India to track USFDA drug recall disclosures

Every week, the US Food and Drugs Administration comes out with an enforcement report that discloses details of firm-initiated product recalls that are happening due to technical or manufacturing defects in the world’s largest medicine market. The typical disclosure format indicates the number of faulty units that need to be recalled and the number of countries where they are in circulation.

These disclosures may come handy to India’s drug regulatory agency – Central Drugs Standard Control Organisation (CDSCO) — which does not have a similar system to track the status of faulty or mislabeled drugs and medical devices that are available in the domestic trade channels.

CDSCO is planning to track all such disclosures made by companies and regulatory agencies world over to see if the same batch of products mentioned in such disclosures are also being marketed in India. The agency plans will not be completely off-track considering the fact that every week, USFDA lists outs two to three products which are also under circulation in India, among other countries.
 

USFDA’S JUNE 1 ENFORCEMENT REPORT

• Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on April 4, 2011 
• Manufacturer: Traxtal Technologies Inc, Toronto Ontario, Canada. Firm initiated recall ongoing
• Reason: The PercuNav Field Generator Stand could tip over during set up, during use or during transport
• Volume of product: 65 units (33 units distributed to US and 32 units distributed to other countries)
• Distribution: Nationwide, Australia, Austria, Belgium, China, France, Germany, Hong Kong, INDIA, Korea, Netherlands, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom

• Recalling Firm: Beckman Coulter Inc, Brea, CA, by letter on April 12, 2011
• Manufacturer: Beckman Coulter, Inc, Miami, FL Firm initiated recall ongoing
• Reason: The recall was initiated because Beckman Coulter confirmed the auto prune would not remove patient results if patient records included demographics in which results were less than 30 days old
• Volume of product: 673 units total 
• Distribution: Nationwide, Canada, Australia, Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, INDIA, Israel, Italy, Japan, Republic of Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom

“To be fair, there are several multinational companies that write to us about such voluntary product recalls. However, not all are doing this as it is not mandatory under current laws,” a senior CDSCO official said.

The move is part of the regulatory authority’s attempt to strengthen its vigil over sale of not-of-standard medicines and medical products in the country. In order to optimally utilise its human resources, CDSCO has transferred some of its routine responsibilities from the central office to its zonal offices. Thus, no objection certificates for grant of license to manufacture drugs for test purposes and drugs that are meant exclusively for exports will now be given by the four zonal offices of CDSCO.

Permission for import of small quantity of medicines and products of dual use (including non-medicinal purposes) will all be handled by CDSCO offices in Chennai, Mumbai, Kolkata and Ghaziabad (Uttar Pradesh).