15 June 2016
By: Mohammad Shahbaz Alam
New Delhi: June 15, 2016, The Indian pharmaceutical industry is estimated to be worth US$ 26 billion and planning to achieve US$ 50 billion by 2020.It is only possible when regulators will provide service to the industry people like a client.
It is very sad to acknowledge that a Guajarati company order is going to be expired soon because CDSCO has not accepted application for shelf life extension for export and CDSCO people suggested to file application online or submit in the regional office of CDSCO in Gujarat.
Now CDSCO has started accepting online application for import and medical device and not for shelf life extension for export. No icon is there in online portal. This is the one case came into my knowledge because my NGO Rab Di Meher”” gather this information with proof.”Why negligence is there and who will issue NOC in this case.
I really appreciate initiative taken by CDSCO to stop taking NOC for export for few regulated countries like Europe and America. My suggestion is country friendly, export NOC, product permission, COPP and FSC should be issued on fastest mode to strengthen export because without these four documents registration process gets delayed. Currently the procedure is very rubbish, firstly exporter has to apply for export NOC, and after getting NOC they apply for product permission and then apply for COPP and FSC. This procedure takes more than 2 months time.
Currently signing authority for product permission, COPP and FSC had gone for 15 days leave in Gandhinager office. It is not fair at all because show must go on by any means process should not be stoped.
Regulatory body has no single window service at the moment and they are not aware about TQM (Total Quality Management) tool. In TQM work cannot be stopped and alternate signing authority should be there if main signing authority is not available. Again if both the signing authority is not there in the office then third person should be assigned likewise.
It would be kind enough if regulator issues all four documents necessary for export registration from one office in one go then our export will grow faster and we can get more orders in advance.Yes offcourse then we can achieve vision 2020 of US$ 50 billion.