Exports of 13 APIs - including paracetamol,
tinidazole, metronidazole, vitamin B1, vitamin B6, vitamin B12, acyclovir,
progesterone - along with formulations made from these APIs, would be
restricted.
Illustration: Uttam Ghosh
In the wake
of the coronavirus (Covid-19) outbreak and supply disruptions from China, India
on Tuesday “restricted” exports of 13 active pharmaceutical ingredients (APIs)
and their formulations to ensure there was no shortage of key drugs.
The
Directorate General of Foreign Trade (DGFT) said in a notification issued on
Tuesday that exports of 13 APIs - including paracetamol, tinidazole
(antibiotic), metronidazole (antibiotic), vitamin B1, vitamin B6, vitamin B12,
acyclovir (anti-viral), progesterone (hormone) - along with formulations made
from these APIs, would be restricted.
“Exporters of
these items would now have to take government approval before they can export.
"This
will help to ensure that key drugs and their raw materials are not exported in
large quantities from the country and there is no shortage here,” he said.
This is a
temporary measure, he added.
“Supplies
have started coming from China, but factories in Hubei province are still not
functioning normally.
"Therefore,
as a precautionary measure, the government has taken this step. We will lift
the restrictions as soon the situation normalises,” the official said.
The managing
director of a Mumbai-based mid-sized firm, which exports to the US, said the
move would practically stall exports of these APIs and formulations.
“The DGFT
notification refers to Schedule 2 of the ITC (HS) Export Policy, 2018, which
deals with restricted items.
"To
secure the necessary no objection certificate from the relevant departments
would involve a four-stage process that takes at least 30-45 days to complete,”
he said.
In such a
situation, exports would nearly come to a standstill for a month or so.
Sudarshan
Jain, secretary general of the Indian Pharmaceutical Alliance (IPA), said they
were waiting for the finer details on how the restrictions would be imposed.
The
department of pharmaceuticals (DoP) had formed a panel to examine the situation,
and it had recommended restrictions be imposed on exports of 12 APIs.
Industry
claimed that there was enough stock of raw material in the country to take care
of immediate needs.
A Vaidheesh,
managing director of GSK India, said the government was cautious given the
uncertainty about supplies and the decision would help if there was a big
outbreak here.
According to
Pharmaceuticals Export Promotion Council (Pharmexcil) estimates, India is set
to beat financial year 2018-19’s (FY19’s) export figures this year.
Between April
and December, pharma exports clocked an 11.5 per cent growth over the
corresponding period the previous year, and the December quarter was
particularly buoyant (clocking a 14.6 per cent growth).
Total exports
were likely to touch $22 billion in FY20, beating FY19’s $19.13 billion.
Exports
account for about half the Indian pharma industry, estimated to be worth $39-40
billion.
Pharmexcil
has requested relaxation in restrictions.
It said if
restrictions are imposed with immediate effect it could result in financial
losses for exporters.
Pharmexcil
said failure to meet commitments could result in cancellation of entire orders
or huge penalties.
Pharmexcil
has requested DGFT to allow free export of drugs manufactured before the
notification and those lying at ports.
It also
requested DGFT consider the feasibility to exempt drugs manufactured for
exports to be exempted.
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