Drugs firm in trouble for unlicensed output

PUBLISHED : Monday, 25 October, 2010, 12:00am
UPDATED : Monday, 25 October, 2010, 12:00am

A drug manufacturer that carried on production when its licence was suspended may have its licence revoked or even face criminal charges.

The warning was issued by Director of Health Dr Lam Ping-yan yesterday. Lam said the Pharmacy and Poisons (Manufacturers Licensing) Committee would discuss the case of Neochem Pharmaceutical Laboratories. The department was seeking legal advice from the Department of Justice on whether the company was criminally liable. He said the maximum penalty was a HK$100,000 fine and two months in jail.

On Friday, the Department of Health instructed Neochem to recall from the market 42 batches of 37 registered products, as they were produced when the plant was not licensed to manufacture.

Between March and July, Neochem recalled, on four occasions, five products from the local market because all were found to have insufficient active ingredients.

The committee suspended Neochem's manufacturer licence in April. It was fully restored in September after Neochem satisfied the committee that it was in compliance with good manufacturing practices.

Through surveillance, the department discovered Neochem had produced between July and August, without licence, 42 batches of 37 registered products.

Lam also commented on the case of an unnecessary autopsy carried out last week on a 77-year-old woman after a series of administrative errors by staff at Fu Shan Public Mortuary. Lam described the incident as medical workers' 'worst nightmare'. Since there would be disciplinary proceedings if there was found to be any fault from staff, the department's investigation report had to be conducted in a careful and thorough manner, he said. Lam said once the report was complete, he would explain the findings to the family.

The woman died of heart failure in Kwong Wah Hospital, Yau Ma Tei, on October 17. A day after her death, the coroner accepted the family's request that an autopsy not be performed. However, an autopsy was subsequently carried out at Fu Shan Public Mortuary, in Sha Tin, after paperwork relating to another case was mixed up with the woman's documents. A doctor only discovered the mistake after the autopsy.

In another blunder which came to light last week, a dead baby was left on a mortuary trolley overnight after an assistant at Princess Margaret Hospital, Kwai Chung, failed to follow guidelines that required the body to be put in a freezer. It was spotted the next afternoon.

The Hospital Authority confirmed that the assistant involved in last month's incident, who was sacked, was not mentally retarded as some media had reported.

Out of order

The Department of Health ordered Neochem to recall 42 batches

The number of registered products the company produced without licence between July and August: 37