General Specifications for specific recommendations and HRI form, format, and placement examples.

Ideally the GS1 Company Prefix registered to the Brand Owner of the product should be used. If the brand owner does not provide their company prefix, then either the actual Manufacturer or Exporter has to identify the drugs using a GS1 Company Prefix registered to them to comply with the requirements. 

Per GS1 definitions, all three packaging configurations would be considered secondary packages.

Each blister should be treated as the primary pack. One carton consisting of the 10X10 blisters (i.e., 10 blisters with 10 tablets in each blister) should be treated as the secondary pack.

Yes. Each serial number shall be unique, whether primary, secondary, or tertiary. In the case of the tertiary, this will be accomplished via the SSCC, as the tertiary is considered the Logistic Unit per the specifications.

Yes. The team will guide you and help you with the step-up activities. You must use your digital signature to sign and upload the IVEDA files