India’s Central Drug Authority May Be Shelved; Four Zonal Authorities Mooted
This article was originally published in The Pink Sheet Daily
Executive Summary
Disseminated power appears to be the goal, but would the system require four times the paperwork?
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MUMBAI, India - Efforts to streamline India's drug regulatory system into a single central authority may suffer a body blow as the parliamentary committee set up to study the proposed changes may recommend scrapping the new body. Top industry sources told PharmAsia News that the committee is not completely convinced about the advantages of having a Central Drug Authority. The Parliamentary Standing Committee on Health and Family Welfare headed by Amar Singh is empowered to review provisions of the proposed central authority. According to industry sources, the committee collectively feels that the formation of a Central Drug Authority may not be in the best interest of small- and medium-sized Indian companies. Instead, it is learned the committee is now in favor of setting up four zonal centers that could have powers to regulate the drug companies in their respective region. A report on the committee's observations will be sent to the health ministry shortly. "To run each time to New Delhi for dozens of documentations is not desirable for a small company with presence maybe in south, west or east India," a governing member of a top drug industry association told PharmAsia News. For the last several months, members of the parliamentary committee have been meeting various companies from across India for their views on the proposed legislation. Many felt that emulating the U.S. FDA or Health Canada central authority may not work in a country like India with its widely scattered industry presence. "The new rules within the central drug authority may also seem to be favoring multinational companies in many areas like speeding up clinical trials," the source said. The Central Drug Authority, if allowed to be formed, could leave enormous powers in the hands of a few people, the source indicated. "The health ministry seems to be uncomfortable about the policy making powers that may go to bureaucrats heading these bodies. This may not augur well for the drug industry at large," he said. The proposed Central Drug Authority was proposed to have newly framed regulations in line with developed countries like the U.S. and Canada. It was to have complete control over several sectors like medical devices, drug approvals, registration and approval of clinical trials, manufacturing and marketing licenses for medicines and monitoring quality standards. India's Drug Controller General Surinder Singh told PharmAsia News in an exclusive interview that as part of regulatory overhaul, a single window clearance would be facilitated before the central drug authority comes into being (1 (Also see "India’s Drug Watchdog DCGI Speeds Up Regulatory Overhaul; Single Window Clearance to Precede Central Drug Authority" - Scrip, 11 Sep, 2008.)). The Indian Medical Association had already opposed the Central Drug Authority before strengthening the State Food and Drug Administrations (2 (Also see "Parliamentary Panel Not Yet Ready To Recommend India’s CDA Bill" - Scrip, 22 May, 2008.)). - Vikas Dandekar ([email protected]) [Editor's note: This article appears courtesy of 3 PharmAsiaNews.com, F-D-C Reports' new site for Asian biotech and pharmaceutical news. 4 Register for a 30-day risk free trial.] |