The Central Drugs Standard Control Organization (CDSCO)
of India will set up dedicated temperature and atmosphere-controlled
areas at airport terminals in India, to maintain the safety, efficacy,
and quality of imported and exported drugs and pharma products, in line
with the product requirements and good manufacturing practice
(GMP) compliance, within the cargo premises of the airports.
The Drugs Controller General of India (DCGI) Dr Surinder Singh, said,
“We have a budget of
crore for this initiative, and the first pharma zone will be set up at
the Indira Gandhi International Airport (IGIA), New Delhi.” Other
terminals where similar pharma zones will be established, once
initiated in New Delhi, include all the five international airports in
India, plus the Nhava Sheva seaport. These pharma zones have been set
up in the light of the increasing volumes of export and import of drugs
from the country over the years.
The CDSCO zeroed in on New Delhi to establish its first pharma zone,
primarily because of the increased number of new pharmaceutical
companies mushrooming in north India, due to the government policy
initiatives excise/ income tax incentives.
The current drugs exports from India is projected at
crore. India’s pharmaceutical exports mainly comprise of formulations
(over 55 percent) followed by bulk drugs (43 percent) and the remaining
comprises of herbal exports.
US law may hit Indian exporters
The proposed Foreign Manufacturers Legal Accountability Act of 2010
(FMLAA) seeks to protect US consumers by requiring foreign
manufacturers and producers to take direct responsibility on any
liability arising out of such manufacturers’ or producers’ products.
Expressing disappointment at yet another protectionist measure
emanating from the US, Chandrajit Banerjee, director general,
Confederation of Indian Industry (CII), New Delhi said, “CII’s
preliminary estimates suggest that the additional cost of compliance
with this new US law for Indian companies could be anywhere
crore ($300 to $500 mn). This would significantly impact the
competitiveness of Indian exports”.
The act requires all foreign manufacturers exporting packaged products
(that includes drugs, devices, cosmetics, biological products, consumer
products, chemical substances, new chemical substances and pesticides,
to establish a registered agent in the US, who would be in a position
to take legal responsibility for the liabilities arising out of these
products, thus also bringing Indian exporters into the ambit of US
The FMLAA would prove to be very expensive for Indian exporters,
especially for small and medium scale manufacturers and producers. For
one, the cost of hiring registered agents on a permanent basis will
prove prohibitive. Such a provision would be unjustified because many
Indian exporters do not export to the US all year round; some, not even
every year. This proposed law is also of grave concern because it
applies not just to finished products, but also to intermediates.
to initiate inspection of clinical trial sites
The Drugs Controller General of India (DCGI) announced that India is
soon to commence regular and on-the-spot inspections of clinical trial
sites to ensure transparency and volunteer safety in the country. This
could perhaps change the landscape of the clinical trial industry in
India, which has been beset with lapses in adherence to safety
Dr Surinder Singh, DCGI, said, “This will commence in September and we
will begin by inspecting trial sites in Bangalore, Mumbai, Kolkata,
Chennai and New Delhi. This will not just strengthen the clinical trial
scenario in India, but also ensure that volunteers are in safe hands
and there are no violations in protocols”.
For this, there will be a collaboration with the US Food and Drug
Administration, in terms of training of inspectors. “Altogether, we
have 169 inspectors. Out of this, 25 inspectors have been trained
already, and 20 more will be trained to audit these sites,” said Dr
In terms of conducting clinical trials, there have been a number of
loopholes in India, volunteer safety being one of them. Off late, a
number of big pharmaceutical companies have been conducting trials in
India, without being reviewed by the Ethics Committee.
In April 2010, the Indian government suspended trials in Indian States
for Merck’s cervical cancer vaccine, Gardasil, after reports of the
vaccine being allegedly tested on children, before being tested on
adults. This is how, putting in place a system of stringent checks and
balances becomes imperative.