The exporters of pharmaceutical products in Tamil Nadu can now have 24 hour services from the customs authorities to clear their export consignments. They need not wait for working days for clearing and forwarding services from the department, said Sanjay Kumar Agarwal, commissioner of Customs, Chennai Port.
“The facility is available for both exporters and importers. Even if the containers are coming on holidays or during night, they can get the products cleared by the customs. This facility will help bring down the transaction costs of the exporters and importers to a great extend. Exporters other than pharma can also utilize this facility,” he said while addressing a seminar on ‘GLP, CTD and Patent Awareness Programme’ organized by Pharmexcil in association with IDMA Tamil Nadu state branch.
He said the Ministry of commerce had set up a Task Force in October 2009 comprising of representatives from Federation of Indian Export Organisations (FIEO), FICCI, CII and other bodies to identify areas where more attention is called for to enhance the competitiveness of Indian exports. Based on its recommendations, the clearing facilities for dry containers at eight seaports in the country have been made round the clock (24 x 7). This facility is now available in Chennai port and can be availed of by the pharma exporters.
He said one-tenth of the pharma exports from the country is going from Chennai. The Chennai customs office has the facilities to undertake all the customs related work now. Last year the customs office in Chennai collected more revenue than previous years, Agarwal pointed out.
Later making a power point presentation on Good Laboratory Practices, PBN Prasad, the Deputy Drugs Controller, CDSCO, south zone, said it is the responsibility of the management of the pharmaceutical manufacturing companies to comply with the GLP requirements. The regulatory department has to be concerned about the quality, integrity and reliability of the laboratory data submitted by each company. He recalled that some products received from Latin American countries were rejected because of quality issues. All those products which are meant for exports and for domestic use must be tested as per the norms of GLP.
Adherence of GLP is now mandatory for all the manufacturing companies with Centre notifying the same through an order on November 10, 2008 under Schedule “L-1” of the Drugs and Cosmetics Rules, 1945 with effect from November 1, 2010. According to Prasad GLP is required to avoid repetition of testing and help keep the system under control.
The Schedule L1 mandates the manufacturing units to strictly adhere to good laboratory practices which are different from licensing requirements. This also demands the small and medium scale manufacturing units (SMEs) in the pharmaceutical sector to implement the norms. Further it urges the regulatory authorities in the centre and the state to improve the quality of testing, the deputy drugs controller said.