Drive To Add FDA Drug Police In India Delayed

Five months after the main U.S. drug regulator promised to expand the office that oversees Indian companies that make the medicine to patients in the United States, an exodus of workers the effort cramps.

The offices of the Food and Drug Administration of India are being directed by Carl Sciacchitano, who is also advisor to the FDA for international scientific matters. The agency is looking for a new leader for the team after the departure of Altaf Lal a year after taking the job. Atul Agrawal, the security officer monitoring consumer, has also departed.



In February, FDA Commissioner Margaret Hamburg, visited India and expressed concern about the quality of generic drugs manufactured there. She promised then to increase to 19 from 12 the number of responsible for reviewing about 600 manufacturing plants local drug workers. Now, however, only eight employees are based there full time, said Christopher Kelly, a spokesman for the FDA.

The FDA "is in the final stages of hiring additional investigators" with the aim of expanding permanent office in time, Kelly said. Six employees are being rotated in three to four months at a time to help, said in an email.

Neither Lal Agrawal could not be reached for comment, nor has the agency refused to discuss the circumstances behind their departures, citing privacy rules. Lal Agrawal and returned to the U.S. Lal and left since the FDA said Kelly. Sciacchitano took over as acting director on June 1 and the FDA plans to find a permanent director "in the coming months," according to Kelly.
Prohibited plants

since the beginning of 2013, 25 plants in India have been added to the list of facilities prohibited from sending drugs to the U.S. Hamburg, the head of the FDA, visited India in early February and met with both drug manufacturers and health officials.

The amount of U.S. patients get medicines from India doubled to 12 percent in 2012 from 6 percent in 2008, becoming the second largest importer of drugs to the U.S. after Canada.

Prohibited plants include those run by Sun Pharmaceutical Industries Ltd. (SUNP), which is the largest drug manufacturer in India, Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL) warning letters and inspection reports allege companies manipulated quality testing and operation of insanitary conditions.

Both Sun and Wockhardt recalled generic drugs for depression or high blood pressure earlier this year because the drugs fail to comply with the dissolution tests that indicate whether a generic absorbs the same as copying treatment brand reports according to FDA enforcement.

The Indian government authorized the FDA to hire additional staff in March 2013, Kelly said, after Congress passed a law in 2012 that created a program user fee funded by the manufacturers of generic drugs in part to help increase staff and FDA inspections in outposts overseas including India.
"Different Culture '

"It's hard to make people stay there for long periods of time," said Robert Pollock, senior advisor Lachman Consultants who previously served as acting deputy director Office of Generic Drugs FDA. "It's so different from the U.S. culture is so different.''

The agency conducted 111 inspections of drugs in India in fiscal 2013, less than 20 percent of manufacturers registered in the country, according to data provided by the FDA Kelly drugs. This is an increase of 72 in FY2010 and 98 in FY2011, even though it is below 141 in fiscal 2012.
The FDA has increased its collaboration with Indian regulators through workshops and shadowing exercises to bring them up to speed on the rules of the FDA and help with the supervision of the generic drug industry.

"There are only so many companies that can inspect regardless of the number of people we have in the country," Agrawal said, according to a transcript of an industry conference in San Diego last month. "And only so much information you can gather. Eventually, we will have to establish that entwined relationship between us and them that we trust them in the long term."

R&D, Quality Assurance Professionals To See Good Hiring This Year

MUMBAI: The year 2013 is likely to be a great day for professionals working in research and development and quality assurance is expected that consumer goods companies to hire 700 people in the field from January to April, according to a comprehensive personnel staffing and recruiting firm.

"It is estimated that approximately 700 new openings will be created in the period from January to April of professionals who possess skills Quality and R & D.



   "This is seen as an opportunity boom for people working in the traditional domestic tuning to expand their career graph and enhance it with better exposure and international opportunities available to multinational companies," said an analysis report trend posted by Gi Group.

