The Health Ministry, through its regulatory body the Drug Control Authority (DCA) has reminded licencees and pharmaceutical drug manufacturers not to make changes to their production process without approval.

Health director-general Dr Mohd Ismail Merican, who is the DCA chairman, said stern action would be taken against those found to have flouted the rules as their action could affect the quality and effectiveness of medicines approved by the ministry.

"The DCA has a policy of not allowing any unapproved modification to the manufacturing process," he said in a statement.

He said that companies wishing to make changes should first submit data to the ministry to prove that the quality of products was maintained and that the changes were in accordance with the standard set by the ministry.

"Companies should ensure that pharmaceutical products in the market are in accordance with the formulation, requirement and standard set by the ministry.

"Any change which affect the quality of the products is prohibited and all critical changes should be approved by the DCA," he said.

Dr Mohd Ismail said the ministry would monitor pharmaceutical products sold in Malaysia to ensure they were produced in accordance with the regulations set by the authority.

"We will not hesitate to suspend or cancel the registration of medicines which are found to be unsafe, ineffective or low in quality," he said, adding that the authority would also order the withdrawal of such products from the market.

He advised medical practitioners, health professionals and consumers to report to the DCA if they came across problems pertaining to the quality of medicines in the market.

Under the Control of Drugs and Cosmetics Regulations 1984, all pharmaceutical products should be registered with the DCA before they could be manufactured, imported, distributed or used in the country.

"All pharmaceutical products, either innovator or generic medicines, will be scientifically tested to ensure they are safe, of high quality and effective and on par with internationally-accepted standard before they are allowed to enter the Malaysian market," he said.

He said the Health Ministry had carried out bioequivalence studies on generic medicines since 1999 and had cancelled or suspended the registration of 213 products.

In 2008 and 2009, the DCA rejected 66 new applications as the applicants failed to submit complete and satisfactory bioequivalence studies, he said.

- Bernama