The Hindu Business Line : Centre to upgrade Drug Controller office in Gujarat

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Centre to upgrade Drug Controller office in Gujarat

DGCI plans compulsory registration for all clinical trial research organisations and such organisations will be audited.

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Ahmedabad, March 12 The Centre has decided to upgrade the status of the Drug Controller’s office in Gujarat to zonal office keeping in view of the concentration of pharmaceutical, medical devices and growing clinical research organisations in the State, Mr Surinder Singh, Drug Controller-General of India (DGCI), said here today.

This would facilitate convenience, speedy clearance, and approval for the pharmaceutical, medical devices and clinical research industry based in Gujarat, he said at the opening session of the three-day exhibition network event for fine and specialty chemicals and pharmaceuticals industries, ‘InformEx India 2009’ here.

Mr Singh, who was the guest of honour, elaborated upon the measures the Centre has initiated to streamline the procedures for Government clearances and approval for pharmaceutical and medical devices industry as well as to ensure patient safety and safe clinical research practices.

Audit of clinical trials

The DCGI was working to implement best regulatory practices in medical, bio-medical and medical devices industry. He urged the industry to adopt global trends and practices to survive in these competitive times. Sixty two more posts of drug inspectors have been cleared, which would help in speedy clearing of procedures, he added.

To enable more safety and transparency, registration of all organisations involved in clinical trials and research will be made mandatory and such organisations will be audited for adherence of protocols and laid down procedures for patient safety.

He also informed that a registry of clinical research organisations will be made which will have important data such as design of CR, target and sponsors’ details etc.

He said that in consultation with the Medical Council of India, pharmacology vigilance centres will be established in select medical colleges to oversee the various aspects of safety and adherence of guidelines.

The e-governance initiatives are also being stepped up to increase transparency in the procedures and clearances, and encourage adaptation of the best practices in global environment.

InfomEx India

InformEx India is the first and only edition of InformEx outside the US, which has a 25-year history of serving manufacturers and buyers of specialty and fine chemicals from all over the world, according to a release.

More then 1,000 participants have registered from across India and countries such as the US, Japan, Singapore, South Africa. InformEx India is expected to draw more than 3,000 visitors in three days.

Over 100 top chemical and pharmaceutical companies will participate in the exhibition.

InformEx India is an information exchange event between buyers and vendors with specific needs and skills.

Mr. Pankaj Patel, Chairman of the Advisory Committee of InformEx 2009, and Chairman and Managing Director, Zydus Cadila, said the holding of the event in Gujarat marked the State’s status for its capabilities in manufacturing, product development and other areas of chemical and pharmaceutical industry as well as a research hub. The event was expected to strengthen the industry, allowing opportunities of networking and business growth, he added.

India is emerging as an important chemicals and pharmaceutical destination, having more FDA approved sites outside of the US than any other country.

The next edition of InformEx India will be held in 2011, and promises to become a regular calendar event for Gujarat, further enhancing its position, Mr M. Gandhi, Managing Director, UBMIndia, said.

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