The Maharashtra Food and Drug Administration (FDA) seeking the intervention of DCGI to reduce pack sizes of medicine strips as chemists are facing issues to dispense drugs as per dosages prescribed by doctors.
The state FDA had sent a written letter to DCGI regarding the issues of state chemists while providing medicines to the patients. Issues like the back strip of medicines have printed with the date of expiry, the batch number and manufacturing date only in one place and when chemist cut the strip to give prescribed dosage then they have no proof to show medicine’s validity to new patients.
A president of the Maharashtra Registered Pharmacists Association (MRPA), Kailash Tandale said that this is a practical problem and if the strip is cut, the above information is not completely left visible on the remaining pack and it’s hard to convince other buyers about the medicine originality and validity.
According to the Rule 65 (11) of Drugs and Cosmetics Rules, Chemists need to dispense drugs as per doctor’s prescription. Let’s take an example, Suppose a doctor prescribed a treatment course of 3 tablets for 3 days, chemists need to cut 3 tablets from the strip and give it to the patient, instead of selling the entire pack and if the chemists who fail to do so often face license suspension. And for the similar cases, Maharashtra FDA had suspended license last year of five chemists retailers who denied to dispense medicines by cutting their strips.
Many chemists objected FDA’s crackdown on retailers for non-compliance with Rule 65(11), as the problem is practical and genuine. FDA acted on the demands of the chemists and sent a letter to DCGI for amending the pack rules to lower its size. DCGI has the power to enforce smaller packaging norms as Schedule P1 deals with packing guidelines. If DCGI approved FDA appeal, then more drugs can introduce under P1 category and urged drug makers to change the pack size of drugs.