Drug Controller office in Gujarat to get zonal status

Keeping in view the concentration of pharmaceutical, medical devices, and growing clinical research organisations in Gujarat, the central government has decided to upgrade the Drug Controller’s office in Gujarat to Zonal office status.

“This would mean a lot of convenience, speedy clearance and approval to the pharmaceutical, medical devices, and clinical research industries, based in Gujarat,” said Surinder Singh, Drug Controller General of India (DCGI).

He said this at the opening session of a three-day event, InformExIndia 2009, on Thursday in Ahmedabad. He urged the industry to adapt to the global trends and practices in order to survive in today’s competitive environment.

Talking about the various initiatives that DCGI office has taken to improve the working of drug control offices in the country, Singh said that 62 more posts of drug inspectors had been cleared, which would help in speedy clearing of procedures.

Singh further said that in order to bring more safety and transparency, registration of all the organisations involved in clinical trails and research will be made mandatory and such organisation would be audited for the adherence to protocols and procedures for patient safety. He also informed that a registry of clinical research organisation would be made, which would have important data like design of CR, target and sponsors’ details.

He also announced that soon in consultation with Medical Council of India, vigilance centres will be established in select medical colleges of India, which will oversee the various aspects of safety and adherence of guidelines.