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Policy anomalies mar Indian API firms, help China rule the roost
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Arun Srinivasan, New Delhi
January 12 , 2018
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As increased dependence on import of active pharmaceutical ingredients
(APIs) from China is raising national security concerns, serious
anomalies in the current regulatory framework are destroying the
indigenous manufacturing sector, it is learnt.
The existing rules
don’t allow a domestic manufacturer to go for capacity expansion or
diversification to meet market demand without prior consent from
pollution control boards (PCBs) even if there is no change in pollution
load. The approval can take up to six months to arrive.
“The
firms should be allowed to make changes in product mix and increase
capacity if there is no change in pollution load after intimating the
PCB concerned instead of waiting for their green signal. Moreover, as
per existing norms, individual units which are connected to central
effluent treatment plants (CETPs) are required to treat their effluent
to the same level as mandatorily required by the CETP. This is double
effort and leads to steep rise in capital expenditure,” Yogin Majmudar,
chairman of bulk drugs committee, Indian Drug Manufacturers Association
(IDMA), told Pharmabiz.
“The volume of effluent generated from
API manufacturing is insignificant compared to large chemical plants.
Wherever there is a functional CETP, connected units should be allowed
to send effluent after neutralising it. With this single measure,
treatment cost, which is more than 10 per cent of the total cost, will
come down substantially. It will help us compete with Chinese firms in
pricing,” Majmudar added.
Another major impediment to the
indigenous industry is the extremely low registration and inspection
fees for pharma product exporters to India. Inspection of API units is
also not mandatory. China charges hefty registration fees and takes more
than 2 years to grant permission.
If proper and regular
inspections are conducted, many Chinese bulk drug exporters will be out
of the game, industry sources say. The argument holds water as recently
India’s drug regulator Drug Controller General of India (DCGI) has
banned the import of ingredients of drugs from six major Chinese
pharmaceutical firms citing quality issues and rule violations.
In
its order, the Central Drug Standards Control Organisation (CDSCO) said
the APIs supplied by these firms may lead to health risks. Similar
orders have been sent out to port offices so that their products don’t
enter the country.
According to official figures, India imports about 84 per cent of its API requirement. APIs worth Rs.13,853 crore were purchased from China in 2015-16 or 65.3 per cent of the Rs.21,217
crore total APIs consumed in the country. These included ingredients
for essential antibiotics. The rest came from Europe, Japan and the US.
“As
of now, there is no specified time limit for approvals for manufacture
or export of new bulk drugs. Precious time can be saved by making
approval procedures time-bound for all manufacturing permissions. For
exports, NOCs may be dispensed with for all types of APIs as long as
they confirm to Pharmacopeia standards certified by the manufacturer
exporter,” an industry representative pointed out.
Instead of
reforming archaic rules, the government is focused on announcing mega
ventures, the person added. The much-publicised project to develop bulk
drug manufacturing zones, which was expected to give the sector a fresh
fillip, has hit the wall in the absence a conducive regulatory
environment. API and intermediate units are spread across the country
with a significant presence in four or five states. So the benefit of
common facilities such as CETP, subsidised power and land availability
is not available making the industry uncompetitive.
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