Pharmacists across the country have expressed huge concern over the lack of clarity in the recently published gazette notification on Schedule H1, which deals with regulating the use of antibiotics in the country. Raj Vaidya, a community pharmacist, points out that there are lot of gray areas in the notification that needs to be clarified so as to avoid complications arising due to misinterpretation of some clauses by different persons or authorities.

Pharmacists fear that if left unclarified, the present situation may lead to chaos and confusion threatening to cause discomfort to the smooth functioning of the pharmacies. The government had in September amended the Drugs and Cosmetics (D&C) Rules to insert Schedule H1 category to curb the indiscriminate use of antibiotics and some other vital drugs, by placing 46 antibiotics under this category.

In a letter addressed to the Drugs Controller General of India (DCGI), Vaidya has urged the Centre to clarify whether the records of sale of Schedule H1 products have to be maintained in a handwritten form, or can it be saved in the inventory or billing software. This demand comes in the wake of confusion in the interpretation of the said clause which fails to stress on how to do it. Vaidya points out that since more that 50 per cent of chemists now use computerised inventory and billing, it would be appropriate that an option may be given to the licencee to keep the records by writing by hand or to collate the records in the inventory software, and take a daily print out of the same and maintain in serial order.

Further, to ensure nationwide uniformity in maintaining this he wants the CDSCO to include the exact format of maintaining the Register to be included in the schedule and rules. He also insist that there needs to be more clarity in the area of address of the prescriber which has to recorded in a register as, as there is a confusion among pharmacists over filling the address of the doctor as he or she may be a visiting doctor, or a doctor practising with multiple centres.

In his representation he further stressed that the centre needs to urgently clarify whether these new Rules regarding Schedule H1 are applicable to hospitals and nursing homes not having a retail license as well, and whether they have to maintain a separate register for recording the utilisation of Schedule H1 products as specified. “It is very important that these rules are made applicable to them along with doctors dispensing medicines to their own patients covered under Schedule K. This is mainly because the strictness of need for a prescription due to these new Rules, may lead medical practitioners to prescribe a higher quantity of the drug under Schedule H1, on one prescription so that the patient is not faced with inconvenience,” Vaidya said.

He pointed out that even the upper limit for number of days of treatment to be prescribed or the maximum quantity to be prescribed per prescription is not specified in the Rules. which he feels is a must, so as to avoid conflict or complications due to misinterpretation and ambiguities. Raising several doubts over the implementation of this rule, he has requested the CDSCO to explain what steps are being taken by them to give clarifications to all the states as well as practitioners of other systems of medicine that the latter are not permitted to prescribe Schedule H1 as well as other allopathic drug.