In a bid to promote the concept of Good Distribution Practices, the CDSCO has planned a Pharma Zone project in three cities of New Delhi, Mumbai and Hyderabad. The Pharma Zones will come up within the international airports. The first of the Pharma Zone's is now underway at the Indira Gandhi International Airport, New Delhi at a cost of Rs 7 crore.

The Pharma Zones will be equipped with cold storage facility, cold chain vans and labs to offer services like the drug sampling, medical device audits, pharmcovigilance and quality control and detect spurious and narcotic drug movement. It will avert the chance of cross-contamination and drugs need to be stored at varied temperatures from -20 deg C to ensure efficacy.

The stake holders of the project include infrastructure majors GVK and GMR, along with Cargo & Shipping Agents, importers and the pharma industry. While GVK is handling the project at Mumbai, GMR will oversee the construction at New Delhi and Hyderabad.

"To begin with, we will consider the economic viability of the Pharma zones at these three locations before we go ahead with other cities. The key objective of the Pharma Zones is that it will help increase the credibility of Indian pharma industry among its international customers. Moreover it will facilitate drug manufacturers with convenient clearances," said Dr Surinder Singh, Drugs Controller General of India.

India pharma industry is valued at around US$18 billion of which 50 per cent are exports. Over 90 per cent of pharma exports are through airports. The management of these three Pharma Zones would be decided during the next meeting, he added.

Delving on the growing importance of the Indian regulatory authority, Debashish Panda, joint secretary, drugs, Ministry of health and family welfare stated that considerable interest has been evinced by international regulators from France and Brazil to team up for an alliance. This will help both the regulatory authorities to understand the needs of the sector.

The regulatory authority also provided insight on India being the first country to get the re-approval for vaccines from the WHO recently and are awaiting for the notification of the same.

Currently DCGI is looking at a gamut of operations including clinical trials for which new rules are framed to benchmark clinical research organizations. It is also now going to maintain the clinical trial data registry. Around 40 per cent of the bio-equivalence studies are taking place from India and therefore need for a dedicated team for the clinical trial sector is mandated. The US FDA has also started to train Indian drug inspectors to gear up for stringent audits, stated Dr Singh.

Meanwhile, in the wake of the growing activity DCGI is also hard pressed for staff. The estimated vacancy is 111 personnel of which 56 posts are filled up. Interviews are on for the remaining vacancies. In addition, the Union government has also sanctioned an additional 71 posts in the technical cadre, besides permitting contractual jobs, said Dr Singh.