The drug administration mechanism in the country, which always failed to match up with the pace of the industry drawing more flaks than bouquet often, is finally on the right track of evolution. If the current initiatives progress to the logical ends as per the plans, India will have a better regulatory mechanism in the Central Drugs Standard Control Organisation (CDSCO) in the near future.
The moves towards bringing in total e-governance, ongoing training of officials with the help of World Health Organisation (WHO), Health Canada and US Food and Drug Administration (FDA), proposed framing of clearer norms and laws in the so-far neglected areas of clinical trials, medical devices and pharmacovigilance and above all better infrastructure augur well for the country's Rs 65,000-crore drug industry. The newly opened FDA Bhavan with the state-of-the-art facilities has already given a shot to the modernisation drive of CDSCO.
The health ministry will be spending around Rs 250 crore for the e-governance programme, which will help the industry to overcome some of their worst nightmares associated with Indian regulatory system. Imbibing the edge of the country in its information technology (IT) enabled arena, the e-governance would bring in transparency and efficiency in the working of the CDSCO. The stakeholders will be able to file and track their applications and get their approvals without delay once the comprehensive system comes into existence.
The application developed by a New York-based technology solutions provider MGRM will make available details of licensing, regulation, monitoring and even inspection audits. Thus this system will work not only for companies, who will be able to submit all applications and data online, but also facilitate the interface between various officials of the drug controller's office. So much so that companies will even be able to file, track and review their applications online from anywhere in the world. This apart, the project will also aid companies in tracking the movement of their applications and enabling them to base their development targets on this. The model of work distribution entailed herein will ensure privacy and data protection. Also, unauthorised attempt to access information will immediately send off an alert making it difficult to break into the system.
The first phase of the project is expected to be completed in a year, following which CDSCO, along with MGRM will float national tender inviting developers to bid for the project. The project itself is expected to be up and running by 2013, according to drug controller general of India (DCGI) Dr Surinder Singh, who has brought a sea change to the system after taking over reigns in February 2008.
The e-governance initiative has received interest from the WHO and Health Canada. They have shown interest in signing a memorandum of understanding for the same. One of the advantages of the initiative is curbing the volunteers from enrolling into multiple clinical trials in quick succession at the prospect of high remuneration. The finger printing software, which is a part of the project, will interlink clinical trial software, allowing companies to enrol only first time volunteers.
To put the things on right track, the CDSCO has already moved to the FDA Bhavan, which matches with the standards of the best corporate house headquarters. The new headquarters has also a transparent and smooth system of functioning in place to make it industry friendly, thanks to the commitment of Dr Singh.
The system of clearing the applications in different categories has got specific time-frames. This time-frame is displayed in the lobby. The clearances, notices, status of pending applications and correspondence in all matters are also displayed on the notice boards on a daily basis to enable the industry to know about the status of their applications. The CDSCO has also started uploading the latest dispatch details on its website on a daily basis so that stakeholders can know about the status of their applications.