The Government took various measures to increase the supply of essential drugs such as granting expeditious approvals to new manufacturing sites of existing manufacturers to enhance their production capacity, issuing licences to new manufacturers/importers, helping the manufacturers in sourcing raw material and helping importers in getting maximum supplies on priority through support from diplomatic channels, restricting exports for a certain period, and allocating Remdesivir, Tocilizumab and Amphotericin B, during the period of limited supply, to states in an equitable manner to ensure availability of these drugs across the country, informed Mansukh Mandaviya, Union Health Minister in Lok Sabha yesterday.
He also said that the domestic production and import of critical drugs were monitored regularly by the government. Regular meetings were held with manufacturers to identify and address the issues faced by them in the augmentation of the production. The availability of all major drugs required for the management of COVID-19 was regularly monitored through weekly surveys of retail pharmacies.
Remdesivir is a patented drug of Gilead Life Sciences USA, manufactured in India under voluntary licences granted by the patent holder to seven Indian pharmaceutical companies. With the accelerated approval of 40 additional manufacturing sites by the Central Drugs Standard Control Organisation (CDSCO), the number of approved manufacturing sites has increased from 22 in mid-April, 2021 to 62 in June 2021. The domestic production capacity of all the seven licensed manufacturers was thus augmented from 38 lakh vials per month in mid-April, 2021 to nearly 122 lakh vials per month in June 2021. The total domestic production of Remdesivir by seven licensed manufacturers between 1st April and 25th July, 2021 is 1,68,14,752 vials.
Besides, Tocilizumab is a patented drug of Hoffman La Roche, a Swiss multinational company, which is not manufactured in India and is available here via imports only. Its imported quantity was maximised — 1,00,020 vials (80 mg) and 13,001 vials (400mg) were commercially imported between 1st April and 25th July, 2021. In addition, 50,024 vials (80 mg) were received in donation from Roche in the month of May 2021.
Apart from it, the Department of Pharmaceuticals (DoP) and the Drug Controller General of India (DCGI) coordinated with the industry for the identification of manufacturers and expeditious approvals of new manufacturing facilities. The DCGI issued manufacturing/marketing permission of Amphotericin B Liposomal Injection to 11 new companies in the months of May and June 2021. The domestic production of Liposomal Amphotericin B between 1st May and 30th June, 2021 was 4,53,555 vials. The expected production in the month of July, 2021 was 3,45,864 vials.
Further, DoP and the Indian Embassy in the USA worked continuously with importers and manufacturers to maximise the quantity of imports of Liposomal Amphotericin B and also for early delivery of supplies. The total import of Liposomal Amphotericin B between 1st May and 29th July, 2021 is 10,77,677 vials. The Indian Missions all over the world were instructed to immediately identify additional sources of the Liposomal Amphotericin B. The Ministry of External Affairs (MEA) also helped domestic manufacturers in getting supplies of key excipients viz HSPC and DSPG-Na required for the production of Liposomal Amphotericin B from sources abroad, he mentioned.
He also said that the domestic production and imports of other drugs required for the management of COVID-19 namely dexamethasone, methylprednisolone, paracetamol etc. was monitored regularly and there was sufficient availability of these drugs to meet the increased demand.
The allocation of Remdesivir, Tocilizumab and Amphotericin B was started on 21st April, 27th April and 11th May, 2021 respectively. The allocation of Remdesivir and Amphotericin B has now been discontinued due to the sufficient availability of these medicines. The last allocation of Remdesivir was done on 23rd May, 2021 and that of Amphotericin B was done on 24th July, 2021, the minister notified.