Will 2024 be a year of regulatory renaissance?

On December 6, India’s Central Drugs Standard Control Organisation (CDSCO) issued a letter asking state and union territory regulators to defer the proposed risk based inspections of manufacturing units and private testing labs scheduled between December 11-22, to focus on verifying the supply chain and quality of propylene glycol (PG), a key ingredient in cough syrups.

The letter has detailed instructions on verification at the cough syrup manufacturing plant, tracking back to the source (manufacturer or importer) of PG. The letter hopes that this exercise will ‘rule out possible quality issues related to DEG/EG and diversion of industrial grade PG in the pharma industry.’

The timing is crucial, as consumption of cough syrups spikes during the winter months. In fact, the December 6 letter on PG comes after the CDSCO chief urged pharma manufacturers to pay special attention to the quality of not just the APIs but also various excipients that are added to their products.

The CDSCO’s risk based inspection drive over the past year was spurred by global censure over the deaths of children in Gambia and other nations, allegedly after consuming coughs syrups imported from India. While WHO’s tests showed up higher than acceptable levels of DEG/EG, tests done by India’s regulators gave a clean chit to the manufacturer. The most recent twist in the tale is that a state regulator was allegedly bribed by the manufacturer Maiden Pharma to switch the samples. As expected, Maiden Pharma’s promoter refutes the charge but it is more important to unveil the ‘knaves among the knights’ to start changing public perception.

After a period of denial, the CDSCO started cracking down in December 2022, with a series of risk based inspections. There were training sessions for its regulators to ensure better coordination between central and state inspection officials.

A year later, after four phases of risk based inspections, covering over 300 inspections, it’s clear that these actions were designed not just to pull up pharma companies, but to shake up the regulators themselves.

30 per cent of the plants inspected received closure notices; while other companies had their licenses revoked or received warning letters. Speaking recently at the 4th US Pharmacopeia South Asia Regional Chapter meeting, Dr Rajeev Raghuvanshi, Drug Controller General of India commented that the real value of the risk based inspections were not the closures of erring manufacturing plants. He stressed that post the risk based inspections, “the whole ecosystem of pharma manufacturing here is now sensitised towards the quality issues. And that is actually giving lots of advantages to us now as a regulator that things are getting aligned.”

He was also frank enough to share the responsibility for the ‘aberrations” which came to light during the RBIs because “it’s not only the manufacturers but for me, the regulator is also responsible … because we let that happen and that is why that happened.” He went on to add that after all the sensitisation, “it’s time for fixing accountability also at the regulators.”

Going by these comments, it’s clear that global and now domestic scrutiny on quality concerns might just turn out to be a blessing in disguise. Regulators now seem more amenable to introducing additional quality checks.

For instance, on December 21, the drugs controller of the state of Uttarakhand issued a ban on cough syrup manufacturers who do not have gas chromatography (GCs) systems in their quality control labs for testing of EG/DEG in propylene glycol used in cough syrups. Manufacturers who procure GCs must provide proof of such purchase and their manufacturing license will be renewed only after a physical verification of such systems.

However, will the presence of GCs guarantee the required amount of testing? Will CDSCO prescribe standards which can be enforced, not just for EG/DEG levels but also for a host of other undesirable contaminants like residual solvents etc? And what will it take to break the nexus between corrupt officials and unethical manufacturers? Can it be expected to do a credible clean up outside, without first cleaning up its own backyard?

2024 will thus be a year to rebuild trust in the CDSCO, with more stringent regulations, coupled with stricter implementation of these regulations. However the trickier part is weeding out the corrupt from its ranks, even while it aims to do the same with pharma companies