The death of 69 children in The Gambia earlier this month, reportedly caused by consumption of Indian-origin cough syrups, highlights the critical need to monitor manufacture and sale procedures in pharmaceutical companies.
This brings to focus the fact that 113 out of 129 positions (87%) of the drug inspector posts are vacant in the state drugs control department.
Drug inspectors are responsible for routine checks of drug manufacturing units, pharmaceutical outlets and blood banks.
However, this massive vacancy is mostly due to the Karnataka High Court staying the government’s selection process, because a few candidates moved the court questioning the qualification criteria.
In 2018, the government issued a notification to recruit 83 drug inspectors, out of which 66 made it to the final
list.
Some of those not selected approached the Karnataka Administrative Tribunal (KAT), arguing that the qualification criteria for the posts were flawed.
According to the petitioners, the notification had said that the candidates should have a B Pharma degree, along with 18 months of experience in manufacturing or testing of schedule C/C1 drugs.
The complainants argued that 18 months of experience was not required as per the Drugs and Cosmetics Rules, 1945.
After KAT dismissed the case, the complainants moved the High Court.
The court stayed the selection process in June 2021, saying the petitioners seemed to have the qualifications required as per the Drugs and Cosmetics Rules.
In February, the HC said judgment had been reserved in the case — which has not come so far — and the court stay on recruitment continues.
As per the drugs control department’s website, the state has 696 drug manufacturing units, 103 cosmetic manufacturing units and 282 blood banks. There are over a lakh wholesale and retail pharma outlets.
No inspection done
As per the Drugs and Cosmetics Act, drug inspectors must first audit the units to see if they are fit for licence.
They must then inspect the licensed facilities twice a year to see if the drugs are of good quality, whether qualified personnel are present in pharma shops, whether storage is done properly in blood banks, etc, said a department official.
The drug inspectors must get drug samples tested in case of complaints.
“If a drug from another state sold here is found to be substandard, drug inspectors are supposed to go to that state for investigation and file an FIR. They also have to look into issues raised by the department’s state intelligence bureau,” the official said.
Of the 51 circles under the department, a majority don’t have drug inspectors at present.
Here, the additional drug controllers (ADCs) have additional charge, says state drug controller B T Khanapure.
However, ADCs have a different set of duties and it is doubtful if they can perform the role of drug inspectors.
“Till the court gives the final order, we can do nothing,” said Khanapure.