Of the estimated numbers, about 20 percent are likely to be recruited for mid-level management and said. In explaining this sudden increase, Gi Group, India CEO Asim Handa said companies with key overseas market in the plan of the Asia-Pacific to build domestic manufacturing implementation in order to reduce excise taxes or import duties or export duties.

For most of these global manufacturers, India is emerging as a favorite destination for setting up a new unit, which will support its local distribution plan said.

The initial team that is built for a manufacturing set-up, especially in consumer goods, it has professionals in product development, quality control and assurance provider likewise said.

"Companies that plan to invest in India are looking for in the country becoming its supply center for other international destinations, courtesy of his supreme connectivity in the territory of Asia Pacific. Moreover, it is expected that investment announcements made the past to see the initial implementation in 2013 year, "Handa said.

According to the report, more will be held pan India talent search to recruit for key positions that are likely to give an opportunity for potential candidates to move their base to a new city.

Companies can identify ideal candidates for large national consumer giants and multinationals, with funding from their headquarters, are expected to offer a hike to 60 percent for the best candidate, and said, adding the increase is estimated to average 30 to 35 percent.
Many opportunities for staff are likely to open in the purchasing function well said.

North is likely to witness more openings for R & D, Quality and Acquisitions since most large companies plan to set up manufacturing plants in this part of the country.

It is expected that states like Tamil Nadu, Uttar Pradesh and Andhra Pradesh to witness relatively high openings in the field of Quality provided following configurations to support high-volume manufacturing.

For some of these companies, huge R & D configuration already exists in your office, so that more attention will be focused on meeting local operating standards, he added.

Indian Regulators To Shadow U.S. FDA On Plant Inspections

Indian regulators will be notified when the Food and Drug Administration U.S. is inspecting plants that produce generic drugs in the country, and join to observe the standards of the FDA.

The agreement between government officials in India and FDA Commissioner Margaret Hamburg came during his visit to India this week, the FDA said yesterday. Hamburg, who told Bloomberg News, last week that expanded inspections of overseas plants, also met in a closed session with 16 pharmaceutical companies and affiliated groups in India to discuss the quality of manufacture.



U.S. lawmakers are scheduled to listen to the doctors, researchers and patient advocates at a conference of 26 February on whether generics inferior leaks in the U.S. medical system abroad. Harry Lever, a cardiologist at the Cleveland Clinic, said he will tell them that generic drugs manufactured by companies based in India for heart failure often do not work as they should, opening questions about the FDA's ability to track growth of generics business of India.

"It's like taking a squad to fight a huge army," Lever said in a telephone interview, referring to the efforts of the FDA to inspect drug plants in India.

Lever said he is awaiting test results of samples sent to questionable drugs Preston Mason, a researcher at Brigham and Women's Hospital in Boston. Mason previously reviewed the generic versions of Pfizer Inc. (PFE)’s Lipitor 15 countries and factory waste sometimes rendered ineffective drugs were found.

Pills produced by U.S. generic manufacturer Mylan Inc. (MYL) and Actavis Plc (ACT) were not contaminated, as reported by Mason in his research published in the June issue of the Journal of Clinical Lipidology.


Charges collected

in 2012, the FDA gave it the power to collect fees from manufacturers of generic drugs, in part, to pay for increased inspections of facilities outside the U.S. While the Indian government has cleared the way for the FDA to increase the number of staff members at December 19, it is unclear how many are based today. The agency has refused to provide a number.

Congressional aides are watching how well the FDA ramps up inspections abroad and may raise the issue of the quality of medicines as part of an oversight hearing of the FDA in the Senate in the coming months, according to a staff member on the Senate Health, Education, Labor and pension Committee was not authorized to speak publicly about it.

Generic drug makers Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL), whose executives were among those attending the meeting with Hamburg, has banned the sale of drugs in the U.S. plants from India due to quality problems. In the latest incident last month, a fourth installation Ranbaxy was banned from U.S. exports after FDA inspectors found drugs were re-evaluated to obtain favorable results after the initial analysis failed.