Main reasons for edits are whilst it’s good in principle to highlight unethical practices, there is a danger in highlighting specifics; also some practical industry points. Will not be shown in detail in this post but for example – gathering local mice will be used as example to explain lab mice and good practice.
The story begins with two Indian brothers, one married to a Polish lady and he is interested in developing a drug, the other brother wants to develop an app. Neither of them have pharma or health tech experience but the second brother is very experienced at coding applications.
… Following a visit from his Polish in-laws X hears about a herb in Poland which is apparently good for treating stomach ulcers. They live in a village / town which has quite poor water sanitation and stomach ulcers are very common. X decides to develop a pill using the herb and tells Y brother who decides to develop a skin temperature monitoring app at the same time.
Unfortunately X doesn’t do any online research but Y checks to see if anyone else doing skin monitoring apps. (links to is the idea mine?)
They find an old office and workshop. X persuades the bank to give him a loan to convert the workshop into a laboratory and Y uses the office when needed. It is on the edge of town / village so there are a lot of mice that X can use for his pre-clinical trials. X goes to Poland and tries to bring back 500kg of the herb but gets stopped at customs back in India. He forgot to check the import regulations before he left and he is missing a certificate that he now needs to import the herb. He is stuck in his van for a week whilst his brother manages to arrange the certificate from Poland. (link to conditions and also reference to clinical trial phase with underlying issue of not planning business properly so incurring additional costs and time)
Y is doing well – he has created and tested the first version of his app on neighbours, friends and family and he shows the results to a doctor friend who compares with other reports and finds they are very similar. He applies for a patent in India. He asks his brother to do the same but his brother is reluctant because he is busy with his pre-clinical trials and working out how to combine the substances into the correct pill composition. (link to api & excipient diagram / explanation)
Y gets patent and with further good results, he researches next steps and goes to Delhi to have a meeting with the regulatory advisers. (link to patent etc). Y gets regulatory approval for his app and pre-orders are 100 times more than expected.
Two, three years pass. X starts a clinical trial application after a local hospital has a large outbreak of stomach ulcers following the collapse of part of the local sewage system and the repairs being delayed. He has to increase his loan to produce the pill but then has to stop because he runs out of money to develop the pill. (link to clinical trials phases and business planning)
Y’s doctor’s friend is going to an international pharma conference in Mumbai and offers him a lift. He creates a poster showing early results. At the conference he meets a Russian company who are successfully selling a Siberian drug to treat indigestion in India. They decide to help him and agree to invest in the development of the pill.
X continues to work with the Russian company to continue clinical trials back at the local hospital. However the Russian company realise that there is the same drug already with marketing approval in Russia and EMA to treat the stomach ulcers so it is too late for a patent.
Totally fed up, X goes home and realises that he cannot afford his mortgage repayments so they move in with Y. Fortunately Y’s sales are massive and he can afford to buy X and family an apartment. Whilst unable to continue the drug development, X tries a self experiment and adds the herb to some juice. He tries drinking over a month and notices that his eczema cleared up.
He calls the Russian company and they check – there is no patent or similar health drink currently applying for regulatory approval. He sells his car, van and begins pre-clinical trials again. The results are excellent so the Russian company help find a partner to finance the clinical trials. Y also finds him a pharma partner in India who is familiar with the documentation and pays for the service to get it through regulatory approval. (links to clinical trials and obtaining approval)
Several years later, he gets marketing and health technology assessment approval and begins selling in India. Meanwhile, the Russian company open up an opportunity to market the pill in Poland after a recent expansion of their own operations there.(links to after marketing approval)
And everyone lives happily without stomach ulcers, ever after.