iNdiA cLiNical ReSeArcH Indian CDSCO to set up pharma zones at airport terminals
Mohan Asrani
The Central Drugs Standard Control Organisation (CDSCO) will set up
separate dedicated temperature and atmosphere-controlled areas at
airport terminals in India to maintain the safety, efficacy, and
quality of imported and export drugs and pharma products, in line with
the product requirements and GMP compliance, within the cargo premises
of the airports.
The Drugs Controller General of India (DCGI), India, Dr Surinder
Singh, mentioned, “We have a budget of Rs 25 crores 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 such pharma zones will be established, once initiated
in New Delhi, include all the five international airports in India,
plus the Nhava Sheva sea port. 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.
Requirements in a pharma zone include a : comfort zone having
temperature below 25° C (22-25° C) for examination, storage in bonded
area, cold room facility to maintain varied temperature (-20, +2-8
Degrees Centigrade ), humidity control to prevent moisture damage in
summer and freeze in winter, sampling, dispensing area and basic
testing facility, Palletisation area to ensure preparation of pallets
in the cool chain facility, fixed location system for different dose
forms, provision to keep narcotic and allied, separately.
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
excise/ income tax incentives. Moreover, New Delhi has seen an
increase in volumes of Exports and Imports in last 4 years, based on
the statistics of shipments handled by ADC office at IGIA.
In terms of area land space, there have been volume projections
vis-à-vis possible area requirement by the CDSCO. The current exports
area requirement comes to 458 sq. m, while the current imports area
requirement comes is 193 sq. m, thus aggregating the total area
requirement to 651 sq. m. Projected exports area requirement is
about 1907 sq. m, while the projected imports area requirement in the
coming years would be 327 sq m. Besides this, there has been an
additional area requirement of about 1400 sq.m. Thus, the total area
to meet the projected requirements is about 3700 sq. m.
The current drugs exports is projected at Rs 42,000 crores. India's
pharmaceutical exports mainly comprise of formulations (over 55 per
cent) followed by bulk drugs ( 43 per cent) and the remaining
comprises of herbal exports. The exports have been on the rise at a
CAGR of 21 per cent in the last five years. The US is the top export
destination for Indian pharma companies, with a share close to 20
percent. The other major export destinations include Russia, Germany,
Australia and the UK. In 2008-2009, according to the Department of
pharmaceuticals, import of drugs to India was about Rs 8552 crores.