Department of Pharmaceuticals (DoP) will resubmit to the Planning Commission a proposal to set up a full-fledged training centre specially to cater to the industry in developing regulatory and documentation skills.
Though a similar proposal with a requirement of Rs.100 crore was made for implementation during the current 11th Five Year Plan, it was not approved by the Planning Commission. Hence the DoP wants to redraft the proposal and seek allocation of minimum Rs.20 crore for setting up such a training centre as part of the 12th Plan, sources said.
The centre will impart training especially on WHO-GMP standards, other manufacturing standards like US FDA, The Medicines and Healthcare products Regulatory Agency (MHRA), Therapeutic Goods Administration (TGA) of Australia, The European Directorate for the Quality of Medicines (EDQM) of the European Council, besides those related to international pharmacopoeia standards and lab requirements required for achieving such standards compliance.
The DoP wants to train minimum 5000 qualified professionals in the industry on the standards and related process. Since documentation of industry is so weak, but important part of standards upgradation and compliance need to be strengthened, according to the DoP sources.
Before introducing this capacity building programme in the international standards of manufacturing, the DoP also plans to hire professional consultants for preparing Standard Operating Procedures (SOP) and develop software for helping the SMEs to achieve compliance. The Department will also think of distributing this software free of cost to the industry, under the proposed scheme.
DoP would issue advertisements in newspapers to invite the interested companies for training and the office of the Drug Controller General of India (DCGI) would be involved to give full technical guidance support in the training, as per the scheme.