India to Restart Penicillin G Manufacture UPSC

Description

PENICILLIN G

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Picture Courtesy: https://www.ipha.ie/continued-long-waits-for-new-medicines-in-ireland-means-minister-donnellys-new-working-group-must-deliver-change/

Context: The Union Health Minister recently announced that India is set to revive domestic production of Penicillin G by mid-2024.

Details

India to restart the manufacturing of Penicillin G, a key antibiotic, after a gap of three decades. The last manufacturing plants in India shutdown their operations in the 1990s.

Why Did Penicillin G Manufacturing in India Stopped in the 1990s?

Subsidized Chinese Competition: China has implemented a number of policies to support its pharmaceutical industry, including tax breaks, subsidies for research and development, and cheap loans. This has allowed Chinese companies to produce drugs at a lower cost, making it difficult for Indian companies to compete on price.
India Shift towards Formulations: When cheaper Active Pharmaceutical Ingredients (APIs) became available from China, Indian manufacturers responded with a strategic shift. They focused their efforts on formulations, which involved importing the bulk APIs and turning them into finished medications that are ready for patients to use.
Drug Price Controls: Indian government's price controls on essential medicines have further decreased the profit margins for domestic manufacturers. These price controls are often set below the production cost for essential drugs, making it difficult for Indian companies to make a profit on these medications. This discourages investment in research and development, as companies may be less likely to invest in new drugs if they cannot recover their costs through higher prices.

What are Active Ingredients?

●Active ingredients are the essential components in medications that produce the desired effect on the body. They are like the key that unlocks a specific biological process in the body, triggering a healing response or symptom relief.

●Active ingredients can be man-made chemicals, called Active Pharmaceutical Ingredients (APIs), or natural substances derived from plants, animals, or even microbes.

●Active ingredient can also be called active substance, referring to the component in a medication that has a direct healing effect.

●Inactive ingredients are called excipients, they are fillers, binders, and other materials that help deliver the active ingredient effectively. They play a key role in ensuring the medication reaches the target site in the body at the right dose and dissolves or releases at the desired rate.

Significance of the Initiative

The COVID-19 pandemic exposed the vulnerabilities of depending on other countries for key medicines. Disruptions in global supply chains during the pandemic highlighted the need to have a strong domestic API manufacturing sector. A strong domestic API industry is essential for safeguarding public health and national security.
India is prioritizing self-reliance in the production of essential drugs to reduce its dependency on foreign suppliers and safeguard the nation's health security. By restarting domestic Penicillin G production, India is taking a significant step towards achieving self-sufficiency in antibiotics.

Production Linked Incentive (PLI) Scheme

●The PLI scheme was launched by the government to boost domestic manufacturing of essential drugs and active pharmaceutical ingredients (APIs).

●It provides financial incentives to companies that set up and scale up API manufacturing facilities in India. These incentives can take the form of direct subsidies or tax breaks.

●It makes domestic production of Penicillin G and other essential drugs more competitive with cheaper imports.

●By providing financial assistance, the PLI scheme aims to create a level playing field for domestic manufacturers and encourage them to invest in API production.

●It can help to create a stronger and more resilient supply chain for essential medicines in India. By reducing dependency on imports, India can ensure a continuous supply of critical drugs at affordable prices, even during global disruptions.

Penicillin G

Benzylpenicillin, also known as penicillin G, is a powerful antibiotic used to treat a wide range of bacterial infections. It's particularly effective against Pneumonia, Strep throat, Syphilis, Tetanus.
Due to limited oral bioavailability, it is primarily taken via injection.
It is produced by fermentation of Penicillium chrysogenum, involving fermentation, recovery, and purification.