Express View on resumption of penicillin production: A step in the right direction
Three decades after the India’s last penicillin manufacturing unit was shut down , the country will start producing this active pharmaceutical ingredient (API or bulk drug) used in several antibiotics . According to the Union Ministry of Health and Family Welfare (MoHFW), production of penicillin-G (or pen-G) will resume this year.
This was phased out in the 1990s, when the country’s markets were flooded with cheaper alternatives, largely from China. The decline in API production was noticed only in a few circles until late 2019, when supply chains were disrupted following China’s stringent regulations on its industry. The Covid pandemic made the problem grave and API shortages threatened to have serious ramifications outside India’s borders, given the country’s status as the largest manufacturer of generic medicines . The resumption of penicillin manufacturing owes in great measure to the government’s production-linked investment (PLI) scheme.
Pen-G manufacture is cost-intensive and involves a complex fermentation and extraction process. That’s why drug manufacturers find it prudent to outsource their production. The situation has compounded in the last few years because Chinese penicillin makers have been producing well below their capacity. In 2019, the public sector Hindustan Antibiotics Ltd was reportedly the government’s first choice to restart its production under the Make in India scheme. However, the PSU expressed its inability to participate in the venture , citing resource constraints . About the same time, the Department of Health Research informed the MoHFW that India needs more than 13,000 million doses of penicillin in the next three years to deal with bacterial infections that cause rheumatic fever – India has amongst the highest death rates from such illnesses. The government also received requests from doctors to procure this bulk drug. Broad-spectrum antibiotics, such as azithromycin, that have been used as penicillin substitutes are known to harm essential bacteria naturally present in the human body, leaving a patient vulnerable to harmful germs.
The PLI scheme envisages a support of 20 per cent for the first four years, 15 per cent for the fifth year, and 5 per cent for the sixth year on eligible sales of fermentation-based bulk drugs and hormones such as insulin. It’s early years for the scheme and India still imports close to 90 per cent of all APIs for antibiotics. The challenge for the country’s health authorities will be to ensure that the focus on self-reliance does not affect the affordability of medicines. They should also make sure that the companies can sustain themselves once the government hand holding is over.