India, the world’s pharmacy, seeking self-sufficiency
More than 60 children died in The Gambia from toxic syrups made in Haryana. A third of the drugs sold worldwide come from India. The development of its pharmaceutical industry has been possible thanks to "reverse engineering" and process patents. Now the government wants to end its dependence on China and manufacture its own active ingredients.
Milan (AsiaNews) – The Indian government has ordered an investigation into Maiden Pharmaceuticals, which is based in the northern state of Haryana, after the World Health Organisation (WHO) linked the deaths of 66 children in The Gambia to four cough syrups made by the Indian company for export only.
According to Indian authorities, the country’s drug regulatory agency began investigations after it was contacted by WHO on 29 September, but a first alert was sounded by Gambian authorities in July, when too many children were being hospitalised with serious kidney problems.
According to WHO Director-General Tedros Adhanom Ghebreyesus, "unacceptable" levels of toxins in the syrups were causing kidney injuries.
In fact, in the past seven years at least six drugs made by Maiden Pharmaceuticals did not meet the safety and efficacy standards necessary for sale. Four of these failed their test in the past year.
India produces a third of all drugs used worldwide and is home to some of the fastest growing pharmaceutical firms. This began in 1970, when the government introduced the Patents Act, which recognises process patents, not product patents.
This means that Indian pharmaceutical companies can produce equivalent drugs without being forced to pay royalties to the original patent holders. In a few years, the industry grew by leaps and bounds. The number of pharmaceutical firms rose from 2,200 in 1970 to 24,000 in 1995.
To meet the demand for trained staff, Indian colleges boosted their pharmaceutical programmes.
In 2021, the Indian pharmaceutical market, which today is worth US$ 42 billion, reported 17.7 per cent growth, and could reach US$ 65 billion by 2024 or even triple to 120-130 billion by 2030.
Since the 1990s, exports have played a key role, so much so that at present India meets half of the global demand for vaccines, 40 per cent of generic drugs in the United States, and 25 per cent in the United Kingdom. This means that one in three pills ingested in the US and one in four in the UK are made in India.
The ability to develop generic drugs at a low price is due to the availability of skilled labour. And thanks to "reverse engineering" India was able to manufacture drugs for AIDS (Zidovudine) and cancer (Imatinib) a few years after they were first introduced in the United States with discounts of up to 99 per cent. This made them accessible to low-income countries, especially in Africa.
About 80 per cent of the antiretrovirals used worldwide to fight HIV are made by Indian companies. India is also a major exporter of vaccines, as during the COVID-19 pandemic. According to government figures, India has provided over 201 million doses to about 100 countries as of May 2022.
Up to 65 per cent of children worldwide have been given at least one vaccine made by the well-known Serum Institute of India (SII). However, from April to October 2021, it stopped exporting AstraZeneca vaccines to meet domestic demand; up to that point only 0.5 per cent of the Indian population had been vaccinated when the second wave swept across the country.
Some other observers note however that China is actually the world’s real pharmacy since India imports from its northern neighbour 68 per cent (or 85 per cent according to other sources) of the active ingredients that go into making the drugs.
Now something has begun to change. Thanks to a government plan launched in 2020 (at the height of border tensions with China), in March of this year India begun to produce 32 active ingredients in 35 plants located throughout the country.
The short-term goal is to reduce dependence on China by 35 per cent by the end of the decade. The Indian government has also allocated US$ two billion in incentives to encourage domestic and foreign companies to manufacture at least 53 active ingredients that are now imported from China. The long-term goal is almost total self-sufficiency.
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08/12/2018 09:00