Pharmabiz
 

Industry wants govt. to fast track regulatory approvals & renewals of licenses

Our Bureau, MumbaiWednesday, December 10, 2014, 08:00 Hrs  [IST]

Concerned by the huge loss incurred to the industry, due to delay in getting timely approvals or renewals of licences, industry wants the centre to take initiative towards fast tracking the same. Experts strongly feel that to boost the confidence of the industry, the government needs to focus on bringing inclusive development in the regulatory system at the earliest.

Industry wants government to be more aggressive towards bringing in pro active changes in the regulatory system like butting out bureaucratic red tape and fast tracking approval process of licences than just bringing in passive changes. This demand comes in the light of the recent composition of the expert committee and the subsequent sub committees under its leg last week by the Central Drugs Standard Control Organization (CDSCO) for examining and recommending changes for simplifying forms and formats, to be filled by the applicants to reduce their numbers.

Many feel that though the government’s initiative to simplify regulatory forms and formats is welcome, priority should have been given on first removing the bottlenecks in the system. Given that the industry is not happy with the current format adopted for regulatory work, however our biggest concern remains to be hazy and unorganised system that is not well tuned with the centre, pointed out a Source.

A highly placed source from the industry further informed that though this initiative is good, the industry will hardly benefit from the same. As the industry's biggest issue remains to be delayed response time and the subsequent time and money loss incurred due to the existing red tape in the undefined system.

“We are certainly encouraged by the fact that the government has finally started taking some steps towards addressing our issues, but what the government needs to realise is to tap the correct issues first and foremost, to ensure that it really helps the industry. One of our long-standing demands had been to create a single window system with uniform code of procedures across state to ensure timely and hassle free services. Any measure in this front will address most of our issues,” informed the source.

While expressing relief over the latest turn of events that shows governments keen interest in involving stakeholders in the decision making process, another source stressed that government should at the earliest also set up an expert committee to look in to expediting the approval, renewal, process of licences as well.

 
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