In order to coordinate all aspects of drugs safety and identify the emerging threats, an Office of Drugs Safety (ODS) may be set up as a separate division for the drugs control department, suggests the reform report prepared by the drugs control department in Kerala.

The reform report is an action plan to strengthen the regulatory mechanism of the state and to check the sale of medicines.

It wants to ensure that time bound action be initiated for every violation, failure, threat, organised crimes etc. in the manufacture, marketing, supply and sale of drugs in the state.

“As drug safety and post marketing surveillance is not one of the priority areas of the drugs control administration, banned and defective pharmaceuticals have infiltrated the market in the recent years. So, a separate division to coordinate and monitor all aspects of drugs safety titled ODS is needed,” said a senior officer in the department, who also provided inputs for the reform report.

He said even though the state has the highest per capita consumption of drugs, the drug control department has no mechanism to monitor the adverse drug reactions. But the consumers as well as the traders in Kerala are all well educated and they form an ideal pool for adverse drug event detection and reporting. This helps for a concrete foundation for a strong monitoring system in the state and that is for the present action plan is mooted, the officer told Pharmabiz.

While briefing about the proposal, he said the ODS can be headed by a senior experienced officer in the rank of deputy drugs controller, with other members from medical fraternity. The officers from the intelligence branch of the department can be deputed to staff the division. The primary duty of the Office will be to address public health threats arising out of irrational combinations, unapproved drugs, drugs with similar names, circumvention of NPPA, circulation of defective pharma products, clandestine network of promoting drugs etc.

The report includes some important suggestions as regards clinical trials also. It says that the Office of Drugs Safety must ensure the clinical trials carried out in the state are in compliance to Schedule Y of the Drugs and Cosmetics (D&C) Act.

The ODS should also set up and manage a drug information centre with participations from professional organisations like Indian Pharmaceutical Association to provide unbiased and relevant information related to drugs, he added.