medical devices - US FDA

5 : auditors inspect Indian regulatory ~q.R 1,,- p~ority again,. gives 100 score.

yn-r >~Meph Alexander, New Delhi time, whereas m the prevIous tration of measles vaccme. The 1JfX.~ similar assessment held in late auditors were drawn from the try, ~ . HO inspectors along 2007, we had been given just US Food and Drug Administra::u- : with drug control around 40 score;' DeGr Dr tion, Belgium, France, Egypt, officials from other Surinder Singh told Pharmabiz. Thailand and the WHO headso countries, held a com- The auditors inspected differ- quarters in Geneva.
ce prehensive audit of the national ent areas like clinical trials, mar- After the inspections in 2007, st regulatory authority (NRA) in ketinglicence authorisation, reg- WHO made certain adverse d India and gave a high score of ulatory aspects and vaccine remarks about the functioning d 100, reversing its earlier adverse manufacturing during their stay of the Indian mechanism and r: observations about the bad in the country. Theauditino team the three public sector vaccine plight of regulatory y tern in irL<:pected the Central Dru manufacturing units had the country two years aoo. Con ~ - tion uspended operations for the "As many as 13 a' ill -s. Den - ~ ,~~ the lack of WHO-GMP norms. No the WHO and other na - -..: -,e Cer.;::a. O;-u Laboratory, new applications for vaccines a week-lono audit in diiierent Kasauli, ,-here ecounm· yac- manufacturing was also grantaspects and carried out on-site cine testing is done. The officials ed since then after the WHO inspections to assess the per- also carried out field inspections practically debarred the In.dian f ~ -ce . [aharashtra vaccine manufacturers from ::-- _ _1la2· catio. for

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India to move wro dispute settlement body over seizure of drugs at EU ports

Our Bureau, New Delhi

NOlA will soon take up the issue of seizure of drug consignments from the country en route to Brazil and Africa by European authorities, especially the Dutch ,officials, on the grounds of alleged patent violation recently to the dispute settlement body of the World Trade Organisation, "We have requested the European authorities to reconsider the dedsion, They have already released two consignments, but after holding them for months, It is useless to get the drugs back after 90 days, We are waiting for the formal reply from ED on our request and meanwhile preparing ourselves to take the matter to the WIO dispute settlement body," Commerce Secretary G K Pillai told Pharmabiz, Though the matter was raised strongly in the international fora and directly with the concerned authorities including Netherlands, India is almost ready to

move the case with WIO dispute settlement body as a favourable reply from them is unlikely, sources said. The case will be pushed within a few weeks time as the ED still sticking to its stand, India is also reportedly not very keen on the offer of the WTO director general to mediate in the matter between the two sides, it is learnt.
India is of the view that ED has breached the provisions of traderelated aspects of intellectual property rights and General Agreement on Tariffs and Trade that covers international trade in goods. No consideration was given that these seized consignments were destined to other countries where there were no patent protections for these drugs. "There was not an iota of.
evidence that any of these products were likely to be diverted to the European markets, a must as per the TRIPS Agreement for such an action," Pillai said.



asks' cos to submit safety info of medical devices

agency's most stringent pre- of Class-III device types pre- they may be marketed. Class- devices that do not require market review process. dating the 1976 law, as was rec- III devices include heart premarket approval.
_:: IDA armounced These 25 device types, which ommended by the US Govern- valves and intraocular lenses. After Congress enacted the ufacturers of 25 are listed in the Federal Regis- ment Accountability Office Class-I and Class-II devices medical device law in 1976, the ; medical devices ter armouncement posted, were (GAO) in a January 2009 report pose lower risks and include FDA classified these 25 device --.:..rred prior to 1976 marketed in the US prior to the to Congress. devices such as adhesive types into Class-III (premarket " afety and effec- Medical Device Amendments The FDA classifies medical bandages and wheelchairs. approval). Under the law, these 'ormation to the to the Food, Drug, and Cosmet- devices into three categories Most Class-II devices and devices were not immediately :hat it may evaluate ic Act of 1976, That law author- according to their level of risk. some Class-I devices are mar- required to undergo the pree"el for each device ized the FDA to review new Class-III devices represent the keted after submission of pre- market approval roc ,The , 'ces found by the FDA medical devices. The highest level of risk and gener- market notification e tabli h- la\ . re;rui.J:ed - :-.igh risk to consumers announcement is the first step ally require a showing of safe- ing their substantial equiva- rule subjecting the eor - :, . :equired to undergo the towards completing the review ty and effectiveness before lence to legally marketed that requirement. until that
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time, new devices within those device types have been cleared through the premarket notification process, in which the agency determines whether they are substantially equivalent to legally marketed devices not requiring premarket approvaL Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require premarket approval.
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yremar=" apprO\"al). Cnder the la\\~ these devices were not immediately required to undergo the premarket approval proces " The law required the ill.:' rule subjecting the de\ices '0 that requirement. Until that -..................... time, new devices within those device types have been cleared through the premarket notification proce , U which the agency determines whether they are substantially equi\'alen;
to legally marKereC devices not requirin premarket approval.
Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require premarket approval.
"We are taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency," said Daniel G Schultz, director of the FDA's Center for Devices and Radiological Health. "New pre market notification submissions for devices of these 2S types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness." As of 1994, there were approximately 149 Class-III, pre-1976 types of medical devices that had not yet been subject to premarket approval.
Since then, the FDA has made significant progress in reviewing and issuing new regulations for all but 27 of those device types, including the review of 55 types since January 2000. (The FDA has already initiated this process for two device types, which will be completed separately). .

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