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 The All India Drugs Control Officers' Confederation (AIDCOC), the apex body of drug control officers in the country, has raised concerns over the suspension of the state drugs controller of Karnataka linked to the maternal death of four pregnant women in the state without identifying the cause of the deaths and a proper investigation.
The Karnataka government has suspended the state drugs controller Dr Umesh S earlier this month, pending inquiry, after four maternal deaths were reported in the district hospital, Bellary between November 9 and 11, 2024, allegedly due to the use of substandard Ringer's lactate intravenous (IV) fluid manufactured by West Bengal-based Paschim Banga Pharmaceuticals.
AIDCOC urged the State government to revoke the suspension of the drug controller and called for a thorough joint investigation by the central drug regulator and the State drug regulators of Karnataka and West Bengal on the IV fluid that has allegedly caused the death of four pregnant women in Karnataka.
The Confederation has submitted a representation to the Karnataka State Government, stating that the action against the State drug controller was in a hurry and unjustifiable. The suspension also sets a bad precedent, which may discourage the drug controllers across the country from carrying out their duties without fear of becoming soft targets in such incidents.
The officials point out that the drug controller has issued a circular to all his officials to pick up samples of the IV fluid a few months back and a few batches were identified as not of quality standard. The manufacturing company then challenged the results and the matter was referred to the Central Drug Laboratory (CDL), Kolkata. Certain batches were released by the Karnataka State Medical Supplies Corporation (KSMSCL) after testing them in some NABL accredited laboratories.
"The drug control officials at district level has picked up some of the batches already and a few of them were found to be NSQ (not-of-standard) quality. That is a red flag and the state medical supplies corporation should have stayed away from using the products till the air is cleared without any doubt," said Ravi Udaya Bhaskar, honorary director general, AIDCOC.
The drug controller has acted promptly in directing the officials to pick up and test the samples, which shows that there is no dereliction of duty by the state drug controller, he averred.
Besides, the cause of death and the role of the IV fluid in it should be thoroughly investigated, considering that the IV fluid would have been widely circulated in various parts of the State and the deaths were reported only in Bellary.
"CDSCO is the dual licensing authority for products including IV fluids, bloods and vaccines. The CDSCO, and the drug controllers of West Bengal and Karnataka need to jointly investigate the incident. Without this, suspending the drug controller is not justified," he added.
The state health secretary has sent a letter to the Drugs Controller General (India) to investigate the matter and take action against the manufacturer and other concerned on priority basis.
The state government in its communication suspending the drug controller said that the official should have prosecuted the company after finding quality issues in various parameters including tests for sterility, bacterial endotoxins and particulate matter etc., with 22 batches of the 95 batches tested by them.
Also, he did not submit a report on the remaining batches which were tested, while he should have issued a circular to all the concerned pharmacies directing them to supply these batches until testing of all batches are complete.
The Confederation argues that the drug controller could not have prosecuted the company after finding the quality issues since the company challenged the findings in another forum.
The health secretary, in the letter to the DCGI, said that the batches of the product had been frozen for use during March, 2023 by KSMSCL, based on two batches found to be NSQ by the drugs testing laboratory in Karnataka, and the CDL, Kolkata has found them as standard quality following the manufacturer challenging the state laboratory's result in the Court.
The state drug regulator drew different batches of the drug following a letter of KSMSCL, and 22 batches have
Since August, 2024, some of the earlier frozen batches which had not been yet tested by the officers of the drugs control department, or which had been found to be standard quality by the government analyst, had been released by KSMSCL, after those were certified to be standard quality by NABL empanelled laboratories. The secretary said that the Medical Supplies Corporation has not released any of such batches found to be NSQ by the government analyst of the state drug testing laboratory even though some of these batches were found to be SQ by CDL, Kolkata.
"Now again, all such batches have been frozen by the state after recent maternal deaths in Bellary, based on a strong suspicion on the quality of such batches as these batches had come to use in the said hospital just before reporting of the said deaths," added the secretary in the letter to the DCGI.
The firm has been permitted to manufacture the said drug under the license issued by the licensing authority of West Bengal, and the CDL, Kolkata also comes under the purview of the DCGI's office, it added.
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