Natco Pharma seeks compulsory license for COVID-19 drug

Hyderabad-based Natco Pharma said it has decided to seek a compulsory license from the government of India to manufacture Baricitinib tablets to treat COVID-19 patients.

Compulsory licensing is an internationally recognized patent provision under which the government of a country can give permission to a company to manufacture a patent-protected product for emergency use if the patent owner does not provide the permission to do so.

“Natco will be requesting a Compulsory License based on emergency use and in light of the grave and serious public health emergency across India due to the Pandemic. The company is ready to launch the product this week, so as to make the product available to suffering patients across India,” the Indian company said in a statement today.

Baricitinib is sold under the brand name Olumiant by US-based pharma manufacturer Eli Lilly & Co.

Even under compulsory licensing, the licensee still has to pay reasonable royalties to the patent holder.

The move comes amid widespread scarcity of key drugs used in the management of COVID-19 in India in the wake of a sharp increase in the number of infections in the country.

Officially, India sees around 400,000 new COVID-19 infections per day — the highest for any country in the world. The real numbers may be much higher.

The sudden outbreak has led to widespread scarcity of COVID-19 drugs such as remdesivir in the Indian market, despite questions being raised about their effectiveness.

Most chemists have run out of such drugs. Even in the rare case where such drugs are in stock, people are having to stand in line for up to 5 hours in front of chemist stores to get their hands on such drugs.

Chemists have even imposed quotas on the number of tablets a single person can buy in an effort to prevent hoarding.

Despite that, key drugs — including remdesivir — are being sold at several times their sticker prices through unauthorized channels.

Baricitinib is used for treating joint inflammation in rheumatoid arthritis patients.

However, it has been found useful as a combination drug with remdesivir for managing the symptoms of COVID-19. It is not supposed to be used as a standalone therapy for COVID-19.