DCGI setting up Pharma Zones in India
The Drugs Controller General of India (DCGI), India’s home grown equivalent of FDA of the US is setting up a EXIM port office in Bangalore.
According to an DCGI topper, the export-import center in Bangalore International Airport will help pharma makers in Bangalore in having a hassle-free dedicated export and import place for pharmaceuticals products.
“This is in view to address the long pending demand from the industry in Bangalore. They wanted a exports and imports center at the Bangalore airport. The setting up of this port will save time for the pharma exporters in Bangalore,” Dr Surinder Singh, Drug Controller General of India, CDSCO said in Bangalore. “The Bangalore International Airport Limited (BIAL) authorities have also given us space for a sub-zonal office in Karnataka. Mani Vannan, Senior Deputy Director, Port Facility will take over as head assisted by two Assistant Drug Inspectors.”
Source : BioSpectrum
There are four port offices in India at Mumbai, Chennai, Kolkata and Ghaziabad and two subzones at Hyderabad and Ahmedabad, and both of them are being upgraded as full fledged zones soon increasing the total number of zones in India to six.
The federal government also intends to have a subzonal office in Karnataka—, where there are a lot of mid and small tier drug companies. Bangalore is the capital of Karnataka state. The office will initially function from opened in the Karnataka State Drugs Control Department and later shift to a permanent facility. A new sub-zone will also be set up in Baddi, Himachal Pradesh—a tax free manufacturing location.
Debashish Panda, Joint secretary Drugs, Ministry of health & family welfare, Government of India, said, “The zones will look after facilitation of inspections, issuing of licenses, approvals and eventually managing clinical trial audits. The infrastructure is being set up and the office will be in place by the end of May 2009.. The infrastructure will be strengthened in the following months.”
The DCGI is also starting “pharma zones.” These are dedicated areas for export and import of pharmaceutical products having cold storage facility and laboratory for testing samples.
The federal health ministry is setting up an expert panel to hammer out the details of the proposal at Delhi, Mumbai and Hyderabad airport. Besides, pharma zones will also be set up at sea ports. DCGI is in discussion with the civil aviation ministry and the port trusts on the modalities. The pharma zones will be in place by March 2010.
The total investment planned for these pharma zones is Rs 70 million which will be borne by GMR, the Bangalore based consortium developing the Delhi airport and Hyderabad-based GVK group which is developing the Mumbai airport. Details will be finalized in consultation with them.
The pharma zones will have cold storage centers for drugs.. The facilities would be worked out depending on the proposed volume of medicines handled. It will prevent the possibility of cross-contamination and drugs will be stored at different temperatures as prescribed to ensure efficacy.
Dr Surinder said, “This is a part of our GDP (Good Distribution Practices) and our strategy in making things better and more centralized. As we move towards the clinical trial audits, we need to make our presence better. This is also a step towards gearing up the country with $60 billion worth of drugs going off patent. We want India to take at least 40% of that share. This will require quality infrastructure, more inspections and audits.”
Speaking about its recent move towards making clinical trial registry mandatory, the Dr Surinder said, “We don’t want Indians to be treated as guinea pigs. Therefore we have made it mandatory for Clinical Research Organizations to register the trials through Indian Council of Medical Research (ICMR). We expect things to become transparent with this step and we will know what trials are being conducted in India. We will be issuing an order in another week’s time. We are also getting our people trained from the FDA for clinical trial audits . They will learn to audit bioequivalence centers. Clinical trial auditing will become very important in the coming years. We will randomly pick up centers for such audits to keep a regular check in the system and if there is a misconduct or fraud, we will take actions.”
Expressing anguish at the increasing number of CROs in India, Dr. Surinder said the government wants to impose tighter rules in registering CROs. “We want to have strict guidelines for registration of CROs. There is a mushrooming of CROs in India. . We want to have a benchmark for them. We have framed the guidelines, they have gone to the important authorities for final approval. By these mechanisms we intend to improve the credibility any reliability. We want to ensure the quality of the data that is generated.”
Tags: Pharma Zones in India