To educate the state drug inspectors about the latest developments in the industry and also to provide them an overview on the latest capabilities at the pharma-biotech manufacturing facilities, the Karnataka drugs control department in association with the industry will impart practical on-site training to its inspection squad.
The training will broadly focus on the different manufacturing aspects along with the stages of production. It will provide an overview on the good practices implemented at these companies. The practical training will offer ample exposure on the management strategies and the professionalism displayed at the companies.
The exposure at the industry will provide information about the Code of Conduct. Making complaints on the violations in production practices is a critical component in pharma inspections, Dr BR Jagashetty, drugs controller, government of Karnataka told Pharmabiz.
"Our team of inspectors from the department are competent in ascertaining the manufacturing violations. However, they need to be educated further on the proper way to coordinate with industry as these inspections are different from pharmacy retail checks. It is therefore vital to have hands-on-exposure on the latest technologies in manufacture, he added.
The inspections are also guided by certain principles and it is required that the team from the drugs control department needs to have ample experience in many of these areas. These include providing evidence for all judgments and apply a consistent approach to inspection practices. Inspectors also need to be fair and treat everyone with respect and consideration. Good listening temperament, honest feedback, maintaining confidentiality and sharing information according to the rules are some of the other business manners that need to be inculcated for industry inspections.
Once the training is complete, the inspectors can carry out more inspections at the manufacturing plants. The State has around 237 production units. In July, the drugs control department carried out 61 manufacturing unit inspections which is the highest so far. The drugs department has been primarily focusing on pharmacy retail scrutiny. Another issue affecting pace of inspections is the shortage of personnel. Currently, there are around 60 inspectors and the government is expected to fill in the vacancies, stated Dr Jagashetty.
In this connection, the State drugs control department had put forth a project report to the Karnataka health and family welfare department highlighting the need to impart practical training for its inspection team. The health department in turn has provided the consent.
The department has communicated to the industry to allocate time to train the inspectors. The consent has come in from six leading pharma-biotech companies: Biocon, Micro Labs, Medreich Sterilabs, Strides Arcolab, AstraZeneca Pharma India and Geletac where the inspectors will undergo the exposure to the advanced high technology manufacturing plant activities.
The training is expected to commence in the first week of September and the State drugs control department has identified three groups of inspector for the same.
Each group comprises one assistant drugs controller and two drug inspectors. The training will be for 3 days in a week spread over four months. A total of around 10 personnel from the State drugs control department will attend the session.