The proposed amendments of the Pharmacy Act 1948, to make the community pharmacist more responsible and to comprehensively revamp the pharmacy practices and education in the country, is likely to be delayed following the lethargy of the Central Government to pursue the PCI recommendations.

The draft amendments, formulated by numerous experts and committees of PCI in the last two years, were approved by the 62-member general council, law committee and executive committee of the Pharmacy Council of India (PCI) after a three-day meeting held in Mumbai during the first week of February, this year. Then the amendments were forwarded to the health ministry. The health ministry is yet to review the proposals, it is learnt. As per the procedure, the draft needs vetting from the health ministry, law ministry and the HRD ministry, before the cabinet approval and its subsequent introduction in the Parliament. As per the current pace of progress, it would take minimum one to one and a half years to enact the proposals as legislation, said sources.

Meanwhile, Dr B Suresh, president of the Pharmacy Council of India (PCI) told Pharmabiz that the delay was natural since the amendments were comprehensive and elaborate. “The delay is natural as normally it takes one to one and a half years to enact such legislations. Our work has been completed and it is with the health ministry, which has to further pursue our recommendations. I am pressurizing the ministry to take it up at the earliest,” said Suresh.

As Pharmabiz reported earlier, the proposed amendments include a new provision to levy professional charges for pharmacist services, ensuring continuous education programmes for pharmacists, mandatory patient counselling centres/drug information centres in medical shops to ensure the pharmacists are updating their knowledge base and are an essential part of healthcare management.

The proposed amendment to Section 10 envisages bringing pharmacy education totally under PCI, dissociating from the AICTE and mandate colleges to get prior approval from PCI, before starting pharmacy colleges. Section 42 of the Pharmacy Act, which elaborates about qualifications for dispensing medicines, will be amended to ensure strict punishment for violators, from the present 6-month imprisonment and 1000 rupees fine to six-month imprisonment and Rs 10,000 penalty.

Similarly, at present, any registered pharmacist can renew his license every five year by paying the fees and dues over the years. With the amendment, it is necessary for the pharmacist to show certificates of at least one-week Continuous Education Programme (CEP), conducted by state pharmacy council or similar authorized institutions, for renewing the license. Amendments in Section 26 of the Pharmacy Act will ensure strict conditions and ethics related to pharmacy practices, especially storage practices, by ensuring appointment of adequate pharmacy inspectors to monitor the pharmacists.

The amendments will also make constitutional changes in PCI's administrative structure.