FDA seizes sanitizers, masks and PPE kits worth over Rs. 6 lakhs
Based on 912 inspections done related to sanitizer, mask and PPE kits over the past one week, the Maharashtra Food and Drug Administration (FDA) has seized material worth Rs. 6,14,000 starting from May 8, 2020 to May 13, 2020.
On the basis of the secret information, raid was carried on May 7, 2020 at the premises of Vinayak Gaikwad situated at Nashik. Firm was involved in manufacturing of sanitizers and hand wash without a valid licence. Total seized material included sanitizers, hand wash, empty bottles, caps, printed labels and manufacturing utensils. The team of Maharashtra FDA officials which raided comprised drug inspector (DI), intelligence branch (IB), Nashik, with DIs More and Deshmukh led by Joint Commissioner (JC) Nashik and Sunil Bhardwaj JC Vigilance under the guidance of Maharashtra FDA Commissioner Arun Unhale.
During the week, the state drug regulator resolved around 11 cases of non-compliance to Essential Commodities (EC) Order and Drugs and Cosmetics (D&C) Act based on 58 calls at Toll free number 1800222365 and 022 26592362/26592263/26592365. The state regulator had seized stock worth Rs. 1.80 crore hand sanitisers and masks based on 10,339 inspections over the past two weeks.
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.
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.
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 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 N-95 respirator mask.