No NOC for Pharmaceutical Exports to Developed Countries: The
Central Drugs Standard Control Organisation (CDSCO) has relaxed the
drug regulatory clearance for the pharmaceutical exporters of India
to developed countries through wide No.DCGI/MISC/2015 (199) dated
on December 11, 2015. It has been decided that the requirement of
'no-objection certificates' with respect to Shipping Bills
from the port offices of the CDSCO for the export consignments to
USA, Canada, Japan, Australia and European Union shall not be
insisted with effect from January 1, 2016. This is being done in
pursuit to bring ease in the drug regulatory practices in India
related to export of drugs, medical devices and cosmetics. All the
stakeholders are however required to comply with the regulatory
requirements of the importing countries as per their specific
Regulation of e-Pharmacies: Circular issued by the Drugs
Controller General of India (DGCI) dated December 30, 2015 does not
impose any ban on e-pharmacies but only seeking strict adherence to
the Drugs and Cosmetics Act and Rules. Online players based act as
aggregators of both organised and unorganised retailers and should
fully comply with all the rules stated by the Drugs and Cosmetics
Act and should not allow any fulfillment of requirements without a
proper prescription. The Drugs and Cosmetic Rules, 1945, under
which the circular has been issued, regulates the sale and
distribution of drugs in the country and does not distinguish
between conventional and over-the-Internet sale of drugs. In the
recent past, a few trade bodies of offline pharmacies have filed
complaints stating that online medical stores are violating
provisions under the Act. In this regard, the All India Drugs
Control Officer's Confederation (AIDCOC) has in its letter to
the sub-committee on e-pharmacy, suggested few amendments in Drugs
and Cosmetics Rules, 1945, which include a separate part under
Drugs and Cosmetic Rules, 1945 be incorporated to recognize online
pharmacy including market place; market places should be required
to register with the state licensing authority in which such market
place (web platform) is located; market place should be subject to
separate set of conditions of registration certificate which should
include requirement of appointing registered pharmacist, ensuring
that orders for Schedule H, Schedule H1 and X drugs are forwarded
to the licensed pharmacy only if it is supported by valid
Proposed Cap on Sale Margins: With regard to the probe on
"astronomical" price mark-ups on generic medicines that
drug makers sell through distributors, as ordered by the Prime
Minister's Office, a senior official in the Department of
Pharmaceuticals (DoP) informed in mid January that a committee set
up last year under the DoP has proposed a cap of 35% to check
irrational margins on medicines. This margin is the margin which
wholesales and retailers earn by selling the medicines. A total of
680 medicines are under the National List of Essential Medicines (
NLEM) under the scheduled category of DPCO, 2013. The NPPA has
already fixed the ceiling prices in respect of 530 medicines.
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