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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)

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