Drug control admn to begin online licensing

Ambika Sharma

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Tribune News Service

Solan, March 15

As a step towards ease of doing business Drug Control Administration (DCA) will soon initiate online certifications like Certificate of Pharmaceutical Product (COPP) for various export oriented units (EOUs) to enable speedier approvals.

The department was already in the process of introducing online licensing system which included both grant and renewal of a licence as well as product approvals.

A software XIDMIN has been developed by the NIC Gujarat and a two-day training was imparted to manufacturers as well as the staff of the DCA last week to attune them to its working.

The manufacturers have been directed to avail their password and ID by registering through the software and then upload their data pertaining to various certifications, products, etc., availed by them.

Drug Controller Navneet Marwaha while confirming the news said as many as 250 manufacturers have already availed their ID and password and about 50-70 manufacturers were registering on a daily basis. He said there were about 700 manufacturers. Though a three-month period has been set aside to complete this process, it could also begin early if registration is sought by all manufacturers.

A team of officials from the NIC Gujarat conducted a two-day workshop at Baddi last week to apprise the manufacturers and the staff of the DCA about the nitty-gritty of this software.

Marwaha said in the first stage online licensing and product approvals would be initiated and efforts were afoot to add various certifications including COPP to especially facilitate the EOUs. There were more than 130 units which had export certifications like WHO, US FDA, European Union, etc.

The introduction of the online system will facilitate speedier grant of licenses and various approvals in a transparent and time-bound manner where a manufacturer will not be required to visit any office. Issues like provision of adequate staff by rationalization of work were also being worked out to ensure optimal use of the existing staff, said Marwaha.

Since the Central Drug Standard Control Organisation was also in the process of introducing all online clearances, adopting such a system was the need of the hour.

Though few states like Maharashtra had begun online certification, it was yet to be adopted in totality. Other states like Gujarat, which housed a sizeable number of pharmaceutical manufacturers, was also yet to adopt it, thus making Himachal one of the first states to adopt it in totality.