Keen to diversify and meet the changing drug regulatory requirements in the country, the health ministry is soon set to revise the Drugs and Cosmetics Rules 1945. This strategic move is aimed at adopting progressive changes, while omitting unnecessary provisions from the rule book to bring in ease in regulations, enforcement and ensure better safety of patients.
To look into this matter, the Centre last week constituted ten separate committees each headed by senior members from the drug controller general’s office which includes joint drug controllers or deputy drug controller (DDCs) along with representatives from different state licensing authority, other government and industry stakeholders having expertise in the respective area. This committee will be responsible to deliberate and examine various provisions in the current rules and give their observation and suggestions on the changes needed in the rules either by amending the rules to include new ones as per current needs or omit the ones that have no importance in current regulatory context.
A highly placed source closely associated with this development informed that each group has been assigned as per key chapters in the rules. There is a group to study rules relating to good manufacturing practices (GMP) requirements; group to oversee sales and manufacturing of drugs; a separate group to examine import and export aspect; group to examine clinical trials and approval of new drugs; groups for studying rules relating to cosmetics; veterinary drugs; OTCs; biological drugs; stem cells and regenerative medicines and a group to examine phyto-pharmaceuticals.
“The current rules under the D&C Rules 1945, that are enforced through out the country is too outdated as they were drafted in pre independence era. Though amended several times, it definitely is high time to focus on revising the whole set of rules to meet our current challenges and regulatory compliance requirements. This will be a progressive step towards further strengthening the enforcement parameters which is key to ensure public health,” stated Dr H G Koshia commissioner of Gujarat FDCA. He is also part of the group set up for the examination of provisions relating to sale of drugs.