India ensures drug availability for treatment of black fungus
The MEA is playing an important role in reaching out to various players abroad
To meet the demand of Amphotericin-B medicine required for the treatment of Mucormycosis (black fungus) which has been seen as a post COVID complication, India is leaving no stone unturned.
Through active measures to augment production, and import and ensure equitable distribution, the government has been able to mobilise over 6.67 lakh vials of the Amphotericin B for patients in the states and UTs and Central Health Institutes.
The Ministry of External Affairs is playing an important role in reaching out to various players abroad.
Through its missions all over the world, the MEA has identified new sources of Amphotericin B/ Liposomal Amphotericin B injections and alternative drugs for treatment of Mucormycosis. Out of the identified sources, the MoHFW has called upon the MEA to take steps to procure Liposomal Amphotericin-B from Australia, Russia, Germany, Argentina, Belgium and China.
The MEA has also been actively working on ensuring supplies of key excipients, HSPC and DSPG-NA from sources abroad for production of Liposomal Amphotericin B in India.
The Department of Pharmaceuticals and the Indian Embassy in the US are working continuously with the Mylan Labs for increasing import and ensuring early delivery from M/s Gilead Inc. the US. Out of total Orders placed with Gilead for 9,05,000 vials, the stocks of 5,33,971 vials have already been received till 16th June by M/s Mylan, the main importer. The remaining deliveries are being expedited.
In order to ensure equitable distribution of the limited stocks, it was decided to make allocation of limited stocks among states, which would ensure that all states with patients of Mucormycosis would get a fair chance of accessing a share of the supplies.
The allocation by the Central government is being done only in respect of Liposomal Amphotericin-B, barring one manufacturer Bharat Serum, which produces Liposomal, Lipid and emulsion form of the drug. The allocation of Conventional Amphotericin is also being done since June 14, 2021, after assessing the demand and availability.
For equitable distribution, allotments are being made to the States/ UTs in accordance with the proportion of their reported case load in respect of the entire country. The number of patients in a particular State is derived from the portal of Ministry of Health and Family Welfare, in which the States themselves enter the figures of patient load in their respective states. This allocation regime is an interim arrangement till the supply of the drug stabilises vis a vis the demand.
Physical distribution and availability of the drug in a particular city/ hospital is managed by the State governments concerned. Liposomal Amphotericin-B is directly procured by State governments from the manufacturers based on the allocation made and the drug is subsequently made available to the hospitals. Through allocations made till June 14, 2021, a total 6,67,360 vials have been allocated by the Department of Pharmaceuticals to States / UTs. In addition, 53,000 vials of Conventional Amphotericin B were also allocated to States / UTs on June 14.
Supply arrangements are being monitored by the National Pharmaceuticals Pricing Authority (NPPA) under the Department so as to ensure expeditious availability of the drug to the needy. NPPA has put in place a strongly responsive system to ensure timely supplies of allocated volumes and maintains continuous contact with States / UTs and suppliers to troubleshoot any issues in reaching the drugs to the Health Departments of States/ UTs.
On June 7, 2021, MoHFW has circulated the advisory of the National Task Force on COVID-19 for treatment and management of Covid related Mucormycosis (CAM), which explains in detail, the manner and conditions under which various Mucormycosis drugs like Amphotericin B lipid complex, liposomal Amphotericin B, Amphotericin deoxycholate form, Posaconazole etc. are to be used. The Department of Pharmaceuticals has also on June 10, 2021 issued an advisory to the Health Secretaries of all State governments/UTs reiterating the need of ensuring judicious use of allocated drugs and efficient distribution within their State/UTs.
Government continues to closely monitor in contact with state governments and manufacturers, the production, import, supplies and availability of the drugs required for treatment of Mucormycosis.