Monitor the adverse drug reactions associated with Hydroxychroloquine : Health ministry tells Drug Controller

New Delhi:  With questions being raised over the side effects of Hydroxychloroquine, the drug recommended for prophylactic use in certain conditions of COVID-19, the Union Health ministry was recently seen directing the apex drug regulator to ensure the pharmacovigilance for adverse drug reactions associated with the drug

A letter issued by the Ministry of  Ministry of Health and Family Welfare (MoHFW) to the Drug Controller General of India ( DCGI) directed, "Further, there is also a strong need to ensure that the prophylactic use of Hydroxychloroquine to be coupled with the pharmacovigilance for adverse drug reaction through self-reporting using Pharmacovigilance of India helpline/ application. The adverse drugs reaction on these drugs also needs to be analyzed."

Warning against stockpiling of medicines and creating supply chain shortages, the Union health ministry has directed the country's top drug regulator to ensure there is no shortage of essential and critical drugs pertaining to COVID-19 disease and to ensure no black marketing, legal holdings and stockpiling of drugs.

Further, the health ministry has asked the drug controller to conduct random market surveys and ensure availability of sufficient quantity of drugs in the domestic retail market besides ensuring that the products conform to all prescribed specifications.

In the letter issued by the Ministry of Health and Family Welfare (MoHFW), the Drug Controller General of India (DCGI) has been asked to maintain checks on the availability of drugs for use in the treatment of COVID-19 disease, in consultation with other agencies concerned such as National Centre for Disease Control (NCDC), Indian Council of Medical Research (ICMR), Indian Pharmaceutical Association (IPA) and other relevant state authorities and stakeholders.

"Monitor stockpiling and issue immediate approvals to the applications for the registration, manufacture and import of pharmaceuticals and sterilizers and tightening procedures to monitor for any possible shortages caused by disruption to global supplies," read the letter.

The health ministry said that given India's diverse population and possibly different prescription patterns for medication, the need for cross-sectional audits over time, particularly in patients with comorbidities will be crucial.

"Ongoing preparation and anticipation of the increase in medication needs, not just to battle the ongoing pandemic but of the regular medications consumed by the population on a regular basis is therefore crucial. To meet the objective and to supplement the efforts of the ministry to combat COVID-19, DGCI and other concern agencies are requested to take all necessary steps on a priority basis," the health ministry stated.

The apex drug regulator has been directed to 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.

"Ensure effective communication with the states and Union Territories through Resident Commissioners and also interactions with manufacturers. Also, to ensure that there is an effective regulatory mechanism of quality assured safe and effective medicines, vaccines and medical devices, including in-vitro diagnostics," the letter further read.

The drug controller also has to make sure that the formulations are available at affordable prices in the market and to prevent black marketing, legal holdings and creating artificial shortage through Department of Pharmaceuticals (DoP) and National Pharmaceutical Pricing Authority (NPPA) and all products conform with specifications approved by Central Drug Standard Control Organisation (CDSCO).

"Ensuring that pharmacists continue to adhere to normal ordering patterns and avoid stockpiling of medications. Stockpiling of medications can result in a reduced volume of medicines in the supply chain, which could compromise the ability of the healthcare system to respond to the crisis," read the letter.

"Besides ensuring the availability of drugs, it is also important to examine the utilization rate of medicines, to understand exactly how medicines are being used in practice and to prioritize interventions during such a pandemic," stated the health ministry to the drug controller.

The drug regulator has to review regular reports from national health agencies and manufacturers on drug availability and develop an integrated plan to reduce the impact of any global shortage of drug stocks.

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