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Maha FDA Seeks DCGI Intervention In Reducing Pack Size of Medicines
 
The Maharashtra Food and Drug Administration (FDA) has urged the Drug Controller General of India (DCGI) to reduce the pack size of medicines enabling chemists to dispense drugs as per dosages prescribed by doctors. The FDA had written to DCGI in this regard last week following demands of chemists in the state.

Said Kailash Tandale, president of the Maharashtra Registered Pharmacists Association (MRPA), There is practical problem in dispensing of medicines prescribed by doctors by cutting its strip. The drug manufacturers print the date of expiry along with the batch number and date of manufacturing only in one place at the back of the strip. If the strip is cut, the above information is not visible on the remaining pack. It becomes hard to convince the next patient about the expiry and manufacturing date of the medicines.

On the other hand, we need to dispense medicines as prescribed by a physician as per Rule 65 (11) of Drugs and Cosmetics Rules. If a physician has prescribed a treatment course of 6 tablets for 3 days, we have to cut 6 tablets from the strip and give it to the patient, instead of selling the entire pack. The chemists who fail to do so often face licence suspension, said Tandale.

Last year Maharashtra FDA had suspended licences of five retail chemists denying to dispense medicines by cutting their strip.

A number of chemist associations have taken objection to the FDA's crackdown on retailers for non compliance 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 lower its size.

Said Arjun Khadtare, FDA?joint commissioner (Drugs), Due to chemists' inability to cut strip of drugs, patients were left with no option but to purchase entire strip. Crucial information of drugs such as its name, expiry date and manufacturing date often gets lost after its strip gets cut.? Hence we have written to DCGI to reduce pack size of drugs containing required details in the interest of both chemists and patients.

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