MAHA FDA Asks DCGI to Reduce Pack Size of Medicines

The Maharashtra Food and Drug Administration (FDA) has asked the Drug Controller General of India (DCGI) to reduce the pack size of medicines enabling chemists to dispense drugs according to doses prescribed by doctors. The FDA had written to DCGI in such manner a week ago after requests of chemists in the state.

“There is a practical issue in dispensing of prescriptions prescribed by doctors by cutting its strip. The drug manufacturers print the date of expiry alongside the batch number and date of manufacturing just in one place at the back of the strip. In the event that the strip is cut, the above data isn’t visible on the rest of the pack. It turns out to be difficult to convince the following patient about the expiry and manufacturing date of the medicines”, said Kailash Tandale, leader of the Maharashtra Registered Pharmacists Association (MRPA).

Tandale said, On the other hand, we have to dispense medicines as prescribed by a physician according to Rule 65 (11) of Drugs and Cosmetics Rules. If a doctor has recommended a treatment course of 6 tablets for 3 days, we need to cut 6 tablets from the strip and give it to the patient, rather than selling the whole pack. The chemists who fail to do as such frequently face license suspension.

A year ago Maharashtra FDA had suspended licenses of five retail chemists denying dispensing medicines by cutting their strip. Various chemist associations have taken objection to the FDA’s crackdown on retailers for noncompliance to Rule 65(11). They cited practical difficulty in complying the said Rule.

Acting on their demand, the FDA has taken up the issue with DCGI for amending the pack rules to bring down its size.

FDA joint commissioner (Drugs), “Because of chemists’ inability to cut a strip of drugs, patients were left with no option but to buy the whole strip. Crucial data of drugs, for example, its name, expiry date and manufacturing date regularly gets lost after its strip gets cut. Thus we have written to DCGI to reduce pack size of drugs containing required details of interest in of both chemists and patient”, said Arjun Khadtare.

Schedule P1 deals with packing guidelines and DCGI can enforce smaller packaging standards. When FDA appeal gets approved, DCGI can introduce more drugs under P1 category and direct drug makers to change the pack size of drugs.


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