CDSCO cracks down on export licenses, antibiotic approvals

India’s central drug regulator continues to strategically close the loopholes and rejig India’s drug regulatory protocols, focusing on state licensing authorities and their duties. 

For instance, in a letter dated April 30, the Drugs Controller General (India) directed that CDSCO Zonal offices, and not the state/UT licensing authorities (SLAs), would be responsible for granting manufacturing NOCs in these cases. 

Thus from May 15, fresh applications for NOC for manufacture of drugs meant solely for exports have to be routed online through CDSCO Zonal offices. 

DCGI Dr Rajeev Singh Raghuvanshi’s April 30 letter went a step further, requiring state/UT licensing authorities to hand over all NOCs issued from August 20, 2018 to May 14, 2024 to the respective CDSCO Zonal offices. 

The letter specifies that all manufacturers of drugs meant for exports would be required to first obtain NOCs from the respective CDSCO zonal offices through the online SUGAM portal, before applying for manufacturing licenses from the state licensing authorities. 

The move to streamline manufacturing licences for drug exports and make the process completely online is clearly the latest effort to closely track manufacturers tapping export markets. India’s claim to be the ‘pharmacy of the world’ has been challenged over the past few years, with deaths of children in Gambia, Uzbekistan and other countries being linked to cough syrups and other medicines originating from India. Subsequent inquiries revealed that state authorities had consistently failed to crack down on manufacturing malpractices in many of these units. 

It is hoped that applying through CDSCO’s online SUGAM portal will serve the regulator’s purpose of streamlining export licenses, while increasing scrutiny of manufacturers who have been habitual offenders of good manufacturing practices. A simple correlation with CDSCO’s monthly alerts of brands/companies detected as spurious and/or as Not of Standard Quality could be a useful exercise in directing extra focus on the bad sheep in the fold. 

Once the handover process is over, one hopes that the move could also cut down approval timelines for export-oriented manufacturers, as manufacturers with export-oriented units in various states who would have had to track pending NOCs in multiple states, now need to track just the online SUGAM portals. 

Th next initiative is on controlling antibiotic resistance by controlling the manufacturing and sale of antibiotics and their irrational combinations. Since the CDSCO has now been tasked to conduct a six monthly review of fixed drug combinations of antibiotics marketed in states, DCGI has given state licensing authorities two weeks to provide the list of antibiotic combinations licensed by them for manufacturing and marketing in their states. 

More significantly, the May 16 letter also requested the state licensing authorities to monitor and report the availability of unapproved antibiotic combinations in their states. 

This crackdown on the approvals of antibiotic combinations and preventing their misuse is part of the overall mandate of an ICMR expert committee to create a pathway for strategic access of new antibiotics and to regulate against the overuse and irrational use of existing antibiotics in India. 

These diktats from the DCGI represent steps along the journey to strengthen the regulatory system, an image makeover if you will. But to revamp India’s reputation as a destination of quality affordable medicines, we need to have a credible regulatory system in sync with global regulations. 

Recognising that credibility will have to start from within, the DCGI has asked all officials of state licensing authorities and CDSCO zonal and sub zonal offices to complete online certification courses from the CDSCO-WHO-THSTI Regulatory Webinar Series. The webinar series has courses dealing with effective implementation of Good Review Practices, Good Regulatory Practices, and Quality Management System requirements for national inspectorates which are designed as per WHO specified standards. All officials need to complete the course, comprising a recorded lecture and a PowerPoint presentation, with an automated feedback mechanism. The e-certificates generated post completion of the courses need to be sent to the CDSCO. 

It is significant that CDSCO and state licensing officials are expected to follow WHO-specified guidelines for all facilities, not just exports. Training workshops to gear up industry to follow the revised Schedule M also continue across the country, emphasising that there will be no leniency on implementing the deadlines to upgrade to these new norms. 

While all regulatory reform is a continuous process, will measures like online courses guarantee more effective regulation and better quality medicines? It is the attitude and dedication to the cause of good quality that goes beyond certifications and inspections that will make the real difference.