Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections: A Look At India (Part 6)
This article was originally published in PharmAsia News
Executive Summary
Like most other Asian nations, India will not consider an application for marketing approval of a drug unless it comes with a certificate of pharmaceutical product showing that a major market has already approved the product, said Mark Rosolowsky, executive director, GRS-CMC, Bristol-Myers Squibb
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Like most other Asian nations, India will not consider an application for marketing approval of a drug unless it comes with a certificate of pharmaceutical product showing that a major market has already approved the product, said Mark Rosolowsky, executive director, GRS-CMC, Bristol-Myers Squibb. India used to require applicants to present a CPP from a major market before they conduct required local clinical studies in India. Now they can do the local clinical studies in parallel with their global Phase III studies, cutting a year from the approval process. Unlike other Asia-Pacific countries, India sets no numerical requirements for the number of patients enrolled in the local Phase III studies. But it may ask for pharmacokinetic studies to precede the clinical studies, Rosolowsky said. And in the case of drugs for unmet medical needs and lifesaving drugs, applicants can seek a waiver from the local clinical studies requirement. It is possible now to conduct first-in-human studies in India, but only for compounds discovered and developed in India. It's unclear what constitutes discovery in India, Rosolowsky said. "If the patent holder had scientists from India, that would be looked upon favorably by the health authorities." Applications must be in the ICH CTD format, while incorporating local regulatory requirements. Proliferation Of New Biologics Regs Rosolowsky added that much of what is new in India revolves around biologics, "and it's not surprising since Dr. Reddy's is a major manufacturer of biologics and biosimilars. So over the past couple of years, there has been a proliferation of regulations pertaining to biologics." Dr. Reddy's has emerged as the most active player in the biosimilars space with its latest launch of Cresp - a biosimilar darbepoetin of Aranesp branded by Amgen (Also see "Dr. Reddy's Launches World's First Aranesp Biosimilar In India, Vows To Bring Out More" - Scrip, 9 Aug, 2010.). One of the new biologics regulations is a product permission document for biologicals. This annex to Module 1 of the CTD provides a summary of key quality information, which, Rosolowsky explained, "the health authority will use as a reference document for post-approval inspections and post-approval change evaluations." He said that in August, India published a companion document, or guidance, on post-approval changes in biological products. It establishes three levels of categories for these changes. Level I major changes and Level II notifiable changes require health authority approval. When it first published these changes, the Indian authority required itself to approve Level 1 changes in 60 days and Level 2 changes in 30 days, "and they said, 'if you don't hear from us within those time spans, then you can consider yourself approved. Soon after that they came out with an amendment that rescinded that pocket approval." He said they applied a modern, risk-based approach to post-approval changes that was modeled after the EU variations guidelines. Roche - maker of blockbuster biotech products like Avastin and Mabthera - has called for a stricter regulatory and approval mechanism for biosimilars being launched in markets like India even as the European Union rolled out its draft guidelines for developing biosimilar versions of complex monoclonal antibodies Nov. 26 (Also see "Roche Lashes Out At Biosimilars Regulations In Emerging Markets, Calls For Stricter Pharmacovigilance Of Launched Products" - Scrip, 8 Dec, 2010.) He noted that India has been making an unusual request for CTD dossiers from manufacturers' country of origin. "It's unclear why they're asking for that." Also in November, India's Central Drugs Standard Control Organization issued a new CTD guidance for small-molecule new chemical entities. CDSCO posts its guidances at http://www.cdsco.nic.in/, Rosolowsky noted. - Bowman Cox ([email protected]) [Editor's note: This is part six of a longer story that appeared in the December 2010 issue of the Gold Sheet. (Also see "Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections (Part 1)" - Scrip, 22 Dec, 2010.) covered general CMC requirements and ASEAN, (Also see "Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections - A Look At Taiwan (Part 2)" - Scrip, 7 Jan, 2011.) covered Taiwan, (Also see "Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections - A Look At Korea (Part 3)" - Scrip, 10 Jan, 2011.) covered Korea, (Also see "Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections - A Look At China (Part 4)" - Scrip, 25 Jan, 2011.) covered China and (Also see "Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections: A Look At Japan (Part 5)" - Scrip, 28 Jan, 2011.) covered Japan. Not a subscriber of the Gold Sheet? Click here to receive a complementary copy.] |