Can India put an end to API over-reliance?

While meeting the demands of countries like US, Brazil and Israel, India, being the largest producer of antimalarial drugs, is struggling to fulfil its own domestic needs of hydroxychloroquine amid coronavirus outbreak. Local pharma companies in the country are especially facing a shortage of API required for HCQ production.

Hyderabad:There is no cure for the novel coronavirus yet. The pharma industry has not come up with medication either. Efforts to develop a vaccine are still underway. In this context, some drugs used to treat other diseases have been proved to provide relief to COVID-19 patients.

As a result, the demand for such drugs has shot up. Some of them include anti-HIV, antimalarial and antibiotic drugs. India is home to the third-largest pharmaceutical industry in the world. In fact, the India's pharma industry has expanded in the past two to three decades. Right from developing countries like Africa to developed countries like the US, several nations are importing drugs from India.

In addition, India is the largest producer of antimalarial drugs. Many countries including the US, Brazil and Israel have requested India to supply hydroxychloroquine (HCQ). At the same time, we need to meet our domestic needs. Under these circumstances, national pharma companies have multiplied their production capacity. But here lies the problem.

Pharma companies face a shortage of key ingredients to meet the current demand. Companies in Andhra Pradesh and Telangana have almost emptied their reserves. Industry experts say that it is impossible to take on production unless ingredients are supplied. Local pharma companies are especially facing a shortage of Active Pharmaceutical Ingredients (API) required for HCQ production.

The pharma companies in Andhra Pradesh and Telangana primarily produce anti-HIV drugs, azithromycin and chloroquine. Currently, the demand for chloroquine is high. Local pharma companies are making hydroxychloroquine and chloroquine phosphate tablets as the drug has a high demand in domestic and international markets. But there are not enough APIs to meet the production requirements.

Before the onset of COVID-19, HCQ tablets had no market. It was manufactured for diseases such as malaria, rheumatoid arthritis and lupus. Usage and export of HCQ were also low. Resultantly, companies did not focus on the storage of API needed for HCQ production. The demand for HCQ has increased after the spread of COVID-19.

Pharma companies started producing the drug, using optimum amounts of API. Further production cannot continue unless a fresh stock of API is imported. Chloroquine manufacturers include leading pharmaceutical industries such as Ipca Laboratories, Zydus, Cipla and Hyderabad-based companies like Hetero Drugs, Natco Pharma and Laurus Labs. Though they have scaled up HCQ production, there is a shortage of API.

Some of these companies have ordered raw materials from China and awaiting the containers. On the other hand, some of the local bulk and API units are now involved in the production of raw materials and intermediates for the manufacture of HCQ.

The Drugs Control Administration of Telangana has also identified this challenge and requested some bulk drug units to manufacture intermediates. The majority of these units were shut down after demand for chloroquine has dwindled. They are being reopened now. One of the local pharma companies’ spokesmen said that they were awaiting API consignments from China.

Apart from HCQ, production of broad-spectrum antibiotics and antiviral drugs such as azithromycin, chloroquine phosphate, paracetamol, montelukast, oseltamivir, favipiravir, lopinavir, remdesivir and ivermectin has accelerated for use against COVID-19.