Central Drugs Standard Control Organization (CDSCO) emphasize on GMP and GLP compliance to pharmaceutical manufacturers. But it seems like pharma manufacturers are not serious about implementation of GMP and GLP for their manufacturing plants. Before one year, CDSCO asked manufacturers to carry out an assessment of their units and assign themselves quality ratings but so far Indian pharma manufacturers have not submitted self-inspection reports.
Universal adoption of Good Manufacturing Practices (GMP) by pharmaceutical sector and to explore the possibility of self-certification by the pharmaceutical units followed by third party certification followed by detailed audit have been deliberated at the highest level.
CDSCO had earlier prepared a detailed checklist for all manufacturing facilities to comply with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) as specified under Schedule M and Schedule L-1 of the Drugs and Cosmetics Act and Rules there under. The checklist includes an elaborate tool kit for verification of GMP/GLP along with benchmarks based on the concept of rating manufacturing units on the basis of an estimated risk that they may pose to users of medicines. This checklist was devised with a view to ensure that each manufacturing unit carries out self-assessment to GMP/GLP compliance.
All drug manufacturers and pharmaceutical associations were requested by CDSCO to make self-assessment of their manufacturing units as part of their self-audit and mandatorily share their reports with State Licensing Authorities and CDSCO. However, CDSCO is yet to receive self-inspection reports from the manufacturers.
Dr. G. N. Singh, Drugs Controller General India also requested State Drugs Controllers to direct all the drug manufacturers under their jurisdiction to submit the report of the self assessment of their units along with self-certification stating that they are complying with GMP/GLP requirement as per Drugs and Cosmetic Rules.
