India Looks To Model New Central Drug Authority After U.S. FDA
This article was originally published in PharmAsia News
Executive Summary
NEW DELHI - With elections to parliament slated for next year, India's Congress Party-led government is expected to soon pass a slew of bills in the pharmaceutical sector, including that for a central drug authority
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NEW DELHI - With elections to parliament slated for next year, India's Congress Party-led government is expected to soon pass a slew of bills in the pharmaceutical sector, including that for a central drug authority. The CDA bill has been approved by the country's Cabinet of Ministers and is currently in parliament. Sources told PharmAsia News that it is expected to pass both houses of parliament this year. The government says the CDA will emulate the U.S. Food and Drug Administration. Health Minister Anbumani Ramadoss said: "In the long run, the goal is to ensure that any drug approved in India should directly be approved by the U.S. FDA." The CDA is intended to streamline the process of drug manufacture in the country and also act as an effective monitoring agency. Its directive would be to establish a more transparent, efficient and uniform system of drug regulation, government officials said. It will help centralize the product approval process and improve manufacturing quality supervision. Disparity in licensing standards among Indian states, and non-compliance with central government directions have been a major reason for proliferation of irrational drugs, mainly fixed-dose combination drugs, in the market, according to analysts. The plan, therefore, is to remove drug licensing power from states and vest that with the CDA. "The multiple licensing authority with the states have made it easy to manufacture spurious drugs. With the CDA act we are going to have one law that will be implemented in the whole country and thus check such malpractices," a government official closely associated with the process told PharmAsia News. The CDA bill is expected to curb unethical clinical practices by imposing hefty fines and prison terms for offenders. Sources say the authority will have the power to prosecute clinical research organizations and pharmaceutical companies with a five-year jail term and a nearly $50,000 penalty for violating approved procedures. India has increasingly been attracting the attention of global pharmaceutical majors. But, a major complaint is the listless regulatory system in the country (Also see "Booming Clinical Research Business Could Trigger Regulatory Overhaul In India" - Scrip, 8 Mar, 2008.). For instance, three central agencies have to approve a clinical study before it can begin in India. In the U.S. it takes on average four weeks to get a study approved, compared to at least 14 weeks in India, according to analysts. The CDA is expected to speed up this process. Under the CDA, 10 new government divisions would be set up in New Delhi. These divisions would be responsible for specific areas, such as regulations, biotechnology products, imports, quality control, enforcement, legal and consumer affairs, and medical devices/diagnostics. Though Food and Drug Administrations at the state level would still be responsible for issuing drug sales licenses, the CDA would eventually take over issuing manufacturing licenses after a five-year transition period. Officials said the new authority would be fully autonomous and financially self-sustaining. It would be supported by an advisory board. The executive wing of the regulator would be headed by the drugs controller of India. - Kumar Amitav Chaliha ([email protected]) |