DRUG MANUFACTURING: BLOCKCHAIN IN PHARMACEUTICAL INDUSTRY

By shubham singh

Written solely by the student, Shubham Singh, who is responsible for all the glory and the pitfalls of the write up. This was part of citizen science effort under the leadership of Sukant Khurana

Since 2000, in excess of 500 new medicines have been affirmed by the FDA, helping patients’ live more and peacefully. Prescriptions are changing numerous tumors into treatable conditions, diminishing the effect of cardiovascular sickness, offering new choices for patients with difficult to-treat illnesses like Alzheimer’s and Parkinson’s, and battling even the rarest of conditions.

As indicated by an investigation at Forbes, organizations can hope to burn through $350 million in their voyage of attempting to put up a solitary medication for sale to the public. One site reports that exclusive 5 out of 5,000 medications make it to human testing after preclinical testing, and around 1 of every 5,000 new medications makes it to the market.

As you can see from above that the rate of production of new medicine is quite low and cost to manufacturing is quite high.

To help you better understand the problem first we need to understand the steps required for any drug manufacturing.

Brief description of drug manufacturing process

To begin with the medicine is produced by Research and development of a Pharma organization. The Pharma organization at that point send the medication to clinical trials on mice or diverse creature for time of approx. 3 to 4 years this step is called Phase 1 After that the information is recorded and send to lab where we move to Phase 2 where it is tried on little gathering of sound human volunteers for a given timeframe .In the event that if the medication is esteemed safe and is adequate it will move to phase 3 where it will be tried on patients who have a particular condition. The above treatment is given to a huge no. of individuals to check adequacy, quantity and side effects. After the success of all the trials we then move on to the next step. At some point the report is submitted for survey to U.S FDA

Image EUPATI.

According to the report and FDA criteria if the medication is safe and effective then its gets FDA promoting endorsement in the market it additionally works for an administered period for 13 months after which it has been affirmed totally.

From the different manufacturing steps you can see that it is quite lengthy and complex process which cost lots of time and money.

Next assumption is to consider are there any faults in the current method or drawbacks. Some of them are listed below:-

•Not assessing and tending to FDA remarks deliberately after report analysis.

•Providing the absolute minimum measure of data to the FDA

•Waiting too long to get ready for the FDA’s office examination

•Inadequate communication between FDA and the Pharma organization

•Counterfeiting and defilement

These are the major drawbacks that we suffer in the whole process. Are there any solutions to these problems?

Yes there is and we have heard about it in the past few years continuously and it is called block chain and the next section will give us overview of what is it and how will we would use it in solving these problem’s

Image — mckinsey.de/2011–01–19/building-supply-chain-future

OVERVIEW OF BLOCK CHAIN

Bit coin everyone would have heard about it .How much is the exchange rate of a single bit coin is? But for this section it is not necessary we only need to know about the technology on which its transaction works on.

Block chain from the sound of it is like a chain of blocks but it is more than that. I think this definition will help you get a better understanding of block chain

The Block chain, a decentralized, distributed ledger is collectively managed by a bunch of stakeholders. Every entry in the ledger is secured cryptographically, and it is made immutable using cryptographic hashes by linking it to the previous entry. A block chain node is run by each major stakeholder, which mirrors the transactions that happen in the network instantly, keeping the ledger in sync. Unlike centrally located traditional databases, block chain makes it easy to share records across computer networks, as well as removing the single point of failure traditional databases come with as it is distributed over the networks.

From the above definition you can see it is more than just blocks. It is a whole new network that is secure and opens to every member who is included in it.

But still the question arises how it will help us in solving our problem

Solution to the problem

While there are various natural applications for block chain out in the open human services, shouldn’t something be said about the pharmaceutical area?

Yes it can be done .The Block chain may provide solution to this area.

Steps on how it will help in pharmaceutical manufacturing process.

Providing a decentralized network between Manufacturer, FDA, Market and consumer as compared to single supply chain. Usually as we know these supply chains constantly spoke to a straight, one-path process: from the medication maker to the customer. As advancements are incorporating the patient more into the whole pharmaceutical industry — not as an end-client, but rather as a dynamic shaper of results, supply chains change into two-way lanes. The digital ledger provided by the block chain is the reason for 2 way communication. Block chain innovation could secure this procedure via mechanizing correspondence between all the parties involved.

As you can see it provides an open and secure communication between all parties involved not only this but it also improves the clinical trials stage.

The block chain increases the value of clinical trials. The way that, while acquiring advertising endorsement for creative items, an immense piece of all clinical trial information embraced by Pharma players has not been accounted for has turned into a hotly debated issue . Obviously, the purpose for this it is to intentionally making a hole in data by filtering out all the more engaging trial information. This in the end may cause loss of trust and additionally express that the most good trial information was displayed to specialists for item advancement as well. Presently if the block chain bolsters the clinical trials, all conventions, comes about and other related data will be unchanging and time-stamped, bringing about less blunders and information snooping. The FDA will not only save time in reporting but also provide better feedback and also get correct tamper free information.

The last but not the least problem of counterfeiting can also be solved. From the report you can see how much of a problem it has become.

According to the report:-

Tracking the full extent of the counterfeit drugs trade is difficult, the World Health Organization pegged global fake drug sales at $75bn in 2010, a 90% increase over five years. In many developing countries in Asia, Africa and South America, counterfeit drugs comprise between 10% and 30% of the total medicines on sale.

-Who report (2010?)

The block chain is extremely helpful in building a sealed Pharma Store network Administration, with unique inbuilt security highlights to stop the course of substandard medications and forging. Indeed, even at the level of individual Stock Keeping Unit (SKU), the block chain will guarantee the following of the inventory network for particular wellsprings of any item.

Block chain solves almost all the problem of manufacturing including communication gap, information transfer and counterfeiting in Pharma and also saves time and money.

CONCLUSION

Medicine manufacturing in Pharmaceuticals might look like a normal procedure .However it requires time and productivity. Even big Pharma players are always looking for methods to cut cost and provide stability.

With the help of block chain we not only provide better communication and security to the pharmaceutical company. But we also provide customer satisfaction and their trust to be restored in pharmaceutical company.

References

1. https://www.cognitiveclouds.com/insights/blockchain-tech-for-indian-pharmaceutical-industry-2/

2. http://medicalfuturist.com/robotics-blockchain-redesign-pharma-supply-chain/

3. https://www.pharmpro.com/article/2015/11/steps-challenges-getting-drug-market

4. https://ispe.org/initiatives/drug-shortages/webinar

5. https://ispe.org/ispeak/drug-shortages-introductory-webinar

6. https://medium.com/@amitashwini/blockchain-tech-for-indian-pharmaceutical-industry-db77613f90c1

7. http://medicalfuturist.com/robotics-blockchain-redesign-pharma-supply-chain/

8. https://www.cognitiveclouds.com/insights/blockchain-tech-for-indian-pharmaceutical-industry-2/

9. http://www.tapanray.in/blockchain-pharma-keeps-an-eye-on-the-ball/

10. https://www.phrma.org/science/in-the-pipeline/medicines-in-development