DCGI office plans to extend tenure of drug test licences, export NOCs to 3 years
DCGI may go for an increased tenure of test licenses for drugs and extension of export NOCs for three years in a bid overhaul the existing systems of export. Pharmaceutical exporters have been experiencing serious problems in the international markets on account of delays in getting government approvals in the past.
The authorities are planning to extend the tenure of test licences, export NOCs and even the WHO GMP certificates from the existing one year to three years so that the exporters and manufacturers need not to go through the grind every year to renew their licences.
"We are open-minded. We can look at extending the tenures and make things more simple, but at the same time without compromising on regulatory aspects,'' DCGI Dr Surinder Singh disclosed recently, in response to the industry requests in this regard.
Instead of applying for export of a particular product to a particular country every time, the industry has requested for a more liberal regime. One of their demands was to issue NOC to a particular country for a specified quantity, without looking into the time limit for exporting the same. They also have urged the DCGI to look into abolishing the stipulation of purchase order as pre-requisite for seeking NOC.
Considering the requests, the DCGI office is likely to look into the possibility of issuing 'consolidated export approval' for a product for a longer period and to more than one destination. Though that is not easy to come through as import laws differed from country to country, at least extension of tenure from one year to three years minimum is likely on the cards.
However, the Finance Ministry under which the customs department works, has suggested looking into the implementation aspects of giving 'consolidated approvals' carefully and work it out with the Customs Department before finalising the proposal. There were instances like exporting drugs, banned in India, to other countries where they are not banned. And there could also be chance of manipulating the quantity of export some times, it was pointed out.
The test licences, currently given for one year, may also be extended upto three years so that the delay in clearance of applications being caused to manufacturers every year could be avoided, it is learnt. The DCGI office is also taking a favourable stand on extending the one-year tenure of WHO GMP certificates. The shortage of staff, faced by the CDSCO, however was cited as a problem in accepting the demand by the industry to centralise the system of WHO certification, without involving the state authorities.