1. DCGI's sub-committee to frame guidelines on regulation
of online pharmacies
With the recent surge in e-commerce permeating into the drugs
and pharmaceutical industry, state food and drugs administration
("FDA") authorities are frowning upon
online pharmacies. The Maharashtra FDA had initiated action against
online marketplaces like SnapDeal and Amazon while the Gujarat FDA
too had registered a case against certain online pharmacies.
Realizing the need for constituting guidelines for online
pharmacies, the DGCI has formed a sub-committee under the
chairmanship of Harshadeep Kamble, Commissioner Food and Drug's
Administration & Food Safety Commissioner, Maharashtra, to
assess the feasibility of online pharmacies. The sub-committee is
also in consultation with state drug controllers, trade bodies,
pharmacy chains, e-tailers, states chemists and druggists
associations, and consumer forums. The sub-committee is seeking to
allow online sale of drugs while putting in place additional
safeguards for pharmacy licensing and sale of over the counter
drugs, and recognition of electronic record of prescriptions in
terms of the Rules.
PSA view: The Drugs and Cosmetics Rules, 1945
require a pharmacist to stamp the prescription after dispensing the
medicine. In case of online pharmacy this mandate cannot be met
with. This is precisely the reason why the authorities get a reason
to frown upon online pharmacies. But the question here is, do the
brick and mortar pharmacies adhere by this rule? The answer is
"No". Let us wait and watch and see what the guidelines
2. FSSAI scraps product approval advisory after Supreme Court
The FSSAI had introduced the product approval advisory on May
11, 2013 to streamline the product approval procedure for food
products for which the standards are not specified under Food
Safety Standards Act, 2006 ("Act"),
rules and regulations made thereunder. In August, 2014, Vital
Neutraceuticals Private Limited and lobby group Indian Drug
Manufacturers' Association challenged the FSSAI's product
approval advisory, on the grounds that it involved arbitrary and
non-scientific criteria for product approval and was beyond its
powers as provided by the Act, which was upheld by the Bombay High
Court. The Supreme Court, in September, 2015 has dismissed the
appeal against the Bombay High Court order, following which the
FSSAI has issued a notification withdrawing its product approval
PSA view: The controversy has arisen in the
wake of the product approval advisory extending to food
items/ingredients/additives covered within Section 22 of the Act,
which also includes "proprietary foods". This was posing
additional delay in launch of packaged foods for the manufacturers,
who are already burdened with pre-marketing FSSAI compliances
involving labeling, manufacturing license, good manufacturing
practices (GMPs), advertisements and import licenses. However, the
FSSAI is in the process of notifying guidelines for proprietary
foods, health supplements and additives, which were not covered
earlier under the Food Safety and Standards Regulations of 2011.
These guidelines have been put up on the FSSAI website for inviting
comments from the public and the stakeholders. This move furthers
the FSSAI's efforts to bring domestic food safety and security
standards in line with the international standards prescribed under
3. DTAB has ruled out double animal testing for approval of new
drugs and clinical trials in India
The DTAB recently recommended that repeated animal testing by
the Central Drugs Standard Control Organization was not required
for permission for a new drug or clinical trial. This ruling was
based on the fact that India is a signatory to the Organisation for
Economic Co-operation and Development
("OECD") agreement on "mutual
acceptance of data" since 2011, which mandates that "test
data generated in any member country in accordance with OECD Test
Guidelines and Principles of Good Laboratory Practice
("GLP") shall be accepted in other
member countries". The committee deliberated and agreed that
"for drugs approved in other countries where complete
toxicological data generated in a GLP certified laboratory and in
alignment with the requirements prescribed under the Drugs and
Cosmetics Act, 1940 and Rules, 1945 (Schedule Y), further toxicity
study may not be required if complete data as per prescribed
requirements is submitted during application for new drug
PSA view: This ruling not only appeals to the
organizations lobbying for animal rights but also eases the burden
on the pharmaceutical industry by reducing their expenditure on
such tests and eliminating one step in the process for the launch
of new drugs in the Indian market.
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