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Productivity Council finds 40% SSI
units shut due to enforcement of GMP norms
Almost 40 per cent of the small scale drug units had to close down their
operations during the past 3 years as they were not able to bear the cost of
implementing Schedule M norms. The Union health ministry enforced the Schedule M
norms from 2005 as a step towards improving the operations of the small scale
sector in the new competitive environment.
This fact came into the notice of the National Productivity Council (NPC) during
its sample survey in May and June covering the SSI clusters located in Karnal,
Chandigarh, Mumbai, Indore, Ahmedabad, Baroda, Himatnagar, Vatva and
Surendranagar to assess the ground realities in connection with the proposed
Pharmaceutical Technology Upgradation Fund (PTUF) Scheme, it is learnt. The
Chemicals Ministry, which has conceived the scheme, had asked the Council to
study the SSI sector before finalising the project.
The units have in general cited lack of funds and excise duty structure as the
main reasons for failing to complete the implementation of Schedule M norms, as
the Council found that R&D was practically absent in these units.
The study also has reportedly assessed that about 50 per cent of closed units
and around 4000 running units would get the benefit of the scheme. The majority
of units were at different stages of compliance of Schedule M and substantial
improvement has been noted in different aspects like layout design,
housekeeping, protective instruments, new machineries for tablet/capsule making,
coating, printing and packaging and bottle cleaning. About 10 per cent of units
were found to have obtained ISO 9001 quality certification.
However, areas of concern were training of employees, documentation including
computerisation, lab equipments, good laboratory practices, quality management
systems, safety, lack of professional guidance to implement the norms and the
absence of technical forums for the SSI industry.
It was found that 95 per cent of SSI units were principally focused towards
manufacturing of tablets and capsules. But R&D was practically absent in all the
units.
Before implementation of Schedule M, the SSI units were running mainly to comply
with the pharmacopoeia requirements without much knowledge and concern about
technology, manufacturing environment, quality systems, documentation and health
and safety, the Council observed.
(Ref: Chronicle Pharmabiz dated 17 August 2008)
To make the inspections and other related activities in the country more
frequent and foolproof, the US FDA may soon establish its offices in Delhi,
Mumbai and Hyderabad in India.
According to sources, the proposal to establish US FDA offices in the country is
in an advanced stage and it may see the light of the day soon. A US FDA
delegation had recently visited India and had held detailed discussions with
Union health minister Dr Anbumani Ramadoss in this regard. The delegation also
met senior health ministry officials including Drug Controller General of India
(DCGI) Dr Surinder Singh and discussed the plan to establish three offices in
India. Earlier, the proposal was to establish only one office in Delhi, but it
has been changed to set up two more offices in Mumbai and Hyderabad, sources
said.
The establishment of the US FDA offices in the country will result in the
frequent inspection of the US FDA approved plants in the country. There are
around 100 US FDA approved plants in different parts of the country. With
offices in Delhi, Mumbai and Hyderabad, the US FDA officials can audit these
facilities, even without any notice. There can be surprise visits also by these
officials. At present the US FDA officials inspect these facilities periodically
to ensure that these units comply with the good manufacturing practices to
maintain the quality of the products. Usually, they come for audit with prior
notice.
After the establishment of US FDA offices in India, the inspections will be
carried out jointly by the officials of US FDA and the DCGI office. Apart from
the approved plants, the joint team will audit the facilities which will apply
for US FDA approval. The Health Ministry may make the joint inspection
mandatory, sources said.
(Ref: Chronicle Pharmabiz dated 17 August 2008)
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