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(iii) The Central Government allocated 11 lakhs vials of Remdesivir to nineteen States with a high case load between 21 to 30 April through a letter issued on 21 April 2021. This allocation was revised and expanded to all States and UTs through a letter issued on 24 April 2021;

PART G

(iv) The Central Government has directed the States to appoint nodal officers to ensure unrestricted and timely movement of Remdesivir. A control room has been set up in this regard by the National Pharmaceutical Pricing Authority29 which is monitoring supplies as allocated. A helpline has been set up by NPPA and manufacturers have been directed to address the hindrances in the movement of the drug. A WhatsApp group with nodal officers has also been created to enable coordination and officials of MHA, NPPA and CDSCO are also part of the group;

(vii) CDSCO has directed all State Drug Controllers on 10 April 2021 to conduct a special investigation drive to prevent hoarding and black-marketing of Remdesivir in the country. DCGI and State Drug Controllers have been taking stringent action against such activities and enforcement action has been taken in thirty-four cases across the country;

“NPPA” “API” PART G

However, it is being prescribed by certain doctors. The clinical management protocol is a dynamic document which is reviewed periodically and is subject to further evaluation based on medical research and evidence that comes up in future; and

(ii) On 24 April 2021, Department of Pharmaceuticals31, NPPA and DCGI had reviewed the production and supply of other drugs such as Favipiravir, Enoxaparin, Ivermectin, Methylprednisolone, Paracetamol and Hydroxy- chloroquine. A meeting was conducted on 25 April 2021 by NPPA and DCGI with manufacturers to review stock position, availability and production plans.

53 We note that there are certain medicines which are being prescribed by doctors which are not mentioned in the National Clinical Management Protocol for COVID-19 like Favipiravir. However, since these medicines are being prescribed by doctors, people are facing significant inconvenience in obtaining them due to their shortage in certain parts of the country. The Central Government should consider whether the production of such medicines should be augmented to meet the demand or instructions should be given to the doctors to not recommend such medicines unless they have been included in the national protocol. 54 It has been submitted on behalf of the Central Government that on 24 April 2021, DoP, NPPA and DGCI reviewed the production and supply of drugs such as Favipiravir, Enoxaparin, Ivermectin, Methylprednisolone, Paracetamol and Hydroxy-chloroquine. The supply of Remdesivir and Tociluzumab is already under the consideration of the Central Government. A meeting was also held on the level of ten percent of maximum retail price for next twelve months. (2) The manufacturer shall be liable to deposit the overcharged amount along with interest thereon from the date of the increase in price in addition to the penalty.” PART G 25 April 2021 by DoP, NPPA and DGCI with the manufacturers to review stock position, availability and production plans. The Central Government should provide details of estimated demand of essential drugs mentioned above, production capacity, existing stocks, details of allocation and supply of such drugs.