Maha FDA Continues Crackdown On Unethical Marketing Of Hand Sanitisers And Masks

Mumbai, 23 April 2020:

In yet another major crackdown on unethical marketing of hand sanitisers and masks, the Maharashtra Food and Drug Administration (FDA) has seized stock worth Rs. 1.80 crore hand sanitisers and masks based on 10,339 inspections over the past two weeks.

The state drug regulator has resolved around 121 cases of non-compliance to Essential Commodities (EC) Order and Drugs and Cosmetics (D&C) Act over the past one month based on 404 calls at Toll free number 1800222365 and 022 26592362/ 26592263/ 26592365.

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.

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 past. The FDA officials have maintained that they are keeping a strict vigil to maintain adequate supplies of hand sanitizers, masks and medicines in the state.

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 (including clean water, towels, etc.), capacity to promote improved compliance with hand hygiene by making the process faster and more convenient and minimisation of risks from adverse events because of increased safety associated with better acceptability and tolerance than other products.

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. Masks are of different types. The type of mask to be used is related to particular risk profile of the category of personnel and his/her work.

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 N-95 respirator mask. Pharmabiz