Bristol-Myers Squibb withdraws asunaprevir NDA from US FDA

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the US, Bristol-Myers Squibb has decided that it will not pursue US Food and Drug Administration (US FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an

Bristol-Myers Squibb’s HCV strategy has always been to focus on the unique unmet medical need of each local market. For example, in Japan we were pleased to receive regulatory approval for the dual regimen of daclatasvir and asunaprevir in July, bringing Japanese patients with HCV the first all-oral, interferon- and ribavirin-free treatment regimen.

NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

Indian pharma industry

Indian pharma industry needs to arm itself to be in perpetual audit mode. This is because of the new stringent global regulatory norms that are being enforced and the frequent inspections by the international regulatory enforcement teams, said Dr Vinay G Nayak, president, technical operations, Alembic Pharmaceuticals.

Since 2008, the US FDA issued 483s warning letters and imposed ban on production plants of Indian pharma companies following non adherence to quality standards and have put the sector under surveillance. The only way to gain confidence of the regulator, clear doubts and relax scrutiny would be to put in place systems to document practices, prevent microbial contamination of drugs, bring in reliability and integrity in procedures across laboratory and manufacturing systems, he added.

The way forward for a confident regulatory compliance would be to automate process of manufacturing, computerise lab operations, install surveillance systems across the facility to bring in transparency and accountability at all levels. There should be review of standard operating procedures versus practice, said Dr Nayak in his presentation on ‘Quality audit case studies- major quality issues and trends’, presented at the recently concluded IPA Platinum jubilee event.

Genaric Exports - Pharma

Indian pharmaceutical industry received yet another blow to its reputation from the US FDA when it charged Wockhardt Ltd of  manipulating data related to production trials of drugs at its two Indian factories, which had earlier been banned from shipping medicines to the US. The Wockhardt factories located at Waluj and Chikalthana in Maharashtra had to halt exports to the US sometime ago. The US FDA in a letter to the company stated that the lack of reliability and accuracy of data generated by Wockhardt’s laboratory is a serious cGMP deficiency that raises concerns about the integrity of all data generated by the company.

 Data integrity issues at drug manufacturing plants attract severe penal action from the US FDA and other international regulatory agencies. The US regulator further said that the company had not only violated standards of manufacturing practices but also misguided the regulator. These are serious charges on a company like Wockhardt which earns a substantial part of its revenue from exports to various developed markets and the US is perhaps the most important destination among them.

Global GMP norms - Gearing

To serve compliance and regulatory needs of the fast growing life science community in India, UL and US FDA have also extended their Cooperative Research and Development Agreement (CRADA) for five additional years, extending the agreement till 2019. US FDA’s CRADA with UL is the only learning technology agreement of its kind between US FDA and a private sector company.

The extended CRADA agreement between US FDA and UL is designed to address training needs that include topics related to international inspections, import and export of products that fall under US FDA purview and intra agency and intra government co-operative agreements. It also involves access to the FDA’s Office of Regulatory Affairs online curriculum via ComplianceWire, which is UL EduNeering’s cloud-based learning platform.

Designed specifically for Indian life science industry, the Learning Management System (LMS) called Compliance Wire is built on a cloud- based model which helps reduce IT and validation costs. Capable to cater globally in 34 languages, the system helps in audit readiness for training records while being fully secure and complies with US FDA’s electronic signature governance requirements. Equipped to provide SOP management, it adapts well to the strategic agility of the growing business needs of organizations.


With the coming of Obama Care and exports of generics, Active Pharmaceutical Ingredients (APIs) and finished drug products from India to the US projected to grow by 40 per cent, Indian life science companies are in dire need of achieving regulatory compliance to minimize organizational risk and improve quality and business performance through training on GMP compliance.