News18
Schedule M prescribes good manufacturing practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products. (Representative Image: Shutterstock)
The panel suggests creating e-training modules and certification course modules. It also suggests preparing the guidelines for the selection criteria of the candidates for the training.
Moving postal delivery to emails, India’s apex drug regulatory agency is working to improve the ways and skills of its inspectors to keep up with the changing needs of the pharmaceutical industry, News18 has learnt.
To keep pace with advancements in the pharmaceuticals, biological, medical devices industries and application of Schedule M, the training cell of the Central Drugs Standard Control Organisation (CDSCO) has initiated a training program to develop human resources at both central and state levels. These programs include tailored training modules for various levels of induction, as well as basic and advanced courses.
The move will be beneficial for the inspectors as the industry in India is preparing for the execution of Schedule M, to retain the confidence of global health regulators in made-in-India medicines.
The proposal was submitted to the apex panel of the Drug Consultative Committee (DCC) for optimising training processes and support mechanisms for regulatory officers.
The proposal was discussed in the meeting held in June where several measures were decided, according to the minutes of the 64th meeting of DCC, seen by News18.
The first change that the panel has recommended and the Drug Controller General of India (DCGI) has approved is the nomination details of the participants that will now be communicated through “email” instead of “postal delivery.”
More changes recommended by the panel
The panel has suggested preparing the guidelines for the selection criteria of the candidates for the training and also the preparation of the checklist to assess the performance evaluation of candidates before and after the training.
The panel has suggested creating e-training modules and certification course modules. “Availability of the e-training modules and certification course modules for the Revised Schedule M, inspection and report writing, Prosecution, etc., along with the case studies,” the panel said.
It also has recommended that “state licensing authority (SLA) should provide support for the regional training program for identifying venues, topics, duration etc. to enhance localised training efforts.”
“Permission from the higher authority may be taken for the nomination of the candidate by the state regulator for the domestic training programmes on an annual basis,” the panel said.
Revised Schedule M
The Ministry of Health and Family Welfare (MoHFW) had in June notified the revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945. Schedule M prescribes good manufacturing practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products.
