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Zonal Offices of CDSCO May Be Grated Powers For Issuing
Licences Under CDA
The Centre may tone down the much-criticised provision of issuing manufacturing
licences only by a cetralised agency based in Delhi under the proposed Central
Drug Authority of India, by empowering the zonal offices of the Central Drugs
Standard Control Organization (CDSCO) also to issue licences.
The Parliamentary standing committee on health on family welfare, which has been
examining the Drug and Cosmetics (Amendment) Bill 2007 seeking to set up the CDA,
is likely to make a recommendation in this regard. The Committee has recommended
that instead of entrusting entire powers of the State licensing authorities with
the CDA, four zonal offices of the CDSCO should also be made licensing
authorities for the respective regions, it is learnt.
The clause in the bill to centralise the licensing system had invited srath from
different quarters especially the small and medium scale companies and
associations representing them during the sitting of the parliamentary panel
headed by Amar Singh. The small scale drug manufacturers accused the proposed
CDA as a ‘tool’ to make their lives worse. It would be nearly impossible for the
manufacturers based in different corners of the country to come and seek
licences from Delhi for every drug, they claimed.
Taking into consideration theses difficulties, the Parliamentary committee is
understood to have made the suggestion for devolution of the powers to the zonal
offices, so that the original goals of having a centralised regime for
streamlining and monitoring the sector could still be met even while ensuring
better logistics for the industry. As zonal wings are directly manned by the
Central office, the entire licensing system still remain centralised. This would
also lead to procedural delays which could happen due to piling up of
applications at one point.
(Ref : Chronicle Pharmabiz dated October 2, 2008)
ThermoFisher To Make A’bad Global Clinical Packaging Hub
No Sooner had it injected $100 million in acquiring two Indian companies and
setting up a greenfield clinical trials supplies packaging facility in Ahmedabad
than TermoFisher Scientific Inc is hungry for more action in India.
The $11-billion US-based global R&D equipment maker, supplier and services giant
which is targeting revenues of $125 million in 2008 in India, is eyeing more
Indian acquisitions after buying out Qualigens and Chemito. It is also making
plans to establish nearly 30% of its global clinical supplies packaging capacity
in Ahmedabad, up from the existing 7% of global capacity.
"India being a key component of our growth strategy, we are interested in good
buys in the $10-50 million turnover in speciality diagnostics equipments and
biosciences reagents space," Marjin E Dekkers, president and chief executive
officer, ThermoFisher Scientific, said.
Dekkers, who was in town to unveil the company’s sixth clinical trials supply
packaging facility in the world after US, UK and Switzerland, said the company
was looking at ongoing slowdown as an opportunity for expansion through organic
and inorganic route.
"With emphasis on cutting R&D costs, MNCs are looking at outsourcing clinical
trials and research work to low-cost destinations like India," he explained,
According to him, a large patient pool, the largest number of FDA-approved
facilities outside US, 7 lakh speciality hospitals beds, 221 medical colleges,
skilled English speaking medical professionals and scientists and 50% lower
costs than US and Europe India an ideal clinical trials destination.
(Ref : The Times of India dated November 20, 2008) |
