The FSSAI has launched a new mobile application
("App") which allows food business
operators to check their compliance and allows customers to raise
complaints regarding food safety. This App is available on android
platform, with built-in geolocation function which allows all
android device users to automatically detect their location. While
food business operators ("FBOs") can use
this for registration and to check compliance of multiple outlets,
customers can use the same to file complaints regarding quality of
packaged food and ready-to-eat food served in outlets along with
photos. The App also allows FBOs to use the food safety inspection
tool to either self-check compliance or seek expert inspection and
generate automated reports for multiple locations. At the same time
it also has provision for the customers to enter the
license/registration number of the FBO to submit information about
manufacturing date, expiry date and general adherence to food
safety standards by any food business operator. The customer is
also given the option of rating the overall hygiene of the food
serving establishment. The App also provides access to regular
updates about new FSSAI guidelines and directives along with
webinars for online training in license/registration process,
packaging and labeling and food product approval to help FBOs as
well as customers understand the regulatory parameters better.
PSA view: The App is one of the recent moves by
the sectoral regulator, FSSAI to revamp its image among consumers
as well as food business operators. It will serve as an important
and convenient tool for the consumers to report contravention of
food safety standards and at the same time allow food business
operators to ensure compliance to such standards and prepare for
inspections and approvals.
2. Ban on 344 fixed dose combination drugs
Vide a series of standing orders published by a notification
dated March 10, 2016, the Ministry of Health and Family Welfare
("MoHFW") banned "the manufacture
for sale, sale and distribution for human use" of 344
different fixed dose combinations drugs ("FDC
Drugs"). FDC Drugs, which are made by combining
two or more approved drugs in a fixed ratio into a single dosage,
require the prior approval of Central Drugs Standard Control
Organization ("CDSCO"). These include
several common cough syrup solutions, analgesics and antibiotic
combinations, many of which are sold over the counter. This move
comes after an expert committee formed to examine the efficacy of
these drug combinations recommended that certain fixed dose
combinations had no therapeutic justification and were likely to
pose risk to humans. The MoHFW highlights that the banned drugs
have safer alternatives available in the market. Several
manufacturers of affected products, including Pfizer, Abbott,
Macleods Pharma and Glenmark Pharmaceuticals have appealed to
the courts and received interim injunctions against these standing
PSA view: This move has hit the revenue and
sales of the over the counter drugs in India. However, the bigger
picture suggests that this would also result in improving the
regulation of FDC drugs. India has several such FDC Drugs which are
unavailable in other states like UK and the USA. The Expert
Committee recommendation indicates that some of these fixed dose
combinations might pose certain risks in the long term which
required attention from the CDCSO. With a stay on the ban obtained
by various leading drug manufacturing companies, we have to await a
final decision on the validity of these standing orders to see its
long term effect on the over the counter drug market in India.
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