The Union ministry of health and family welfare has directed to all state governments and Union territory administrations to promote rational use of hydroxychloroquine (HCQ) 2000 mg and azithromycin 500 mg tablets to ensure their availability in the domestic market in the wake of COVID-19 outbreak.
The health ministry has written to state governments and Union territory administrations in this regard on April 15, 2020 following reports of acute shortage of HCQ in some parts of the country due to panic buying.
The drug has been completely sold out at majority of drug stores in the country as people purchased it in bulk, believing that it will protect them against COVID-19. Confirming the shortage of HCQ, All India Organisation of Chemists and Druggists (AIOCD) general secretary Rajiv Singhal blamed panic buying for it. By Monday fresh stock of HCQ is coming to market, there will be no shortage, he added.
As per the clinical management protocol, HCQ in combination with azithromycin is to be considered as an off-label indication only in patients with severe COVID-19 and requiring ICU management, under close medical supervision and monitoring of its side effects, stated an advisory issued by Union ministry of health and family welfare.
Similarly, as per the protocol for prophylaxis for COVID-19 infection, HCQ has been prescribed only for asymptomatic healthcare workers and asymptomatic household contacts and laboratory confirmed cases, on the prescription of medical practitioner.
India is one of the largest suppliers of active pharmaceutical ingredient of HCQ and its formulation, hence there is no need for panic, said the advisory.
HCQ being touted as 'game changer' in the fight against the COVID-19 pandemic is used for treatment of rheumatoid arthritis, malaria and lupus.
The health ministry has already ensured more than adequate supply of HCQ tablets for all patients, health workers and household contacts of confirmed cases.
The ministry through a gazette notification last month had brought HCQ under Schedule H1 drug to regulate its sale, distribution and prevent its misuse by the general public in the wake of COVID-19 outbreak. Schedule H1 stipulates that the drug can be sold only on prescription.
The guidelines issued by the ministry stated that HCQ should be utilized as per prescription as it may have adverse effects on health and is not advised for patients with cardiac irregularities or those suffering for cardiac disease which can be harmful.
The Central government is taking steps to ensure that there is no hoarding of medicines and that all essential drugs are available at all medical stores across the country. Illegal sale or dispensing of HCQ will lead to legal action under Drugs and Cosmetics Act, 1940.
Earlier on April 13, 2020, National Pharmaceutical Pricing Authority (NPPA) had instructed AIOCD, a representative body of around 8.5 lakh chemists in the country to sell the same on prescription only as per direction of the government.
NPPA tasked with monitoring the availability of drugs has written to AIOCD in this regard to restrain panic buying of HCQ for prophylaxis for COVID-19 infection resulting in its short supply in the domestic market.
People are thronging medical stores to buy HCQ for prophylaxis of coronavirus infection following the recommendation of National Task Force for COVID-19 constituted by Indian Council of Medical Research (ICMR).
Following the NPPA direction, AIOCD has written to chemists from across the country on April 14, 2020 asking them to sell the drug on prescription only and provide limited quantity to the patients taking the same for long but on prescription only.
Ruling out the shortage of the HCQ in the country, Indian drug industry stated that there is enough stock of the drug in the country and drug firms are ready to ramp up the production to meet domestic as well as export requirements.