US drug regulator wants office in India

Posted Atlivemint.com

New Delhi/Hyderabad: The US health department, along with its drug regulator, wants to depute personnel to India’s proposed pharmaceuticals watchdog, Central Drug Authority, and establish a regional office here, as part of a strategy to help monitor quality beyond their borders and ensure imports of safe products into the world’s largest economy.

Acknowledging that an increasing proportion of food products, drugs, vaccines and medical devices consumed by US citizens were manufactured overseas, the US food and drug administration, or FDA, is preparing a plan to set up regional offices, hire independent inspectors and collaborate with their counterparts in different countries for stricter implementation of safety and quality norms.

The agency faced criticism last year for slipping up on inspecting non-US drug makers.

Such an arrangement, if it materializes, could mean increased scrutiny on Indian drug makers, who own the largest number of FDA-approved manufacturing plants outside the US, and also account for half of all approvals for drug raw material called active pharmaceutical ingredients and a quarter of formulation drug approvals.

“We are open to them (the Indian government) bringing people down to Washington and other places where FDA works and we have signalled the willingness to even talk about having an FDA person here,” US secretary of health and human services Michael O. Leavitt told Mint.

The US and Indian governments, he added, were still “in the early stages of the conversation”.
Leavitt explained that having more US personnel abroad was a “part of a general strategy, whose purpose will be to help others understand where US’ standards are, build their own capabilities and facilitate communication”.

As a sign of increasing dependence on cheaper manufacturing overseas, US imported $48.3 billion (Rs1.99 trillion then) in pharmaceutical products in 2007 until end August, up from $42.3 billion a year earlier.

Elaborating on the possibility of US FDA having an India office, one among several regional offices planned, the regulator’s commissioner Andrew C. von Eschenbach said it was part of the rethinking at the agency in tightening regulations for drugs, medical devices and food.

“We have multilateral and bilateral agreements in place but it is different than having a US FDA presence outside of US on a continuous, on going basis. We look to put at least five of these kinds of opportunities around of the world,” he said.

Leavitt and von Eschenbach are touring India along with officials to meeting government officials and drug makers.

Last week, the delegation was in China, where it signed agreements mandating food producers get their exports certified by local authorities and comply with US standards on food safety.

Last year, Chinese exports to the US of ingredients used to make pet food were found to be contaminated by melamine, a prohibited chemical used in making plastic. This led to one of the largest animal food recalls in the US.

No similar agreement is being sought with New Delhi, Leavitt said.
“We are not here because there is a problem. We are here because there is a possibility,” added von Eschenbach.

Calling the US proposal a “good intention”, a Union health ministry senior official pointed out differences between regulatory arrangements in the two countries. “The involvement with the US FDA will be better at a later stage when we have the concept of dossier filing, stringent pharmacovigilance and a patient information system,” the official said, adding such a regime was yet to be formed in India.

Dossier filing involves detailed regulatory submissions on chemical composition, efficacy, contra-indications and other minute details of any chemical that goes into making a drug.

Most drugs sold in India get approved based on such filings in the US or Europe, which the office of the drug controller general of India then investigates for its therapeutical equivalence.

Dossier filing is required only for new drugs developed here in India, which are very few in number and, so, not an area of expertise of Indian drug regulators. Pharmacovigilance is the monitoring of a drug for its efficacy and adverse reactions once it has been introduced in the market.

The prospect of tighter regulation is being welcomed, at least publicly, by Indian drug makers and sector experts.

Says Cipla Ltd’s chief executive officer Amar Lulla: “Today, even though our sites might be FDA-approved, they have reservations and cast a doubt on the quality” even if it is unstated. Lulla added that a regional FDA office will only enhance the credibility of regulation-compliant drug makers as they will come under continuous watch.

The FDA and US health department plan comes close on the heels of a recent US government audit which pointed out that in a year, FDA inspected just 7% of the drug makers outside the US that export drugs to that country.

There are approximately 800 FDA investigators trained to conduct foreign inspections, performing more than 200 foreign drug manufacturing inspections a year.

Against this, there are thousands of FDA-approved drug manufacturing facilities globally. For the fiscal year to March 2007, FDA could inspect 13 of 714 firms in China and 65 of 410 Indian drug makers, according to the US government report.

With 906 approved API makers in China and 400 in India, FDA is “logistically” better off if it is to set up an office in the region, Sanjiv Kaul managing director of private equity firm, ChrysCapital Investment Advisors, said in a November interview.

“Closer working with FDA will only benefit the Indian drug companies as they will cross over from a principal-agent relationship to that of collaborators.”

January 11, 2008