Hong Kong Regulators Review Manufacturing, Supply Chain Regulations In Wake Of Tainted Products Leading To Six Deaths

HONG KONG - A review of Hong Kong's drug regulatory infrastructure could lead to more stringent requirements for pharmaceutical manufacturers, importers and distributors.

"It is not my intention, through regulatory activities, to influence the market. But those who are not up to standard will be subject to some pressure," Sandra Lee, Hong Kong's permanent secretary for Food and Health told PharmAsia News.

A number of incidents in the last month have shaken public confidence in Hong Kong's regulatory system. The incidents ranged from drugs with fabricated expiry dates to tainted products distributed through government-run hospitals that have been linked to the deaths of six cancer patients.

In the latest incident last week, importer Zuellig Pharma was forced to recall Viscotears eye drops after staff at United Christian Hospital noted that the product was not properly registered. When Viscotears, made by Novartis, was first introduced in Hong Kong 15 years ago, it did not need registration because it did not contain medical products. Four years ago, however, Novartis made changes to the formulation that would have required registration, but the product was never registered as a drug. Hong Kong's Hospital Authority is now recalling 10,000 bottles of the eye drops.

In another incident, 10 patients received expired cough medicine at a public clinic.

In yet another, 93,000 bottles of sterilized water produced by Japan's Otsuka used to dilute anesthetic drugs before surgery were found to contain 30 milliliters more than what the label showed.

Meanwhile, Hong Kong's Hospital Authority, which accounts for about half the drugs sold in the city, is no longer prescribing allopurinol and metformin, two drugs found to be tainted in March. At least one local drug manufacturer has suspended all of its operations

The spate of incidents led to a public outcry. According to a survey by the University of Hong Kong, the various scandals led to a loss of confidence in the city's top health official, Secretary for Food and Health York Chow, whose popularity rating dropped from 38 percent to 32 percent. Chow put the blame squarely on the shoulders of slack or complacent staff. He also set up a committee to review the city's drug regulation system.

The Review Committee on Regulation of Pharmaceutical Products held its first meeting on April 3, and will spend up to nine months reviewing Hong Kong's regulatory system. Lee chairs the committee.

"We are looking at the regulations for manufacturing as well as distribution," said Lee.

The government wants to make sure blunders don't happen, or prevent them as much as possible.

"In the last few months we have become more vigilant and when we dug deeper we found out more," Lee said, adding that Hong Kong's regulatory process is strong enough but there are always areas that require strengthening, particularly as the industry is changing so quickly.

The push to improve drug regulations comes as Hong Kong makes a serious effort to become a hub for biotechnology research and development.

"We want to promote the brand in Hong Kong for drug manufacturers," she said.

At the same time, Hong Kong's Hospital Authority will reexamine the drugs it uses.

"The most important task ahead is to restore public confidence in the supply and regulatory system of pharmaceutical products," said Chow on April 1, two days before launching the committee. "The pharmaceutical industry and the pharmacy profession should turn crisis into opportunity to further enhance professional standards and promote partnership and teamwork."

One major issue for the committee will be upgrading the good manufacturing practices scheme. Manufacturers accredited under GMP can produce drugs for the local market, but it was such manufacturers that failed to prevent the problems that led to the current situation. There are 25 local manufacturers in Hong Kong.

Under current regulations, manufacturers are responsible to register products made locally. For imported products, the registration burden falls on the importer. Hong Kong does not do its own testing or approval for drugs but requires registration approval from two of a list of countries, expert evaluation reports on the safety, efficacy and quality of the products, and clinical and scientific documentation. Generic versions of products that have been registered for more than five years do not have to produce clinical or scientific documentation on efficacy.

The drug registration system is separate from the manufacturing registration and control system, which is the focus of the committee and relies on GMP registration and one or two inspections a year by two inspectors from the department of health, a spokesperson said. The system has been in place since 1978 and was last reviewed in the 1990s. Manufacturers abroad have to receive GMP certification from their local drug regulatory authorities and the certification must be based on a recent inspection.

Lee's committee has been split into two working groups, one to review manufacturing and the other looking at the supply chain. After it finishes its review, it will put forward recommendations to the government on how to strengthen the city's regulations.

"We will be reasonable. There are other overseas regulations that are far more stringent," Lee said.

Hong Kong health authorities have also elicited the help of Australian drug experts to guide it in setting manufacturing standards for pharmaceuticals (PharmAsia News, March 19, 2009).

- Alfred Romann ([email protected])