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PCI wants CDSCO to empower drug officers to file case directly if pharmacists are found absent at outlets

Nandita Vijay, Bengaluru
Monday, September 27, 2021, 08:00 Hrs  [IST]

The Pharmacy Council of India (PCI) has asked the Public Grievances Cell of the Central Drugs Standard Control Organization (HQ) to ensure that enforcement officers can file the case at courts directly if pharmacists are found absent at the pharmacy outlets. This is because non-presence of pharmacist to dispense drugs is a breach of Rule 65 (1), (2) and (3) of the Drugs and Cosmetics Rules, 1945.

Our concern has been brought to the notice of the PCI which has asked CDSCO to look into the issue. CDSCO will now communicate to the state drugs control departments, said Ashokswamy Heroor, president, Karnataka State Registered Pharmacists Association (KSRPA).

The apprehension of the KSRPA was that the absence of pharmacists at the outlets needed to be closely watched across the medical shops. The reason attributed to the absence of pharmacists was that they did not renew their registrations with the State Pharmacy Council.

Stating it as a violation of the Rule 65 (1), (2) and (3) of the Drugs and Cosmetics Rules, 1945, which prescribe that the supply of any drug, on the prescription of a registered medical practitioner should be dispensed only under the supervision of a registered pharmacist, Heroor pointed out that immediate action needs to be taken. Hence, PCI has forwarded it to CDSCO to look into the issue immediately and give the onus to the state enforcement wing to file case in the court for the violations.

In his communication early this month to PCI, Heroor has said that the sale bills too should bear the signature of the registered pharmacist as per Rule 65 (3) (g); 65 (21) (g) (x) etc.

Besides, KSRPA had also brought this issue to the notice of the Karnataka government and the state drugs control department pointing out that many medical shops are operational without registered pharmacists and that there was a need for immediate action. While we are aware that state pharmacy councils are keeping close tabs and issuing notices, from a regulator perspective action is much desired, said Heroor.

With the PCI’s move to direct CDSCO to look into the issue, Heroor said that action much be taken as dispensing drugs without adequate qualification will affect patients’ health. This is because there are many such cases where pharmacists have not renewed their registration for years. Such medical shops are dispensing medicines in the absence of a registered pharmacist,  is an offence under Section 18(a) (vi); punishable under Section 27 (d) of The Drugs and Cosmetics Act 1940.


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Md salahuddin Sep 27, 2021 11:35 AM
The action should be start as soon as possible it will helpfull to entire pharmacy field.
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