Maha FDA Detects 39 Cases Of Non-Compliance To EC Order

Mumbai, 11 May 2020:

In its ongoing crackdown on illegal sale of hand sanitisers and masks, the Maharashtra Food and Drug Administration (FDA) has detected 39 cases of non-compliance to Essential Commodities (EC) Order and Drugs and Cosmetics (D&C) Act out of the total 158 calls received through its toll free helpline numbers.

It has also seized stock worth Rs. 94 lakhs of hand sanitisers and masks based on 2,379 inspections and total 5 raids since April 21 till date. The state drug regulator had earlier seized stock worth Rs. 1.80 crore hand sanitisers and masks based on 10,339 inspections over the past two weeks.

The FDA officials have maintained that they are keeping a strict vigil to maintain adequate supplies of PPE kits, hand sanitizers, masks and medicines in the state. The state drug regulator has been receiving cases of non-compliance to EC Order and D&C Act over the past one month through its Toll free number 1800222365 and 022 26592362/ 26592263/ 26592365.

The state drug regulator has resolved around 121 cases of non-compliance D&C Act in the past based on 404 calls at Toll free numbers.

The Central government had notified EC Order, 2020 to regulate the production, quality, distribution and logistics of masks (2ply and 3ply surgical masks, N95 masks) and hand sanitisers for COVID-19 management. It was widely reported that the key ingredient to manufacture hand sanitiser like isopropyl alcohol (IPA) was being sold at exorbitant rates due to black marketing and creating artificial shortages.

The state regulator also conducted 54 raids on firms and seized of hand sanitisers and masks worth Rs. 1.77 crore based on 8,033 inspections in the month of March.

At present, alcohol-based hand sanitisers are the only known means for rapidly and effectively inactivating a wide array of potentially harmful microorganisms on hands.

WHO recommends alcohol-based hand sanitisers based on the following factors like evidence-based, intrinsic advantages of fast-acting and broad-spectrum microbicidal activity with a minimal risk of generating resistance to antimicrobial agents, suitability for use in resource-limited or remote areas with lack of accessibility to sinks or other facilities for hand hygiene.

The droplet precautions or airborne precautions using masks are crucial while dealing with a suspect or confirmed case of COVID-19 or performing aerosol generating procedures.

There are two types of masks which are recommended for various categories of personnel working in hospital or community settings, depending upon the work environment - triple layer medical mask and an N-95 respirator mask.

Maharashtra FDA has also appealed to the citizens to report all issues related to unavailability of medicines and black marketing of essential drugs and products at the toll free numbers. Pharmabiz