Karnataka drugs controller Raghurama Bhandary, has raised the whip on its enforcement wing going by the complaints alleging that pharmacy trade outlets are found to violate Rule 65 (10) of the Drugs and Cosmetics Rules by selling Schedule H drugs and employing unregistered pharmacists.

Any laxity by the enforcement wing would be viewed seriously and names of such officers would be sent to the Karnataka government, stated the Karnataka drugs controller.

In a circular is issued to caution its enforcement wing, Bhandary called on taking stern action against violators of Rule 65 (10) of the Drugs and Cosmetics Rules if trade outlets are found selling Schedule H drug without a prescription.

It is now evident that despite these circulars that are being issued intermittently, drugs inspectors and assistant drugs controllers have not taken effective steps in this regard to curb such illegal practices by the pharmacy trade across the state. Now there are repeated complaints coming forth and strict action would be implemented against the erring enforcement officials failing to take effective steps to curb such illegal practices, he said.

“All officers need to conduct effective inspections and resort to suspension or cancellation of licences. They could even prosecute the medical shops if they found to selling Schedule H drugs including the habit forming medicines,” he pointed out.  

The drugs control officers should now gather information on similar lines that of intelligence wings to track dealers who are indulging in clandestine sale of habit forming drugs and not of standard  quality medicines. They need to initiate appropriate action. Further, the enforcement team should keep an alert and a strict watch to identify outlets without registered pharmacists, he said.

Karnataka drugs controller stated that it had come to the notice of his department that Schedule H drugs are being sold rampantly by the chemists  without prescription of a registered medical practitioner (RMP). There are also instances of prescriptions being written by unqualified medical practitioners.

He further stated that the licencing authorities are now empowered with ‘xinded’ software to verify the names of the registered pharmacists working in one or more medical shops. In this regard, he called on all pharmacy outlets in the state  to ascertain the details of the qualification and the D Pharm certificate which qualifies him before considering the candidate for appointment. The enforcement team should conduct in-depth inspections and audit outlets where qualified pharmacists are absent.

“In the past many such circulars have been issued urging the enforcement officers to take punitive measures against such erring chemists and druggists under the provisions of the Drugs and Cosmetics Rules 1945. Now as per the Rules, every medical shop should employ at least one qualified pharmacy diploma or degree holder as a whole time employee. To ensure this requirement is fulfilled, affidavits are being collected from each registered pharmacist before granting the shop licences, said Bhandary.

“It is made clear to all the enforcement officers that if the said violations are detected by the supervisory officers during their counter checks then the jurisdiction officers would be held responsible and disciplinary action would be taken for their negligence”, said the Karnataka Drugs Controller.