According to the Food Safety and Standards (Licensing and Registration of Food Business) Amendment Regulations, 2018, an
e-commerce FBO (which includes sellers and brand owner who display or offer their food products, through e-commerce, and
providers of transportation services for the food products and/or providing last mile delivery transportation to the end
consumers), is required to obtain central license from the concerned central licensing authority.

FSSAI Guidance Note on ‘Food Hygiene and Safety Guidelines for Food Businesses during Coronavirus Disease (COVID-
19) Pandemic’ (“COVID-19 Guidance Note”)

The COVID-19 Guidance Note was issued with an intent to provide guidance to food businesses, including their personnel
involved in handling of food and other employees to prevent spread of COVID-19 in the work environment and any incidental
contamination of food/food packages. It also provides guidance in relation to operative mechanism such as establishment of an
in-house emergency response team in large food businesses to deal with suspected COVID-19 infections effectively. It
mandates that employers should have a COVID-19 screening protocol in place to screen all personnel entering the premise. All
the employees or visitors should be screened at entry point for the symptoms of COVID-19 such as, among others, temperature
(using non-contact type thermometer), cough, cold etc. The entrance shall mandatorily have measures installed for hand
hygiene. Employees and food handlers should be encouraged to self-declare any symptoms of any respiratory illness before
visiting the premises. To spread awareness and contain the spread of the disease, employers should employ and ensure
compliance with numerous measures such as, among others, display of posters/standees/audio visuals on preventive measures
for COVID-19, frequent usage of alcohol-based sanitizers, avoidance of close contact with symptomatic personnel, usage of
face masks, and frequent cleaning and disinfection. Food sectors involved in food services, takeaways and deliveries shall
ensure, among others, that the food service area shall be thoroughly cleaned and disinfected after every meal, hand wash
facilities should be made available to the workers, employees wear a clean uniform, mask/face cover, gloves and head covers
at all times, adoption of contactless delivery. The COVID-19 Guidance Note prescribes guidelines for management of the food
establishment to handle a COVID-19 suspect/positive case in accordance with the guidelines issued by Ministry of Health and
Family Welfare and clean and disinfect the premises accessed by the COVID-19 positive person.

The COVID-19 Guidance Note mandates strict adherence to General Hygiene Practices specified under Schedule IV of Food
Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 (“Schedule IV”). Schedule IV
enumerates multiple compulsory measures to be adopted by FBOs in the interest of human nutrition, safety, and hygiene.
Schedule IV mandates that the premises shall be clean, adequately lighted, and ventilated, and sufficient free space for
movement shall be made available. In relation to personal hygiene — all employees should wash their hands properly and they
should be made aware of measures to avoid cross-contamination. Further, among other things, eating, chewing, smoking,
spitting and nose blowing shall be prohibited within the premises especially while handling food, and persons suffering from
infectious diseases shall not be permitted to work. Any cuts or wounds shall remain covered at all time and the person should
not be allowed to come in direct contact with food.

Medical Devices Rules, 2017 (“Medical Devices Rules”) and the Medical Devices (Amendment) Rules, 2020

The Medical Devices Rules governs the registration and licenses by importers and manufacturers of medical devices. It is
primarily focused on the quality and safety control to ensure the highest standards assurance of a medical device before they
can be distributed / sold in the market. It has been classified according to patient risk in different classes (Class A, B, C & D)
to ensures that patients have access to high quality, safe, and effective medical devices, by restricting their access to the unsafe
and sub-standard products. The State Licensing Authority (State Drugs Controller) is the competent authority for all matters
relating to these devices. It will be entitled to enforce all norms regarding the sale, manufacturer, stock, and any other practice
related to Class A and Class B medical devices. The Central Licensing Authority is responsible for providing the required
licenses for the import and manufacture of Class C and Class D products. According to the Medical Devices (Amendment)
Rules, 2020, the manufacturers or importers of Medical Devices will be required to compulsorily register their medical devices
with the Drugs Controller General of India. The Central Licensing Authority may verify the documents at any point of time and
investigate quality or safety related failure or complaint. In case the registrant fails to comply with any of the provisions of
these rules, it may after giving the registrant an opportunity to show-cause as to why an order for cancellation of registration
should not be passed, by an order in writing stating the reasons thereof, cancel the registration number or suspend it for such
period as it thinks fit either wholly or in respect of any of the medical devices to which it relates.

Telangana Allopathic Private Medical Care Establishments (Registration and Regulation) Act, 2002 (“Private Medical Care
Establishments Act”)

The Private Medical Care Establishments Act governs the registration and regulation of private medical care establishments.
The usage of 'Private Medical Care Establishments' which means a clinic, a consultation room, a hospital, a medical laboratory,
a diagnostic centre, a maternity home, a nursing home, an infertility or fertility clinic, a physiotherapy establishment, a
polyclinic and any other like establishment providing inpatient or day care procedures, including surgery facilities by whatever
name called, and administered or maintained by a person or body of persons whether incorporated or not, other than the Central
or the State Government or any local authority or any other authority or body constituted by or under any Statute of a competent
Legislature. An application for registration shall be made to the authority within three months from such commencement in

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