Part IV-Quality Control

4.1 Strengthening infrastructural facilities
It is decided to step up the Central and State infrastructural facilities for quality control in a phased manner during the VII and VIII Five Year Plan periods. The progress made in the provision of these infrastructural facilities and the effect on enforcing quality control would be reviewed at the end of the VII Five Year Plan with a view to make the necessary corrections and to strengthen the machinery for ensuring quality control.

4.2 Internal Testing Facilities
During the VII Five Year Plan period, it will be ensured, through intensive inspection and corrective action, that all manufacturers have internal testing facilities.

4.3 Good Manufacturing Practices
Statutory effect would soon be given to the good manufacturing practices which lay down the minimum requirements to be observed in terms of accommodation, equipment, qualified personnel, testing facilities and hygiene in a manufacturing unit.

4.4 Loan Licensing
It is decided to discontinue the loan licensing system in a phased manner before the end of the VII Five Year Plan.

4.5 Certification Scheme
With a view to promote quality-consciousness in the field of drugs both among the manufacturers and user-agencies and to simultaneously reduce the workload on the statutory Drug Controller Agencies, efforts will be made to introduce a certification system under which recognized institutions with proven expertise and testing facilities can certify the adoption by formulators of good manufacturing practices and the quality of formulations manufactured.