FDA to Establish Offices in India by 2009

July 21, 2008

As part of its effort to improve monitoring of imported products, the FDA plans to open two offices in India by next year.

The offices, to be located in Delhi and Mumbai, are part of the FDA Without Borders initiative announced by FDA Commissioner Andrew von Eschenbach in March.

A growing number of medical devices, drugs and food products are being exported from India to the U.S. The FDA “believes we can better help assure the safety and manufacturing quality of these products by having FDA personnel full time in India to work with our counterpart agencies there,” Christopher Kelly, a spokesman for the FDA’s Office of International Programs, said.

Kelly said the offices will help the agency “make better, more risk-based decisions on where to use our inspection resources — both in the field and at our borders.”

In addition to inspecting India-based companies, the FDA will work with private and public entities interested in certifying that products headed for the U.S. market meet U.S. public health standards, Kelly said.

The FDA also is in the process of finalizing an agreement with the Chinese government to open three offices there and hopes to have agency officials in Beijing, Shanghai and Guangzhou by the end of September, Kelly said.

Electronic Quality Systems Can Reduce Cost of Recalls

July 21, 2008

Switching from paper-based quality systems to integrated, electronic systems could lower recall costs for devicemakers, a quality system expert says.

When a major medical device company that used a paper-based quality system needed to recall a batch of product, it was forced to initiate a large-scale recall because its system could not readily provide data on specific batches, Chris Parsons of Camstar, a provider of manufacturing execution and quality systems, said in an interview.

The firm’s reliance on paper records caused the elements of the quality system to be disconnected or fragmented, making it difficult for the company to access critical information, he added.

“They couldn’t find the needle in the haystack, so they had to recall the entire haystack,” he said. “As a result, they lost market share to a competitor and hundreds of millions in lost sales and market capitalization on top of recall expenses.”

A “closed-loop system” could reduce a manufacturer’s exposure by telling it exactly which products are at risk or prevent issues altogether, Parsons said. Thus, a company could do a limited recall, saving money and credibility. A closed-loop system involves electronically connecting information from the sourcing, manufacturing, quality, design and engineering departments. It creates a centralized repository of manufacturing and quality data, allowing trends and problems to be detected before adverse events occur.

Parsons noted that the FDA is moving from reactive to proactive postmarket surveillance as evidenced by its Sentinel initiative, which targets device safety. Electronic quality systems may help manufacturers mirror the FDA’s shift and move from a reactive to a proactive approach to their own postmarket activities.

Click here to learn more on recalls

Government Approves Drugs & Cosmetics Amendment Bill in India

July 21, 2008

India boasts of over 80 US FDA-approved plants, the largest number in any country other than the US. But even as these plants are said to be in compliance with the exacting standards set by the US FDA, there is absolutely no guarantee that all of India’s over 20,000 pharmaceutical manufacturing units relentlessly employ the good manufacturing practices (GMP), as revised by India’s drug regulator some three years ago. The fact that some hundred odd inspectors across the country are supposed to verify at frequent intervals the GMP compliance of these 20,000 units itself tells the story.

That is just about the plant quality and exactitude of manufacturing processes many Indian drug units follow. More precarious are the systems of material sourcing (procurement of active pharmaceutical ingredients or bulk drugs). Over 350 bulk drugs are indigenously manufactured and some 200, which include many that are also indigenously manufactured, are imported from China and Eastern Europe, among others, even as the country is also a major exporter of bulk drugs.

The quality of pharmaceutical products could also degenerate owing to inept handling and poor storage facilities at chemist shops and other retail outlets. It is obvious that large number of pharmacy stores in India care a damn for the good pharmacy practices (GPP) prescribed by the government. Storage requirements of biological products, intravenous fluids and vaccines should ideally be more stringent (with specified temperature controls etc.), but there are serious doubts as to whether these requirements are strictly and invariably met. While public sector healthcare centres are a sorry spectacle, even the private sector is largely going scot-free for laxity on this front.

Regulatory experts in India have, in the last few years, turned increasingly vocal on the need for bolstering pharmaco-vigilance (the regulatory term for monitoring, documenting and auditing of adverse reactions caused by new drugs in the years shortly after their market launch). Although some guidelines for adverse drug reaction (ADR) monitoring were issued a few years ago, it is indubitable that these are not followed in right earnest.

ComplianceOnline is bringing one day conference on Complying with GMP and cGMP Requirements – Streamlining Quality Assurance & FDA Compliance”

Source: Business Standard

The Numbers Game: Manmohan Singh-led government in trouble

July 21, 2008

Every political party in India is now playing the number game.

The Congress-led United Progressive Alliance government, whose strength was reduced after the withdrawal of support by the Left Front, is expected to be short of the magic figure of 272 in the 543-member Lok Sabha. While the UPA is banking on undecided parties and Independent MPs, smaller parties are watching the political drama unfold and waiting for their chance to play kingmaker.

Will the UPA survive Tuesday’s vote of confidence or will the Manmohan Singh-led government crumble due to lack of support?

A ready reckoner of who is with the UPA, who is against it and who is yet to decide.