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From Global Leader to Global Authority!


The U.S. Food and Drug Administration (FDA) approved a record number of generic drugs in the U.S. during the fiscal year (FY) that ended on September 30, 2017, with Indian companies accounting for nearly 40% of the approvals.  While the FDA’s report does not give details country-wise, an industry analysis (here) of the monthly generic drug approvals company-wise indicated that Indian companies received a total of 295 out of 763 approvals.  The Times of India reported (here) 300 ANDA approvals in calendar year 2017.  Lachman previously reported (here) that the FDA’s Office of Generic Drugs (OGD) fully approved 249 ANDAs during the first quarter of FY 2018.  As Bob Pollock estimates (here), if this pace keeps up, the OGD could approve 996 ANDAs by the end of the FY.  It will be interesting to see what percentage of that will be claimed by Indian applicants.

The reason I am bringing up statistics is because India aims to be a global leader in end-to-end drug manufacturing by the year 2020.  So, it is not surprising that the Indian industry has been collaborating to figure out issues and opportunities related to quality, regulatory, and compliance for a number of years.  This year, CPhI and UBM India are hosting the Seventh Annual Global Pharma Regulatory Summit 2018 (here) in Mumbai which started on May 30.  During the next few days, the conference will focus on the rationale and interpretation of regulatory guidelines published and precedents set by CSDCO, FDA, EMA, PMDA, Africa, and CFDA, among other regulatory authorities.  The conference promises to showcase many renowned international and Indian experts from regulatory and compliance practice areas.

In opening remarks, the Chair, Dr. Raphael Nudelman, said that the key focus of the pharma industry and regulators nowadays should be harmonization.  Dr. Chandrashekhar Ranga, Deputy Drugs Controller of India and chief guest of the event, also talked about the need for harmonization of regulations and requirements, and sharing of information with the industry.  However, he acknowledged the challenges of harmonization in light of the impact it may have on the domestic industry.  He talked about the Memoranda of Understanding (MOU) that CSDCO signed with the U.S. FDA and MHRA to leverage the knowledge and coverage.  Just a day before, Dr. S. Eswara Reddy, Drugs Controller General of India, stated (here) that India can be a top pharmaceutical regulator, and it wants global authority status.  The industry and regulatory authority must be equally involved when it comes to matching global standards.

The first day of this conference was focused on the U.S. regulatory landscape; data integrity was one of the important and earlier topics covered discussed, followed by elemental and genotoxic impurities.  As the day progressed, the session moved on to regulation of complex and differentiated generics and then to U.S. regulatory requirements for biosimilars.  The first day of the three-day conference ended with a presentation on lifecycle management of products from quality and regulatory perspectives.

It is interesting to note that there appeared to be no FDA, EMA, or other regulatory authority presence at the conference.  The FDA has made it no secret that it has been strengthening its presence in India (here) for the purpose of conducting inspections of medical product and food facilities that export to the U.S.  The FDA wants to engage with Indian regulatory authorities to build confidence in each other and develop quality standards, etc.  At the same time, the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) are implementing a new concept of operations (here) to fully integrate the drug review programs with facility evaluations and inspections.  This will ensure alignment between the FDA’s field professionals and its review staff.  It would have been interesting and valuable to hear the FDA or EMA perspective on progress as Indian pharma is slowly moving toward its goal of becoming one of the global leaders in the pharma space once dominated by western players.