Steps taken by Government to ensure drug availability for treatment of Mucormycosis

Steps taken by Government to ensure drug availability for treatment of Mucormycosis

New Delhi:

The Department ofPharmaceuticals (DoP) along with inputs from CDSCO has been continuouslyassessing the availability of drugs for treating Mucormycosis - both throughdomestic manufacturing and import. Since early  May, 2021 the details of production, stock, supplies made and purchaseorders were obtained from the manufacturers and their co-operation sought toovercome the gap between supply and demand. An inter-departmental meeting washeld on 10th May, 2021 with Department of Pharmaceuticals, Ministry of Health& Family Welfare (MoHFW), Central Drugs Standard Control Organisation(CDSCO) and Directorate General of Health Services (DGHS)to take stock of thesituation. A view emerged that allocation of limited stocks among theStates/UTs would ensure that all States get a fair chance of accessing a shareof the available supplies, till the supply demand gap is overcome.

Production enhancement

In order to augment thedomestic manufacture, the Government is continuously engaging with themanufacturers to resolve their issues related to raw materials. Department ofPharmaceuticals and the Drug Controller General of India (DCGI) have activelycoordinated with the industry for identification of manufacturers, alternatedrugs and expeditious approvals of new manufacturing facilities. Themanufacturing firms were contacted and have been sensitized about the need toincrease production. The existing manufacturers have also been called upon toincrease production of Liposomal Amphotericin-B. Ramping up production ofalternative drugs/forms for treating the disease is also being actively pursuedwith the manufacturers. Various concerns of manufacturers and importers,including those related to licensing and availability of raw material issues,import license are being speedily addressed.

The existing five manufacturersof Liposomal Amphotericin B are Bharat Serums and Vaccines Limited, Cipla, SunPharma, BDR Pharmaceuticals and Lifecare Innovations.  The expected release by them for the month ofJune is about 2.63 lakh vials. Manufacturing of liposomal formulation involvesa complicated process and can only be done by industries having advancedtechnology. DCGI, after consultation with the association of Drugsmanufacturers, has issued manufacturing / marketing permission of AmphotericinB Liposomal Injection to six firms, viz., Emcure, Gufic, Alembic,  Lyka, Natco Limited and IntasPharma. The expected release by the six newmanufacturers for the month of June is about 1.13 lakh vials.

The domestic productioncapacity of Amphotericin B Liposomal Injection has increased from about 62000in April 2021, to 1.63 lakh vials in May 2021 and is expected to cross 3.75lakh vials in June, which is a fivefold increase in a short time span.

Regular Monitoring ofproduction is being carried out by the Government and several meetings heldwith the manufacturers to identify the issues involved in the augmentation ofthe production. Companies manufacturing APIs have also been contacted by theGovernment and asked to ensure increased and continuous supplies for augmentingproduction.

Import facilitation

Ministry of External Affairs(MEA) is playing an important role in reaching out to various players abroad. Throughits missions all over the world, MEA has identified new sources of AmphotericinB/ Liposomal Amphotericin B injections and alternative drugs for treatment ofMucormycosis. Out of the identified sources, the MoHFW has called upon MEA totake steps to procure Liposomal Amphotericin-B from Australia, Russia, Germany,Argentina, Belgium and China. MEA has also been actively working on ensuringsupplies of key excipient, HSPC and DSPG-NA from sources abroad for productionof Liposomal Amphotericin B in India.

Department of Pharmaceuticalsand the Indian Embassy in the USA are working continuously with the Mylan Labsfor increasing import and ensuring early delivery from M/s Gilead Inc. USA. Outof total Orders placed with Gilead for 9,05,000 vials, the stocks of 5,33,971vials have already been received till 16th June by M/s Mylan, the mainimporter. The remaining deliveries are being expedited.

Making allocation

In order to ensure equitabledistribution of the limited stocks, it was decided to make allocation oflimited stocks among states, which would ensure that all states with patientsof Mucormycosis would get a fair chance of accessing a share of thesupplies.  The allocation by the CentralGovernment is being done only in respect of Lyposomal Amphotericin-B, barringone manufacturer Bharat Serum, which produces Lyposomal, Lipid and emulsionform of the drug. The allocation of Conventional Amphotericine is also beingdone since 14th June 2021, after assessing the demand and availability.

For equitable distribution,allotments are being made to the States/ UTs in accordance with the proportionof their reported case load in respect of the entire country. The number ofpatients in a particular State is derived from the portal of Ministry of Healthand Family Welfare, in which the States themselves enter the figures of patientload in their respective states. This allocation regime is an interimarrangement till the supply of the drug stabilises vis a vis the demand.

Physical distribution andavailability of the drug in a particular city/ hospital is managed by the StateGovernments concerned. Liposomal Amphotericin-B is directly procured by StateGovernments from the manufacturers based on the allocation made and the drug issubsequently made available to the Hospitals. Through allocations made till14th June, 2021, a total 6,67,360 vials have been allocated by Department ofPharmaceuticals to States / UTs. In addition, 53,000 vials of ConventionalAmphotericin B were also allocated to States / UTs on 14th June.

Ensuring supply

Supply arrangements are beingmonitored by the National Pharmaceuticals Pricing Authority (NPPA) under theDepartment 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 ofallocated volumes and maintains continuous contact with States / UTs andsuppliers to trouble shoot any issues in reaching the drugs to the HealthDepartments of States/ UTs.

On 7th June, 2021, MoHFW hascirculated the advisory of the National Task Force on COVID-19 for treatmentand management of Covid related Mucormycosis (CAM), which explains in detail,the manner and conditions under which various Mucormycosis drugs likeAmphotericin B lipid complex, liposomal Amphotericin B, Amphotericindeoxycholate form, Posaconazole etc. are to be used. Department ofPharmaceuticals has also on 10th June, 2021 issued an advisory to the HealthSecretaries of all State governments/UTs reiterating the need of ensuringjudicious use of allocated drugs and efficient distribution within theirState/UTs.

Government continues to closelymonitor in contact with state governments and manufacturers, the production,import, supplies and availability of the drugs required for treatment ofMucormycosis.