DCGI to SDCs: Ensure availability of critical drugs

DCGI has asked all SDCs to take steps to ensure availability of sufficient quantity of critical drugs in the domestic retail markets

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To manage the situation arising out of COVID-19 pandemic, the Drugs Controller General of India (DCGI) has directed state and Union Territory State drugs controllers (SDCs) to take steps to ensure availability of sufficient quantity of critical drugs in the domestic retail markets besides ensuring that the products conform to the prescribed specifications.

The Union health ministry on April 16, 2020 has come out with a list of 55 drugs for ICU management of COVID-19 patients admitted to hospitals. Hydroxychloroquine (200mg) and azithromycin (500mg) tablets have already been recommended for patients requiring ICU management, asymptomatic healthcare workers and asymptomatic household contacts of positive cases.

To download the DCGI letter 16-04-20 along with list of 55 critical medicines for Covid-19, click here

The list of 55 drugs contains vasopressors—injection noradrenaline Img/ml, injection vasopressin 5mg/ml, injection dobutamine Img/ml, injection adrenile 1 mg/ml, and injection atropine sulphate 1 mg/ml. The list also contains arrhythmia drugs/emergency cardiac drugs such as injection amiodarone 150mg, injection enalaprilat 1.25mg, and injection labetalol 5mg/ml (10ml).

The list also has analgesia sedatives/muscle ralaxants–injection midazolam l0mg, vecuronium 4mg/ml, injection suxamethonium 50mg/ml, and injection fentanyl 50mcg/ml.

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Antibiotics/antimicrobial agents found place in the list are injection amoxcillin/clavulinic acid (500mg/125mg), injection ceftriaxone 1gm, injection meropenam 1gm, injection targocid 400mg, injection vancomycin 500 mg, injection ciprofloxacin 500mg, injection levofloxacin 500mg, injection cefotaxime 1gm, injection artesunate 120mg, injection linezolid 600mg, injection clindamycin 600mg, and injection metronidazole 500mg.

Besides this, the list has nebulisation products—salbutamol respiratory solution 5mg, salbutamol/pratropium solution 5mg/500mcg, formetrol/budesonide (20mcg/0.5mg). The list also contains anti-epileptic drugs—diazepam 5mg/ml (2ml), injection sodium valproate 100mg/ml, and injection levetiracetam 500mg.

There are IV fluids in the list which includes normal saline, ringer’s lactate, dextrose normal saline, and mannitol 20% (500ml).

Other drugs in the list are lignocaine 2% injection (30ml), chlorhexidine mouth wash, chlorhexidine skin preparation, betadine skin preparation, heparin 5000 IU/ml injection (5ml), injection enoxaprin 0.6ml, injection tranexamic acid 0mg/ml, injection frusemide 10mg/ml (2ml), injection hydrocortisone acetate 100mg/1ml, injection potassium chloride 15% (10ml), injection sodium bicarbonate 7.5%, regular insulin (100U/ml), paracetamol 500mg tablet, levocetrizine 5mg tablet, pantoprazole 40mg tablet, prednisolone 5mg tablet, cetrizine 10mg tablet, oseltamivir 75mg tablet, amlodipine 5mg tablet, and atenolol 50mg tablet.

Also read: Only modern medicines permitted for treatment of COVID-19

In addition, the ministry has also provided a general list containing essential drugs that are projected to be required in the country during next three-month. The list includes non-steroidal anti-inflammatory agents, antibacterial agents, anti-fungal drugs, drugs affecting blood, cardiovascular drugs, dermatological drugs, antiallergic medicine/medicine for anaphylaxis, respiratory tract drugs, anticonvulsants/antiepileptics, antianxiety medications, hormonal products, anesthetic/analgesic agents etc.

DCGI in a letter asked state and Union territory drug controllers to monitor stockpiling of drugs including sanitizers and keep strict vigil on any possible shortages of the drugs caused by disruption to global supplies.

The stake and UT drugs control authorities were also instructed to maintain checks on availability of drugs for use in the treatment of COVID-19 disease in consultation with relevant stakeholders, develop a pandemic communication strategy with dealers, distributors and pharmacies to help determine available quantities of medical supplies used in slowing the spread of the virus.

The DCGI further asked them to ensure that the drug formulations are available at affordable prices in the market and prevent black-marketing, illegal hoarding and artificial shortages as well as ensure that retailers/wholesalers continue to adhere to normal ordering patterns and avoid stockpiling of medications. Stockpiling of medications can result in reduced volume of medicines in supply chains, which could compromise the ability of the healthcare system to respond to a crisis.

Accordingly DCGI has directed to chemists and druggists associations to ask their members to ensure availability of the drugs with assured quality at affordable price and to supplement the efforts of the government for management of the situation arising due to COVID-19 in the country.