To ensure effective implementation of the Drugs and Cosmetics (D&C) Act across the country, state drug controllers from around eight states have demanded the Central Drugs Standard Control Organisation (CDSCO) to draft and adopt a common training module for all the newly recruited drug officials.

Through this initiative they want to ensure that all the officials are strictly made to undergo a common training programme by the CDSCO, after their appointment. This demand comes in the wake of absence of any centrally sponsored training module in the country, developed and structured on common guidelines to ensure systematic and symmetrical implementation of D&C Act across all the states.

Some of the drug officials feel that this lacunae in providing centrally pioneered training to the drug officials is leading to lack of understanding among the new recruits in uniformly interpreting the regulatory requirements as needed for effective regulation. At present, each of the state regulatory body has its own individually designed training programme for their newly recruited drug officials which is done in house. At times some state regulatory body may collaborate with other international drug regulatory bodies like US FDA or MHRA for cross training purpose, but otherwise there is no hard and fast rule on how drug officials need to be trained.

According to Dr H G Koshia, commissioner of Gujarat FDCA, “Lack of centrally sponsored training programme for drug officials is a major concern for us especially, when it comes to uniform implementation of the D&C Act across the country. We have noticed that there are many states who do not have the expertise or push to undertake stringent training programme for their officials which will adversely affect effective monitoring and regulatory practices. Thus it is high time for the centre to acknowledge this urgent requirement and take stern steps towards bringing and adopting common guidelines for the training purpose that will entitle all the drug officials to undergo same procedure.”

This he believes will help in better enforcement of the drug regulations as required  in a uniform manner throughout the country thus safeguarding the life and well-being of all the patients. He suggested that to ensure better delivery of services the module should be based on a model that will concentrate on training the officials as per the latest regulatory requirement so that they are well trained to face the challenges thrown at them.

Many feel that the CDSCO should also look into exploring the possibility of long term collaboration with other international drug regulatory bodies as well for this training programme so as to expose the Indian drug officials to the global challenges as well.