Maharashtra FDA allays fears of shortage of HCQ tabs either in govt hospital pharmacies or in retail pharmacies

Shardul Nautiyal, Mumbai

Thursday, May 7, 2020, 08:00 Hrs [IST]

Refuting the reports that there is shortage of hydroxychloroquine (HCQ) tablets in the drug retail supply chain in the state, the Maharashtra Food and Drug Administration (FDA) has acknowledged that there is adequate stock of HCQ tablets both in government hospital pharmacies and also in retailer pharmacies across the state.

Substantiating the same, the state FDA has also submitted its reports about HCQ drug availability to the Central Drugs Standard Control Organisation (CDSCO), which states that there is stock of 12,61,338 HCQ tablets at government hospital based pharmacies and 19,11,954 HCQ tablets with private retailers and stockists till date.

“Maharashtra FDA has sent updated stock details of HCQ to the CDSCO. It is also keeping a strict vigil on the movement of the stock of HCQ. As per Union health ministry, sale of these drugs should be strictly dispensed on the prescription of a registered medical practitioner (RMP). Hence, the state drug regulator has issued circulars to all chemists in the state to not sell these drugs without a valid prescription and the inspectorate staffs are also directed to monitor the sale of this drug,” informed J B Mantri, joint commissioner (HQ) Maharashtra Food and Drug Administration (FDA) and state drug controlling authority.

HCQ drug is now a Schedule H1 drug. Therefore, retailers are being extra cautious in dispensing the drug as they have to mandatorily maintain the record of sale and purchase, according to senior FDA officials associated with the development while clarifying that while common retailer may not keep the stock, the government hospital attached pharmacy stores have sufficient stock of HCQ drug.

“At present, adequate stock of the HCQ is available at most of the hospital based pharmacies and leading medical stores in Maharashtra. Maharashtra FDA has started 24x7 control room at its Mumbai head office for reporting issues related to availability of essential drugs through its toll free number 1800222365 and 022 26592362/ 26592263/ 26592365. Till date, Maharashtra FDA Office has not reported any issue of shortage of HCQ at any level,” Mantri further emphasized.

“HCQ production in the country has also been increased from 12.23 crore to 30 crore per month. The country has also released about 16 crore tablets of HCQ to Central and State institutions as well as pharmacies against requirement of about 2.5 crore tablets,” according to Department of Pharmaceuticals (DoP) secretary Dr P D Vaghela.

HCQ, an anti-malarial drug, is commonly used to treat rheumatoid arthritis, lupus and malaria. It decreases pain and swelling in arthritis patients. The drug has shot to popularity with clinical trials underway globally to investigate its possible use in treating the COVID-19 infected patients and also its use as a prophylactic medicine for COVID-19.

India had banned its export briefly, but later lifted its supply for the US. On April 1, 2020, the Centre made it mandatory for chemists to sell the medicine with doctor’s prescription only by including HCQ drug under Schedule H1 category.

In a notification on March 25, 2020, the government placed HCQ on a restricted items list and then put a blanket ban on any export of the drug on April 4, 2020. It later on revoked the ban on April 6, 2020, effectively overturning the previous notification.

Schedule H1 was introduced by the Centre through Gazette notification dated August 30, 2013 to check indiscriminate use of antibiotics, anti-TB and some other drugs in the country.