|
The Indian pharma's re-emergence in penicillin G manufacturing through the Union government’s production linked incentive (PLI) scheme has set a positive precedent.
Following a recent media report on the PLI scheme enabling two pharma companies: Aurobindo Pharma and Kinvan to commence production of penicillin G and clavulanic acid, industry observers noted that resumption of penicillin G production move is significant not only for meeting domestic demand but also for India to become a potentially key player in the global supply chain for antibiotics.
Penicillin G, an essential antibiotic, is in demand in India and worldwide for its efficacy against a wide range of infections. However, its production had declined in India due to various factors such as competition from cheaper imports and regulatory challenges, they added.
Musing over India’s capability in the past to manufacture most APIs (active pharmaceutical ingredients) including penicillin G, Harish K Jain, president, Federation of Pharmaceutical Entrepreneurs (FOPE) and director, Embiotic Labs said, there were a handful of Indian companies in including one from Karnataka engaged in penicillin G manufacture. The process technology was imported and Union government had encouraged companies to manufacture penicillin within India. Unfortunately, this technology became obsolete because of no efforts by Indian pharma to research and indigenize the production process to reduce the manufacturing cost. This saw China grab the chance to manufacture penicillin G in a cost-effective manner resulting in a drastic fall of the drug price, he added.
With highly subsidized exports from China, Indian penicillin production plants became unviable. This led to total import dependence on China. Medicine security for world's largest populous country is non-negotiable and we cannot be dependent on imported APIs specially life saving antibiotics, pointed our Jain.
However due to uncertain global security situation, government of India nudged by pharma associations introduced the PLI scheme to manufacture critical APIs and intermediates locally. We are seeing the fruits of this scheme now and very soon more than half of penicillin G as well as clavulanate potassium will manufactured from here, Jain told Pharmabiz.
With the continuation and expansion of PLI scheme, India will be able to manufacture for domestic consumption and exports. Using penicillin G as the base a slew of semi synthetic antibiotics like cephalosporin and other ß-lactams, carbapenems, and monobactams can be manufactured too. This will give a fillip to the eco-system of the bulk drug and formulations. Of course, it is the patient which benefits ultimately as India battles the surge of communicable and infectious diseases, said Jain.
From a Karnataka perspective, there are promising prospects for penicillin production, KAPL is engaged in erythromycin manufacture but at its facility at Ujjain in Madhya Pradesh formulations azithromycin or macrolide range of antibiotics can be manufactured.
According to Kaushik Desai, pharma consultant, the best outcome of the PLI scheme and Make in India initiative is aimed at enhancing domestic manufacturing capabilities and promoting self-reliance. By providing financial incentives, the scheme encourages companies to ramp up production capacities and invest in technology upgrades. It is an excellent example of collaborative approach. The learnings of past experiences must have been taken into account to ensure sustainability of the project.
“India's decision to resume penicillin G production signifies a strategic move towards strengthening its pharmaceutical industry, addressing healthcare needs, and promoting self-sufficiency in critical drug manufacturing,” added Desai.
|