FDA Urges Indian Pharma to Make Quality #1 Priority

FDA Urges Indian Pharma to Make Quality #1 Priority

May 5th, 2014 // 2:29 pm @


Top management of drugmaking companies must make quality control their top priority, said a senior USFood and Drug Administration (FDA) official at Hyderabad kicking off a series of FDA- Drug Controller General of India workshops to be held this year for Indian pharma companies to help them comply better to the US prescribed standards. 

“Companies must ensure that they are saying what they do and they do what they say and demonstrate that they did it” said Leslie Ball, deputy director , office of international program, FDA. Since the beginning of last year, there’s been a spike in “violations” at India based drug plants, according to data from FDA’s Centre forDrug Evaluation and Research, the US drug safety office. The sites of leading drugmakers such as Ranbaxy LaboratoriesBSE -0.57 %, WockhardtBSE 1.09 %, Strides ArcolabBSE -2.30 % and Sun PharmaBSE -0.59 % are on the list. Many of these allegations relate to ‘data-fudging’. 

This regulatory workshop in tie-up with Indian Pharma Alliance, a grouping of leading domestic drugmakers would be followed by 16 more of such meetings across India, which would be attended by 350 delegates from Indian pharma companies and 40 representative from central and state drug regulators’ offices. 

Howard Sklamberg, deputy commissioner, global regulatory operations and policy, (FDA) said in video message that leadership is all about choices and senior management in the companies must commit to pro-active rather than reactive approach to quality control and allocate adequate resources for managing quality. Every time the top executives see a slippage happen, they should follow it through with a sound internal investigation, he said. 

At a time when leading Indian pharmaceutical companies have been cited for infringements by the US drug regulator, its chief Margaret Hamburg made her first visit to India in February this year. During her visit to India Hamburg had told ET “While some Indian companies operate state-of-the-art facilities and meet CGMPs (current good manufacturing practices), others do encounter problems and operational challenges. Staff from the FDA’s India office will work with these companies to identify the problems and will take the necessary steps to self-correct”. 

An ET analysis showed that India-based drug manufacturing sites, including those of multinationals, accounted for over half of warning letters sent out globally by the US drug safety office in 2013. This is seen as high especially when compared with warnings letters that India received over the last three and half years, which were just a tenth of all warning letters sent out by the US drug safety office. 

“Indian companies, which account for 40% of drug master files to date and 37% ofAbbreviated New Drug Applications in 2012, accounted for 12% of US FDA warning letters,” said DG Shah, secretary general of the Indian Pharmaceutical Alliance, a grouping of leading domestic drugmakers. Shah said he conducted a quantitative analysis of the FDA’s enforcement actions from 2010 to June this year. India is the second largest supplier of over-the-counter and prescription drugs to the United States.Industry must effect a cultural change in attitude and implement processes vertically and horizontally across the company to keep up with a changing regulatory landscape of increased scrutiny worldwide, said Shah. He however expects the regulators to shift their role from just policing to training and communicating the rationale of prescribed processes, for companies to better appreciate those that can mitigate risks related to drug safety. “When a student slips in performance, the teacher also has to partake responsibility for it and take measures to help the student” he said, drawing a parallel between regulators and teachers. 

During her visit early this year, when Hamburg was asked whether FDA is being too stringent with Indian drugmakers as believed in a section of the government, she had said, “It’s because of our commitment to protecting the health of the American public that we’ve been focused on increasing our collaborative efforts and risk-based inspectional activity in India for a number of years already. And the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 does require the FDA to achieve the same inspectional schedule for foreign and domestic drug manufacturing facilities .FDASIA also requires the FDA to clear the backlog of applications by the end of the first five-year user-fee authorisation period”. Because of these new requirements and additional resources, the FDA will increase the number of risk-based generic drug inspections conducted both in the US and abroad, including in India, she had added.


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