To train the regulatory officers to enable them to devise strategies for optimum utilisation of available resources and to upgrade their technical, professional and other functional skills, the Central Drugs Standard Control Organisation (CDSCO) has begun the Induction Programme for assistant drug inspectors, which is a three-month long training programme from October 5 to December 31, 2015.

Major focus of the training, which is being held at National Institute of Biologicals, Noida, will be on technical and regulatory framework in India such as Drugs and Cosmetics Act and Rules, Drugs and Magic Remedies Act, and Narcotic Drugs and Psychotropic Substances Act; legal and administrative issues; managerial and ethical issues; and IT and communication skills. Besides, there will be basic introduction to GMP, GLP, GCP, etc.

The CDSCO has roped in a team of high level resource personnel for this programme. To begin with, CDSCO will engage faculty drawn from regulatory agencies, administrative and police services, pharmaceutical industry, management institutes and colleges and also training modules adopted by other regulators.

The faculty would comprise retired /current drug regulatory personnel; experts from outside for personality development; officials from CBI, IB, legal departments, subject experts from academic institutions like NIPER, IIT, IISc, etc; subject experts and professionals from industry on GMP, GCP, GLP etc; experts from international organisations including WHO etc; and retired/current senior government officials.

The technical areas which will be covered in the programme include good manufacturing practices; good laboratory practices; good clinical practices; good distribution and storage practices; principles of product development and pre-formulation studies; new drug approval process; clinical trials including BA/BE studies; pharmacovigillance; quality audits and inspections – planning, procedures, report writing; and quality assurance and safety aspects in blood and blood products.

Besides, the programme will cover special feature of manufacture and quality assurance in vaccines and sera, r-DNA products, active pharmaceutical ingredients, medical devices, stem cells, monoclonal antibodies, antimicrobial resistance etc; advances in biotechnology and immunology; drug discovery and development; and international regulatory framework including WHO.

The legal areas of the programme include in-depth knowledge of drug laws – Drugs and Cosmetics Act and Rules; Narcotic Drugs and Psychotropic Substances Act; Drugs Price Control Order; Drugs and Magic Remedies Act; Intellectual Property Rights; and Patent Act.

It will also cover principles of jurisprudence, and principles of natural justice; principles of interpretation; applicability of code of Criminal Procedure Code in investigations and trials under drug laws; fundamentals of Evidence Act; investigation techniques including gathering of intelligence and making proper use of such intelligence; and launching of prosecutions.

According to senior officials in the CDSCO, there is a constant need for such training programmes as the drug regulatory system needs to keep itself abreast of the fast-changing scientific innovations, evolving international regulatory framework and other developments. The central role of the Indian pharma industry and globalisation necessitate that the regulatory framework has to constantly evolve by integrating new developments. It is, therefore imperative for the present and future drug control officials to continuously upgrade their skills and knowledge, and gain expertise in a variety of subjects to meet with such functional requirements.

As the government has started recruiting a number of regulatory personnel, the need of the hour is to train the regulatory officers to enable them to devise strategies for optimum utilisation of available resources. Training that could constantly upgrade their technical, professional and other functional skills would play an important role in their professional growth and diligent execution of their responsibilities, officials said.

It is proposed to develop an extensive training programmes for various regulatory officials covering all areas of functions of CDSCO including deputing the inspectors in various zonal offices, port, sub-zonal offices for receiving practical experiences, hands-on training in the various regulatory functions of CDSCO. It has also been decided that all regulatory personnel working in CDSCO will undergo basic and advanced training programmes.