Generic Drug Supply and Raw Materials Supply

In March 2021, Boris Johnson, Prime Minister, announced the UK was acquiring 10m doses from the Serum Institute of India, the world’s largest vaccine manufacturer and the key source of doses for Covax, a vaccine-sharing agreement on which poor and middle-income countries are relying.

In a short time, India became overwhelmed with Covid 19 cases, and this tsunami is killing the population of India at a rapid rate. Millions had turned out for the annual Hindi festival and elections, there was no social distancing and few people wore masks; such was the confidence that they were done with Covid. Now they need the rest of the world to step up and help control this devastating situation.

In the US, 90 percent of drugs are generic and supplied by Indian Pharmaceutical companies, according to an April 2020 study by the Confederation of Indian Industry (CII) and KPMG. Most of the world, including the UK relies on Indian generic drug supplies, and in turn, India relies on China for the raw materials Active Pharmaceutical Ingredients (APIs).

1979: The Indira Ghandi administration passed the Patent Act of 1970, which granted legal protection only to the processes used to make a drug, not a drug’s content.. This was in response to its huge population being unable to afford imported patented drugs, and needed to find a solution.

Indian companies excelled in reverse engineering big-name drugs and launched copycat versions — legally.

Around the mid1980s, regulatory changes allowed the US market to be more open to cheap copycat drugs, too.

Naturally, the pharmaceutical giants, which had invested millions of dollars in creating new drugs, pushed back.

1995: the World Trade Organization (WTO) introduced an agreement giving drug patents 20 years’ protection — and companies were given 10 years to comply.

But when the HIV/AIDs crisis hit during that 10-year transition window, it was clear that poor countries needed cheap drugs

1999: the most common cause of death in sub-Saharan Africa, where many people couldn’t afford antiretrovirals, was HIV/AIDs.

The WTO conceded that member states could grant licenses to manufacturers to make generic versions of patented medicines needed to protect public health.

In 2001, an Indian pharmaceutical company, Chemical, Industrial and Pharmaceutical Laboratories (Cipla), reverse-engineered several brand-name drugs, and combined them in a revolutionary anti-HIV drug cocktail. African countries and aid groups were offered the drug for $1 a day, a discount of more than 96% on brand-name versions.

2020: Chemical, Industrial and Pharmaceutical Laboratories (Cipla), has worked to reverse engineer three drugs being tested to fight Covid-19 — Remdesivir, Favipiravir and Baloxavir.

The supply of raw materials from China to Indian Pharma has never been as high as it was pre the Pandemic. When the current wave of Covid struck, there was insufficient API’s in stock.

During the 1990s the Chinese government initiated the growth in becoming world leaders in API plant facilities. They have 7000 API manufacturers and India has 1500. China can use economies of scale to keep costs down. But if they have to shut down, as in lockdowns, the supply chain slows right down. Thus the world’s dependency on China and India for supplying the world during a pandemic, grinds to a halt. Drug costs then soar.

Investments in Mega Pharma Parks in India had to be shelved back in 2008, but now Bulk Pharma Parks are planned as part of a $1.3 billion package to boost domestic production of bulk drugs and exports.

This dependency on China and India at such a critical time has made the penny drop finally as richer countries prepare to become more self-sufficient. This will not be the last Pandemic.

According to the US FDA, as of August 2019, only 28% of manufacturing facilities making APIs for the US market were based in America. The rest were in the EU (26%), India (18%), China (13%) and elsewhere (15%).

But there is no quick fix and China will remain dominant in the supply chain for many years to come. We humans must work together to save ourselves, otherwise, all is lost.

I have put together many blogs which have highlighted how we have industrialized much of the world, and in so doing, robbed it of its resources, and extensively contaminated the air we breathe, the water we drink, the soil in which we grow food. As chronic illnesses are identified as a result, the Pharma Industry grows to meet the demand. Billions of dollars accumulate in the hands of those who invest. Science is hailed for saving lives with its contributions to medical breakthroughs.

Yet we would not be ill if we had not destroyed the ecosystem balance. We are now at the ‘Last Chance Saloon’. Connect the dots. Stop this incessant wheel of harm we do to ourselves. Even procuring raw materials to manufacture drugs creates more harm.

We cannot reverse the harm we have done, but we can use our creative abilities to care for our fellow human beings. We can ensure everyone has clean water, good sanitation, decent homes and access to free healthcare at the point of need. This would be the intelligent solution since it would decrease disease dramatically, then we should not need all these drugs or so much medical intervention.

But those caught up in the Pharma Industry only want it to grow and tell us it is for our sakes. If so, why not run a parallel experiment and make life cleaner and healthier for all. If we succeed we could find ways for the Pharma products to rebalance the ecosystem and then we have a Win-Win solution.

We are a bit late to take the steps to stop Bolsonaro from destroying the Rainforest. But a decade ago scientists were finding thousands of new plants and animals and documenting their existence. The Pharma Industry could have stepped in and stopped the destruction and saved the Rainforest for careful and responsible exploitation of plants which would have helped with creating more vital drugs. But they did not and now 98% of the Brazilian Rainforest is beyond rescue.

So many chances we have had to genuinely put the Planet first. Profit before people, and certainly before the Planet. This wonderful Planet. Watching more plants and animals go extinct is a precursor to our own extinction. Voices are raised as they defend their portion of the ecosystem from the threats, and corporates silence those voices. So many activists have been murdered. For why? For the consumption of what little there is left to grab, use and discard. We humans are in a sorry place.

About borderslynn

Retired, living in the Scottish Borders after living most of my life in cities in England. I can now indulge my interest in all aspects of living close to nature in a wild landscape. I live on what was once the Iapetus Ocean which took millions of years to travel from the Southern Hemisphere to here in the Northern Hemisphere. That set me thinking and questioning and seeking answers. In 1998 I co-wrote Millennium Countdown (US)/ A Business Guide to the Year 2000 (UK) see
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